Infectious Disease Practitioner

The contagious Delta variant has become the dominant form of the coronavirus in the United States, now accounting for more than 51% of COVID-19 cases in the country, according to new CDC data to updated on July 6.

The variant, also known as B.1.617.2 and first detected in India, makes up more than 80% of new cases in some Midwestern states, including Iowa, Kansas, and Missouri. Delta also accounts for 74% of cases in Western states such as Colorado and Utah and 59% of cases in Southern states such as Louisiana and Texas.

Communities with low vaccination rates are bearing the brunt of new Delta cases. Public health experts are urging those who are unvaccinated to get a shot to protect themselves and their communities against future surges.

“Right now we have two Americas: the vaccinated and the unvaccinated,” Paul Offit, MD, an infectious disease specialist at Children’s Hospital of Philadelphia, told NPR.

“We’re feeling pretty good right now because it’s the summer,” he said. “But come winter, if we still have a significant percentage of the population that is unvaccinated, we’re going to see this virus surge again.”

So far, COVID-19 vaccines appear to protect people against the Delta variant. But health officials are watching other variants that could evade vaccine protection and lead to major outbreaks this year.

For instance, certain mutations in the Epsilon variant may allow it to evade the immunity from past infections and current COVID-19 vaccines, according to a new study published July 1 in the Science. The variant, also known as B.1.427/B.1.429 and first identified in California, has now been reported in 34 countries and could become widespread in the United States.

Researchers from the University of Washington and clinics in Switzerland tested the variant in blood samples from vaccinated people, as well as those who were previously infected with COVID-19. They found that the neutralizing power was reduced by about 2 to 3½ times.

The research team also visualized the variant and found that three mutations on Epsilon’s spike protein allow the virus to escape certain antibodies and lower the strength of vaccines.

Epsilon “relies on an indirect and unusual neutralization-escape strategy,” they wrote, saying that understanding these escape routes could help scientists track new variants, curb the pandemic, and create booster shots.

In Australia, for instance, public health officials have detected the Lambda variant, which could be more infectious than the Delta variant and resistant to vaccines, according to Sky News.

A hotel quarantine program in New South Wales identified the variant in someone who had returned from travel, the news outlet reported. Also known as C.37, Lambda was named a “variant of interest” by the World Health Organization in June.

Lambda was first identified in Peru in December and now accounts for more than 80% of the country’s cases, according to the Financial Times. It has since been found in 27 countries, including the U.S., U.K., and Germany.

The variant has seven mutations on the spike protein that allow the virus to infect human cells, the news outlet reported. One mutation is like another mutation on the Delta variant, which could make it more contagious.

In a preprint study published July 1, researchers at the University of Chile at Santiago found that Lambda is better able to escape antibodies created by the CoronaVac vaccine made by Sinovac in China. In the paper, which hasn’t yet been peer-reviewed, researchers tested blood samples from local health care workers in Santiago who had received two doses of the vaccine.

“Our data revealed that the spike protein ... carries mutations conferring increased infectivity and the ability to escape from neutralizing antibodies,” they wrote.

The research team urged countries to continue testing for contagious variants, even in areas with high vaccination rates, so scientists can identify mutations quickly and analyze whether new variants can escape vaccines.

“The world has to get its act together,” Saad Omer, PhD, director of the Yale Institute for Global Health, told NPR. “Otherwise yet another, potentially more dangerous, variant could emerge.”

A version of this article first appeared on WebMD.com.

The contagious Delta variant has become the dominant form of the coronavirus in the United States, now accounting for more than 51% of COVID-19 cases in the country, according to new CDC data to updated on July 6.

The variant, also known as B.1.617.2 and first detected in India, makes up more than 80% of new cases in some Midwestern states, including Iowa, Kansas, and Missouri. Delta also accounts for 74% of cases in Western states such as Colorado and Utah and 59% of cases in Southern states such as Louisiana and Texas.

Communities with low vaccination rates are bearing the brunt of new Delta cases. Public health experts are urging those who are unvaccinated to get a shot to protect themselves and their communities against future surges.

“Right now we have two Americas: the vaccinated and the unvaccinated,” Paul Offit, MD, an infectious disease specialist at Children’s Hospital of Philadelphia, told NPR.

“We’re feeling pretty good right now because it’s the summer,” he said. “But come winter, if we still have a significant percentage of the population that is unvaccinated, we’re going to see this virus surge again.”

So far, COVID-19 vaccines appear to protect people against the Delta variant. But health officials are watching other variants that could evade vaccine protection and lead to major outbreaks this year.

For instance, certain mutations in the Epsilon variant may allow it to evade the immunity from past infections and current COVID-19 vaccines, according to a new study published July 1 in the Science. The variant, also known as B.1.427/B.1.429 and first identified in California, has now been reported in 34 countries and could become widespread in the United States.

Researchers from the University of Washington and clinics in Switzerland tested the variant in blood samples from vaccinated people, as well as those who were previously infected with COVID-19. They found that the neutralizing power was reduced by about 2 to 3½ times.

The research team also visualized the variant and found that three mutations on Epsilon’s spike protein allow the virus to escape certain antibodies and lower the strength of vaccines.

Epsilon “relies on an indirect and unusual neutralization-escape strategy,” they wrote, saying that understanding these escape routes could help scientists track new variants, curb the pandemic, and create booster shots.

In Australia, for instance, public health officials have detected the Lambda variant, which could be more infectious than the Delta variant and resistant to vaccines, according to Sky News.

A hotel quarantine program in New South Wales identified the variant in someone who had returned from travel, the news outlet reported. Also known as C.37, Lambda was named a “variant of interest” by the World Health Organization in June.

Lambda was first identified in Peru in December and now accounts for more than 80% of the country’s cases, according to the Financial Times. It has since been found in 27 countries, including the U.S., U.K., and Germany.

The variant has seven mutations on the spike protein that allow the virus to infect human cells, the news outlet reported. One mutation is like another mutation on the Delta variant, which could make it more contagious.

In a preprint study published July 1, researchers at the University of Chile at Santiago found that Lambda is better able to escape antibodies created by the CoronaVac vaccine made by Sinovac in China. In the paper, which hasn’t yet been peer-reviewed, researchers tested blood samples from local health care workers in Santiago who had received two doses of the vaccine.

“Our data revealed that the spike protein ... carries mutations conferring increased infectivity and the ability to escape from neutralizing antibodies,” they wrote.

The research team urged countries to continue testing for contagious variants, even in areas with high vaccination rates, so scientists can identify mutations quickly and analyze whether new variants can escape vaccines.

“The world has to get its act together,” Saad Omer, PhD, director of the Yale Institute for Global Health, told NPR. “Otherwise yet another, potentially more dangerous, variant could emerge.”

