Clinician Reviews

Sugary and artificially sweetened drinks are each associated with an increased risk of developing cardiovascular disease, according to results from a large prospective cohort study.

© Irochka/Fotolia.com

However, the design of that study fails to take into account other sources of dietary sugar, according to one expert.

In a research letter published online Oct. 26 in the Journal of the American College of Cardiology, Eloi Chazelas, a PhD candidate at Sorbonne Paris Nord University in Paris, and colleagues, shared results from nearly 105,000 subjects (79% women, mean age 43 at baseline, median follow up 6.6 years) enrolled in the NutriNet-Santé cohort study.

In this observational study, which began recruiting in 2009, dietary patterns are self-reported by subjects, while health outcomes are validated by investigators.

Mr. Chazelas and his colleagues identified 1,379 first incident cases of stroke, transient ischemic attack, myocardial infarction, acute coronary syndrome, and angioplasty in the cohort during 2009-2019. Cases that occurred during the first 3 years’ follow up were excluded from the analysis, to avoid potential reverse causality bias.

After adjustment for a wide range of dietary, demographic and health confounders, the investigators found that high consumers of sugary drinks or artificially sweetened drinks saw 20% and 32% higher risk of such events, respectively, compared with people who reported drinking neither beverage type (hazard ratio: 1.20; 95% confidence interval 1.04-1.40, P for trend < .0009 and HR: 1.32; 95% CI, 1.00-1.73, P for trend < .03).

Sugary drinks were defined as containing 5% or more of sugars, including natural fruit juices. The high consumers in the study had a median intake of 185 mL per day of sugary drinks, or 176 mL per day for artificially sweetened drinks. Natural noncaloric sweeteners such as Stevia were included in the artificially sweetened group.

The findings, Mr. Chazelas and colleagues wrote in their analysis, add to evidence that artificially sweetened beverages “might not be a healthy substitute for sugary drinks.” While research has suggested that artificial sweeteners induce glucose intolerance by disturbing gut microbiota, they noted, more and bigger studies are needed to understand the mechanisms by which they might bear on cardiovascular disease risk.

Robert A. Vogel, MD, of the University of Colorado Denver, urged caution in interpreting the researchers’ results. In an interview, Dr. Vogel, a preventive cardiologist, said that it is “notoriously difficult” to evaluate what a food or food group does to the body outside of a carefully controlled trial. What little randomized trial evidence exists comparing the health effects of artificially sweetened and sugary drinks includes a 2012 trial in children that found diet drinks associated with reductions in body fat – if anything a positive indication for heart health.

SOURCE: Chazelas et al. JACC 2020;76(18):2175-80.

Sugary and artificially sweetened drinks are each associated with an increased risk of developing cardiovascular disease, according to results from a large prospective cohort study.

© Irochka/Fotolia.com

However, the design of that study fails to take into account other sources of dietary sugar, according to one expert.

In a research letter published online Oct. 26 in the Journal of the American College of Cardiology, Eloi Chazelas, a PhD candidate at Sorbonne Paris Nord University in Paris, and colleagues, shared results from nearly 105,000 subjects (79% women, mean age 43 at baseline, median follow up 6.6 years) enrolled in the NutriNet-Santé cohort study.

In this observational study, which began recruiting in 2009, dietary patterns are self-reported by subjects, while health outcomes are validated by investigators.

Mr. Chazelas and his colleagues identified 1,379 first incident cases of stroke, transient ischemic attack, myocardial infarction, acute coronary syndrome, and angioplasty in the cohort during 2009-2019. Cases that occurred during the first 3 years’ follow up were excluded from the analysis, to avoid potential reverse causality bias.

After adjustment for a wide range of dietary, demographic and health confounders, the investigators found that high consumers of sugary drinks or artificially sweetened drinks saw 20% and 32% higher risk of such events, respectively, compared with people who reported drinking neither beverage type (hazard ratio: 1.20; 95% confidence interval 1.04-1.40, P for trend < .0009 and HR: 1.32; 95% CI, 1.00-1.73, P for trend < .03).

Sugary drinks were defined as containing 5% or more of sugars, including natural fruit juices. The high consumers in the study had a median intake of 185 mL per day of sugary drinks, or 176 mL per day for artificially sweetened drinks. Natural noncaloric sweeteners such as Stevia were included in the artificially sweetened group.

The findings, Mr. Chazelas and colleagues wrote in their analysis, add to evidence that artificially sweetened beverages “might not be a healthy substitute for sugary drinks.” While research has suggested that artificial sweeteners induce glucose intolerance by disturbing gut microbiota, they noted, more and bigger studies are needed to understand the mechanisms by which they might bear on cardiovascular disease risk.

Robert A. Vogel, MD, of the University of Colorado Denver, urged caution in interpreting the researchers’ results. In an interview, Dr. Vogel, a preventive cardiologist, said that it is “notoriously difficult” to evaluate what a food or food group does to the body outside of a carefully controlled trial. What little randomized trial evidence exists comparing the health effects of artificially sweetened and sugary drinks includes a 2012 trial in children that found diet drinks associated with reductions in body fat – if anything a positive indication for heart health.

SOURCE: Chazelas et al. JACC 2020;76(18):2175-80.

Sugary and artificially sweetened drinks are each associated with an increased risk of developing cardiovascular disease, according to results from a large prospective cohort study.

© Irochka/Fotolia.com

However, the design of that study fails to take into account other sources of dietary sugar, according to one expert.

In a research letter published online Oct. 26 in the Journal of the American College of Cardiology, Eloi Chazelas, a PhD candidate at Sorbonne Paris Nord University in Paris, and colleagues, shared results from nearly 105,000 subjects (79% women, mean age 43 at baseline, median follow up 6.6 years) enrolled in the NutriNet-Santé cohort study.

In this observational study, which began recruiting in 2009, dietary patterns are self-reported by subjects, while health outcomes are validated by investigators.

Mr. Chazelas and his colleagues identified 1,379 first incident cases of stroke, transient ischemic attack, myocardial infarction, acute coronary syndrome, and angioplasty in the cohort during 2009-2019. Cases that occurred during the first 3 years’ follow up were excluded from the analysis, to avoid potential reverse causality bias.

After adjustment for a wide range of dietary, demographic and health confounders, the investigators found that high consumers of sugary drinks or artificially sweetened drinks saw 20% and 32% higher risk of such events, respectively, compared with people who reported drinking neither beverage type (hazard ratio: 1.20; 95% confidence interval 1.04-1.40, P for trend < .0009 and HR: 1.32; 95% CI, 1.00-1.73, P for trend < .03).

Sugary drinks were defined as containing 5% or more of sugars, including natural fruit juices. The high consumers in the study had a median intake of 185 mL per day of sugary drinks, or 176 mL per day for artificially sweetened drinks. Natural noncaloric sweeteners such as Stevia were included in the artificially sweetened group.

The findings, Mr. Chazelas and colleagues wrote in their analysis, add to evidence that artificially sweetened beverages “might not be a healthy substitute for sugary drinks.” While research has suggested that artificial sweeteners induce glucose intolerance by disturbing gut microbiota, they noted, more and bigger studies are needed to understand the mechanisms by which they might bear on cardiovascular disease risk.

Robert A. Vogel, MD, of the University of Colorado Denver, urged caution in interpreting the researchers’ results. In an interview, Dr. Vogel, a preventive cardiologist, said that it is “notoriously difficult” to evaluate what a food or food group does to the body outside of a carefully controlled trial. What little randomized trial evidence exists comparing the health effects of artificially sweetened and sugary drinks includes a 2012 trial in children that found diet drinks associated with reductions in body fat – if anything a positive indication for heart health.

SOURCE: Chazelas et al. JACC 2020;76(18):2175-80.

Some medical societies feature sessions at their annual meetings that feel like they’re 24 hours long, yet few have the courage to schedule a session that actually runs all day and all night. But the five societies sponsoring the IDWeek conference had that courage. The first 24 hours of the meeting was devoted to the most pressing infectious-disease crisis of the last 100 years: the COVID-19 pandemic. They called it “COVID-19: Chasing the Sun.”

Dr. Fauci predicts a vaccine answer in mid-November

In the first segment, at 10 am Eastern time, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and the nation’s top infectious-disease expert, began the day by noting that five of the six companies the US invested in to develop a vaccine are conducting phase 3 trials. He said, “we feel confident that we will have an answer likely in mid-November to the beginning of December as to whether we have a safe and effective vaccine”. He added he was “cautiously optimistic” that “we will have a safe and effective vaccine by the end of the year, which we can begin to distribute as we go into 2021.” He highlighted the COVID-19 Prevention Network website for more information on the trials.

Glaring racial health disparities in U.S.

Some of the most glaring health disparities surrounding COVID-19 in the United States were described by Carlos del Rio, MD, professor of medicine at Emory University in Atlanta, Georgia. He pointed out that while white people have about 23 cases per 10,000 population, Blacks have about 62 cases per 10,000, and Latinos have 73 cases per 10,000. While whites don’t see a huge jump in cases until age 80, he said, “among Blacks and Latinos you start seeing that huge increase at a younger age. In fact, starting at age 20, you start seeing a major, major change.”

COVID-19 diagnostics

Audrey Odom John, MD, PhD, chief of pediatric infectious diseases at Children’s Hospital of Philadelphia, is working on a new way of diagnosing COVID-19 infection in children by testing their breath. “We’re really taking advantage of a fundamental biological fact, which is that people stink,” she said. Breath shows the health of the body as a whole, “and it’s easy to see how breath volatiles might arise from a respiratory infection.” Testing breath is easy and inexpensive, which makes it particularly attractive as a potential test globally, she said.

Long-term effects of COVID-19

Post-COVID illness threatens to overwhelm the health system in the United States, even if only 1% of the 8 million people who have been infected have some sort of long-term deficit, “which would be a very conservative estimate,” said John O’Horo, MD, MPH, with the Mayo Clinic in Rochester, Minn. Neurologic dysfunction is going to be a “fairly significant thing to keep an eye on,” he added. Preeti Malani, MD, chief health officer in infectious diseases at the University of Michigan, Ann Arbor, said the emotional aspects of the illness are “striking” and may be the major long-term effect for most patients.

Challenging cases in COVID-19: Through fire and water

In a case presented to panelists during an afternoon session, a Mexican-born woman, 42, presents to urgent care with fever, dyspnea, dry cough, and pleuritic pain, for over a week. Multiple family members have had recent respiratory illness as well. She is obese, on no medications, was not traveling. She’s a nonsmoker and lives in a multigenerational household in the Mission District of San Francisco. Her heart rate is 116, respiratory rate is 36, and her oxygen saturation on room air is 77%. She is admitted to a local hospital and quickly declines, is intubated and started on hydroxychloroquine (HCQ). One day later she is transferred to a hospital for consideration of extracorporeal membrane oxygenation (ECMO).

Panelists were asked a variety of questions about how they would treat this patient. For example, would they continue HCQ? Ravina Kullar, PharmD, MPH, an infectious disease expert from Newport Beach, Calif., answered that she would not continue the HCQ because of lack of evidence and potential harms. Asked whether she would start remdesivir, Dr. Kullar said she would steer her away from that if the patient developed renal failure. Co-moderator Peter Chin-Hong, MD, a medical educator with the University of California, San Francisco, noted that contact tracing will be important as the patient returns to her housing-dense community.
 

In-hospital infection prevention

The CDC acknowledged aerosol spread of COVID-19 this month, but David Weber, MD, MPH, professor in infectious diseases at the University of North Carolina at Chapel Hill, said, “this does not change anything we need to do in the hospital,” as long as protective pandemic protocols continue to be followed.

There is no evidence, he noted, that SARS-CoV-2 is transmitted far enough that a hospitalized patient could infect people in other rooms or corridors or floors. Opening windows in COVID-19 patients’ rooms is “not an option,” he said, and could be harmful as fungal elements in outside air may introduce new pathogens. The degree to which improved ventilation systems reduce transmission has not been identified and studies are needed to look at that, he said.
 

Preventing COVID transmission in the community

Mary-Margaret Fill, MD, deputy state epidemiologist in Tennessee, highlighted COVID-19’s spread in prisons. As of mid-October, she said, there are more than 147,000 cases among the U.S. prison population and there have been 1,246 deaths. This translates to a case rate of about 9800 cases per 100,000 people, she said, “double the highest case rate for any state in the country and over three times greater than our national case rate of about 2,500 cases per 100,000 persons.”

Testing varies widely, she noted. For instance, some states test only new prisoners, and some test only when they are symptomatic. One of the strategies to fight this spread is having staff, who go in and out of the community, be assigned to work with only certain groups at a prison. Another is widespread testing of all prisoners. And when prisoners have to leave the prison for care or court dates, a third strategy would be quarantining them upon their return.
 

COVID-19 vaccines

As the session stretched into the evening in the United States, Mary Marovich, MD, director of vaccine research, AIDS division, with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health, said while each of the government-funded vaccine studies has its own trial, there are standardized objectives for direct comparisons. The studies are being conducted within the same clinical trial networks, and collaborative laboratories apply the same immunoassays and define the infections in the same way. They are all randomized, placebo-controlled trials and all but one have a 30,000-volunteer sample size. She said that while a vaccine is the goal to end the pandemic, monoclonal antibodies, such as those in convalescent plasma, “may serve as a critical bridge.”

The good, the bad, and the ugly during COVID-19 in Latin America

Latin America and the Caribbean are currently the regions hardest hit by COVID-19. Gustavo D. Lopardo, of the Asociacion Panamericana de Infectologia, noted that even before the pandemic Latin America suffered from widespread poverty and inequality. While overcrowding and poverty are determining factors in the spread of the virus, diabetes and obesity – both highly prevalent – are worsening COVID outcomes.

The countries of the region have dealt with asynchronous waves of transmission within their borders by implementing different containment strategies, with dissimilar results. The presenters covered the spectrum of the pandemic, from the “ugly” in Peru, which has the highest mortality rate in the region, to the “good” in Uruguay, where testing is “winning against COVID-19.” Paradoxically, Chile has both the highest cumulative incidence and the lowest case fatality rate of COVID-19 in the region.

In the social and political turmoil imposed by COVID-19, Clóvis Arns da Cunha, MD, president of the Brazilian Society of Infectious Diseases and professor at the Federal University of Paraná, pointed out that “fake news [has become] a public health problem in Brazil” and elsewhere.
 

Diagnostics and therapeutics in Latin America

Eleven of the 15 countries with the highest death rate in the world are located in Latin America or the Caribbean. Dr. Arns de Cunha pointed out that tests are hard to come by and inadequate diagnostic testing is a major problem. Latin American countries have not been able to compete with the United States and Europe in purchasing polymerase chain reaction test kits from China and South Korea. The test is the best diagnostic tool in the first week of symptoms, but its scale-up has proved to be a challenge in Latin America.

Furthermore, the most sensitive serological markers, CLIA and ECLIA, which perform best after 2 weeks of symptom onset, are not widely available in Latin America where many patients do not have access to the public health system. The detection of silent hypoxemia in symptomatic patients with COVID-19 can save lives; hence, Arns da Cunha praised the program that distributed 100,000 digital oximeters to hundreds of cities in Brazil, targeting vulnerable populations.
 

The COVID-19 experience in Japan

Takuya Yamagishi, MD, PhD, chief of the Antimicrobial Resistance Research Center at the National Institute of Infectious Diseases in Japan, played an instrumental role in the epidemiological investigation that took place on the Diamond Princess Cruise Ship in February 2020. That COVID-19 outbreak is the largest disease outbreak involving a cruise ship to date, with 712 confirmed COVID-19 cases and 13 deaths.

The ship-based quarantine prompted a massive public health response with unique challenges. In those early days, investigators uncovered important facts about COVID-19 epidemiology, generating hot debates regarding the public health strategy at the time. Notably, the majority of asymptomatically infected persons remained asymptomatic throughout the course of the infection, transmission from asymptomatic cases was almost as likely as transmission from symptomatic cases, and isolation of passengers in their cabins prevented inter-cabin transmission but not intra-cabin transmission.
 

Swift response in Asia Pacific region

Infectious-disease experts from Taiwan, Singapore, and Australia, who have been at the forefront of clinical care, research, and policy-making, spoke about their experiences.

Taiwan was one of the first countries to adopt a swift response to COVID-19, shortly after they recognized an outbreak of pneumonia of unknown etiology in China and long before the WHO declared a public health emergency, said Ping-Ing Lee, MD, PhD, from the National Taiwan University Children’s Hospital.

The country began onboard health checks on flights from Wuhan as early as Dec. 31, 2019. Dr. Lee attributed Taiwan’s success in prevention and control of COVID-19 to the rigorous use of face masks and environmental disinfection procedures. Regarding the country’s antilockdown stance, he said, “Lockdown may be effective; however, it is associated with a tremendous economic loss.”

In his presentation on remdesivir vs corticosteroids, David Lye, MBBS, said, “I think remdesivir as an antiviral seems to work well given early, but steroids will need to be studied further in terms of its conflicting evidence in multiple well-designed RCTs as well as [their] potential side effects.” He is director of the Infectious Disease Research and Training Office, National Centre for Infectious Diseases, Singapore.

Allen C. Cheng, MBBS, PhD, of Monash University in Melbourne, noted that “control is possible. We seemed to have controlled this twice at the moment with fairly draconian action, but every day does matter.”
 

China past the first wave

China has already passed the first wave, explained Lei Zhou, MD, of the Chinese Center for Disease Control and Prevention, but there are still some small-scale resurgences. So far a total of four waves have been identified. She also mentioned that contact tracing is intense and highlighted the case of Xinfadi Market in Beijing, the site of an outbreak in June 2020.

Gui-Qiang Wang, MD, from the Department of Infectious Disease, Peking University First Hospital, emphasized the importance of a chest CT for the diagnosis of COVID-19. “In the early stage of the disease, patients may not show any symptoms; however, on CT scan you can see pneumonia. Also, early intervention of high-risk groups and monitoring of warning indicators for disease progression is extremely important,” he said.

“Early antiviral therapy is expected to stop progression, but still needs evaluation,” he said. “Convalescent plasma is safe and effective, but its source is limited; steroid therapy needs to explore appropriate population and timing; and thymosin α is safe, and its effect on outcomes needs large-sample clinical trial.”

Time to Call for an ‘Arab CDC?’

The eastern Mediterranean is geographically, politically, economically, and religiously a very distinct and sensitive region, and “COVID-19 is an added insult to this already frail region of the world,” said Zaid Haddadin, MD, Vanderbilt University Medical Center, Nashville, Tenn.