A version of this article first appeared on WebMD.com.

The contagious Delta variant has become the dominant form of the coronavirus in the United States, now accounting for more than 51% of COVID-19 cases in the country, according to new CDC data to updated on July 6.

The variant, also known as B.1.617.2 and first detected in India, makes up more than 80% of new cases in some Midwestern states, including Iowa, Kansas, and Missouri. Delta also accounts for 74% of cases in Western states such as Colorado and Utah and 59% of cases in Southern states such as Louisiana and Texas.

Communities with low vaccination rates are bearing the brunt of new Delta cases. Public health experts are urging those who are unvaccinated to get a shot to protect themselves and their communities against future surges.

“Right now we have two Americas: the vaccinated and the unvaccinated,” Paul Offit, MD, an infectious disease specialist at Children’s Hospital of Philadelphia, told NPR.

“We’re feeling pretty good right now because it’s the summer,” he said. “But come winter, if we still have a significant percentage of the population that is unvaccinated, we’re going to see this virus surge again.”

So far, COVID-19 vaccines appear to protect people against the Delta variant. But health officials are watching other variants that could evade vaccine protection and lead to major outbreaks this year.

For instance, certain mutations in the Epsilon variant may allow it to evade the immunity from past infections and current COVID-19 vaccines, according to a new study published July 1 in the Science. The variant, also known as B.1.427/B.1.429 and first identified in California, has now been reported in 34 countries and could become widespread in the United States.

Researchers from the University of Washington and clinics in Switzerland tested the variant in blood samples from vaccinated people, as well as those who were previously infected with COVID-19. They found that the neutralizing power was reduced by about 2 to 3½ times.

The research team also visualized the variant and found that three mutations on Epsilon’s spike protein allow the virus to escape certain antibodies and lower the strength of vaccines.

Epsilon “relies on an indirect and unusual neutralization-escape strategy,” they wrote, saying that understanding these escape routes could help scientists track new variants, curb the pandemic, and create booster shots.

In Australia, for instance, public health officials have detected the Lambda variant, which could be more infectious than the Delta variant and resistant to vaccines, according to Sky News.

A hotel quarantine program in New South Wales identified the variant in someone who had returned from travel, the news outlet reported. Also known as C.37, Lambda was named a “variant of interest” by the World Health Organization in June.

Lambda was first identified in Peru in December and now accounts for more than 80% of the country’s cases, according to the Financial Times. It has since been found in 27 countries, including the U.S., U.K., and Germany.

The variant has seven mutations on the spike protein that allow the virus to infect human cells, the news outlet reported. One mutation is like another mutation on the Delta variant, which could make it more contagious.

In a preprint study published July 1, researchers at the University of Chile at Santiago found that Lambda is better able to escape antibodies created by the CoronaVac vaccine made by Sinovac in China. In the paper, which hasn’t yet been peer-reviewed, researchers tested blood samples from local health care workers in Santiago who had received two doses of the vaccine.

“Our data revealed that the spike protein ... carries mutations conferring increased infectivity and the ability to escape from neutralizing antibodies,” they wrote.

The research team urged countries to continue testing for contagious variants, even in areas with high vaccination rates, so scientists can identify mutations quickly and analyze whether new variants can escape vaccines.

“The world has to get its act together,” Saad Omer, PhD, director of the Yale Institute for Global Health, told NPR. “Otherwise yet another, potentially more dangerous, variant could emerge.”

A version of this article first appeared on WebMD.com.

The COVID-19 pandemic jump-started a significant role for telemedicine in the routine follow-up of U.S. patients with type 2 diabetes, based on insurance claims records for more than 2.7 million American adults during 2019 and 2020.

During 2019, 0.3% of 1,357,029 adults with type 2 diabetes in a U.S. claims database, OptumLabs Data Warehouse, had one or more telemedicine visits. During 2020, this jumped to 29% of a similar group of U.S. adults once the pandemic kicked in, a nearly 100-fold increase, Sadiq Y. Patel, PhD, and coauthors wrote in a research letter published July 6, 2021, in JAMA Internal Medicine.

The data show that telemedicine visits didn’t seem to negatively impact care, with hemoglobin A1c levels and medication fills remaining constant across the year.

But Robert A. Gabbay, MD, PhD, chief science and medical officer for the American Diabetes Association, said these results, while reassuring, seem “quite surprising” relative to anecdotal reports from colleagues around the United States.

It’s possible they may only apply to the specific patients included in this study – which was limited to those with either commercial or Medicare Advantage health insurance – he noted in an interview.
 

Diabetes well-suited to telemedicine

Dr. Patel, of the department of health care policy at Harvard Medical School, Boston, and coauthors said the information from their study showed “no evidence of a negative association with medication fills or glycemic control” among these patients during the pandemic in 2020, compared with the prepandemic year 2019.

During the first 48 weeks in 2020, A1c levels averaged 7.16% among patients with type 2 diabetes, compared with an average of 7.14% for patients with type 2 diabetes during the first 48 weeks of 2019. Fill rates for prescription medications were 64% during 2020 and 62% during 2019.

A1c levels and medication fill rates “are important markers of the quality of diabetes care, but obviously not the only important things,” said Ateev Mehrotra, MD, corresponding author for the study and a researcher in the same department as Dr. Patel.

“Limited to the metrics we looked at and in this population we did not see any substantial negative impact of the pandemic on the care for patients with type 2 diabetes,” Dr. Mehrotra said in an interview.

“The pandemic catalyzed a tremendous shift to telemedicine among patients with diabetes. Because it is a chronic illness that requires frequent check-ins, diabetes is particularly well suited to using telemedicine,” he added.
 

Telemedicine not a complete replacement for in-patient visits

Dr. Gabbay agreed that “providers and patients have found telemedicine to be a helpful tool for managing patients with diabetes.”

But “most people do not think of this as a complete replacement for in-person visits, and most [U.S.] institutions have started to have more in-person visits. It’s probably about 50/50 at this point,” he said in an interview.

“It represents an impressive effort by the health care community to pivot toward telehealth to ensure that patients with diabetes continue to get care.”

Nevertheless, Dr. Gabbay added that “despite the success of telemedicine many patients still prefer to see their providers in person. I have a number of patients who were overjoyed to come in and be seen in person even when I offered telemedicine as an alternative. There is a relationship and trust piece that is more profound in person.”

And he cautioned that, although A1c “is a helpful measure, it may not fully demonstrate the percentage of patients at high risk.”

The data in the study by Dr. Patel and coauthors showing a steady level of medication refills during the pandemic “is encouraging,” he said, speculating that “people may have had more time [during the pandemic] to focus on medication adherence.”
 

More evidence of telemedicine’s leap

Other U.S. sites that follow patients with type 2 diabetes have recently reported similar findings, albeit on a much more localized level.

At Vanderbilt University Medical Center in Nashville, Tenn., telemedicine consultations for patients with diabetes or other endocrinology disorders spurted from essentially none prior to March 2020 to a peak of nearly 700 visits/week in early May 2020, and then maintained a rate of roughly 500 telemedicine consultations weekly through the end of 2020, said Michelle L. Griffth, MD, during a talk at the 2021 annual ADA scientific sessions.

“We’ve made telehealth a permanent part of our practice,” said Dr. Griffith, medical director of telehealth ambulatory services at Vanderbilt. “We can use this boom in telehealth as a catalyst for diabetes-practice evolution,” she suggested.

It was a similar story at Scripps Health in southern California. During March and April 2020, video telemedicine consultations jumped from a prior rate of about 60/month to about 13,000/week, and then settled back to a monthly rate of about 25,000-30,000 during the balance of 2020, said Athena Philis-Tsimikas, MD, an endocrinologist and vice president of the Scripps Whittier Diabetes Institute in La Jolla, Calif. (These numbers include all telehealth consultations for patients at Scripps, not just patients with diabetes.)

“COVID sped up the process of integrating digital technology into health care,” concluded Dr. Philis-Tsimikas. A big factor driving this transition was the decision of many insurers to reimburse for telemedicine visits, something not done prepandemic.

The study received no commercial support. Dr. Patel, Dr. Mehrotra, Dr. Griffith, Dr. Philis-Tsimikas, and Dr. Gabbay reported no relevant financial relationships.

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

The COVID-19 pandemic jump-started a significant role for telemedicine in the routine follow-up of U.S. patients with type 2 diabetes, based on insurance claims records for more than 2.7 million American adults during 2019 and 2020.

During 2019, 0.3% of 1,357,029 adults with type 2 diabetes in a U.S. claims database, OptumLabs Data Warehouse, had one or more telemedicine visits. During 2020, this jumped to 29% of a similar group of U.S. adults once the pandemic kicked in, a nearly 100-fold increase, Sadiq Y. Patel, PhD, and coauthors wrote in a research letter published July 6, 2021, in JAMA Internal Medicine.

The data show that telemedicine visits didn’t seem to negatively impact care, with hemoglobin A1c levels and medication fills remaining constant across the year.

But Robert A. Gabbay, MD, PhD, chief science and medical officer for the American Diabetes Association, said these results, while reassuring, seem “quite surprising” relative to anecdotal reports from colleagues around the United States.

It’s possible they may only apply to the specific patients included in this study – which was limited to those with either commercial or Medicare Advantage health insurance – he noted in an interview.
 

Diabetes well-suited to telemedicine

Dr. Patel, of the department of health care policy at Harvard Medical School, Boston, and coauthors said the information from their study showed “no evidence of a negative association with medication fills or glycemic control” among these patients during the pandemic in 2020, compared with the prepandemic year 2019.

During the first 48 weeks in 2020, A1c levels averaged 7.16% among patients with type 2 diabetes, compared with an average of 7.14% for patients with type 2 diabetes during the first 48 weeks of 2019. Fill rates for prescription medications were 64% during 2020 and 62% during 2019.

A1c levels and medication fill rates “are important markers of the quality of diabetes care, but obviously not the only important things,” said Ateev Mehrotra, MD, corresponding author for the study and a researcher in the same department as Dr. Patel.

“Limited to the metrics we looked at and in this population we did not see any substantial negative impact of the pandemic on the care for patients with type 2 diabetes,” Dr. Mehrotra said in an interview.

“The pandemic catalyzed a tremendous shift to telemedicine among patients with diabetes. Because it is a chronic illness that requires frequent check-ins, diabetes is particularly well suited to using telemedicine,” he added.
 

Telemedicine not a complete replacement for in-patient visits

Dr. Gabbay agreed that “providers and patients have found telemedicine to be a helpful tool for managing patients with diabetes.”

But “most people do not think of this as a complete replacement for in-person visits, and most [U.S.] institutions have started to have more in-person visits. It’s probably about 50/50 at this point,” he said in an interview.

“It represents an impressive effort by the health care community to pivot toward telehealth to ensure that patients with diabetes continue to get care.”

Nevertheless, Dr. Gabbay added that “despite the success of telemedicine many patients still prefer to see their providers in person. I have a number of patients who were overjoyed to come in and be seen in person even when I offered telemedicine as an alternative. There is a relationship and trust piece that is more profound in person.”

And he cautioned that, although A1c “is a helpful measure, it may not fully demonstrate the percentage of patients at high risk.”

The data in the study by Dr. Patel and coauthors showing a steady level of medication refills during the pandemic “is encouraging,” he said, speculating that “people may have had more time [during the pandemic] to focus on medication adherence.”
 

More evidence of telemedicine’s leap

Other U.S. sites that follow patients with type 2 diabetes have recently reported similar findings, albeit on a much more localized level.

At Vanderbilt University Medical Center in Nashville, Tenn., telemedicine consultations for patients with diabetes or other endocrinology disorders spurted from essentially none prior to March 2020 to a peak of nearly 700 visits/week in early May 2020, and then maintained a rate of roughly 500 telemedicine consultations weekly through the end of 2020, said Michelle L. Griffth, MD, during a talk at the 2021 annual ADA scientific sessions.

“We’ve made telehealth a permanent part of our practice,” said Dr. Griffith, medical director of telehealth ambulatory services at Vanderbilt. “We can use this boom in telehealth as a catalyst for diabetes-practice evolution,” she suggested.

It was a similar story at Scripps Health in southern California. During March and April 2020, video telemedicine consultations jumped from a prior rate of about 60/month to about 13,000/week, and then settled back to a monthly rate of about 25,000-30,000 during the balance of 2020, said Athena Philis-Tsimikas, MD, an endocrinologist and vice president of the Scripps Whittier Diabetes Institute in La Jolla, Calif. (These numbers include all telehealth consultations for patients at Scripps, not just patients with diabetes.)

“COVID sped up the process of integrating digital technology into health care,” concluded Dr. Philis-Tsimikas. A big factor driving this transition was the decision of many insurers to reimburse for telemedicine visits, something not done prepandemic.

The study received no commercial support. Dr. Patel, Dr. Mehrotra, Dr. Griffith, Dr. Philis-Tsimikas, and Dr. Gabbay reported no relevant financial relationships.

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

The COVID-19 pandemic jump-started a significant role for telemedicine in the routine follow-up of U.S. patients with type 2 diabetes, based on insurance claims records for more than 2.7 million American adults during 2019 and 2020.