Poor healthcare and poor public health services are a consequence of weak and fragile governments and infrastructure, the result of war and regional conflicts in many countries. Millions of war refugees live in camps with high population densities and shared facilities, which makes social distancing and community mitigation very challenging. Moreover, the culture includes frequent large social gatherings. Millions of pilgrims visit holy sites in different cities in these countries. There is also movement due to trade and tourism. Travel restrictions are challenging, and there is limited comprehension of precautionary measures.

Najwa Khuri-Bulos, professor of pediatrics and infectious diseases at the University of Jordan, was part of a task force headed by the country’s Ministry of Health. A lockdown was implemented, which helped flatten the curve, but the loosening of restrictions has led to a recent increase in cases. She said, “No country can succeed in controlling spread without the regional collaboration. Perhaps it is time to adopt the call for an Arab CDC.”
 

Africa is “not out of the woods yet”

The Africa CDC has three key pillars as the foundation for their COVID-19 strategy: preventing transmission, preventing deaths, and preventing social harm, according to Raji Tajudeen, MBBS, FWACP, MPH, head of the agency’s Public Health Institutes and Research Division. Africa, with 1.5 million cases of COVID-19, accounts for 5% of global cases. With a recovery rate of 83% and a case fatality rate of 2.4%, the African continent has fared much better than the rest of the world. “Significant improvements have been made, but we are not out of the woods yet,” he cautioned.

Richard Lessells, PhD, from the University of KwaZulu-Natal, agreed. “Unfortunately, South Africa has not been spared from the worst effects of this pandemic despite what you might read in the press and scientific coverage.” He added, “Over 50% of cases and up to two thirds of the deaths in the African region are coming from South Africa.” A bigger challenge for South Africa has been maintaining essential health services during the COVID-19 pandemic, especially since it is also at the heart of the HIV pandemic. On the brighter side, HIV itself has not emerged as a risk factor for COVID-19 infection or severe disease in South Africa.

Dimie Ogoina, MBBS, FWACP, president of the Nigerian Infectious Diseases Society, stated that COVID-19 has significantly affected access to healthcare in Nigeria, particularly immunizations and antenatal care. Immunization uptake is likely to have dropped by 50% in the country.
 

Diagnostic pitfalls in COVID-19

Technical errors associated with the SARS-CoV-2 diagnostic pipeline are a major source of variations in diagnosis, explained Jim Huggett, PhD, senior lecturer, analytical microbiology, University of Surrey, Guildford, England. He believes that PCR assays are currently too biased for a single cutoff to be broadly used, and false-positive signals are most likely because of contamination.

Dana Wolf, MD, Clinical Virology Unit, Hadassah Hebrew University Medical Center in Israel, presented a large-scale data analysis of more than 133,000 pooled samples. Such a pooling strategy appeared to be highly efficient for a wide range of prevalence rates (<1% to 6%). “Our empirical evidence strongly projects on the feasibility and benefits of pooling in the current pandemic setting, to enhance continued surveillance, control, and community reopening,” she said.

Corine Geurts van Kessel, MD, PhD, Department of Virology, Erasmus University Rotterdam (the Netherlands), discussing antibodies testing for SARS-CoV-2, pointed out that disease severity can affect testing accuracy. “Reinfection cases tell us that we cannot rely on immunity acquired by natural infection to confer herd immunity,” she said.
 

Misinformation in the first digital pandemic

The world is not only facing a devastating pandemic, but also an alarming “infodemic” of misinformation. Between January and March 2020, a new COVID-19–related tweet appeared on Twitter every 45 milliseconds. Müge Çevik, MD, MSc, MRCP, an infectious disease clinician, scientist, and science communicator, said that “the greatest challenge for science communication is reaching the audience.”

People have always been skeptical of science reporting by journalists and would rather have scientists communicate with them directly, she noted. Science communication plays a dual role. “On one hand is the need to promote science to a wide audience in order to inform and educate and inspire the next generation of scientists, and on the other hand there is also a need to engage effectively in public dialogue,” she added. Dr. Çevik and colleagues think that “The responsibility of academics should not end with finding the truth. It should end after communicating it.”
 

Treatment in the ICU

Matteo Bassetti, MD, with the University of Genoa (Italy), who was asked about when to use remdesivir in the intensive care unit and for how long, said, “In the majority of cases, 5 days is probably enough.” However, if there is high viremia, he said, physicians may choose to continue the regimen beyond 5 days. Data show it is important to prescribe this drug for patients with oxygen support in an early phase, within 10 days of the first symptoms, he added. “In the late phase, there is a very limited role for remdesivir, as we know that we are already out of the viremic phase.” He also emphasized that there is no role for hydroxychloroquine or lopinavir-ritonavir.

Breaking the chains of transmission

During the wrap-up session, former US CDC Director Tom Frieden, MD, said, “We’re not even halfway through it” about the pandemic trajectory. “And we have to be very clear that the risk of explosive spread will not end with a vaccine.” He is now president and CEO of Resolve to Save Lives.

Different parts of the world will have very different experiences, Dr. Frieden said, noting that Africa, where 4% of the population is older than 65, has a very different risk level than Europe and the United States, where 10%-20% of people are in older age groups.

“We need a one-two punch,” he noted, first preventing spread, and when it does happen, boxing it in. Mask wearing is essential. “States in the US that mandated universal mask-wearing experienced much more rapid declines (in cases) for every 5 days the mandate was in place.”

Michael Ryan, MD, executive director for the WHO’s Health Emergencies Programme, added, “We need to collectively recommit to winning this game. We know how to break the chains of transmission. We need recommitment to a scientific, societal, and political strategy, and an alliance – a contract – between those entities to try to move us forward.”

This article first appeared on Medscape.com.

Some medical societies feature sessions at their annual meetings that feel like they’re 24 hours long, yet few have the courage to schedule a session that actually runs all day and all night. But the five societies sponsoring the IDWeek conference had that courage. The first 24 hours of the meeting was devoted to the most pressing infectious-disease crisis of the last 100 years: the COVID-19 pandemic. They called it “COVID-19: Chasing the Sun.”

Dr. Fauci predicts a vaccine answer in mid-November

In the first segment, at 10 am Eastern time, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and the nation’s top infectious-disease expert, began the day by noting that five of the six companies the US invested in to develop a vaccine are conducting phase 3 trials. He said, “we feel confident that we will have an answer likely in mid-November to the beginning of December as to whether we have a safe and effective vaccine”. He added he was “cautiously optimistic” that “we will have a safe and effective vaccine by the end of the year, which we can begin to distribute as we go into 2021.” He highlighted the COVID-19 Prevention Network website for more information on the trials.

Glaring racial health disparities in U.S.

Some of the most glaring health disparities surrounding COVID-19 in the United States were described by Carlos del Rio, MD, professor of medicine at Emory University in Atlanta, Georgia. He pointed out that while white people have about 23 cases per 10,000 population, Blacks have about 62 cases per 10,000, and Latinos have 73 cases per 10,000. While whites don’t see a huge jump in cases until age 80, he said, “among Blacks and Latinos you start seeing that huge increase at a younger age. In fact, starting at age 20, you start seeing a major, major change.”

COVID-19 diagnostics

Audrey Odom John, MD, PhD, chief of pediatric infectious diseases at Children’s Hospital of Philadelphia, is working on a new way of diagnosing COVID-19 infection in children by testing their breath. “We’re really taking advantage of a fundamental biological fact, which is that people stink,” she said. Breath shows the health of the body as a whole, “and it’s easy to see how breath volatiles might arise from a respiratory infection.” Testing breath is easy and inexpensive, which makes it particularly attractive as a potential test globally, she said.

Long-term effects of COVID-19

Post-COVID illness threatens to overwhelm the health system in the United States, even if only 1% of the 8 million people who have been infected have some sort of long-term deficit, “which would be a very conservative estimate,” said John O’Horo, MD, MPH, with the Mayo Clinic in Rochester, Minn. Neurologic dysfunction is going to be a “fairly significant thing to keep an eye on,” he added. Preeti Malani, MD, chief health officer in infectious diseases at the University of Michigan, Ann Arbor, said the emotional aspects of the illness are “striking” and may be the major long-term effect for most patients.

Challenging cases in COVID-19: Through fire and water

In a case presented to panelists during an afternoon session, a Mexican-born woman, 42, presents to urgent care with fever, dyspnea, dry cough, and pleuritic pain, for over a week. Multiple family members have had recent respiratory illness as well. She is obese, on no medications, was not traveling. She’s a nonsmoker and lives in a multigenerational household in the Mission District of San Francisco. Her heart rate is 116, respiratory rate is 36, and her oxygen saturation on room air is 77%. She is admitted to a local hospital and quickly declines, is intubated and started on hydroxychloroquine (HCQ). One day later she is transferred to a hospital for consideration of extracorporeal membrane oxygenation (ECMO).

Panelists were asked a variety of questions about how they would treat this patient. For example, would they continue HCQ? Ravina Kullar, PharmD, MPH, an infectious disease expert from Newport Beach, Calif., answered that she would not continue the HCQ because of lack of evidence and potential harms. Asked whether she would start remdesivir, Dr. Kullar said she would steer her away from that if the patient developed renal failure. Co-moderator Peter Chin-Hong, MD, a medical educator with the University of California, San Francisco, noted that contact tracing will be important as the patient returns to her housing-dense community.
 

In-hospital infection prevention

The CDC acknowledged aerosol spread of COVID-19 this month, but David Weber, MD, MPH, professor in infectious diseases at the University of North Carolina at Chapel Hill, said, “this does not change anything we need to do in the hospital,” as long as protective pandemic protocols continue to be followed.

There is no evidence, he noted, that SARS-CoV-2 is transmitted far enough that a hospitalized patient could infect people in other rooms or corridors or floors. Opening windows in COVID-19 patients’ rooms is “not an option,” he said, and could be harmful as fungal elements in outside air may introduce new pathogens. The degree to which improved ventilation systems reduce transmission has not been identified and studies are needed to look at that, he said.
 

Preventing COVID transmission in the community

Mary-Margaret Fill, MD, deputy state epidemiologist in Tennessee, highlighted COVID-19’s spread in prisons. As of mid-October, she said, there are more than 147,000 cases among the U.S. prison population and there have been 1,246 deaths. This translates to a case rate of about 9800 cases per 100,000 people, she said, “double the highest case rate for any state in the country and over three times greater than our national case rate of about 2,500 cases per 100,000 persons.”

Testing varies widely, she noted. For instance, some states test only new prisoners, and some test only when they are symptomatic. One of the strategies to fight this spread is having staff, who go in and out of the community, be assigned to work with only certain groups at a prison. Another is widespread testing of all prisoners. And when prisoners have to leave the prison for care or court dates, a third strategy would be quarantining them upon their return.
 

COVID-19 vaccines

As the session stretched into the evening in the United States, Mary Marovich, MD, director of vaccine research, AIDS division, with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health, said while each of the government-funded vaccine studies has its own trial, there are standardized objectives for direct comparisons. The studies are being conducted within the same clinical trial networks, and collaborative laboratories apply the same immunoassays and define the infections in the same way. They are all randomized, placebo-controlled trials and all but one have a 30,000-volunteer sample size. She said that while a vaccine is the goal to end the pandemic, monoclonal antibodies, such as those in convalescent plasma, “may serve as a critical bridge.”

The good, the bad, and the ugly during COVID-19 in Latin America

Latin America and the Caribbean are currently the regions hardest hit by COVID-19. Gustavo D. Lopardo, of the Asociacion Panamericana de Infectologia, noted that even before the pandemic Latin America suffered from widespread poverty and inequality. While overcrowding and poverty are determining factors in the spread of the virus, diabetes and obesity – both highly prevalent – are worsening COVID outcomes.

The countries of the region have dealt with asynchronous waves of transmission within their borders by implementing different containment strategies, with dissimilar results. The presenters covered the spectrum of the pandemic, from the “ugly” in Peru, which has the highest mortality rate in the region, to the “good” in Uruguay, where testing is “winning against COVID-19.” Paradoxically, Chile has both the highest cumulative incidence and the lowest case fatality rate of COVID-19 in the region.

In the social and political turmoil imposed by COVID-19, Clóvis Arns da Cunha, MD, president of the Brazilian Society of Infectious Diseases and professor at the Federal University of Paraná, pointed out that “fake news [has become] a public health problem in Brazil” and elsewhere.
 

Diagnostics and therapeutics in Latin America

Eleven of the 15 countries with the highest death rate in the world are located in Latin America or the Caribbean. Dr. Arns de Cunha pointed out that tests are hard to come by and inadequate diagnostic testing is a major problem. Latin American countries have not been able to compete with the United States and Europe in purchasing polymerase chain reaction test kits from China and South Korea. The test is the best diagnostic tool in the first week of symptoms, but its scale-up has proved to be a challenge in Latin America.

Furthermore, the most sensitive serological markers, CLIA and ECLIA, which perform best after 2 weeks of symptom onset, are not widely available in Latin America where many patients do not have access to the public health system. The detection of silent hypoxemia in symptomatic patients with COVID-19 can save lives; hence, Arns da Cunha praised the program that distributed 100,000 digital oximeters to hundreds of cities in Brazil, targeting vulnerable populations.
 

The COVID-19 experience in Japan

Takuya Yamagishi, MD, PhD, chief of the Antimicrobial Resistance Research Center at the National Institute of Infectious Diseases in Japan, played an instrumental role in the epidemiological investigation that took place on the Diamond Princess Cruise Ship in February 2020. That COVID-19 outbreak is the largest disease outbreak involving a cruise ship to date, with 712 confirmed COVID-19 cases and 13 deaths.

The ship-based quarantine prompted a massive public health response with unique challenges. In those early days, investigators uncovered important facts about COVID-19 epidemiology, generating hot debates regarding the public health strategy at the time. Notably, the majority of asymptomatically infected persons remained asymptomatic throughout the course of the infection, transmission from asymptomatic cases was almost as likely as transmission from symptomatic cases, and isolation of passengers in their cabins prevented inter-cabin transmission but not intra-cabin transmission.
 

Swift response in Asia Pacific region

Infectious-disease experts from Taiwan, Singapore, and Australia, who have been at the forefront of clinical care, research, and policy-making, spoke about their experiences.

Taiwan was one of the first countries to adopt a swift response to COVID-19, shortly after they recognized an outbreak of pneumonia of unknown etiology in China and long before the WHO declared a public health emergency, said Ping-Ing Lee, MD, PhD, from the National Taiwan University Children’s Hospital.

The country began onboard health checks on flights from Wuhan as early as Dec. 31, 2019. Dr. Lee attributed Taiwan’s success in prevention and control of COVID-19 to the rigorous use of face masks and environmental disinfection procedures. Regarding the country’s antilockdown stance, he said, “Lockdown may be effective; however, it is associated with a tremendous economic loss.”

In his presentation on remdesivir vs corticosteroids, David Lye, MBBS, said, “I think remdesivir as an antiviral seems to work well given early, but steroids will need to be studied further in terms of its conflicting evidence in multiple well-designed RCTs as well as [their] potential side effects.” He is director of the Infectious Disease Research and Training Office, National Centre for Infectious Diseases, Singapore.

Allen C. Cheng, MBBS, PhD, of Monash University in Melbourne, noted that “control is possible. We seemed to have controlled this twice at the moment with fairly draconian action, but every day does matter.”
 

China past the first wave

China has already passed the first wave, explained Lei Zhou, MD, of the Chinese Center for Disease Control and Prevention, but there are still some small-scale resurgences. So far a total of four waves have been identified. She also mentioned that contact tracing is intense and highlighted the case of Xinfadi Market in Beijing, the site of an outbreak in June 2020.

Gui-Qiang Wang, MD, from the Department of Infectious Disease, Peking University First Hospital, emphasized the importance of a chest CT for the diagnosis of COVID-19. “In the early stage of the disease, patients may not show any symptoms; however, on CT scan you can see pneumonia. Also, early intervention of high-risk groups and monitoring of warning indicators for disease progression is extremely important,” he said.

“Early antiviral therapy is expected to stop progression, but still needs evaluation,” he said. “Convalescent plasma is safe and effective, but its source is limited; steroid therapy needs to explore appropriate population and timing; and thymosin α is safe, and its effect on outcomes needs large-sample clinical trial.”

Time to Call for an ‘Arab CDC?’

The eastern Mediterranean is geographically, politically, economically, and religiously a very distinct and sensitive region, and “COVID-19 is an added insult to this already frail region of the world,” said Zaid Haddadin, MD, Vanderbilt University Medical Center, Nashville, Tenn.

Poor healthcare and poor public health services are a consequence of weak and fragile governments and infrastructure, the result of war and regional conflicts in many countries. Millions of war refugees live in camps with high population densities and shared facilities, which makes social distancing and community mitigation very challenging. Moreover, the culture includes frequent large social gatherings. Millions of pilgrims visit holy sites in different cities in these countries. There is also movement due to trade and tourism. Travel restrictions are challenging, and there is limited comprehension of precautionary measures.

Najwa Khuri-Bulos, professor of pediatrics and infectious diseases at the University of Jordan, was part of a task force headed by the country’s Ministry of Health. A lockdown was implemented, which helped flatten the curve, but the loosening of restrictions has led to a recent increase in cases. She said, “No country can succeed in controlling spread without the regional collaboration. Perhaps it is time to adopt the call for an Arab CDC.”
 

Africa is “not out of the woods yet”

The Africa CDC has three key pillars as the foundation for their COVID-19 strategy: preventing transmission, preventing deaths, and preventing social harm, according to Raji Tajudeen, MBBS, FWACP, MPH, head of the agency’s Public Health Institutes and Research Division. Africa, with 1.5 million cases of COVID-19, accounts for 5% of global cases. With a recovery rate of 83% and a case fatality rate of 2.4%, the African continent has fared much better than the rest of the world. “Significant improvements have been made, but we are not out of the woods yet,” he cautioned.

Richard Lessells, PhD, from the University of KwaZulu-Natal, agreed. “Unfortunately, South Africa has not been spared from the worst effects of this pandemic despite what you might read in the press and scientific coverage.” He added, “Over 50% of cases and up to two thirds of the deaths in the African region are coming from South Africa.” A bigger challenge for South Africa has been maintaining essential health services during the COVID-19 pandemic, especially since it is also at the heart of the HIV pandemic. On the brighter side, HIV itself has not emerged as a risk factor for COVID-19 infection or severe disease in South Africa.

Dimie Ogoina, MBBS, FWACP, president of the Nigerian Infectious Diseases Society, stated that COVID-19 has significantly affected access to healthcare in Nigeria, particularly immunizations and antenatal care. Immunization uptake is likely to have dropped by 50% in the country.
 