During 2019, 0.3% of 1,357,029 adults with type 2 diabetes in a U.S. claims database, OptumLabs Data Warehouse, had one or more telemedicine visits. During 2020, this jumped to 29% of a similar group of U.S. adults once the pandemic kicked in, a nearly 100-fold increase, Sadiq Y. Patel, PhD, and coauthors wrote in a research letter published July 6, 2021, in JAMA Internal Medicine.

The data show that telemedicine visits didn’t seem to negatively impact care, with hemoglobin A1c levels and medication fills remaining constant across the year.

But Robert A. Gabbay, MD, PhD, chief science and medical officer for the American Diabetes Association, said these results, while reassuring, seem “quite surprising” relative to anecdotal reports from colleagues around the United States.

It’s possible they may only apply to the specific patients included in this study – which was limited to those with either commercial or Medicare Advantage health insurance – he noted in an interview.
 

Diabetes well-suited to telemedicine

Dr. Patel, of the department of health care policy at Harvard Medical School, Boston, and coauthors said the information from their study showed “no evidence of a negative association with medication fills or glycemic control” among these patients during the pandemic in 2020, compared with the prepandemic year 2019.

During the first 48 weeks in 2020, A1c levels averaged 7.16% among patients with type 2 diabetes, compared with an average of 7.14% for patients with type 2 diabetes during the first 48 weeks of 2019. Fill rates for prescription medications were 64% during 2020 and 62% during 2019.

A1c levels and medication fill rates “are important markers of the quality of diabetes care, but obviously not the only important things,” said Ateev Mehrotra, MD, corresponding author for the study and a researcher in the same department as Dr. Patel.

“Limited to the metrics we looked at and in this population we did not see any substantial negative impact of the pandemic on the care for patients with type 2 diabetes,” Dr. Mehrotra said in an interview.

“The pandemic catalyzed a tremendous shift to telemedicine among patients with diabetes. Because it is a chronic illness that requires frequent check-ins, diabetes is particularly well suited to using telemedicine,” he added.
 

Telemedicine not a complete replacement for in-patient visits

Dr. Gabbay agreed that “providers and patients have found telemedicine to be a helpful tool for managing patients with diabetes.”

But “most people do not think of this as a complete replacement for in-person visits, and most [U.S.] institutions have started to have more in-person visits. It’s probably about 50/50 at this point,” he said in an interview.

“It represents an impressive effort by the health care community to pivot toward telehealth to ensure that patients with diabetes continue to get care.”

Nevertheless, Dr. Gabbay added that “despite the success of telemedicine many patients still prefer to see their providers in person. I have a number of patients who were overjoyed to come in and be seen in person even when I offered telemedicine as an alternative. There is a relationship and trust piece that is more profound in person.”

And he cautioned that, although A1c “is a helpful measure, it may not fully demonstrate the percentage of patients at high risk.”

The data in the study by Dr. Patel and coauthors showing a steady level of medication refills during the pandemic “is encouraging,” he said, speculating that “people may have had more time [during the pandemic] to focus on medication adherence.”
 

More evidence of telemedicine’s leap

Other U.S. sites that follow patients with type 2 diabetes have recently reported similar findings, albeit on a much more localized level.

At Vanderbilt University Medical Center in Nashville, Tenn., telemedicine consultations for patients with diabetes or other endocrinology disorders spurted from essentially none prior to March 2020 to a peak of nearly 700 visits/week in early May 2020, and then maintained a rate of roughly 500 telemedicine consultations weekly through the end of 2020, said Michelle L. Griffth, MD, during a talk at the 2021 annual ADA scientific sessions.

“We’ve made telehealth a permanent part of our practice,” said Dr. Griffith, medical director of telehealth ambulatory services at Vanderbilt. “We can use this boom in telehealth as a catalyst for diabetes-practice evolution,” she suggested.

It was a similar story at Scripps Health in southern California. During March and April 2020, video telemedicine consultations jumped from a prior rate of about 60/month to about 13,000/week, and then settled back to a monthly rate of about 25,000-30,000 during the balance of 2020, said Athena Philis-Tsimikas, MD, an endocrinologist and vice president of the Scripps Whittier Diabetes Institute in La Jolla, Calif. (These numbers include all telehealth consultations for patients at Scripps, not just patients with diabetes.)

“COVID sped up the process of integrating digital technology into health care,” concluded Dr. Philis-Tsimikas. A big factor driving this transition was the decision of many insurers to reimburse for telemedicine visits, something not done prepandemic.

The study received no commercial support. Dr. Patel, Dr. Mehrotra, Dr. Griffith, Dr. Philis-Tsimikas, and Dr. Gabbay reported no relevant financial relationships.

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

Stopping nucleoside analog therapy in patients with hepatitis B viral (HBV) infections results in sustained viral suppression in only a minority of patients, but a new study suggests there are immune signatures that may serve as predictive biomarkers to help clinicians determine how to improve immune responses in these patients, according to investigators.

In a study of 359 patients enrolled in clinical trials of antiviral therapy for HBV infections, there were 29 immune-related proteins that were found in significantly higher levels among patients who continued to have viral suppression 24 weeks after the end of treatment, compared with patients who did not maintain viral suppression, reported Henry L.Y. Chan, MD, from the Chinese University of Hong Kong.

“In this study, plasma proteomics shows that sustained HBV suppression following treatment discontinuation is associated with higher levels of innate and adaptive immune responses during treatment, but whether these signatures vary by specific treatment regimens remains to be determined,” he said in an oral session at the meeting sponsored by the European Association for the Study of the Liver.

The clustering of proteins differed between patients treated with nucleoside analogs and those who received pegylated interferon (PEG-IFN), Dr. Chan noted.
 

Is it safe?

Although current international guidelines say that clinicians may consider stopping nucleoside analogs in certain patient populations with the goal of promoting sustained off-treatment responses, pooled data from four large phase 3 studies showed that only 10% of patients had sustained HBV DNA suppression, and only 32% had persistent low-level viremia, Dr. Chan said, citing a presentation from ILC in 2019.

Dr. Chan and colleagues sought to identify immune biomarkers that at the end of treatment predict HBV off-treatment response. This is important because existing treatments do not kill the virus which – even if suppressed – can lead to hepatocellular carcinoma.

The researchers examined plasma samples from patients with chronic hepatitis B who were enrolled in two studies: a registrational study comparing tenofovir disoproxil fumarate with adefovir followed by tenofovir maintenance (GS-US-174-0102) and one comparing TDF plus PEG-IFN with either drug alone (GS-US-174-0149).

They identified a total of 359 patients who had at least two treatment-free follow-up visits, were positive for the hepatitis B S antigen (HBsAg) at the end of the treatment, including patients who had antigen loss on treatment but subsequently seroverted, and had available plasma samples collected before the end of treatment.