Diagnostic pitfalls in COVID-19

Technical errors associated with the SARS-CoV-2 diagnostic pipeline are a major source of variations in diagnosis, explained Jim Huggett, PhD, senior lecturer, analytical microbiology, University of Surrey, Guildford, England. He believes that PCR assays are currently too biased for a single cutoff to be broadly used, and false-positive signals are most likely because of contamination.

Dana Wolf, MD, Clinical Virology Unit, Hadassah Hebrew University Medical Center in Israel, presented a large-scale data analysis of more than 133,000 pooled samples. Such a pooling strategy appeared to be highly efficient for a wide range of prevalence rates (<1% to 6%). “Our empirical evidence strongly projects on the feasibility and benefits of pooling in the current pandemic setting, to enhance continued surveillance, control, and community reopening,” she said.

Corine Geurts van Kessel, MD, PhD, Department of Virology, Erasmus University Rotterdam (the Netherlands), discussing antibodies testing for SARS-CoV-2, pointed out that disease severity can affect testing accuracy. “Reinfection cases tell us that we cannot rely on immunity acquired by natural infection to confer herd immunity,” she said.
 

Misinformation in the first digital pandemic

The world is not only facing a devastating pandemic, but also an alarming “infodemic” of misinformation. Between January and March 2020, a new COVID-19–related tweet appeared on Twitter every 45 milliseconds. Müge Çevik, MD, MSc, MRCP, an infectious disease clinician, scientist, and science communicator, said that “the greatest challenge for science communication is reaching the audience.”

People have always been skeptical of science reporting by journalists and would rather have scientists communicate with them directly, she noted. Science communication plays a dual role. “On one hand is the need to promote science to a wide audience in order to inform and educate and inspire the next generation of scientists, and on the other hand there is also a need to engage effectively in public dialogue,” she added. Dr. Çevik and colleagues think that “The responsibility of academics should not end with finding the truth. It should end after communicating it.”
 

Treatment in the ICU

Matteo Bassetti, MD, with the University of Genoa (Italy), who was asked about when to use remdesivir in the intensive care unit and for how long, said, “In the majority of cases, 5 days is probably enough.” However, if there is high viremia, he said, physicians may choose to continue the regimen beyond 5 days. Data show it is important to prescribe this drug for patients with oxygen support in an early phase, within 10 days of the first symptoms, he added. “In the late phase, there is a very limited role for remdesivir, as we know that we are already out of the viremic phase.” He also emphasized that there is no role for hydroxychloroquine or lopinavir-ritonavir.

Breaking the chains of transmission

During the wrap-up session, former US CDC Director Tom Frieden, MD, said, “We’re not even halfway through it” about the pandemic trajectory. “And we have to be very clear that the risk of explosive spread will not end with a vaccine.” He is now president and CEO of Resolve to Save Lives.

Different parts of the world will have very different experiences, Dr. Frieden said, noting that Africa, where 4% of the population is older than 65, has a very different risk level than Europe and the United States, where 10%-20% of people are in older age groups.

“We need a one-two punch,” he noted, first preventing spread, and when it does happen, boxing it in. Mask wearing is essential. “States in the US that mandated universal mask-wearing experienced much more rapid declines (in cases) for every 5 days the mandate was in place.”

Michael Ryan, MD, executive director for the WHO’s Health Emergencies Programme, added, “We need to collectively recommit to winning this game. We know how to break the chains of transmission. We need recommitment to a scientific, societal, and political strategy, and an alliance – a contract – between those entities to try to move us forward.”

This article first appeared on Medscape.com.

Some medical societies feature sessions at their annual meetings that feel like they’re 24 hours long, yet few have the courage to schedule a session that actually runs all day and all night. But the five societies sponsoring the IDWeek conference had that courage. The first 24 hours of the meeting was devoted to the most pressing infectious-disease crisis of the last 100 years: the COVID-19 pandemic. They called it “COVID-19: Chasing the Sun.”

Dr. Fauci predicts a vaccine answer in mid-November

In the first segment, at 10 am Eastern time, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and the nation’s top infectious-disease expert, began the day by noting that five of the six companies the US invested in to develop a vaccine are conducting phase 3 trials. He said, “we feel confident that we will have an answer likely in mid-November to the beginning of December as to whether we have a safe and effective vaccine”. He added he was “cautiously optimistic” that “we will have a safe and effective vaccine by the end of the year, which we can begin to distribute as we go into 2021.” He highlighted the COVID-19 Prevention Network website for more information on the trials.

Glaring racial health disparities in U.S.

Some of the most glaring health disparities surrounding COVID-19 in the United States were described by Carlos del Rio, MD, professor of medicine at Emory University in Atlanta, Georgia. He pointed out that while white people have about 23 cases per 10,000 population, Blacks have about 62 cases per 10,000, and Latinos have 73 cases per 10,000. While whites don’t see a huge jump in cases until age 80, he said, “among Blacks and Latinos you start seeing that huge increase at a younger age. In fact, starting at age 20, you start seeing a major, major change.”

COVID-19 diagnostics

Audrey Odom John, MD, PhD, chief of pediatric infectious diseases at Children’s Hospital of Philadelphia, is working on a new way of diagnosing COVID-19 infection in children by testing their breath. “We’re really taking advantage of a fundamental biological fact, which is that people stink,” she said. Breath shows the health of the body as a whole, “and it’s easy to see how breath volatiles might arise from a respiratory infection.” Testing breath is easy and inexpensive, which makes it particularly attractive as a potential test globally, she said.

Long-term effects of COVID-19

Post-COVID illness threatens to overwhelm the health system in the United States, even if only 1% of the 8 million people who have been infected have some sort of long-term deficit, “which would be a very conservative estimate,” said John O’Horo, MD, MPH, with the Mayo Clinic in Rochester, Minn. Neurologic dysfunction is going to be a “fairly significant thing to keep an eye on,” he added. Preeti Malani, MD, chief health officer in infectious diseases at the University of Michigan, Ann Arbor, said the emotional aspects of the illness are “striking” and may be the major long-term effect for most patients.

Challenging cases in COVID-19: Through fire and water

In a case presented to panelists during an afternoon session, a Mexican-born woman, 42, presents to urgent care with fever, dyspnea, dry cough, and pleuritic pain, for over a week. Multiple family members have had recent respiratory illness as well. She is obese, on no medications, was not traveling. She’s a nonsmoker and lives in a multigenerational household in the Mission District of San Francisco. Her heart rate is 116, respiratory rate is 36, and her oxygen saturation on room air is 77%. She is admitted to a local hospital and quickly declines, is intubated and started on hydroxychloroquine (HCQ). One day later she is transferred to a hospital for consideration of extracorporeal membrane oxygenation (ECMO).

Panelists were asked a variety of questions about how they would treat this patient. For example, would they continue HCQ? Ravina Kullar, PharmD, MPH, an infectious disease expert from Newport Beach, Calif., answered that she would not continue the HCQ because of lack of evidence and potential harms. Asked whether she would start remdesivir, Dr. Kullar said she would steer her away from that if the patient developed renal failure. Co-moderator Peter Chin-Hong, MD, a medical educator with the University of California, San Francisco, noted that contact tracing will be important as the patient returns to her housing-dense community.
 

In-hospital infection prevention

The CDC acknowledged aerosol spread of COVID-19 this month, but David Weber, MD, MPH, professor in infectious diseases at the University of North Carolina at Chapel Hill, said, “this does not change anything we need to do in the hospital,” as long as protective pandemic protocols continue to be followed.

There is no evidence, he noted, that SARS-CoV-2 is transmitted far enough that a hospitalized patient could infect people in other rooms or corridors or floors. Opening windows in COVID-19 patients’ rooms is “not an option,” he said, and could be harmful as fungal elements in outside air may introduce new pathogens. The degree to which improved ventilation systems reduce transmission has not been identified and studies are needed to look at that, he said.
 

Preventing COVID transmission in the community

Mary-Margaret Fill, MD, deputy state epidemiologist in Tennessee, highlighted COVID-19’s spread in prisons. As of mid-October, she said, there are more than 147,000 cases among the U.S. prison population and there have been 1,246 deaths. This translates to a case rate of about 9800 cases per 100,000 people, she said, “double the highest case rate for any state in the country and over three times greater than our national case rate of about 2,500 cases per 100,000 persons.”

Testing varies widely, she noted. For instance, some states test only new prisoners, and some test only when they are symptomatic. One of the strategies to fight this spread is having staff, who go in and out of the community, be assigned to work with only certain groups at a prison. Another is widespread testing of all prisoners. And when prisoners have to leave the prison for care or court dates, a third strategy would be quarantining them upon their return.
 

COVID-19 vaccines

As the session stretched into the evening in the United States, Mary Marovich, MD, director of vaccine research, AIDS division, with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health, said while each of the government-funded vaccine studies has its own trial, there are standardized objectives for direct comparisons. The studies are being conducted within the same clinical trial networks, and collaborative laboratories apply the same immunoassays and define the infections in the same way. They are all randomized, placebo-controlled trials and all but one have a 30,000-volunteer sample size. She said that while a vaccine is the goal to end the pandemic, monoclonal antibodies, such as those in convalescent plasma, “may serve as a critical bridge.”

The good, the bad, and the ugly during COVID-19 in Latin America

Latin America and the Caribbean are currently the regions hardest hit by COVID-19. Gustavo D. Lopardo, of the Asociacion Panamericana de Infectologia, noted that even before the pandemic Latin America suffered from widespread poverty and inequality. While overcrowding and poverty are determining factors in the spread of the virus, diabetes and obesity – both highly prevalent – are worsening COVID outcomes.

The countries of the region have dealt with asynchronous waves of transmission within their borders by implementing different containment strategies, with dissimilar results. The presenters covered the spectrum of the pandemic, from the “ugly” in Peru, which has the highest mortality rate in the region, to the “good” in Uruguay, where testing is “winning against COVID-19.” Paradoxically, Chile has both the highest cumulative incidence and the lowest case fatality rate of COVID-19 in the region.

In the social and political turmoil imposed by COVID-19, Clóvis Arns da Cunha, MD, president of the Brazilian Society of Infectious Diseases and professor at the Federal University of Paraná, pointed out that “fake news [has become] a public health problem in Brazil” and elsewhere.
 

Diagnostics and therapeutics in Latin America

Eleven of the 15 countries with the highest death rate in the world are located in Latin America or the Caribbean. Dr. Arns de Cunha pointed out that tests are hard to come by and inadequate diagnostic testing is a major problem. Latin American countries have not been able to compete with the United States and Europe in purchasing polymerase chain reaction test kits from China and South Korea. The test is the best diagnostic tool in the first week of symptoms, but its scale-up has proved to be a challenge in Latin America.

Furthermore, the most sensitive serological markers, CLIA and ECLIA, which perform best after 2 weeks of symptom onset, are not widely available in Latin America where many patients do not have access to the public health system. The detection of silent hypoxemia in symptomatic patients with COVID-19 can save lives; hence, Arns da Cunha praised the program that distributed 100,000 digital oximeters to hundreds of cities in Brazil, targeting vulnerable populations.
 

The COVID-19 experience in Japan

Takuya Yamagishi, MD, PhD, chief of the Antimicrobial Resistance Research Center at the National Institute of Infectious Diseases in Japan, played an instrumental role in the epidemiological investigation that took place on the Diamond Princess Cruise Ship in February 2020. That COVID-19 outbreak is the largest disease outbreak involving a cruise ship to date, with 712 confirmed COVID-19 cases and 13 deaths.

The ship-based quarantine prompted a massive public health response with unique challenges. In those early days, investigators uncovered important facts about COVID-19 epidemiology, generating hot debates regarding the public health strategy at the time. Notably, the majority of asymptomatically infected persons remained asymptomatic throughout the course of the infection, transmission from asymptomatic cases was almost as likely as transmission from symptomatic cases, and isolation of passengers in their cabins prevented inter-cabin transmission but not intra-cabin transmission.
 

Swift response in Asia Pacific region

Infectious-disease experts from Taiwan, Singapore, and Australia, who have been at the forefront of clinical care, research, and policy-making, spoke about their experiences.

Taiwan was one of the first countries to adopt a swift response to COVID-19, shortly after they recognized an outbreak of pneumonia of unknown etiology in China and long before the WHO declared a public health emergency, said Ping-Ing Lee, MD, PhD, from the National Taiwan University Children’s Hospital.

The country began onboard health checks on flights from Wuhan as early as Dec. 31, 2019. Dr. Lee attributed Taiwan’s success in prevention and control of COVID-19 to the rigorous use of face masks and environmental disinfection procedures. Regarding the country’s antilockdown stance, he said, “Lockdown may be effective; however, it is associated with a tremendous economic loss.”

In his presentation on remdesivir vs corticosteroids, David Lye, MBBS, said, “I think remdesivir as an antiviral seems to work well given early, but steroids will need to be studied further in terms of its conflicting evidence in multiple well-designed RCTs as well as [their] potential side effects.” He is director of the Infectious Disease Research and Training Office, National Centre for Infectious Diseases, Singapore.

Allen C. Cheng, MBBS, PhD, of Monash University in Melbourne, noted that “control is possible. We seemed to have controlled this twice at the moment with fairly draconian action, but every day does matter.”
 

China past the first wave

China has already passed the first wave, explained Lei Zhou, MD, of the Chinese Center for Disease Control and Prevention, but there are still some small-scale resurgences. So far a total of four waves have been identified. She also mentioned that contact tracing is intense and highlighted the case of Xinfadi Market in Beijing, the site of an outbreak in June 2020.

Gui-Qiang Wang, MD, from the Department of Infectious Disease, Peking University First Hospital, emphasized the importance of a chest CT for the diagnosis of COVID-19. “In the early stage of the disease, patients may not show any symptoms; however, on CT scan you can see pneumonia. Also, early intervention of high-risk groups and monitoring of warning indicators for disease progression is extremely important,” he said.

“Early antiviral therapy is expected to stop progression, but still needs evaluation,” he said. “Convalescent plasma is safe and effective, but its source is limited; steroid therapy needs to explore appropriate population and timing; and thymosin α is safe, and its effect on outcomes needs large-sample clinical trial.”

Time to Call for an ‘Arab CDC?’

The eastern Mediterranean is geographically, politically, economically, and religiously a very distinct and sensitive region, and “COVID-19 is an added insult to this already frail region of the world,” said Zaid Haddadin, MD, Vanderbilt University Medical Center, Nashville, Tenn.

Poor healthcare and poor public health services are a consequence of weak and fragile governments and infrastructure, the result of war and regional conflicts in many countries. Millions of war refugees live in camps with high population densities and shared facilities, which makes social distancing and community mitigation very challenging. Moreover, the culture includes frequent large social gatherings. Millions of pilgrims visit holy sites in different cities in these countries. There is also movement due to trade and tourism. Travel restrictions are challenging, and there is limited comprehension of precautionary measures.

Najwa Khuri-Bulos, professor of pediatrics and infectious diseases at the University of Jordan, was part of a task force headed by the country’s Ministry of Health. A lockdown was implemented, which helped flatten the curve, but the loosening of restrictions has led to a recent increase in cases. She said, “No country can succeed in controlling spread without the regional collaboration. Perhaps it is time to adopt the call for an Arab CDC.”
 

Africa is “not out of the woods yet”

The Africa CDC has three key pillars as the foundation for their COVID-19 strategy: preventing transmission, preventing deaths, and preventing social harm, according to Raji Tajudeen, MBBS, FWACP, MPH, head of the agency’s Public Health Institutes and Research Division. Africa, with 1.5 million cases of COVID-19, accounts for 5% of global cases. With a recovery rate of 83% and a case fatality rate of 2.4%, the African continent has fared much better than the rest of the world. “Significant improvements have been made, but we are not out of the woods yet,” he cautioned.

Richard Lessells, PhD, from the University of KwaZulu-Natal, agreed. “Unfortunately, South Africa has not been spared from the worst effects of this pandemic despite what you might read in the press and scientific coverage.” He added, “Over 50% of cases and up to two thirds of the deaths in the African region are coming from South Africa.” A bigger challenge for South Africa has been maintaining essential health services during the COVID-19 pandemic, especially since it is also at the heart of the HIV pandemic. On the brighter side, HIV itself has not emerged as a risk factor for COVID-19 infection or severe disease in South Africa.

Dimie Ogoina, MBBS, FWACP, president of the Nigerian Infectious Diseases Society, stated that COVID-19 has significantly affected access to healthcare in Nigeria, particularly immunizations and antenatal care. Immunization uptake is likely to have dropped by 50% in the country.
 

Diagnostic pitfalls in COVID-19

Technical errors associated with the SARS-CoV-2 diagnostic pipeline are a major source of variations in diagnosis, explained Jim Huggett, PhD, senior lecturer, analytical microbiology, University of Surrey, Guildford, England. He believes that PCR assays are currently too biased for a single cutoff to be broadly used, and false-positive signals are most likely because of contamination.

Dana Wolf, MD, Clinical Virology Unit, Hadassah Hebrew University Medical Center in Israel, presented a large-scale data analysis of more than 133,000 pooled samples. Such a pooling strategy appeared to be highly efficient for a wide range of prevalence rates (<1% to 6%). “Our empirical evidence strongly projects on the feasibility and benefits of pooling in the current pandemic setting, to enhance continued surveillance, control, and community reopening,” she said.

Corine Geurts van Kessel, MD, PhD, Department of Virology, Erasmus University Rotterdam (the Netherlands), discussing antibodies testing for SARS-CoV-2, pointed out that disease severity can affect testing accuracy. “Reinfection cases tell us that we cannot rely on immunity acquired by natural infection to confer herd immunity,” she said.
 

Misinformation in the first digital pandemic

The world is not only facing a devastating pandemic, but also an alarming “infodemic” of misinformation. Between January and March 2020, a new COVID-19–related tweet appeared on Twitter every 45 milliseconds. Müge Çevik, MD, MSc, MRCP, an infectious disease clinician, scientist, and science communicator, said that “the greatest challenge for science communication is reaching the audience.”

People have always been skeptical of science reporting by journalists and would rather have scientists communicate with them directly, she noted. Science communication plays a dual role. “On one hand is the need to promote science to a wide audience in order to inform and educate and inspire the next generation of scientists, and on the other hand there is also a need to engage effectively in public dialogue,” she added. Dr. Çevik and colleagues think that “The responsibility of academics should not end with finding the truth. It should end after communicating it.”
 

Treatment in the ICU

Matteo Bassetti, MD, with the University of Genoa (Italy), who was asked about when to use remdesivir in the intensive care unit and for how long, said, “In the majority of cases, 5 days is probably enough.” However, if there is high viremia, he said, physicians may choose to continue the regimen beyond 5 days. Data show it is important to prescribe this drug for patients with oxygen support in an early phase, within 10 days of the first symptoms, he added. “In the late phase, there is a very limited role for remdesivir, as we know that we are already out of the viremic phase.” He also emphasized that there is no role for hydroxychloroquine or lopinavir-ritonavir.

Breaking the chains of transmission

During the wrap-up session, former US CDC Director Tom Frieden, MD, said, “We’re not even halfway through it” about the pandemic trajectory. “And we have to be very clear that the risk of explosive spread will not end with a vaccine.” He is now president and CEO of Resolve to Save Lives.

Different parts of the world will have very different experiences, Dr. Frieden said, noting that Africa, where 4% of the population is older than 65, has a very different risk level than Europe and the United States, where 10%-20% of people are in older age groups.

“We need a one-two punch,” he noted, first preventing spread, and when it does happen, boxing it in. Mask wearing is essential. “States in the US that mandated universal mask-wearing experienced much more rapid declines (in cases) for every 5 days the mandate was in place.”

Michael Ryan, MD, executive director for the WHO’s Health Emergencies Programme, added, “We need to collectively recommit to winning this game. We know how to break the chains of transmission. We need recommitment to a scientific, societal, and political strategy, and an alliance – a contract – between those entities to try to move us forward.”

This article first appeared on Medscape.com.

Only 30.6% of American adolescents complete three routinely recommended vaccinations, new research has found, but that number varies widely by state.

The Advisory Committee on Immunization Practices recommends that, by age 17 years, adolescents complete three key immunizations: human papillomavirus (HPV), quadrivalent meningococcal conjugate (MenACWY), and Tdap.

Sara Poston, PharmD, senior director for health outcomes research at GlaxoSmithKline, said at a press conference during IDWeek, an annual scientific meeting on infectious diseases held virtually this year, that her team set out to determine how many teens were completing the vaccinations and how the number varied by state and by behavioral factors.

Completion of the vaccines means getting the HPV series (two doses for people aged 9-14 years at first vaccination or three doses for those aged 15 years or older at first vaccination), completion of the MenACWY series (two doses), and getting a Tdap vaccine (one dose).
 

Rhode Island has the highest rates

Some states are clearly doing better than others. Idaho had the lowest completion rate (11.3%; 95% confidence interval, 6.9%-18.0%), and Rhode Island had the highest (56.4%; 95% CI, 49.8%-62.8%).

In the 2018 National Immunization Survey–Teen (NIS-Teen), Rhode Island had the highest vaccination coverage rate in the nation for meningococcal vaccine (98.7%) and the second-highest coverage rate for Tdap (96.3%) for adolescents aged 13-17 years. Also in 2018, the state had the highest vaccination rates in the nation for the HPV series for both male and female adolescents 13-17 years of age (78.1%), well above the national average of 51.1%.

Researchers used information from the Centers for Disease Control and Prevention as well as 2015-2018 NIS-Teen data to estimate national and state-level completion rates by age 17. They then combined NIS-Teen data with public state-level data to evaluate what was driving or discouraging completion.

“The good news is, we found some variables that we consider actionable and can be used by states and local health departments to improve the rates,” Dr. Poston said.

Those include encouraging a health care visit at age 16 or 17, provider recommendations to families to get the HPV vaccine, and state-level mandates for the MenACWY vaccine.

Those who had a health care visit at 16 or 17 were more than twice as likely to complete their vaccines (odds ratio, 2.35; 95% CI, 1.80-3.07). Those for whom HPV vaccination had ever been recommended by a health care provider were more than three times as likely to complete their vaccinations (OR, 3.24; 95% CI, 2.76-3.80).

Other factors predictive of completing the vaccines included being Black or Hispanic and having Medicaid insurance.

At the state level, “living in a state with a mandate for the meningococcal ACWY vaccine in elementary or secondary school was also associated with likelihood of vaccination,” Dr. Poston said. Teens in states with mandates were 60% more likely to complete the vaccines than those in states without mandates. (OR, 1.6; 95% CI, 1.2-2.3)

Marielle Fricchione, MD, assistant professor of pediatric infectious diseases at Rush Medical College, Chicago said in an interview, “Teen vaccines are notoriously hard to get into kids because it’s hard to get them back into the office for second doses.”

She said that Illinois is one of the states with a two-dose mandate for MenACWY before entering 6th grade and 12th grade, which has kept vaccination coverage high.

Educating providers on how to recommend HPV vaccination is the biggest vaccine focus, she added.
 

Schedule next dose at first visit

One thing her department has found successful in HPV completion is scheduling the second dose while the teen is in the office for the first dose.

“Also, you have to recommend it just as strongly for boys as you do for girls, because oropharyngeal cancer is like an epidemic right now for men, and HPV-related oropharyngeal cancer is on an exponential rise,” Dr. Fricchione said.

According to the CDC, HPV is thought to cause 70% of oropharyngeal cancers in the United States.

Equipping providers with statistics on the effectiveness of HPV vaccination in preventing cancer can take away the uneasiness in talking about sexual transmission.

“That really seems to help them give a strong recommendation. It puts them in a data-driven position to talk about the vaccine,” she said. “Once you put that data in front of the providers, they’re floored.”

Research was funded by GlaxoSmithKline. Dr. Poston is employed by GlaxoSmithKline. Dr. Fricchione disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Only 30.6% of American adolescents complete three routinely recommended vaccinations, new research has found, but that number varies widely by state.

The Advisory Committee on Immunization Practices recommends that, by age 17 years, adolescents complete three key immunizations: human papillomavirus (HPV), quadrivalent meningococcal conjugate (MenACWY), and Tdap.

Sara Poston, PharmD, senior director for health outcomes research at GlaxoSmithKline, said at a press conference during IDWeek, an annual scientific meeting on infectious diseases held virtually this year, that her team set out to determine how many teens were completing the vaccinations and how the number varied by state and by behavioral factors.

Completion of the vaccines means getting the HPV series (two doses for people aged 9-14 years at first vaccination or three doses for those aged 15 years or older at first vaccination), completion of the MenACWY series (two doses), and getting a Tdap vaccine (one dose).
 

Rhode Island has the highest rates

Some states are clearly doing better than others. Idaho had the lowest completion rate (11.3%; 95% confidence interval, 6.9%-18.0%), and Rhode Island had the highest (56.4%; 95% CI, 49.8%-62.8%).

In the 2018 National Immunization Survey–Teen (NIS-Teen), Rhode Island had the highest vaccination coverage rate in the nation for meningococcal vaccine (98.7%) and the second-highest coverage rate for Tdap (96.3%) for adolescents aged 13-17 years. Also in 2018, the state had the highest vaccination rates in the nation for the HPV series for both male and female adolescents 13-17 years of age (78.1%), well above the national average of 51.1%.

Researchers used information from the Centers for Disease Control and Prevention as well as 2015-2018 NIS-Teen data to estimate national and state-level completion rates by age 17. They then combined NIS-Teen data with public state-level data to evaluate what was driving or discouraging completion.

“The good news is, we found some variables that we consider actionable and can be used by states and local health departments to improve the rates,” Dr. Poston said.

Those include encouraging a health care visit at age 16 or 17, provider recommendations to families to get the HPV vaccine, and state-level mandates for the MenACWY vaccine.

Those who had a health care visit at 16 or 17 were more than twice as likely to complete their vaccines (odds ratio, 2.35; 95% CI, 1.80-3.07). Those for whom HPV vaccination had ever been recommended by a health care provider were more than three times as likely to complete their vaccinations (OR, 3.24; 95% CI, 2.76-3.80).

Other factors predictive of completing the vaccines included being Black or Hispanic and having Medicaid insurance.

At the state level, “living in a state with a mandate for the meningococcal ACWY vaccine in elementary or secondary school was also associated with likelihood of vaccination,” Dr. Poston said. Teens in states with mandates were 60% more likely to complete the vaccines than those in states without mandates. (OR, 1.6; 95% CI, 1.2-2.3)

Marielle Fricchione, MD, assistant professor of pediatric infectious diseases at Rush Medical College, Chicago said in an interview, “Teen vaccines are notoriously hard to get into kids because it’s hard to get them back into the office for second doses.”

She said that Illinois is one of the states with a two-dose mandate for MenACWY before entering 6th grade and 12th grade, which has kept vaccination coverage high.

Educating providers on how to recommend HPV vaccination is the biggest vaccine focus, she added.
 

Schedule next dose at first visit

One thing her department has found successful in HPV completion is scheduling the second dose while the teen is in the office for the first dose.

“Also, you have to recommend it just as strongly for boys as you do for girls, because oropharyngeal cancer is like an epidemic right now for men, and HPV-related oropharyngeal cancer is on an exponential rise,” Dr. Fricchione said.

According to the CDC, HPV is thought to cause 70% of oropharyngeal cancers in the United States.

Equipping providers with statistics on the effectiveness of HPV vaccination in preventing cancer can take away the uneasiness in talking about sexual transmission.

“That really seems to help them give a strong recommendation. It puts them in a data-driven position to talk about the vaccine,” she said. “Once you put that data in front of the providers, they’re floored.”

Research was funded by GlaxoSmithKline. Dr. Poston is employed by GlaxoSmithKline. Dr. Fricchione disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Only 30.6% of American adolescents complete three routinely recommended vaccinations, new research has found, but that number varies widely by state.

The Advisory Committee on Immunization Practices recommends that, by age 17 years, adolescents complete three key immunizations: human papillomavirus (HPV), quadrivalent meningococcal conjugate (MenACWY), and Tdap.

Sara Poston, PharmD, senior director for health outcomes research at GlaxoSmithKline, said at a press conference during IDWeek, an annual scientific meeting on infectious diseases held virtually this year, that her team set out to determine how many teens were completing the vaccinations and how the number varied by state and by behavioral factors.

Completion of the vaccines means getting the HPV series (two doses for people aged 9-14 years at first vaccination or three doses for those aged 15 years or older at first vaccination), completion of the MenACWY series (two doses), and getting a Tdap vaccine (one dose).
 

Rhode Island has the highest rates

Some states are clearly doing better than others. Idaho had the lowest completion rate (11.3%; 95% confidence interval, 6.9%-18.0%), and Rhode Island had the highest (56.4%; 95% CI, 49.8%-62.8%).

In the 2018 National Immunization Survey–Teen (NIS-Teen), Rhode Island had the highest vaccination coverage rate in the nation for meningococcal vaccine (98.7%) and the second-highest coverage rate for Tdap (96.3%) for adolescents aged 13-17 years. Also in 2018, the state had the highest vaccination rates in the nation for the HPV series for both male and female adolescents 13-17 years of age (78.1%), well above the national average of 51.1%.

Researchers used information from the Centers for Disease Control and Prevention as well as 2015-2018 NIS-Teen data to estimate national and state-level completion rates by age 17. They then combined NIS-Teen data with public state-level data to evaluate what was driving or discouraging completion.

“The good news is, we found some variables that we consider actionable and can be used by states and local health departments to improve the rates,” Dr. Poston said.

Those include encouraging a health care visit at age 16 or 17, provider recommendations to families to get the HPV vaccine, and state-level mandates for the MenACWY vaccine.

Those who had a health care visit at 16 or 17 were more than twice as likely to complete their vaccines (odds ratio, 2.35; 95% CI, 1.80-3.07). Those for whom HPV vaccination had ever been recommended by a health care provider were more than three times as likely to complete their vaccinations (OR, 3.24; 95% CI, 2.76-3.80).

Other factors predictive of completing the vaccines included being Black or Hispanic and having Medicaid insurance.

At the state level, “living in a state with a mandate for the meningococcal ACWY vaccine in elementary or secondary school was also associated with likelihood of vaccination,” Dr. Poston said. Teens in states with mandates were 60% more likely to complete the vaccines than those in states without mandates. (OR, 1.6; 95% CI, 1.2-2.3)

Marielle Fricchione, MD, assistant professor of pediatric infectious diseases at Rush Medical College, Chicago said in an interview, “Teen vaccines are notoriously hard to get into kids because it’s hard to get them back into the office for second doses.”

She said that Illinois is one of the states with a two-dose mandate for MenACWY before entering 6th grade and 12th grade, which has kept vaccination coverage high.

Educating providers on how to recommend HPV vaccination is the biggest vaccine focus, she added.
 

Schedule next dose at first visit

One thing her department has found successful in HPV completion is scheduling the second dose while the teen is in the office for the first dose.

“Also, you have to recommend it just as strongly for boys as you do for girls, because oropharyngeal cancer is like an epidemic right now for men, and HPV-related oropharyngeal cancer is on an exponential rise,” Dr. Fricchione said.

According to the CDC, HPV is thought to cause 70% of oropharyngeal cancers in the United States.

Equipping providers with statistics on the effectiveness of HPV vaccination in preventing cancer can take away the uneasiness in talking about sexual transmission.

“That really seems to help them give a strong recommendation. It puts them in a data-driven position to talk about the vaccine,” she said. “Once you put that data in front of the providers, they’re floored.”

Research was funded by GlaxoSmithKline. Dr. Poston is employed by GlaxoSmithKline. Dr. Fricchione disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Although the efficacy of two pre-exposure prophylaxis (PrEP) regimens containing differing prodrug formulations of tenofovir are virtually identical, the balance between benefit and risk tips in favor of the combination using the older formulation, tenofovir disoproxil fumarate (TDF), a pharmacology researcher said.

An analysis of the pharmacologic profiles of TDF plus emtricitabine (FTC; Truvada and generic) with tenofovir alafenamide (TAF) plus FTC (Descovy) shows that the risk of decreased bone mineral density and renal toxicity with TDF are significantly lower than those of weight gain and related metabolic and cardiovascular problems associated with the newer tenofovir formulation TAF, according to pharmacology research fellow Andrew Hill, MD, PhD, from the University of Liverpool (England).

“I think when we’re comparing these two drugs overall, we have a clear benefit/risk, and we need to take both of these potential toxicities seriously, “ he said in an online presentation during IDWeek 2020, an annual scientific meeting on infectious diseases held virtually this year.

“But in my view, treating women – Black women – with TAF/FTC is a bad thing,” he continued. “I think it’s going lead to more harm, more myocardial infarctions, more cases of diabetes, and potentially more adverse birth outcomes, and I think that is a risk that is not worth taking, given that the apparent benefit in terms of bone mineral density and renal markers is a hypothesis at best, and is not translated into hard clinical endpoints.”
 

Adverse event profiles

Dr. Hill compared the side effect profiles of the two agents when used both in antiretroviral therapy (ART) in combination the integrase inhibitor dolutegravir (DTG; Tivicay), and in PrEP.

World Health Organization guidelines for first-line ART recommend the use of TDF/FTC/DTG, reserving TAF plus lamivudine (3TC) and DTG for use in special circumstances only, Dr. Hill noted.

He pointed to a pooled analysis of data from eight randomized, controlled trials of treatment-naive people living with HIV who started on ART from 2003 to 2015. The authors found that demographic factors associated with weight gain included lower CD4 cell counter, higher levels of HIV type 1 RNA, no injection drug use, female sex, and Black race.

They also found that, among nucleoside/nucleotide reverse transcriptase inhibitors, TAF was associated with more weight gain than TDF, abacavir, or zidovudine.

“This pattern is seen consistently across studies both of pre-exposure prophylaxis or treatment comparing tenofovir with either TAF or other nucleoside analogs,” he said.

The greater weight gain with TAF versus TDF was seen in both treatment trials and in the DISCOVER PrEP trial.

In addition, in a crossover trial conducted in Germany, patients who switched from TDF to TAF had an approximately 2 kg increase in body weight.

TAF has also been associated with higher grade 3 or 4 glucose and LDL cholesterol than TDF in clinical trials for the treatment of hepatitis B infections, and with higher LDL cholesterol and total cholesterol levels as well as diabetes in patients treated with the drugs in combination in the EMERALD HIV trial.

Clinical trials also tend to underestimate the real-world population of persons at highest risk for adverse events from TAF, Dr. Hill said, noting that the percentage of Black women in phase 3 trials for dolutegravir was 9%, compared with 42% among persons infected with HIV worldwide. The respective percentages for Black men are 16% versus 30%. These differences are similar across clinical trial programs for other ART agents.

“Generally, it’s women and Black people who seem to be at greatest risk for safety issues,” he said.

In the ADVANCE trial comparing TAF/FTC/DTG with TDF/FTC/DTG and a control arm of TDF, FTC and efavirenz, the mean change in weight among men after 3 years on the TAF-based regimen was a gain of 7.2 kg (15.9 lbs), compared with 5.5 kg (12 lbs) with TDF, and 2.6 kg (5.7 lbs) with the efavirenz-containing regimen.

In women enrolled in the same trial, the respective mean weight gains were 12.3 kg (27 lbs), 7.4 kg (16.3 lbs), and 5.5 kg (12 lbs).

“All of our analyses so far have shown that the weight continues to go up. We’re actually seeing people doubling in their body weight. We’ve seen some women come into clinic and their doctors don’t even recognize them because they’ve put on so much weight,” he said.

In women, most of the gain in weight occurs as limb or trunk fat, with a predominance of visceral fat.

People taking TAF in the trial were also at significantly greater risk for developing the metabolic syndrome, and at week 96, 27% of women on TAF/FTC/DTG had treatment-emergent obesity, compared with 17% for those on TDF/FTC/DTG and 11% for those on TDF/FTC/EFV. In men, the respective 96-week rates of treatment-emergent obesity were 7%, 3%, and 2%.

Clinical obesity itself is a risk factor for obstetric complications and birth outcomes, Alzheimer’s disease, type 2 diabetes, cardiovascular disease, hypertension and cancer, and an average 4-year reduction in life expectancy, Dr. Hill said. “I think it’s actually very unlikely that the [World Health Organization] guidelines will now change and allow the widespread use of TAF/FTC in combination with integrase inhibitors worldwide given these potential implications.”
 

Modern times

The bad rap that TDF gets for its alleged effects on bone mineral density and kidneys comes from studies where the drug was given in a boosted regimen that can amplify tenofovir toxicities, Dr. Hill said.

He noted that data from Gilead Sciences shows through 7 years of therapy in previously ART-naive patients, the combination of TDF/3TC/EFV showed sustained durable efficacy, no discontinuations to renal adverse effects, and no evidence of clinically relevant bone effects.

“I think we need to be very careful when we look at tenofovir and TAF. We need to look at the more modern way that these drugs are used, which is not with pharmacokinetic boosters anymore, and in that situation the toxicity profile of tenofovir/3TC – the original TDF – is very favorable,” he said.