The study outcomes were sustained viral suppression 24 weeks after the end of treatment, defined as HBV DNA less than 29 IU/mL, and a low replicative state defined as HBV DNA below 2,000 IU/mL with ALT levels at or below the upper limit of normal.

The median patient age was 39 years. In all, 67% of the population was male, and 70% were Asian.
 

Immune-related proteins

The investigators performed proteomic analyses looking for expression levels in serum or plasma proteins at the end of treatment.

A total of 25 patients had HBV DNA suppression at posttreatment week 24, 111 patients had a low replicative states, and 4 had HBsAg loss.

The patients with HBV DNA suppression had significantly higher expression of 29 immune-related proteins, the majority of which were related to the host immune response.

The proteins included myeloid cell markers, leukocyte-trafficking chemokines, natural killer cell markers, and extracellular matrix and/or extracellular matrix–associated proteins.

Among patients with HBV suppression, there was evidence of enrichment for extracellular remodeling pathways, as well as pathways involved in innate immune response to viral infections and immune regulation.

Among patients with low viral replication, there was a trend toward higher CD8a expression levels at the 24-week follow-up, but there were no proteins with significantly elevated expression levels.

“Assessment of unique protein signatures associated with HBsAg loss following treatment discontinuation is ongoing,” Dr. Chan said.
 

Timing of expression patterns

During the question-and-answer session following his presentation, comoderator Pablo Sarobe, MD, from the Clinica Universidad de Navarra (Spain), said: “I’ve seen that you have compared the different proteins which are detected in your cell samples 24 weeks after stopping treatment. Do you think that these differences are already relevant just at the end of treatment, or that these proteins are being expressed [during] the 24 weeks between the end of treatment and your determination?”

“We only have one time-point sample, so it’s hard to say,” Dr. Chan replied, but he speculated that the delay would not have a direct impact on protein expression, “so probably this expression should last after treatment has stopped. But we only have only posttreatment 24-week data, and we believe that some of the outcome measures may change with longer follow-up. After 1 year some patients in suppression may relapse.”

Asked by an audience member whether the investigators had performed a subanalysis of patients treated with nucleoside analogs, Dr. Chan noted that such an analysis was under consideration, although the patient numbers were relatively small. He did add, however, that protein expression patterns differed among patients treated with nucleoside analogs and PEG-IFN.

The study was funded by Gilead Sciences. Dr. Chan disclosed sponsored lecture activities and consulting for Gilead and others. Dr. Sarobe reported no conflicts of interest.

Stopping nucleoside analog therapy in patients with hepatitis B viral (HBV) infections results in sustained viral suppression in only a minority of patients, but a new study suggests there are immune signatures that may serve as predictive biomarkers to help clinicians determine how to improve immune responses in these patients, according to investigators.

In a study of 359 patients enrolled in clinical trials of antiviral therapy for HBV infections, there were 29 immune-related proteins that were found in significantly higher levels among patients who continued to have viral suppression 24 weeks after the end of treatment, compared with patients who did not maintain viral suppression, reported Henry L.Y. Chan, MD, from the Chinese University of Hong Kong.

“In this study, plasma proteomics shows that sustained HBV suppression following treatment discontinuation is associated with higher levels of innate and adaptive immune responses during treatment, but whether these signatures vary by specific treatment regimens remains to be determined,” he said in an oral session at the meeting sponsored by the European Association for the Study of the Liver.

The clustering of proteins differed between patients treated with nucleoside analogs and those who received pegylated interferon (PEG-IFN), Dr. Chan noted.
 

Is it safe?

Although current international guidelines say that clinicians may consider stopping nucleoside analogs in certain patient populations with the goal of promoting sustained off-treatment responses, pooled data from four large phase 3 studies showed that only 10% of patients had sustained HBV DNA suppression, and only 32% had persistent low-level viremia, Dr. Chan said, citing a presentation from ILC in 2019.

Dr. Chan and colleagues sought to identify immune biomarkers that at the end of treatment predict HBV off-treatment response. This is important because existing treatments do not kill the virus which – even if suppressed – can lead to hepatocellular carcinoma.

The researchers examined plasma samples from patients with chronic hepatitis B who were enrolled in two studies: a registrational study comparing tenofovir disoproxil fumarate with adefovir followed by tenofovir maintenance (GS-US-174-0102) and one comparing TDF plus PEG-IFN with either drug alone (GS-US-174-0149).

They identified a total of 359 patients who had at least two treatment-free follow-up visits, were positive for the hepatitis B S antigen (HBsAg) at the end of the treatment, including patients who had antigen loss on treatment but subsequently seroverted, and had available plasma samples collected before the end of treatment.

The study outcomes were sustained viral suppression 24 weeks after the end of treatment, defined as HBV DNA less than 29 IU/mL, and a low replicative state defined as HBV DNA below 2,000 IU/mL with ALT levels at or below the upper limit of normal.

The median patient age was 39 years. In all, 67% of the population was male, and 70% were Asian.
 

Immune-related proteins

The investigators performed proteomic analyses looking for expression levels in serum or plasma proteins at the end of treatment.

A total of 25 patients had HBV DNA suppression at posttreatment week 24, 111 patients had a low replicative states, and 4 had HBsAg loss.

The patients with HBV DNA suppression had significantly higher expression of 29 immune-related proteins, the majority of which were related to the host immune response.

The proteins included myeloid cell markers, leukocyte-trafficking chemokines, natural killer cell markers, and extracellular matrix and/or extracellular matrix–associated proteins.

Among patients with HBV suppression, there was evidence of enrichment for extracellular remodeling pathways, as well as pathways involved in innate immune response to viral infections and immune regulation.

Among patients with low viral replication, there was a trend toward higher CD8a expression levels at the 24-week follow-up, but there were no proteins with significantly elevated expression levels.

“Assessment of unique protein signatures associated with HBsAg loss following treatment discontinuation is ongoing,” Dr. Chan said.
 

Timing of expression patterns

During the question-and-answer session following his presentation, comoderator Pablo Sarobe, MD, from the Clinica Universidad de Navarra (Spain), said: “I’ve seen that you have compared the different proteins which are detected in your cell samples 24 weeks after stopping treatment. Do you think that these differences are already relevant just at the end of treatment, or that these proteins are being expressed [during] the 24 weeks between the end of treatment and your determination?”

“We only have one time-point sample, so it’s hard to say,” Dr. Chan replied, but he speculated that the delay would not have a direct impact on protein expression, “so probably this expression should last after treatment has stopped. But we only have only posttreatment 24-week data, and we believe that some of the outcome measures may change with longer follow-up. After 1 year some patients in suppression may relapse.”

Asked by an audience member whether the investigators had performed a subanalysis of patients treated with nucleoside analogs, Dr. Chan noted that such an analysis was under consideration, although the patient numbers were relatively small. He did add, however, that protein expression patterns differed among patients treated with nucleoside analogs and PEG-IFN.

The study was funded by Gilead Sciences. Dr. Chan disclosed sponsored lecture activities and consulting for Gilead and others. Dr. Sarobe reported no conflicts of interest.

Stopping nucleoside analog therapy in patients with hepatitis B viral (HBV) infections results in sustained viral suppression in only a minority of patients, but a new study suggests there are immune signatures that may serve as predictive biomarkers to help clinicians determine how to improve immune responses in these patients, according to investigators.

In a study of 359 patients enrolled in clinical trials of antiviral therapy for HBV infections, there were 29 immune-related proteins that were found in significantly higher levels among patients who continued to have viral suppression 24 weeks after the end of treatment, compared with patients who did not maintain viral suppression, reported Henry L.Y. Chan, MD, from the Chinese University of Hong Kong.

“In this study, plasma proteomics shows that sustained HBV suppression following treatment discontinuation is associated with higher levels of innate and adaptive immune responses during treatment, but whether these signatures vary by specific treatment regimens remains to be determined,” he said in an oral session at the meeting sponsored by the European Association for the Study of the Liver.

The clustering of proteins differed between patients treated with nucleoside analogs and those who received pegylated interferon (PEG-IFN), Dr. Chan noted.
 

Is it safe?

Although current international guidelines say that clinicians may consider stopping nucleoside analogs in certain patient populations with the goal of promoting sustained off-treatment responses, pooled data from four large phase 3 studies showed that only 10% of patients had sustained HBV DNA suppression, and only 32% had persistent low-level viremia, Dr. Chan said, citing a presentation from ILC in 2019.

Dr. Chan and colleagues sought to identify immune biomarkers that at the end of treatment predict HBV off-treatment response. This is important because existing treatments do not kill the virus which – even if suppressed – can lead to hepatocellular carcinoma.

The researchers examined plasma samples from patients with chronic hepatitis B who were enrolled in two studies: a registrational study comparing tenofovir disoproxil fumarate with adefovir followed by tenofovir maintenance (GS-US-174-0102) and one comparing TDF plus PEG-IFN with either drug alone (GS-US-174-0149).

They identified a total of 359 patients who had at least two treatment-free follow-up visits, were positive for the hepatitis B S antigen (HBsAg) at the end of the treatment, including patients who had antigen loss on treatment but subsequently seroverted, and had available plasma samples collected before the end of treatment.

The study outcomes were sustained viral suppression 24 weeks after the end of treatment, defined as HBV DNA less than 29 IU/mL, and a low replicative state defined as HBV DNA below 2,000 IU/mL with ALT levels at or below the upper limit of normal.

The median patient age was 39 years. In all, 67% of the population was male, and 70% were Asian.
 

Immune-related proteins

The investigators performed proteomic analyses looking for expression levels in serum or plasma proteins at the end of treatment.

A total of 25 patients had HBV DNA suppression at posttreatment week 24, 111 patients had a low replicative states, and 4 had HBsAg loss.

The patients with HBV DNA suppression had significantly higher expression of 29 immune-related proteins, the majority of which were related to the host immune response.

The proteins included myeloid cell markers, leukocyte-trafficking chemokines, natural killer cell markers, and extracellular matrix and/or extracellular matrix–associated proteins.

Among patients with HBV suppression, there was evidence of enrichment for extracellular remodeling pathways, as well as pathways involved in innate immune response to viral infections and immune regulation.

Among patients with low viral replication, there was a trend toward higher CD8a expression levels at the 24-week follow-up, but there were no proteins with significantly elevated expression levels.

“Assessment of unique protein signatures associated with HBsAg loss following treatment discontinuation is ongoing,” Dr. Chan said.
 

Timing of expression patterns

During the question-and-answer session following his presentation, comoderator Pablo Sarobe, MD, from the Clinica Universidad de Navarra (Spain), said: “I’ve seen that you have compared the different proteins which are detected in your cell samples 24 weeks after stopping treatment. Do you think that these differences are already relevant just at the end of treatment, or that these proteins are being expressed [during] the 24 weeks between the end of treatment and your determination?”

“We only have one time-point sample, so it’s hard to say,” Dr. Chan replied, but he speculated that the delay would not have a direct impact on protein expression, “so probably this expression should last after treatment has stopped. But we only have only posttreatment 24-week data, and we believe that some of the outcome measures may change with longer follow-up. After 1 year some patients in suppression may relapse.”

Asked by an audience member whether the investigators had performed a subanalysis of patients treated with nucleoside analogs, Dr. Chan noted that such an analysis was under consideration, although the patient numbers were relatively small. He did add, however, that protein expression patterns differed among patients treated with nucleoside analogs and PEG-IFN.

The study was funded by Gilead Sciences. Dr. Chan disclosed sponsored lecture activities and consulting for Gilead and others. Dr. Sarobe reported no conflicts of interest.

A Texas grand jury has declined to indict a former health department doctor who was accused of theft because he took nine doses of Moderna COVID-19 vaccine that were about to expire and gave them to acquaintances and friends.

Hasan Gokal, MD, was fired from his job and charged with theft by a public servant. A judge dismissed the theft charge in January 2021, saying there was no probable cause, but prosecutors took the accusation to the Harris County Grand Jury, which on June 30 decided no prosecution was warranted, the Associated Press reported.

“I came as a practicing ER doctor into public health and as an ER doctor, I err on the side of life and that’s how I chose to make my decision,” Dr. Gokal told the Associated Press. “It was the right thing to do and it meant saving more lives.”

Dr. Gokal, 48, was supervising a COVID-19 vaccination clinic Dec. 29, 2020, in Humble, Tex., when the clinic closed for the day with an open vial containing nine doses of Moderna vaccine, the New York Times reported.

Since the vaccine would expire in 6 hours, Dr. Gokal scrambled to find people with medical conditions who needed vaccinating, he said. He gave the last dose to his wife, who has a lung condition, pulmonary sarcoidosis.

Dr. Gokal said he contacted his supervisor before acting and provided documentation the next day. He was fired for breaking protocol and then charged with theft.

“He abused his position to place his friends and family in line in front of people who had gone through the lawful process to be there,” Harris County District Attorney Kim Ogg said in a January statement. “What he did was illegal and he’ll be held accountable under the law.”

The AP reported that on June 30 the DA’s office issued a statement saying: “We respect the decision of the grand jury in this and every case. Evidence, not public opinion, is the guiding principle of our work.”

The AP said numerous doctors voiced support for Dr. Gokal and that the Texas Medical Board dismissed an investigation against him.

Dr. Gokal told the AP he’d still like to work in public health. Since being fired by the health department, he’s worked part time in the emergency departments at two Houston hospitals.