Robert Goldstein, MD, PhD, an infectious disease specialist and medical director of the transgender health program at Massachusetts General Hospital in Boston, who comoderated the session where Dr. Hill presented his data, said that his clinical experience mirrors the pharmacokinetic findings.

“I certainly have strong feelings about the use of TDF in pre-exposure prophylaxis,” he said in an interview. “TDF is an effective and safe formulation of tenofovir to be used in pre-exposure prophylaxis, and one that we have more experience with. It’s the formulation of tenofovir that I use for all of my patients who are on pre-exposure prophylaxis, and I think it is the most cost-effective.’

No funding source was reported. Andrew Hill consults for Tibotec on clinical trial programs for darunavir, etravirine, and rilpivirine. Dr. Goldstein reported having no relevant disclosures.

Although the efficacy of two pre-exposure prophylaxis (PrEP) regimens containing differing prodrug formulations of tenofovir are virtually identical, the balance between benefit and risk tips in favor of the combination using the older formulation, tenofovir disoproxil fumarate (TDF), a pharmacology researcher said.

An analysis of the pharmacologic profiles of TDF plus emtricitabine (FTC; Truvada and generic) with tenofovir alafenamide (TAF) plus FTC (Descovy) shows that the risk of decreased bone mineral density and renal toxicity with TDF are significantly lower than those of weight gain and related metabolic and cardiovascular problems associated with the newer tenofovir formulation TAF, according to pharmacology research fellow Andrew Hill, MD, PhD, from the University of Liverpool (England).

“I think when we’re comparing these two drugs overall, we have a clear benefit/risk, and we need to take both of these potential toxicities seriously, “ he said in an online presentation during IDWeek 2020, an annual scientific meeting on infectious diseases held virtually this year.

“But in my view, treating women – Black women – with TAF/FTC is a bad thing,” he continued. “I think it’s going lead to more harm, more myocardial infarctions, more cases of diabetes, and potentially more adverse birth outcomes, and I think that is a risk that is not worth taking, given that the apparent benefit in terms of bone mineral density and renal markers is a hypothesis at best, and is not translated into hard clinical endpoints.”
 

Adverse event profiles

Dr. Hill compared the side effect profiles of the two agents when used both in antiretroviral therapy (ART) in combination the integrase inhibitor dolutegravir (DTG; Tivicay), and in PrEP.

World Health Organization guidelines for first-line ART recommend the use of TDF/FTC/DTG, reserving TAF plus lamivudine (3TC) and DTG for use in special circumstances only, Dr. Hill noted.

He pointed to a pooled analysis of data from eight randomized, controlled trials of treatment-naive people living with HIV who started on ART from 2003 to 2015. The authors found that demographic factors associated with weight gain included lower CD4 cell counter, higher levels of HIV type 1 RNA, no injection drug use, female sex, and Black race.

They also found that, among nucleoside/nucleotide reverse transcriptase inhibitors, TAF was associated with more weight gain than TDF, abacavir, or zidovudine.

“This pattern is seen consistently across studies both of pre-exposure prophylaxis or treatment comparing tenofovir with either TAF or other nucleoside analogs,” he said.

The greater weight gain with TAF versus TDF was seen in both treatment trials and in the DISCOVER PrEP trial.

In addition, in a crossover trial conducted in Germany, patients who switched from TDF to TAF had an approximately 2 kg increase in body weight.

TAF has also been associated with higher grade 3 or 4 glucose and LDL cholesterol than TDF in clinical trials for the treatment of hepatitis B infections, and with higher LDL cholesterol and total cholesterol levels as well as diabetes in patients treated with the drugs in combination in the EMERALD HIV trial.

Clinical trials also tend to underestimate the real-world population of persons at highest risk for adverse events from TAF, Dr. Hill said, noting that the percentage of Black women in phase 3 trials for dolutegravir was 9%, compared with 42% among persons infected with HIV worldwide. The respective percentages for Black men are 16% versus 30%. These differences are similar across clinical trial programs for other ART agents.

“Generally, it’s women and Black people who seem to be at greatest risk for safety issues,” he said.

In the ADVANCE trial comparing TAF/FTC/DTG with TDF/FTC/DTG and a control arm of TDF, FTC and efavirenz, the mean change in weight among men after 3 years on the TAF-based regimen was a gain of 7.2 kg (15.9 lbs), compared with 5.5 kg (12 lbs) with TDF, and 2.6 kg (5.7 lbs) with the efavirenz-containing regimen.

In women enrolled in the same trial, the respective mean weight gains were 12.3 kg (27 lbs), 7.4 kg (16.3 lbs), and 5.5 kg (12 lbs).

“All of our analyses so far have shown that the weight continues to go up. We’re actually seeing people doubling in their body weight. We’ve seen some women come into clinic and their doctors don’t even recognize them because they’ve put on so much weight,” he said.

In women, most of the gain in weight occurs as limb or trunk fat, with a predominance of visceral fat.

People taking TAF in the trial were also at significantly greater risk for developing the metabolic syndrome, and at week 96, 27% of women on TAF/FTC/DTG had treatment-emergent obesity, compared with 17% for those on TDF/FTC/DTG and 11% for those on TDF/FTC/EFV. In men, the respective 96-week rates of treatment-emergent obesity were 7%, 3%, and 2%.

Clinical obesity itself is a risk factor for obstetric complications and birth outcomes, Alzheimer’s disease, type 2 diabetes, cardiovascular disease, hypertension and cancer, and an average 4-year reduction in life expectancy, Dr. Hill said. “I think it’s actually very unlikely that the [World Health Organization] guidelines will now change and allow the widespread use of TAF/FTC in combination with integrase inhibitors worldwide given these potential implications.”
 

Modern times

The bad rap that TDF gets for its alleged effects on bone mineral density and kidneys comes from studies where the drug was given in a boosted regimen that can amplify tenofovir toxicities, Dr. Hill said.

He noted that data from Gilead Sciences shows through 7 years of therapy in previously ART-naive patients, the combination of TDF/3TC/EFV showed sustained durable efficacy, no discontinuations to renal adverse effects, and no evidence of clinically relevant bone effects.

“I think we need to be very careful when we look at tenofovir and TAF. We need to look at the more modern way that these drugs are used, which is not with pharmacokinetic boosters anymore, and in that situation the toxicity profile of tenofovir/3TC – the original TDF – is very favorable,” he said.

Robert Goldstein, MD, PhD, an infectious disease specialist and medical director of the transgender health program at Massachusetts General Hospital in Boston, who comoderated the session where Dr. Hill presented his data, said that his clinical experience mirrors the pharmacokinetic findings.

“I certainly have strong feelings about the use of TDF in pre-exposure prophylaxis,” he said in an interview. “TDF is an effective and safe formulation of tenofovir to be used in pre-exposure prophylaxis, and one that we have more experience with. It’s the formulation of tenofovir that I use for all of my patients who are on pre-exposure prophylaxis, and I think it is the most cost-effective.’

No funding source was reported. Andrew Hill consults for Tibotec on clinical trial programs for darunavir, etravirine, and rilpivirine. Dr. Goldstein reported having no relevant disclosures.

Although the efficacy of two pre-exposure prophylaxis (PrEP) regimens containing differing prodrug formulations of tenofovir are virtually identical, the balance between benefit and risk tips in favor of the combination using the older formulation, tenofovir disoproxil fumarate (TDF), a pharmacology researcher said.

An analysis of the pharmacologic profiles of TDF plus emtricitabine (FTC; Truvada and generic) with tenofovir alafenamide (TAF) plus FTC (Descovy) shows that the risk of decreased bone mineral density and renal toxicity with TDF are significantly lower than those of weight gain and related metabolic and cardiovascular problems associated with the newer tenofovir formulation TAF, according to pharmacology research fellow Andrew Hill, MD, PhD, from the University of Liverpool (England).

“I think when we’re comparing these two drugs overall, we have a clear benefit/risk, and we need to take both of these potential toxicities seriously, “ he said in an online presentation during IDWeek 2020, an annual scientific meeting on infectious diseases held virtually this year.

“But in my view, treating women – Black women – with TAF/FTC is a bad thing,” he continued. “I think it’s going lead to more harm, more myocardial infarctions, more cases of diabetes, and potentially more adverse birth outcomes, and I think that is a risk that is not worth taking, given that the apparent benefit in terms of bone mineral density and renal markers is a hypothesis at best, and is not translated into hard clinical endpoints.”
 

Adverse event profiles

Dr. Hill compared the side effect profiles of the two agents when used both in antiretroviral therapy (ART) in combination the integrase inhibitor dolutegravir (DTG; Tivicay), and in PrEP.

World Health Organization guidelines for first-line ART recommend the use of TDF/FTC/DTG, reserving TAF plus lamivudine (3TC) and DTG for use in special circumstances only, Dr. Hill noted.

He pointed to a pooled analysis of data from eight randomized, controlled trials of treatment-naive people living with HIV who started on ART from 2003 to 2015. The authors found that demographic factors associated with weight gain included lower CD4 cell counter, higher levels of HIV type 1 RNA, no injection drug use, female sex, and Black race.

They also found that, among nucleoside/nucleotide reverse transcriptase inhibitors, TAF was associated with more weight gain than TDF, abacavir, or zidovudine.

“This pattern is seen consistently across studies both of pre-exposure prophylaxis or treatment comparing tenofovir with either TAF or other nucleoside analogs,” he said.

The greater weight gain with TAF versus TDF was seen in both treatment trials and in the DISCOVER PrEP trial.

In addition, in a crossover trial conducted in Germany, patients who switched from TDF to TAF had an approximately 2 kg increase in body weight.

TAF has also been associated with higher grade 3 or 4 glucose and LDL cholesterol than TDF in clinical trials for the treatment of hepatitis B infections, and with higher LDL cholesterol and total cholesterol levels as well as diabetes in patients treated with the drugs in combination in the EMERALD HIV trial.

Clinical trials also tend to underestimate the real-world population of persons at highest risk for adverse events from TAF, Dr. Hill said, noting that the percentage of Black women in phase 3 trials for dolutegravir was 9%, compared with 42% among persons infected with HIV worldwide. The respective percentages for Black men are 16% versus 30%. These differences are similar across clinical trial programs for other ART agents.

“Generally, it’s women and Black people who seem to be at greatest risk for safety issues,” he said.

In the ADVANCE trial comparing TAF/FTC/DTG with TDF/FTC/DTG and a control arm of TDF, FTC and efavirenz, the mean change in weight among men after 3 years on the TAF-based regimen was a gain of 7.2 kg (15.9 lbs), compared with 5.5 kg (12 lbs) with TDF, and 2.6 kg (5.7 lbs) with the efavirenz-containing regimen.

In women enrolled in the same trial, the respective mean weight gains were 12.3 kg (27 lbs), 7.4 kg (16.3 lbs), and 5.5 kg (12 lbs).

“All of our analyses so far have shown that the weight continues to go up. We’re actually seeing people doubling in their body weight. We’ve seen some women come into clinic and their doctors don’t even recognize them because they’ve put on so much weight,” he said.

In women, most of the gain in weight occurs as limb or trunk fat, with a predominance of visceral fat.

People taking TAF in the trial were also at significantly greater risk for developing the metabolic syndrome, and at week 96, 27% of women on TAF/FTC/DTG had treatment-emergent obesity, compared with 17% for those on TDF/FTC/DTG and 11% for those on TDF/FTC/EFV. In men, the respective 96-week rates of treatment-emergent obesity were 7%, 3%, and 2%.

Clinical obesity itself is a risk factor for obstetric complications and birth outcomes, Alzheimer’s disease, type 2 diabetes, cardiovascular disease, hypertension and cancer, and an average 4-year reduction in life expectancy, Dr. Hill said. “I think it’s actually very unlikely that the [World Health Organization] guidelines will now change and allow the widespread use of TAF/FTC in combination with integrase inhibitors worldwide given these potential implications.”
 

Modern times

The bad rap that TDF gets for its alleged effects on bone mineral density and kidneys comes from studies where the drug was given in a boosted regimen that can amplify tenofovir toxicities, Dr. Hill said.

He noted that data from Gilead Sciences shows through 7 years of therapy in previously ART-naive patients, the combination of TDF/3TC/EFV showed sustained durable efficacy, no discontinuations to renal adverse effects, and no evidence of clinically relevant bone effects.

“I think we need to be very careful when we look at tenofovir and TAF. We need to look at the more modern way that these drugs are used, which is not with pharmacokinetic boosters anymore, and in that situation the toxicity profile of tenofovir/3TC – the original TDF – is very favorable,” he said.

Robert Goldstein, MD, PhD, an infectious disease specialist and medical director of the transgender health program at Massachusetts General Hospital in Boston, who comoderated the session where Dr. Hill presented his data, said that his clinical experience mirrors the pharmacokinetic findings.

“I certainly have strong feelings about the use of TDF in pre-exposure prophylaxis,” he said in an interview. “TDF is an effective and safe formulation of tenofovir to be used in pre-exposure prophylaxis, and one that we have more experience with. It’s the formulation of tenofovir that I use for all of my patients who are on pre-exposure prophylaxis, and I think it is the most cost-effective.’

No funding source was reported. Andrew Hill consults for Tibotec on clinical trial programs for darunavir, etravirine, and rilpivirine. Dr. Goldstein reported having no relevant disclosures.

A patient-centered approach can help guide persons at risk for HIV exposure to decide on the best choice of pre-exposure prophylaxis (PrEP) regimens for them, stifling the noise generated by direct-to-consumer advertising, an infectious disease specialist recommends.

The decision for patients whether to start or remain on the PrEP combination of tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC; Truvada and generic) or on tenofovir alafenamide (TAF) plus FTC (Descovy) is made more fraught by confusion regarding the use of the newer and allegedly safer TAF prodrug of tenofovir in HIV treatment regimens, said Oni Blackstock, MD, founder and executive director of Health Justice and an attending physician in the division of infectious diseases at Harlem Hospital, New York.

“There have been commercials on TV as well as on social media around class-action lawsuits against [Truvada maker] Gilead,” she said in an online presentation during IDWeek 2020, an annual scientific meeting on infectious diseases, held virtually this year.

“These lawsuits focus on TDF for HIV treatment, but they have sown a great deal of confusion about TDF versus TAF for PrEP among potential and actual PrEP users,” she added.

Dr. Blackstock described her approach to shared decision-making regarding TDF/FTC versus TAF/FTC, and to helping patients understand the relative benefits and risks of each formulation.

In January of 2020, Dr. Blackstock, who was then assistant commissioner of the HIV bureau of the New York City Department of Health and Mental Hygiene, issued with other Bureau members a “Dear colleague” letter stating why they believed that TDF/FTC should remain the first-line regimen for PrEP.

That opinion, she said, was bolstered by an editorial published in February 2020 by Douglas E. Krakower, MD, from Beth Israel Deaconess Medical Center in Boston, and colleagues, which questioned the rush to shift from TDF to TAF in HIV treatment, and cautioned against the same approach to PrEP.

“Despite evidence that TAF/FTC would not be cost-effective, compared with generic TDF/FTC , the newer regimen quickly and irrevocably displaced TDF/FTC for HIV treatment in the U.S. A similar shift for PrEP – especially for populations in which TAF/FTC is untested – would be premature, costly, and counterproductive for population impact,” Krakower et al. wrote.
 

Shared decision-making

Clinicians can help patients who may be a candidate for either PrEP regimen by engaging them in shared decision-making.

“The clinician provides information in this case about a prevention strategy, options, benefits and risks, alternatives, and the patient provides their preferences and values, and together the clinician and patient make a decision,” Dr. Blackstock said.

The process differs from the model of informed decision-making, where the clinician gives the patient the information and the patient comes to a decision, or the old, “paternalistic” model in which the clinician gives information and makes recommendations to the patient.

“Shared decision-making has been studied extensively and has been shown to improve patient satisfaction, patient communication, and also potentially reducing health inequities that we see,” she said.

The model for shared decision-making for clinical practice includes three distinct portions: a choice talk, option talk, and decision talk.
 

Choice

To begin the discussion, the physician informs the patients of the availability of choices and justifies them, saying, for example, “there is good information about how these two PrEP options differ that I’d like to discuss with you,” and “the two PrEP options have different side effects … some will matter more to you than other people.”

At this stage the clinician should defer closure by offering a more detailed discussion of the choices.
 

Option

Here the clinician solicits information about what the patient has heard or read about PrEP, describes each option in practical terms, and points out where the two regimens differ, being specific about the pros and cons of each (for example, potential bone mineral density loss or renal complications with TDF, and potential weight gain with subsequent metabolic and cardiovascular consequences with TAF).

The TDF versus TAF-based PrEP discussion could also focus on what’s known about the comparative effectiveness of each regimen.

For example, TDF/FTC has been shown to be about 99% effective at preventing infection in men who have sex with men and in transgender women, also about 99% effective in heterosexual women and men, and 74%-84% effective in persons who inject drugs.

In contrast, TAF/FTC has been shown to be about 99% effective in men who have sex with men and transgender women, but it’s efficacy in the other two categories is unknown, Dr. Blackstock said.

The option discussion should include a comparison of the evidence base for each regimen, including the real-world experience with TDF/FTC since 2012, and much more limited experience with TAF/FTC.

Discussing relative costs, although the wholesale costs of the regimens are similar, there is now a generic version of TDF/FTC made by Teva Pharmaceuticals that sells for about $400 less per month than the brand name, which might make the option more acceptable to health insurers.
 

Decision

The decision talk is about considering the patients preferences and deciding with them what is best.

The clinician could say, for example: “What, from your point of view, matters most to you?”

The clinician should also be willing to allow the patient to defer a decision or to guide them depending on their stated wish, asking something like: “Are you ready to decide, or do you want more time? Do you have more questions? Are there more things we should discuss?

Offering the patient a chance to review the decision can also be a good way to arrive at closure, Dr. Blackstock said.

Robert Goldstein, MD, PhD, an infectious disease specialist and medical director of the transgender health program at Massachusetts General Hospital in Boston, who comoderated the session where Dr. Blackstock presented her talk, said that he also uses a similar approach to the PrEP discussion.

“I use a very patient-centered approach of providing information and talking through the data that are available,” he said.

“I will say that, as patients come to me talking about the transition from TDF to TAF for pre-exposure prophylaxis, I am very clear with them about the limited benefit or no benefit that I see with TAF for pre-exposure prophylaxis, and all of my patients have remained on TDF for pre-exposure prophylaxis,” he added.

No funding source for the presentation was reported. Dr. Blackstock and Dr. Goldstein reported having no conflicts of interest to disclose.