A version of this article first appeared on WebMD.com.

A Texas grand jury has declined to indict a former health department doctor who was accused of theft because he took nine doses of Moderna COVID-19 vaccine that were about to expire and gave them to acquaintances and friends.

Hasan Gokal, MD, was fired from his job and charged with theft by a public servant. A judge dismissed the theft charge in January 2021, saying there was no probable cause, but prosecutors took the accusation to the Harris County Grand Jury, which on June 30 decided no prosecution was warranted, the Associated Press reported.

“I came as a practicing ER doctor into public health and as an ER doctor, I err on the side of life and that’s how I chose to make my decision,” Dr. Gokal told the Associated Press. “It was the right thing to do and it meant saving more lives.”

Dr. Gokal, 48, was supervising a COVID-19 vaccination clinic Dec. 29, 2020, in Humble, Tex., when the clinic closed for the day with an open vial containing nine doses of Moderna vaccine, the New York Times reported.

Since the vaccine would expire in 6 hours, Dr. Gokal scrambled to find people with medical conditions who needed vaccinating, he said. He gave the last dose to his wife, who has a lung condition, pulmonary sarcoidosis.

Dr. Gokal said he contacted his supervisor before acting and provided documentation the next day. He was fired for breaking protocol and then charged with theft.

“He abused his position to place his friends and family in line in front of people who had gone through the lawful process to be there,” Harris County District Attorney Kim Ogg said in a January statement. “What he did was illegal and he’ll be held accountable under the law.”

The AP reported that on June 30 the DA’s office issued a statement saying: “We respect the decision of the grand jury in this and every case. Evidence, not public opinion, is the guiding principle of our work.”

The AP said numerous doctors voiced support for Dr. Gokal and that the Texas Medical Board dismissed an investigation against him.

Dr. Gokal told the AP he’d still like to work in public health. Since being fired by the health department, he’s worked part time in the emergency departments at two Houston hospitals.

A version of this article first appeared on WebMD.com.

A Texas grand jury has declined to indict a former health department doctor who was accused of theft because he took nine doses of Moderna COVID-19 vaccine that were about to expire and gave them to acquaintances and friends.

Hasan Gokal, MD, was fired from his job and charged with theft by a public servant. A judge dismissed the theft charge in January 2021, saying there was no probable cause, but prosecutors took the accusation to the Harris County Grand Jury, which on June 30 decided no prosecution was warranted, the Associated Press reported.

“I came as a practicing ER doctor into public health and as an ER doctor, I err on the side of life and that’s how I chose to make my decision,” Dr. Gokal told the Associated Press. “It was the right thing to do and it meant saving more lives.”

Dr. Gokal, 48, was supervising a COVID-19 vaccination clinic Dec. 29, 2020, in Humble, Tex., when the clinic closed for the day with an open vial containing nine doses of Moderna vaccine, the New York Times reported.

Since the vaccine would expire in 6 hours, Dr. Gokal scrambled to find people with medical conditions who needed vaccinating, he said. He gave the last dose to his wife, who has a lung condition, pulmonary sarcoidosis.

Dr. Gokal said he contacted his supervisor before acting and provided documentation the next day. He was fired for breaking protocol and then charged with theft.

“He abused his position to place his friends and family in line in front of people who had gone through the lawful process to be there,” Harris County District Attorney Kim Ogg said in a January statement. “What he did was illegal and he’ll be held accountable under the law.”

The AP reported that on June 30 the DA’s office issued a statement saying: “We respect the decision of the grand jury in this and every case. Evidence, not public opinion, is the guiding principle of our work.”

The AP said numerous doctors voiced support for Dr. Gokal and that the Texas Medical Board dismissed an investigation against him.

Dr. Gokal told the AP he’d still like to work in public health. Since being fired by the health department, he’s worked part time in the emergency departments at two Houston hospitals.

A version of this article first appeared on WebMD.com.

“What’s my number?” When I hear this from my financial planning clients, I know they mean: “What investment net worth do I need to be financially independent and make practicing medicine optional?” In my 20-year career, this “magic number” is by far the most common thing physicians want to know.

Wiroj Sidhisoradej/EyeEm/Getty Images

If you look online, articles may recommend having a portfolio valued at $2 million, $5 million, and not uncommonly $10 million or more to retire. Really? $10 million? You might be thinking that surely not everyone needs that amount. Luckily, that’s true.

There’s no magic number your portfolio should be – just your number.

It’s human nature to want a simple, clear target to shoot for. But unfortunately, there’s no generic answer when it comes to saving for retirement. Even after a comprehensive hour-long review of a client’s financial plan – including insurance, investments, estate planning, and other items – the most honest answer I can give is: “It depends.” Not satisfying, I know. But there are still too many holes to fill.

By far the most important factor in getting beyond “it depends” is having an accurate estimate of annual retirement expenses. I have clients who live comfortably on $50,000 a year in retirement and others who need $250,000 or more. Knowing how much you need – your personal number – depends on the individual’s unique dream for retirement and calculating what that dream will cost.

Form a guesstimate based on savings and anticipated expenses

The total portfolio value needed to sustain an annual expense of $50,000 a year in retirement spending versus the portfolio size needed for $250,000 or more, blows apart the fiction of a universal “magic number.” It’s just not that simple. While it’s hard to gauge exactly what you will need, the right information can lead to a logical guesstimate about what size portfolio will provide you with financial independence.

In the end, it’s up to you to determine your desired retirement lifestyle. Then, the only way to get there is to calculate how much it will cost and save up for it by following a well-informed financial plan. This plan will be based on strategy that shifts from the middle to the later stages of your medical career and into retirement.

Let’s see how it works.
 

Early to mid-career: Focus on building up retirement savings

We ultimately want to save enough to meet our retirement expenses. But figuring out how much to save when you’re in your 40s and 50s is difficult. A mid-career physician likely has significant family- and child-related expenses. When we become empty-nesters, those expenses will decline. In retirement they may disappear entirely, but new expenses may arise.

With large variations in expenses at different life stages, it’s hard to calculate exactly how much you will need to save. Early on, the most sensible thing is putting aside a “reasonable” percentage of gross income for retirement savings.

What is a ‘reasonable’ savings goal for retirement?

As is often the case with high-income earners, many of our clients don’t have a budget or a clear picture of their current expenses and spending habits. That’s alright as long as they are building up a reasonable nest egg for the future – which begs the question of what is reasonable.

For mid-career docs, a reasonable goal to aim for is putting aside 20% of gross income for retirement. What you spend the rest of your money on is less important than how much you’re saving.