A patient-centered approach can help guide persons at risk for HIV exposure to decide on the best choice of pre-exposure prophylaxis (PrEP) regimens for them, stifling the noise generated by direct-to-consumer advertising, an infectious disease specialist recommends.

The decision for patients whether to start or remain on the PrEP combination of tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC; Truvada and generic) or on tenofovir alafenamide (TAF) plus FTC (Descovy) is made more fraught by confusion regarding the use of the newer and allegedly safer TAF prodrug of tenofovir in HIV treatment regimens, said Oni Blackstock, MD, founder and executive director of Health Justice and an attending physician in the division of infectious diseases at Harlem Hospital, New York.

“There have been commercials on TV as well as on social media around class-action lawsuits against [Truvada maker] Gilead,” she said in an online presentation during IDWeek 2020, an annual scientific meeting on infectious diseases, held virtually this year.

“These lawsuits focus on TDF for HIV treatment, but they have sown a great deal of confusion about TDF versus TAF for PrEP among potential and actual PrEP users,” she added.

Dr. Blackstock described her approach to shared decision-making regarding TDF/FTC versus TAF/FTC, and to helping patients understand the relative benefits and risks of each formulation.

In January of 2020, Dr. Blackstock, who was then assistant commissioner of the HIV bureau of the New York City Department of Health and Mental Hygiene, issued with other Bureau members a “Dear colleague” letter stating why they believed that TDF/FTC should remain the first-line regimen for PrEP.

That opinion, she said, was bolstered by an editorial published in February 2020 by Douglas E. Krakower, MD, from Beth Israel Deaconess Medical Center in Boston, and colleagues, which questioned the rush to shift from TDF to TAF in HIV treatment, and cautioned against the same approach to PrEP.

“Despite evidence that TAF/FTC would not be cost-effective, compared with generic TDF/FTC , the newer regimen quickly and irrevocably displaced TDF/FTC for HIV treatment in the U.S. A similar shift for PrEP – especially for populations in which TAF/FTC is untested – would be premature, costly, and counterproductive for population impact,” Krakower et al. wrote.
 

Shared decision-making

Clinicians can help patients who may be a candidate for either PrEP regimen by engaging them in shared decision-making.

“The clinician provides information in this case about a prevention strategy, options, benefits and risks, alternatives, and the patient provides their preferences and values, and together the clinician and patient make a decision,” Dr. Blackstock said.

The process differs from the model of informed decision-making, where the clinician gives the patient the information and the patient comes to a decision, or the old, “paternalistic” model in which the clinician gives information and makes recommendations to the patient.

“Shared decision-making has been studied extensively and has been shown to improve patient satisfaction, patient communication, and also potentially reducing health inequities that we see,” she said.

The model for shared decision-making for clinical practice includes three distinct portions: a choice talk, option talk, and decision talk.
 

Choice

To begin the discussion, the physician informs the patients of the availability of choices and justifies them, saying, for example, “there is good information about how these two PrEP options differ that I’d like to discuss with you,” and “the two PrEP options have different side effects … some will matter more to you than other people.”

At this stage the clinician should defer closure by offering a more detailed discussion of the choices.
 

Option

Here the clinician solicits information about what the patient has heard or read about PrEP, describes each option in practical terms, and points out where the two regimens differ, being specific about the pros and cons of each (for example, potential bone mineral density loss or renal complications with TDF, and potential weight gain with subsequent metabolic and cardiovascular consequences with TAF).

The TDF versus TAF-based PrEP discussion could also focus on what’s known about the comparative effectiveness of each regimen.

For example, TDF/FTC has been shown to be about 99% effective at preventing infection in men who have sex with men and in transgender women, also about 99% effective in heterosexual women and men, and 74%-84% effective in persons who inject drugs.

In contrast, TAF/FTC has been shown to be about 99% effective in men who have sex with men and transgender women, but it’s efficacy in the other two categories is unknown, Dr. Blackstock said.

The option discussion should include a comparison of the evidence base for each regimen, including the real-world experience with TDF/FTC since 2012, and much more limited experience with TAF/FTC.

Discussing relative costs, although the wholesale costs of the regimens are similar, there is now a generic version of TDF/FTC made by Teva Pharmaceuticals that sells for about $400 less per month than the brand name, which might make the option more acceptable to health insurers.
 

Decision

The decision talk is about considering the patients preferences and deciding with them what is best.

The clinician could say, for example: “What, from your point of view, matters most to you?”

The clinician should also be willing to allow the patient to defer a decision or to guide them depending on their stated wish, asking something like: “Are you ready to decide, or do you want more time? Do you have more questions? Are there more things we should discuss?

Offering the patient a chance to review the decision can also be a good way to arrive at closure, Dr. Blackstock said.

Robert Goldstein, MD, PhD, an infectious disease specialist and medical director of the transgender health program at Massachusetts General Hospital in Boston, who comoderated the session where Dr. Blackstock presented her talk, said that he also uses a similar approach to the PrEP discussion.

“I use a very patient-centered approach of providing information and talking through the data that are available,” he said.

“I will say that, as patients come to me talking about the transition from TDF to TAF for pre-exposure prophylaxis, I am very clear with them about the limited benefit or no benefit that I see with TAF for pre-exposure prophylaxis, and all of my patients have remained on TDF for pre-exposure prophylaxis,” he added.

No funding source for the presentation was reported. Dr. Blackstock and Dr. Goldstein reported having no conflicts of interest to disclose.

A patient-centered approach can help guide persons at risk for HIV exposure to decide on the best choice of pre-exposure prophylaxis (PrEP) regimens for them, stifling the noise generated by direct-to-consumer advertising, an infectious disease specialist recommends.

The decision for patients whether to start or remain on the PrEP combination of tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC; Truvada and generic) or on tenofovir alafenamide (TAF) plus FTC (Descovy) is made more fraught by confusion regarding the use of the newer and allegedly safer TAF prodrug of tenofovir in HIV treatment regimens, said Oni Blackstock, MD, founder and executive director of Health Justice and an attending physician in the division of infectious diseases at Harlem Hospital, New York.

“There have been commercials on TV as well as on social media around class-action lawsuits against [Truvada maker] Gilead,” she said in an online presentation during IDWeek 2020, an annual scientific meeting on infectious diseases, held virtually this year.

“These lawsuits focus on TDF for HIV treatment, but they have sown a great deal of confusion about TDF versus TAF for PrEP among potential and actual PrEP users,” she added.

Dr. Blackstock described her approach to shared decision-making regarding TDF/FTC versus TAF/FTC, and to helping patients understand the relative benefits and risks of each formulation.

In January of 2020, Dr. Blackstock, who was then assistant commissioner of the HIV bureau of the New York City Department of Health and Mental Hygiene, issued with other Bureau members a “Dear colleague” letter stating why they believed that TDF/FTC should remain the first-line regimen for PrEP.

That opinion, she said, was bolstered by an editorial published in February 2020 by Douglas E. Krakower, MD, from Beth Israel Deaconess Medical Center in Boston, and colleagues, which questioned the rush to shift from TDF to TAF in HIV treatment, and cautioned against the same approach to PrEP.

“Despite evidence that TAF/FTC would not be cost-effective, compared with generic TDF/FTC , the newer regimen quickly and irrevocably displaced TDF/FTC for HIV treatment in the U.S. A similar shift for PrEP – especially for populations in which TAF/FTC is untested – would be premature, costly, and counterproductive for population impact,” Krakower et al. wrote.
 

Shared decision-making

Clinicians can help patients who may be a candidate for either PrEP regimen by engaging them in shared decision-making.

“The clinician provides information in this case about a prevention strategy, options, benefits and risks, alternatives, and the patient provides their preferences and values, and together the clinician and patient make a decision,” Dr. Blackstock said.

The process differs from the model of informed decision-making, where the clinician gives the patient the information and the patient comes to a decision, or the old, “paternalistic” model in which the clinician gives information and makes recommendations to the patient.

“Shared decision-making has been studied extensively and has been shown to improve patient satisfaction, patient communication, and also potentially reducing health inequities that we see,” she said.

The model for shared decision-making for clinical practice includes three distinct portions: a choice talk, option talk, and decision talk.
 

Choice

To begin the discussion, the physician informs the patients of the availability of choices and justifies them, saying, for example, “there is good information about how these two PrEP options differ that I’d like to discuss with you,” and “the two PrEP options have different side effects … some will matter more to you than other people.”

At this stage the clinician should defer closure by offering a more detailed discussion of the choices.
 

Option

Here the clinician solicits information about what the patient has heard or read about PrEP, describes each option in practical terms, and points out where the two regimens differ, being specific about the pros and cons of each (for example, potential bone mineral density loss or renal complications with TDF, and potential weight gain with subsequent metabolic and cardiovascular consequences with TAF).

The TDF versus TAF-based PrEP discussion could also focus on what’s known about the comparative effectiveness of each regimen.

For example, TDF/FTC has been shown to be about 99% effective at preventing infection in men who have sex with men and in transgender women, also about 99% effective in heterosexual women and men, and 74%-84% effective in persons who inject drugs.

In contrast, TAF/FTC has been shown to be about 99% effective in men who have sex with men and transgender women, but it’s efficacy in the other two categories is unknown, Dr. Blackstock said.

The option discussion should include a comparison of the evidence base for each regimen, including the real-world experience with TDF/FTC since 2012, and much more limited experience with TAF/FTC.

Discussing relative costs, although the wholesale costs of the regimens are similar, there is now a generic version of TDF/FTC made by Teva Pharmaceuticals that sells for about $400 less per month than the brand name, which might make the option more acceptable to health insurers.
 

Decision

The decision talk is about considering the patients preferences and deciding with them what is best.

The clinician could say, for example: “What, from your point of view, matters most to you?”

The clinician should also be willing to allow the patient to defer a decision or to guide them depending on their stated wish, asking something like: “Are you ready to decide, or do you want more time? Do you have more questions? Are there more things we should discuss?

Offering the patient a chance to review the decision can also be a good way to arrive at closure, Dr. Blackstock said.

Robert Goldstein, MD, PhD, an infectious disease specialist and medical director of the transgender health program at Massachusetts General Hospital in Boston, who comoderated the session where Dr. Blackstock presented her talk, said that he also uses a similar approach to the PrEP discussion.

“I use a very patient-centered approach of providing information and talking through the data that are available,” he said.

“I will say that, as patients come to me talking about the transition from TDF to TAF for pre-exposure prophylaxis, I am very clear with them about the limited benefit or no benefit that I see with TAF for pre-exposure prophylaxis, and all of my patients have remained on TDF for pre-exposure prophylaxis,” he added.

No funding source for the presentation was reported. Dr. Blackstock and Dr. Goldstein reported having no conflicts of interest to disclose.

The COVID-19 pandemic figured prominently in the final debate between President Donald Trump and former Vice President Joe Biden when they met on stage for a 90-minute debate in Nashville, Tennessee, Thursday evening.

The adequacy of the COVID-19 response to date, the likely timeline for vaccine availability, and how to reopen businesses while keeping Americans safe were among the points on which the two candidates disagreed. The two candidates also sparred over the value of the Affordable Care Act (ACA) and the future of healthcare in the United States.

Trump and Biden also differed on whether or not the country is facing a “dark winter” because of the pandemic.

Moderator Kristen Welker, NBC News White House correspondent, asked Trump to comment on the fact that 40,000 people are in the hospital on debate night with COVID-19 and that 16,000 have died since the last presidential debate.

Trump said, “2.2 million people modeled out were expected to die.” He said COVID-19 is a worldwide disease that does not only affect the United States.

“The mortality rate is down 85%, and the excess mortality is also down,” he added. He pointed out that previous spikes in Florida, Texas, and Arizona are now gone, and “spikes and surges in other places will soon be gone.

“It will go away, we are rounding the corner,” Trump said. “From personal experience, I was in the hospital, I had it, and they gave me a therapeutic, some would call it a cure...and now they say I’m immune. Whether it’s for a month or lifetime, nobody has been able to say that, but I’m immune.”

Biden countered by saying that “220,000 people are dead. If you hear nothing else I say tonight, hear this: Anyone who’s responsible for that many deaths should not remain president of the United States of America.”

Biden said there are a thousand deaths a day now and that there are over 70K new cases per day. “The expectation is we will have another 200,000 people down before the end of this year. If we just all wore these masks, we could save 100,000.”

“The New England Journal of Medicine said the way the president has handled this is absolutely tragic,” Biden added.

Vaccine timeline

Welker asked Trump if he could guarantee that there will be a COVID-19 vaccine within weeks.

“I can’t guarantee that, but it will be by end of the year. It will be distributed very quickly,” Trump said. He added that three leading vaccine developers, Johnson & Johnson, Moderna, and Pfizer, “are doing very well.”

“We’re about to go into a dark winter and he has no clear plan,” Biden said. “There is no prospect there will be a vaccine for most Americans by middle of next year.”

“It will not be a dark winter,” Trump responded.

Reopening the economy

Trump and Biden disagreed on how aggressively the economy should be reopened in light of the pandemic.

“I want to open the schools. We can’t keep this country closed,” Trump said. “This is a massive country with a massive economy.” He pointed out that rates of depression and suicide have risen because of the economic shutdown. “The cure cannot be worse than the problem.

“His Democrat governors...shut down so tight, and they’re dying,” the president added, gesturing toward Biden. “We are not going to shut down. We are going to open the schools.” As an example of the resiliency of young people, he mentioned that his son Barron tested positive for COVID-19 and recovered.

“I would shut down the virus, not the country,” Biden said. “It’s his ineptitude that caused so many schools and businesses to close in large part. Instead of being in a sand trap playing golf, he should have been negotiating with Nancy Pelosi.”

“He says we’re learning to live with it,” the former vice president said, but instead, “people are learning to die with it.”

Biden added that reopening the economy and minimizing transmission of COVID-19 are not mutually exclusive. “We can walk and chew gum at the same time.”

Divergence over the ACA

The fate of the ACA also garnered considerable attention. The discussion underlined a vast difference of opinion between the two candidates on the US healthcare system.

The moderator asked Trump what he would do for the 20 million Americans who get their healthcare through the ACA if it’s taken away.

“Through the legislature, I terminated the individual mandate, the worst part of Obamacare,” Trump said. “And now it’s in court because Obamacare is no good.

“Preexisting conditions will stay,” Trump added.

“I want to terminate Obamacare, and I want to come up with a beautiful healthcare [plan],” Trump added, turning the discussion toward private health insurance. “One thing that is very important is we have 180 million out there who have great private healthcare. Joe Biden will terminate all of their healthcare.”

Trump described Biden’s plan as “socialized medicine.” He also emphasized that protections for people with preexisting conditions “will stay.”

The Trump administration is supporting a lawsuit to overturn the ACA. The suit was filed by 18 Republican-led states. Arguments before the US Supreme Court on the constitutionality of the ACA are scheduled for November 10.

The moderator asked what Biden plans to do if the ACA is struck down. “I will pass Obamacare with a public option ― that will be ‘Bidencare.’ “ He said his plan will reduce premiums and drug prices. “I support private insurance. No one lost their private insurance under Obamacare.

“There is no way he can protect preexisting conditions,” Biden said. He added that 10 million people have already lost their private healthcare through unemployment during the pandemic.

Muting the mic

Following what many described as a chaotic first debate at the Cleveland Clinic in Ohio on September 29, the Commission on Presidential Debate opted to allow the muting of the microphone during the first 2 minutes of remarks made by each candidate during each debate segment.

The muting of the microphones appeared to prevent crosstalk during the beginning of each segment of the debate. The candidates did manage to talk over and interrupt each other, as well as the moderator, during portions of the debate.

This article first appeared on Medscape.com.

The COVID-19 pandemic figured prominently in the final debate between President Donald Trump and former Vice President Joe Biden when they met on stage for a 90-minute debate in Nashville, Tennessee, Thursday evening.

The adequacy of the COVID-19 response to date, the likely timeline for vaccine availability, and how to reopen businesses while keeping Americans safe were among the points on which the two candidates disagreed. The two candidates also sparred over the value of the Affordable Care Act (ACA) and the future of healthcare in the United States.

Trump and Biden also differed on whether or not the country is facing a “dark winter” because of the pandemic.

Moderator Kristen Welker, NBC News White House correspondent, asked Trump to comment on the fact that 40,000 people are in the hospital on debate night with COVID-19 and that 16,000 have died since the last presidential debate.

Trump said, “2.2 million people modeled out were expected to die.” He said COVID-19 is a worldwide disease that does not only affect the United States.

“The mortality rate is down 85%, and the excess mortality is also down,” he added. He pointed out that previous spikes in Florida, Texas, and Arizona are now gone, and “spikes and surges in other places will soon be gone.

“It will go away, we are rounding the corner,” Trump said. “From personal experience, I was in the hospital, I had it, and they gave me a therapeutic, some would call it a cure...and now they say I’m immune. Whether it’s for a month or lifetime, nobody has been able to say that, but I’m immune.”

Biden countered by saying that “220,000 people are dead. If you hear nothing else I say tonight, hear this: Anyone who’s responsible for that many deaths should not remain president of the United States of America.”

Biden said there are a thousand deaths a day now and that there are over 70K new cases per day. “The expectation is we will have another 200,000 people down before the end of this year. If we just all wore these masks, we could save 100,000.”

“The New England Journal of Medicine said the way the president has handled this is absolutely tragic,” Biden added.

Vaccine timeline

Welker asked Trump if he could guarantee that there will be a COVID-19 vaccine within weeks.

“I can’t guarantee that, but it will be by end of the year. It will be distributed very quickly,” Trump said. He added that three leading vaccine developers, Johnson & Johnson, Moderna, and Pfizer, “are doing very well.”

“We’re about to go into a dark winter and he has no clear plan,” Biden said. “There is no prospect there will be a vaccine for most Americans by middle of next year.”

“It will not be a dark winter,” Trump responded.

Reopening the economy

Trump and Biden disagreed on how aggressively the economy should be reopened in light of the pandemic.

“I want to open the schools. We can’t keep this country closed,” Trump said. “This is a massive country with a massive economy.” He pointed out that rates of depression and suicide have risen because of the economic shutdown. “The cure cannot be worse than the problem.

“His Democrat governors...shut down so tight, and they’re dying,” the president added, gesturing toward Biden. “We are not going to shut down. We are going to open the schools.” As an example of the resiliency of young people, he mentioned that his son Barron tested positive for COVID-19 and recovered.

“I would shut down the virus, not the country,” Biden said. “It’s his ineptitude that caused so many schools and businesses to close in large part. Instead of being in a sand trap playing golf, he should have been negotiating with Nancy Pelosi.”

“He says we’re learning to live with it,” the former vice president said, but instead, “people are learning to die with it.”

Biden added that reopening the economy and minimizing transmission of COVID-19 are not mutually exclusive. “We can walk and chew gum at the same time.”

Divergence over the ACA

The fate of the ACA also garnered considerable attention. The discussion underlined a vast difference of opinion between the two candidates on the US healthcare system.

The moderator asked Trump what he would do for the 20 million Americans who get their healthcare through the ACA if it’s taken away.

“Through the legislature, I terminated the individual mandate, the worst part of Obamacare,” Trump said. “And now it’s in court because Obamacare is no good.

“Preexisting conditions will stay,” Trump added.

“I want to terminate Obamacare, and I want to come up with a beautiful healthcare [plan],” Trump added, turning the discussion toward private health insurance. “One thing that is very important is we have 180 million out there who have great private healthcare. Joe Biden will terminate all of their healthcare.”

Trump described Biden’s plan as “socialized medicine.” He also emphasized that protections for people with preexisting conditions “will stay.”

The Trump administration is supporting a lawsuit to overturn the ACA. The suit was filed by 18 Republican-led states. Arguments before the US Supreme Court on the constitutionality of the ACA are scheduled for November 10.

The moderator asked what Biden plans to do if the ACA is struck down. “I will pass Obamacare with a public option ― that will be ‘Bidencare.’ “ He said his plan will reduce premiums and drug prices. “I support private insurance. No one lost their private insurance under Obamacare.

“There is no way he can protect preexisting conditions,” Biden said. He added that 10 million people have already lost their private healthcare through unemployment during the pandemic.

Muting the mic

Following what many described as a chaotic first debate at the Cleveland Clinic in Ohio on September 29, the Commission on Presidential Debate opted to allow the muting of the microphone during the first 2 minutes of remarks made by each candidate during each debate segment.

The muting of the microphones appeared to prevent crosstalk during the beginning of each segment of the debate. The candidates did manage to talk over and interrupt each other, as well as the moderator, during portions of the debate.

This article first appeared on Medscape.com.

The COVID-19 pandemic figured prominently in the final debate between President Donald Trump and former Vice President Joe Biden when they met on stage for a 90-minute debate in Nashville, Tennessee, Thursday evening.

The adequacy of the COVID-19 response to date, the likely timeline for vaccine availability, and how to reopen businesses while keeping Americans safe were among the points on which the two candidates disagreed. The two candidates also sparred over the value of the Affordable Care Act (ACA) and the future of healthcare in the United States.

Trump and Biden also differed on whether or not the country is facing a “dark winter” because of the pandemic.

Moderator Kristen Welker, NBC News White House correspondent, asked Trump to comment on the fact that 40,000 people are in the hospital on debate night with COVID-19 and that 16,000 have died since the last presidential debate.

Trump said, “2.2 million people modeled out were expected to die.” He said COVID-19 is a worldwide disease that does not only affect the United States.

“The mortality rate is down 85%, and the excess mortality is also down,” he added. He pointed out that previous spikes in Florida, Texas, and Arizona are now gone, and “spikes and surges in other places will soon be gone.

“It will go away, we are rounding the corner,” Trump said. “From personal experience, I was in the hospital, I had it, and they gave me a therapeutic, some would call it a cure...and now they say I’m immune. Whether it’s for a month or lifetime, nobody has been able to say that, but I’m immune.”

Biden countered by saying that “220,000 people are dead. If you hear nothing else I say tonight, hear this: Anyone who’s responsible for that many deaths should not remain president of the United States of America.”

Biden said there are a thousand deaths a day now and that there are over 70K new cases per day. “The expectation is we will have another 200,000 people down before the end of this year. If we just all wore these masks, we could save 100,000.”

“The New England Journal of Medicine said the way the president has handled this is absolutely tragic,” Biden added.

Vaccine timeline

Welker asked Trump if he could guarantee that there will be a COVID-19 vaccine within weeks.

“I can’t guarantee that, but it will be by end of the year. It will be distributed very quickly,” Trump said. He added that three leading vaccine developers, Johnson & Johnson, Moderna, and Pfizer, “are doing very well.”

“We’re about to go into a dark winter and he has no clear plan,” Biden said. “There is no prospect there will be a vaccine for most Americans by middle of next year.”

“It will not be a dark winter,” Trump responded.

Reopening the economy

Trump and Biden disagreed on how aggressively the economy should be reopened in light of the pandemic.

“I want to open the schools. We can’t keep this country closed,” Trump said. “This is a massive country with a massive economy.” He pointed out that rates of depression and suicide have risen because of the economic shutdown. “The cure cannot be worse than the problem.

“His Democrat governors...shut down so tight, and they’re dying,” the president added, gesturing toward Biden. “We are not going to shut down. We are going to open the schools.” As an example of the resiliency of young people, he mentioned that his son Barron tested positive for COVID-19 and recovered.

“I would shut down the virus, not the country,” Biden said. “It’s his ineptitude that caused so many schools and businesses to close in large part. Instead of being in a sand trap playing golf, he should have been negotiating with Nancy Pelosi.”

“He says we’re learning to live with it,” the former vice president said, but instead, “people are learning to die with it.”

Biden added that reopening the economy and minimizing transmission of COVID-19 are not mutually exclusive. “We can walk and chew gum at the same time.”

Divergence over the ACA

The fate of the ACA also garnered considerable attention. The discussion underlined a vast difference of opinion between the two candidates on the US healthcare system.

The moderator asked Trump what he would do for the 20 million Americans who get their healthcare through the ACA if it’s taken away.

“Through the legislature, I terminated the individual mandate, the worst part of Obamacare,” Trump said. “And now it’s in court because Obamacare is no good.

“Preexisting conditions will stay,” Trump added.

“I want to terminate Obamacare, and I want to come up with a beautiful healthcare [plan],” Trump added, turning the discussion toward private health insurance. “One thing that is very important is we have 180 million out there who have great private healthcare. Joe Biden will terminate all of their healthcare.”

Trump described Biden’s plan as “socialized medicine.” He also emphasized that protections for people with preexisting conditions “will stay.”

The Trump administration is supporting a lawsuit to overturn the ACA. The suit was filed by 18 Republican-led states. Arguments before the US Supreme Court on the constitutionality of the ACA are scheduled for November 10.

The moderator asked what Biden plans to do if the ACA is struck down. “I will pass Obamacare with a public option ― that will be ‘Bidencare.’ “ He said his plan will reduce premiums and drug prices. “I support private insurance. No one lost their private insurance under Obamacare.

“There is no way he can protect preexisting conditions,” Biden said. He added that 10 million people have already lost their private healthcare through unemployment during the pandemic.

Muting the mic

Following what many described as a chaotic first debate at the Cleveland Clinic in Ohio on September 29, the Commission on Presidential Debate opted to allow the muting of the microphone during the first 2 minutes of remarks made by each candidate during each debate segment.

The muting of the microphones appeared to prevent crosstalk during the beginning of each segment of the debate. The candidates did manage to talk over and interrupt each other, as well as the moderator, during portions of the debate.

This article first appeared on Medscape.com.

The ongoing COVID-19 pandemic poses clear threats to mental well-being, but an increase in suicide is not inevitable if appropriate action is taken, one expert says.

“Increases in suicide rates should not be a foregone conclusion, even with the negative effects of the pandemic. If the lessons of suicide prevention research are heeded during and after the pandemic, this potential for increased risk could be substantially mitigated,” writes Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, in an invited communication in JAMA Psychiatry.

“This is a moment in history when suicide prevention must be prioritized as a serious public health concern,” she writes.

Mitigating suicide risk

Although evidence from the first 6 months of the pandemic reveal specific effects on suicide risk, real-time data on suicide deaths are not available in most regions of the world. From emerging data from several countries, there is no evidence of increased suicide rates during the pandemic thus far, Moutier notes.

Still, a number of pandemic-related risk factors could increase individual and population suicide risk.

They include deterioration or recurrence of serious mental illness; increased isolation, loneliness, and bereavement; increased use of drugs and alcohol; job loss and other financial stressors; and increases in domestic violence.

There are mitigating strategies for each of these “threats to suicide risk.” The science is “very clear,” Moutier told Medscape Medical News.

“Suicide risk is never a situation of inevitability. It’s dynamic, with multiple forces at play in each individual and in the population. Lives can be saved simply by making people feel more connected to each other, that they are part of a larger community,” she added.

The political will

Moutier notes that prior to the pandemic, four countries ― Finland, Norway, Sweden, and Australia ― had fully implemented national suicide prevention plans and had achieved reductions in their national suicide rates. However, in the United States, the suicide rate has been steadily increasing since 1999.

A Centers for Disease Control and Prevention survey released in August 2020 found that 40% of US adults reported symptoms of depression, anxiety, or increased substance use during COVID-19 and that about 11% reported suicidal ideation in the past month, all increases from prior surveys.

COVID-19 presents a “new and urgent opportunity” to focus political will, federal investments, and the global community on suicide prevention, Moutier writes.

“The political will to address suicide has actually moved in the right direction during COVID, as evidenced by a number of pieces of legislation that have suddenly found their way to passing that we’ve been working on for years,” she said in an interview.

One example, she said, is the National Suicide Hotline Designation Act, signed into law earlier this month by President Donald Trump.

As previously reported, under the law, beginning in July 2022, Americans experiencing a mental health crisis will be able to dial 9-8-8 and be connected to the services and counselors at the National Suicide Prevention Lifeline.

Moutier reports no relevant financial relationships.

This article first appeared on Medscape.com.

The ongoing COVID-19 pandemic poses clear threats to mental well-being, but an increase in suicide is not inevitable if appropriate action is taken, one expert says.

“Increases in suicide rates should not be a foregone conclusion, even with the negative effects of the pandemic. If the lessons of suicide prevention research are heeded during and after the pandemic, this potential for increased risk could be substantially mitigated,” writes Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, in an invited communication in JAMA Psychiatry.

“This is a moment in history when suicide prevention must be prioritized as a serious public health concern,” she writes.

Mitigating suicide risk

Although evidence from the first 6 months of the pandemic reveal specific effects on suicide risk, real-time data on suicide deaths are not available in most regions of the world. From emerging data from several countries, there is no evidence of increased suicide rates during the pandemic thus far, Moutier notes.

Still, a number of pandemic-related risk factors could increase individual and population suicide risk.

They include deterioration or recurrence of serious mental illness; increased isolation, loneliness, and bereavement; increased use of drugs and alcohol; job loss and other financial stressors; and increases in domestic violence.

There are mitigating strategies for each of these “threats to suicide risk.” The science is “very clear,” Moutier told Medscape Medical News.

“Suicide risk is never a situation of inevitability. It’s dynamic, with multiple forces at play in each individual and in the population. Lives can be saved simply by making people feel more connected to each other, that they are part of a larger community,” she added.

The political will

Moutier notes that prior to the pandemic, four countries ― Finland, Norway, Sweden, and Australia ― had fully implemented national suicide prevention plans and had achieved reductions in their national suicide rates. However, in the United States, the suicide rate has been steadily increasing since 1999.

A Centers for Disease Control and Prevention survey released in August 2020 found that 40% of US adults reported symptoms of depression, anxiety, or increased substance use during COVID-19 and that about 11% reported suicidal ideation in the past month, all increases from prior surveys.

COVID-19 presents a “new and urgent opportunity” to focus political will, federal investments, and the global community on suicide prevention, Moutier writes.

“The political will to address suicide has actually moved in the right direction during COVID, as evidenced by a number of pieces of legislation that have suddenly found their way to passing that we’ve been working on for years,” she said in an interview.

One example, she said, is the National Suicide Hotline Designation Act, signed into law earlier this month by President Donald Trump.

As previously reported, under the law, beginning in July 2022, Americans experiencing a mental health crisis will be able to dial 9-8-8 and be connected to the services and counselors at the National Suicide Prevention Lifeline.

Moutier reports no relevant financial relationships.

This article first appeared on Medscape.com.

The ongoing COVID-19 pandemic poses clear threats to mental well-being, but an increase in suicide is not inevitable if appropriate action is taken, one expert says.

“Increases in suicide rates should not be a foregone conclusion, even with the negative effects of the pandemic. If the lessons of suicide prevention research are heeded during and after the pandemic, this potential for increased risk could be substantially mitigated,” writes Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, in an invited communication in JAMA Psychiatry.

“This is a moment in history when suicide prevention must be prioritized as a serious public health concern,” she writes.

Mitigating suicide risk

Although evidence from the first 6 months of the pandemic reveal specific effects on suicide risk, real-time data on suicide deaths are not available in most regions of the world. From emerging data from several countries, there is no evidence of increased suicide rates during the pandemic thus far, Moutier notes.

Still, a number of pandemic-related risk factors could increase individual and population suicide risk.

They include deterioration or recurrence of serious mental illness; increased isolation, loneliness, and bereavement; increased use of drugs and alcohol; job loss and other financial stressors; and increases in domestic violence.

There are mitigating strategies for each of these “threats to suicide risk.” The science is “very clear,” Moutier told Medscape Medical News.

“Suicide risk is never a situation of inevitability. It’s dynamic, with multiple forces at play in each individual and in the population. Lives can be saved simply by making people feel more connected to each other, that they are part of a larger community,” she added.

The political will

Moutier notes that prior to the pandemic, four countries ― Finland, Norway, Sweden, and Australia ― had fully implemented national suicide prevention plans and had achieved reductions in their national suicide rates. However, in the United States, the suicide rate has been steadily increasing since 1999.

A Centers for Disease Control and Prevention survey released in August 2020 found that 40% of US adults reported symptoms of depression, anxiety, or increased substance use during COVID-19 and that about 11% reported suicidal ideation in the past month, all increases from prior surveys.

COVID-19 presents a “new and urgent opportunity” to focus political will, federal investments, and the global community on suicide prevention, Moutier writes.

“The political will to address suicide has actually moved in the right direction during COVID, as evidenced by a number of pieces of legislation that have suddenly found their way to passing that we’ve been working on for years,” she said in an interview.

One example, she said, is the National Suicide Hotline Designation Act, signed into law earlier this month by President Donald Trump.

As previously reported, under the law, beginning in July 2022, Americans experiencing a mental health crisis will be able to dial 9-8-8 and be connected to the services and counselors at the National Suicide Prevention Lifeline.

Moutier reports no relevant financial relationships.

This article first appeared on Medscape.com.

The Florida Department of Health will investigate the state’s 16,000 coronavirus deaths due to questions about the integrity of the data, according to an announcement issued Wednesday.

State health department officials said the “fatality data reported to the state consistently presents confusion and warrants a rigorous review.” The review is meant to “ensure data integrity.”

“During a pandemic, the public must be able to rely on accurate public health data to make informed decisions,” Scott Rivkees, the surgeon general for Florida, said in the statement.

Among the 95 deaths reported Wednesday for instance, 16 had more than a 2-month separation between the time of testing positive for COVID-19 and passing away, and 5 cases had a 3-month gap. In addition, 11 of the deaths occurred more than a month ago.

The health department then listed data for all 95 cases, including the age, gender, county and the dates of test positivity and death. Palm Beach County had 50 of the COVID-19 deaths.

“To ensure the accuracy of COVID-19 related deaths, the department will be performing additional reviews of all deaths,” Rivkees said. “Timely and accurate data remains a top priority of the Department of Health.”

Last week, Jose Oliva, speaker of the Florida House of Representatives, said medical examiner reports were “often lacking in rigor.” House Democrats then said Republicans were trying to “downplay the death toll,” according to the South Florida Sun Sentinel .

Fred Piccolo Jr., a spokesman for Florida Gov. Ron DeSantis, told the newspaper Wednesday that officials have struggled to obtain timely data. Labs sometimes report test results from weeks before, he added.

“It’s really one of those things that you gotta know if someone is dying of COVID or if they’re not,” Piccolo said. “Then you can legitimately say, here are the numbers.”

Sources

Florida Department of Health, “Florida Surgeon General Implements Additional Review Process for Fatalities Attributed to COVID-19 to Ensure Data Integrity.”

South Florida Sun Sentinel, “Florida to investigate all COVID-19 deaths after questions about ‘integrity’ of data.”

WebMD Health News © 2020 

This article first appeared on Medscape.com.

The Florida Department of Health will investigate the state’s 16,000 coronavirus deaths due to questions about the integrity of the data, according to an announcement issued Wednesday.

State health department officials said the “fatality data reported to the state consistently presents confusion and warrants a rigorous review.” The review is meant to “ensure data integrity.”

“During a pandemic, the public must be able to rely on accurate public health data to make informed decisions,” Scott Rivkees, the surgeon general for Florida, said in the statement.

Among the 95 deaths reported Wednesday for instance, 16 had more than a 2-month separation between the time of testing positive for COVID-19 and passing away, and 5 cases had a 3-month gap. In addition, 11 of the deaths occurred more than a month ago.

The health department then listed data for all 95 cases, including the age, gender, county and the dates of test positivity and death. Palm Beach County had 50 of the COVID-19 deaths.

“To ensure the accuracy of COVID-19 related deaths, the department will be performing additional reviews of all deaths,” Rivkees said. “Timely and accurate data remains a top priority of the Department of Health.”

Last week, Jose Oliva, speaker of the Florida House of Representatives, said medical examiner reports were “often lacking in rigor.” House Democrats then said Republicans were trying to “downplay the death toll,” according to the South Florida Sun Sentinel .

Fred Piccolo Jr., a spokesman for Florida Gov. Ron DeSantis, told the newspaper Wednesday that officials have struggled to obtain timely data. Labs sometimes report test results from weeks before, he added.

“It’s really one of those things that you gotta know if someone is dying of COVID or if they’re not,” Piccolo said. “Then you can legitimately say, here are the numbers.”

Sources

Florida Department of Health, “Florida Surgeon General Implements Additional Review Process for Fatalities Attributed to COVID-19 to Ensure Data Integrity.”

South Florida Sun Sentinel, “Florida to investigate all COVID-19 deaths after questions about ‘integrity’ of data.”

WebMD Health News © 2020 

This article first appeared on Medscape.com.

The Florida Department of Health will investigate the state’s 16,000 coronavirus deaths due to questions about the integrity of the data, according to an announcement issued Wednesday.

State health department officials said the “fatality data reported to the state consistently presents confusion and warrants a rigorous review.” The review is meant to “ensure data integrity.”

“During a pandemic, the public must be able to rely on accurate public health data to make informed decisions,” Scott Rivkees, the surgeon general for Florida, said in the statement.

Among the 95 deaths reported Wednesday for instance, 16 had more than a 2-month separation between the time of testing positive for COVID-19 and passing away, and 5 cases had a 3-month gap. In addition, 11 of the deaths occurred more than a month ago.

The health department then listed data for all 95 cases, including the age, gender, county and the dates of test positivity and death. Palm Beach County had 50 of the COVID-19 deaths.

“To ensure the accuracy of COVID-19 related deaths, the department will be performing additional reviews of all deaths,” Rivkees said. “Timely and accurate data remains a top priority of the Department of Health.”

Last week, Jose Oliva, speaker of the Florida House of Representatives, said medical examiner reports were “often lacking in rigor.” House Democrats then said Republicans were trying to “downplay the death toll,” according to the South Florida Sun Sentinel .

Fred Piccolo Jr., a spokesman for Florida Gov. Ron DeSantis, told the newspaper Wednesday that officials have struggled to obtain timely data. Labs sometimes report test results from weeks before, he added.

“It’s really one of those things that you gotta know if someone is dying of COVID or if they’re not,” Piccolo said. “Then you can legitimately say, here are the numbers.”

Sources

Florida Department of Health, “Florida Surgeon General Implements Additional Review Process for Fatalities Attributed to COVID-19 to Ensure Data Integrity.”

South Florida Sun Sentinel, “Florida to investigate all COVID-19 deaths after questions about ‘integrity’ of data.”

WebMD Health News © 2020 

This article first appeared on Medscape.com.

Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.

Canberk Sezer/Getty Images

There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.

“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”

Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
 

Limited data

The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.

Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.

“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”

Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.

“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.

Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”

Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”

Mitigating risk

COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”

When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”

If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.

Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.

Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”

Dr. Bernhardt had no relevant disclosures.

[email protected]

Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.

Canberk Sezer/Getty Images

There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.

“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”

Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
 

Limited data

The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.

Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.

“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”

Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.

“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.

Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”

Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”

Mitigating risk

COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”

When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”

If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.

Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.

Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”

Dr. Bernhardt had no relevant disclosures.

[email protected]

Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.

Canberk Sezer/Getty Images

There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.

“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”

Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
 

Limited data

The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.

Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.

“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”

Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.

“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.

Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”

Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”

Mitigating risk

COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”

When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”

If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.

Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.

Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”

Dr. Bernhardt had no relevant disclosures.

[email protected]

Women with polycystic ovarian syndrome (PCOS) before menopause appear to have a greater risk of stroke, heart attack, and other cardiovascular events after menopause, according to findings presented at the virtual American Society for Reproductive Medicine (ASRM) 2020 Scientific Congress.

“We found a PCOS diagnosis prior to menopause was associated with a 64% increased risk of cardiovascular disease after menopause independent of age at enrollment, race, body mass index, and smoking status,” presenter Jacob Christ, MD, a resident at the University of Washington in Seattle, told attendees. “Taken together, our results suggest that women with PCOS have more risk factors for future cardiovascular disease at baseline, and a present PCOS diagnosis prior to menopause is associated with an increased risk of cardiovascular disease after menopause.”

The results are important to consider in women seeking care related to fertility, according to Amanda N. Kallen, MD, assistant professor of reproductive endocrinology and infertility at Yale Medicine in New Haven, Conn.

“As fertility specialists, we often see women with PCOS visit us when they are having trouble conceiving, but often [they] do not return to our care once they’ve built their family,” said Dr. Kallen, who was not involved in the research.

“This excellent talk emphasized how critical it is for us as reproductive endocrinologists to have ongoing discussions with PCOS patients about long-term cardiovascular risks at every opportunity, and to emphasize that these risks persist long after the reproductive years have ended,” Dr. Kallen said in an interview.
 

Identifying women at higher risk

Characteristics of PCOS in adolescence are already understood, including hyperandrogenism, acne, irregular bleeding, and variable ages of menarche, Dr. Christ explained. Similarly, in women’s reproductive years, PCOS is linked to abnormal uterine bleeding, hirsutism, dyslipidemia, infertility, impaired glucose tolerance, gestational diabetes, and preeclampsia.

“What is less clear is if baseline cardiometabolic dysfunction during reproductive years translates into cardiovascular disease after menopause,” Dr. Christ said. “Menopausal changes may reduce risk of cardiovascular disease among PCOS women, as it is known that overall, androgen levels decline during menopause. Furthermore, ovarian aging may be delayed in PCOS women, which may be protective against cardiovascular disease.”

To learn more, the researchers completed a secondary analysis of data from the Study of Women’s Health Across the Nation (SWAN), a prospective cohort study. Women enrolled in the study were aged 42-52 years at baseline, had a uterus and at least one ovary, and menstruated within the previous 3 months. Women were considered to have PCOS if they had both biochemical hyperandrogenism and a history of irregular menses.

The researchers included participants in the secondary analysis if they had complete data on the women’s baseline menstrual status and total testosterone and if the women had at least one follow-up visit after menopause. Menopause was approximated as 51 years old if not otherwise reported (or 1 year after study entry if age 51 at entry). At the follow-up visit, women self-reported any cardiovascular disease events since menopause.

The study’s primary outcome was the first postmenopausal cardiovascular event. These included any of the following: myocardial infarction, cerebrovascular accident or stroke, angina, percutaneous coronary intervention or angioplasty, coronary artery bypass graft, heart failure, carotid artery procedure, peripheral artery disease or lower extremity procedure, renal artery procedure, deep vein thrombosis, pulmonary embolism, and abdominal aortic aneurysm.

Among 1,340 women included in the analysis, 174 (13%) women had PCOS and 1,166 did not. The average age at screening and at menopause were not significantly different between the groups, but they did differ based on other baseline characteristics.

More women with PCOS frequently smoked cigarettes (22%) vs. those without PCOS (12.7%), and women with PCOS had an average body mass index of 31.3, vs. 26.7 among those without PCOS. Women with PCOS also had higher systolic blood pressure (120.7 vs. 115.8 mm Hg), higher total cholesterol (202 vs. 192 mg/dL), and higher fasting blood glucose (103.7 vs. 89.2 mg/dL; P < .01 for all).

After the researchers controlled for age at enrollment, race, BMI, and smoking status, women with PCOS had 1.6 times greater odds of a cardiovascular event after menopause compared with women without PCOS (odds ratio [OR], 1.6; P = .029). Those with PCOS also had a significantly higher Atherosclerotic Cardiovascular Disease risk scores (P = .024), but their Framingham 10-year risk score was not significantly different from those without PCOS.

Although the findings are not necessarily surprising, the study’s value particularly lay in its size, prospective data collection, and rigorous methods, said Ginny Ryan, MD, MA, professor and division chief of reproductive endocrinology and infertility at the University of Washington in Seattle.

“While this study’s criteria used to identify subjects with PCOS selected a population with a particularly severe phenotype of PCOS and thus a higher risk population for cardiovascular disease, it is vital for women’s health providers to truly understand the medium- and long-term life-threatening associations found more commonly in many with PCOS,” Dr. Ryan, who attended the talk and was not involved in the research, said in an interview.

“This study emphasizes the importance of identifying PCOS before menopause, not just for the patient’s immediate well-being, but also so that appropriate counseling and referral can take place to optimize primary, secondary, and tertiary prevention efforts against CVD and related morbidity and mortality,” Dr. Ryan said. “Providers who focus on reproductive health and reproductive-aged women have the opportunity to play a vital role in optimizing the long-term health of their patients.”

Aside from being a prospective cohort with more than 2 decades of follow-up, the study’s other strengths included the definition of PCOS before menopause and use of multiple markers of postmenopausal cardiovascular disease, Dr. Christ said. The study’s main weaknesses were the exclusion of mild PCOS, the self-reporting of cardiovascular events, and the multiple ways of defining menopause.

Dr. Kallen is a consultant for Gynaesight and a reviewer for Healthline. Dr. Christ and Dr. Ryan have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Women with polycystic ovarian syndrome (PCOS) before menopause appear to have a greater risk of stroke, heart attack, and other cardiovascular events after menopause, according to findings presented at the virtual American Society for Reproductive Medicine (ASRM) 2020 Scientific Congress.

“We found a PCOS diagnosis prior to menopause was associated with a 64% increased risk of cardiovascular disease after menopause independent of age at enrollment, race, body mass index, and smoking status,” presenter Jacob Christ, MD, a resident at the University of Washington in Seattle, told attendees. “Taken together, our results suggest that women with PCOS have more risk factors for future cardiovascular disease at baseline, and a present PCOS diagnosis prior to menopause is associated with an increased risk of cardiovascular disease after menopause.”

The results are important to consider in women seeking care related to fertility, according to Amanda N. Kallen, MD, assistant professor of reproductive endocrinology and infertility at Yale Medicine in New Haven, Conn.

“As fertility specialists, we often see women with PCOS visit us when they are having trouble conceiving, but often [they] do not return to our care once they’ve built their family,” said Dr. Kallen, who was not involved in the research.

“This excellent talk emphasized how critical it is for us as reproductive endocrinologists to have ongoing discussions with PCOS patients about long-term cardiovascular risks at every opportunity, and to emphasize that these risks persist long after the reproductive years have ended,” Dr. Kallen said in an interview.
 

Identifying women at higher risk

Characteristics of PCOS in adolescence are already understood, including hyperandrogenism, acne, irregular bleeding, and variable ages of menarche, Dr. Christ explained. Similarly, in women’s reproductive years, PCOS is linked to abnormal uterine bleeding, hirsutism, dyslipidemia, infertility, impaired glucose tolerance, gestational diabetes, and preeclampsia.

“What is less clear is if baseline cardiometabolic dysfunction during reproductive years translates into cardiovascular disease after menopause,” Dr. Christ said. “Menopausal changes may reduce risk of cardiovascular disease among PCOS women, as it is known that overall, androgen levels decline during menopause. Furthermore, ovarian aging may be delayed in PCOS women, which may be protective against cardiovascular disease.”

To learn more, the researchers completed a secondary analysis of data from the Study of Women’s Health Across the Nation (SWAN), a prospective cohort study. Women enrolled in the study were aged 42-52 years at baseline, had a uterus and at least one ovary, and menstruated within the previous 3 months. Women were considered to have PCOS if they had both biochemical hyperandrogenism and a history of irregular menses.

The researchers included participants in the secondary analysis if they had complete data on the women’s baseline menstrual status and total testosterone and if the women had at least one follow-up visit after menopause. Menopause was approximated as 51 years old if not otherwise reported (or 1 year after study entry if age 51 at entry). At the follow-up visit, women self-reported any cardiovascular disease events since menopause.

The study’s primary outcome was the first postmenopausal cardiovascular event. These included any of the following: myocardial infarction, cerebrovascular accident or stroke, angina, percutaneous coronary intervention or angioplasty, coronary artery bypass graft, heart failure, carotid artery procedure, peripheral artery disease or lower extremity procedure, renal artery procedure, deep vein thrombosis, pulmonary embolism, and abdominal aortic aneurysm.

Among 1,340 women included in the analysis, 174 (13%) women had PCOS and 1,166 did not. The average age at screening and at menopause were not significantly different between the groups, but they did differ based on other baseline characteristics.

More women with PCOS frequently smoked cigarettes (22%) vs. those without PCOS (12.7%), and women with PCOS had an average body mass index of 31.3, vs. 26.7 among those without PCOS. Women with PCOS also had higher systolic blood pressure (120.7 vs. 115.8 mm Hg), higher total cholesterol (202 vs. 192 mg/dL), and higher fasting blood glucose (103.7 vs. 89.2 mg/dL; P < .01 for all).

After the researchers controlled for age at enrollment, race, BMI, and smoking status, women with PCOS had 1.6 times greater odds of a cardiovascular event after menopause compared with women without PCOS (odds ratio [OR], 1.6; P = .029). Those with PCOS also had a significantly higher Atherosclerotic Cardiovascular Disease risk scores (P = .024), but their Framingham 10-year risk score was not significantly different from those without PCOS.

Although the findings are not necessarily surprising, the study’s value particularly lay in its size, prospective data collection, and rigorous methods, said Ginny Ryan, MD, MA, professor and division chief of reproductive endocrinology and infertility at the University of Washington in Seattle.

“While this study’s criteria used to identify subjects with PCOS selected a population with a particularly severe phenotype of PCOS and thus a higher risk population for cardiovascular disease, it is vital for women’s health providers to truly understand the medium- and long-term life-threatening associations found more commonly in many with PCOS,” Dr. Ryan, who attended the talk and was not involved in the research, said in an interview.

“This study emphasizes the importance of identifying PCOS before menopause, not just for the patient’s immediate well-being, but also so that appropriate counseling and referral can take place to optimize primary, secondary, and tertiary prevention efforts against CVD and related morbidity and mortality,” Dr. Ryan said. “Providers who focus on reproductive health and reproductive-aged women have the opportunity to play a vital role in optimizing the long-term health of their patients.”

Aside from being a prospective cohort with more than 2 decades of follow-up, the study’s other strengths included the definition of PCOS before menopause and use of multiple markers of postmenopausal cardiovascular disease, Dr. Christ said. The study’s main weaknesses were the exclusion of mild PCOS, the self-reporting of cardiovascular events, and the multiple ways of defining menopause.

Dr. Kallen is a consultant for Gynaesight and a reviewer for Healthline. Dr. Christ and Dr. Ryan have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Women with polycystic ovarian syndrome (PCOS) before menopause appear to have a greater risk of stroke, heart attack, and other cardiovascular events after menopause, according to findings presented at the virtual American Society for Reproductive Medicine (ASRM) 2020 Scientific Congress.

“We found a PCOS diagnosis prior to menopause was associated with a 64% increased risk of cardiovascular disease after menopause independent of age at enrollment, race, body mass index, and smoking status,” presenter Jacob Christ, MD, a resident at the University of Washington in Seattle, told attendees. “Taken together, our results suggest that women with PCOS have more risk factors for future cardiovascular disease at baseline, and a present PCOS diagnosis prior to menopause is associated with an increased risk of cardiovascular disease after menopause.”

The results are important to consider in women seeking care related to fertility, according to Amanda N. Kallen, MD, assistant professor of reproductive endocrinology and infertility at Yale Medicine in New Haven, Conn.

“As fertility specialists, we often see women with PCOS visit us when they are having trouble conceiving, but often [they] do not return to our care once they’ve built their family,” said Dr. Kallen, who was not involved in the research.

“This excellent talk emphasized how critical it is for us as reproductive endocrinologists to have ongoing discussions with PCOS patients about long-term cardiovascular risks at every opportunity, and to emphasize that these risks persist long after the reproductive years have ended,” Dr. Kallen said in an interview.
 

Identifying women at higher risk

Characteristics of PCOS in adolescence are already understood, including hyperandrogenism, acne, irregular bleeding, and variable ages of menarche, Dr. Christ explained. Similarly, in women’s reproductive years, PCOS is linked to abnormal uterine bleeding, hirsutism, dyslipidemia, infertility, impaired glucose tolerance, gestational diabetes, and preeclampsia.

“What is less clear is if baseline cardiometabolic dysfunction during reproductive years translates into cardiovascular disease after menopause,” Dr. Christ said. “Menopausal changes may reduce risk of cardiovascular disease among PCOS women, as it is known that overall, androgen levels decline during menopause. Furthermore, ovarian aging may be delayed in PCOS women, which may be protective against cardiovascular disease.”

To learn more, the researchers completed a secondary analysis of data from the Study of Women’s Health Across the Nation (SWAN), a prospective cohort study. Women enrolled in the study were aged 42-52 years at baseline, had a uterus and at least one ovary, and menstruated within the previous 3 months. Women were considered to have PCOS if they had both biochemical hyperandrogenism and a history of irregular menses.

The researchers included participants in the secondary analysis if they had complete data on the women’s baseline menstrual status and total testosterone and if the women had at least one follow-up visit after menopause. Menopause was approximated as 51 years old if not otherwise reported (or 1 year after study entry if age 51 at entry). At the follow-up visit, women self-reported any cardiovascular disease events since menopause.

The study’s primary outcome was the first postmenopausal cardiovascular event. These included any of the following: myocardial infarction, cerebrovascular accident or stroke, angina, percutaneous coronary intervention or angioplasty, coronary artery bypass graft, heart failure, carotid artery procedure, peripheral artery disease or lower extremity procedure, renal artery procedure, deep vein thrombosis, pulmonary embolism, and abdominal aortic aneurysm.

Among 1,340 women included in the analysis, 174 (13%) women had PCOS and 1,166 did not. The average age at screening and at menopause were not significantly different between the groups, but they did differ based on other baseline characteristics.

More women with PCOS frequently smoked cigarettes (22%) vs. those without PCOS (12.7%), and women with PCOS had an average body mass index of 31.3, vs. 26.7 among those without PCOS. Women with PCOS also had higher systolic blood pressure (120.7 vs. 115.8 mm Hg), higher total cholesterol (202 vs. 192 mg/dL), and higher fasting blood glucose (103.7 vs. 89.2 mg/dL; P < .01 for all).

After the researchers controlled for age at enrollment, race, BMI, and smoking status, women with PCOS had 1.6 times greater odds of a cardiovascular event after menopause compared with women without PCOS (odds ratio [OR], 1.6; P = .029). Those with PCOS also had a significantly higher Atherosclerotic Cardiovascular Disease risk scores (P = .024), but their Framingham 10-year risk score was not significantly different from those without PCOS.

Although the findings are not necessarily surprising, the study’s value particularly lay in its size, prospective data collection, and rigorous methods, said Ginny Ryan, MD, MA, professor and division chief of reproductive endocrinology and infertility at the University of Washington in Seattle.

“While this study’s criteria used to identify subjects with PCOS selected a population with a particularly severe phenotype of PCOS and thus a higher risk population for cardiovascular disease, it is vital for women’s health providers to truly understand the medium- and long-term life-threatening associations found more commonly in many with PCOS,” Dr. Ryan, who attended the talk and was not involved in the research, said in an interview.

“This study emphasizes the importance of identifying PCOS before menopause, not just for the patient’s immediate well-being, but also so that appropriate counseling and referral can take place to optimize primary, secondary, and tertiary prevention efforts against CVD and related morbidity and mortality,” Dr. Ryan said. “Providers who focus on reproductive health and reproductive-aged women have the opportunity to play a vital role in optimizing the long-term health of their patients.”

Aside from being a prospective cohort with more than 2 decades of follow-up, the study’s other strengths included the definition of PCOS before menopause and use of multiple markers of postmenopausal cardiovascular disease, Dr. Christ said. The study’s main weaknesses were the exclusion of mild PCOS, the self-reporting of cardiovascular events, and the multiple ways of defining menopause.

Dr. Kallen is a consultant for Gynaesight and a reviewer for Healthline. Dr. Christ and Dr. Ryan have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.