This is quite different from how you’ll handle expenses during retirement, when you no longer have a steady stream of income; rather, you have a pot of money that needs to last you another 20, 30, or even 40 years. At that point, thinking about specific expenses becomes more important (more on this topic later). That said, if you’re a mid-career doctor who is not meeting this 20% savings goal, it’s time to make a plan that will free up cash for retirement savings and investments.
 

Later-career docs: Calculate your spending level in retirement

Financial success means having a portfolio that can support your retirement dreams – with the confidence that your money will last and you won’t need to watch every dollar you spend. As you near retirement, your focus will shift away from accumulating savings to calculating the annual expenses you will have to meet in retirement.

A good place to start is figuring out which expenses will be necessary and which will be more flexible. To do this, separate your anticipated spending into these two categories:

• Fixed expenses: You can confidently forecast your “must-have” fixed expenses – such as property taxes, property/casualty insurance, health care costs, utilities, and groceries – because they remain steady from month to month.
• Discretionary expenses: These “like-to-have” expenses vary from month to month. This makes them harder to predict but easier to control. They might include dining out, travel, and charitable contributions.

As a retiree, understanding your fixed and discretionary expenses can help you prepare for a bear market, when the stock market can decline by 20% or more. Your portfolio won’t consist entirely of stocks, so it shouldn’t drop to that degree. Still, it will decline significantly. You may need to cut back on spending for a year or 2 to allow your portfolio to recover, particularly if the portfolio declines early in retirement.

Are you ready for retirement?

During the long bull market preceding the great recession of 2007 and 2009, many physicians retired –only to return to their practices when their portfolio values plummeted. In the exuberance of the moment, many failed to heed the warnings of many economists and got caught flat-footed.

Right now it’s a bull market, but we’re seeing concerning signs, such as an out-of-control housing market and rumblings about inflation and rising consumer costs. Sound familiar? If you hope to retire soon, take the time to objectively look around the corner so you can plan appropriately – whether your goal is to retire completely, stay in practice part-time, or even take on a new opportunity.

In an “it-depends” world, don’t be lured by a fictitious magic number, no matter what comes up when you Google: “When can I retire?” Instead, save early, imagine your dream retirement, and calculate expenses later to see what’s possible.

Dr. Greenwald is a graduate of the Albert Einstein College of Medicine, New York. Dr. Greenwald completed his internal medicine residency at the University of Minnesota, Minneapolis. He practiced internal medicine in the Twin Cities for 11 years before making the transition to financial planning for physicians, beginning in 1998.

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

“What’s my number?” When I hear this from my financial planning clients, I know they mean: “What investment net worth do I need to be financially independent and make practicing medicine optional?” In my 20-year career, this “magic number” is by far the most common thing physicians want to know.

Wiroj Sidhisoradej/EyeEm/Getty Images

If you look online, articles may recommend having a portfolio valued at $2 million, $5 million, and not uncommonly $10 million or more to retire. Really? $10 million? You might be thinking that surely not everyone needs that amount. Luckily, that’s true.

There’s no magic number your portfolio should be – just your number.

It’s human nature to want a simple, clear target to shoot for. But unfortunately, there’s no generic answer when it comes to saving for retirement. Even after a comprehensive hour-long review of a client’s financial plan – including insurance, investments, estate planning, and other items – the most honest answer I can give is: “It depends.” Not satisfying, I know. But there are still too many holes to fill.

By far the most important factor in getting beyond “it depends” is having an accurate estimate of annual retirement expenses. I have clients who live comfortably on $50,000 a year in retirement and others who need $250,000 or more. Knowing how much you need – your personal number – depends on the individual’s unique dream for retirement and calculating what that dream will cost.

Form a guesstimate based on savings and anticipated expenses

The total portfolio value needed to sustain an annual expense of $50,000 a year in retirement spending versus the portfolio size needed for $250,000 or more, blows apart the fiction of a universal “magic number.” It’s just not that simple. While it’s hard to gauge exactly what you will need, the right information can lead to a logical guesstimate about what size portfolio will provide you with financial independence.

In the end, it’s up to you to determine your desired retirement lifestyle. Then, the only way to get there is to calculate how much it will cost and save up for it by following a well-informed financial plan. This plan will be based on strategy that shifts from the middle to the later stages of your medical career and into retirement.

Let’s see how it works.
 

Early to mid-career: Focus on building up retirement savings

We ultimately want to save enough to meet our retirement expenses. But figuring out how much to save when you’re in your 40s and 50s is difficult. A mid-career physician likely has significant family- and child-related expenses. When we become empty-nesters, those expenses will decline. In retirement they may disappear entirely, but new expenses may arise.

With large variations in expenses at different life stages, it’s hard to calculate exactly how much you will need to save. Early on, the most sensible thing is putting aside a “reasonable” percentage of gross income for retirement savings.

What is a ‘reasonable’ savings goal for retirement?

As is often the case with high-income earners, many of our clients don’t have a budget or a clear picture of their current expenses and spending habits. That’s alright as long as they are building up a reasonable nest egg for the future – which begs the question of what is reasonable.

For mid-career docs, a reasonable goal to aim for is putting aside 20% of gross income for retirement. What you spend the rest of your money on is less important than how much you’re saving.

This is quite different from how you’ll handle expenses during retirement, when you no longer have a steady stream of income; rather, you have a pot of money that needs to last you another 20, 30, or even 40 years. At that point, thinking about specific expenses becomes more important (more on this topic later). That said, if you’re a mid-career doctor who is not meeting this 20% savings goal, it’s time to make a plan that will free up cash for retirement savings and investments.
 

Later-career docs: Calculate your spending level in retirement

Financial success means having a portfolio that can support your retirement dreams – with the confidence that your money will last and you won’t need to watch every dollar you spend. As you near retirement, your focus will shift away from accumulating savings to calculating the annual expenses you will have to meet in retirement.

A good place to start is figuring out which expenses will be necessary and which will be more flexible. To do this, separate your anticipated spending into these two categories:

• Fixed expenses: You can confidently forecast your “must-have” fixed expenses – such as property taxes, property/casualty insurance, health care costs, utilities, and groceries – because they remain steady from month to month.
• Discretionary expenses: These “like-to-have” expenses vary from month to month. This makes them harder to predict but easier to control. They might include dining out, travel, and charitable contributions.

As a retiree, understanding your fixed and discretionary expenses can help you prepare for a bear market, when the stock market can decline by 20% or more. Your portfolio won’t consist entirely of stocks, so it shouldn’t drop to that degree. Still, it will decline significantly. You may need to cut back on spending for a year or 2 to allow your portfolio to recover, particularly if the portfolio declines early in retirement.

Are you ready for retirement?

During the long bull market preceding the great recession of 2007 and 2009, many physicians retired –only to return to their practices when their portfolio values plummeted. In the exuberance of the moment, many failed to heed the warnings of many economists and got caught flat-footed.

Right now it’s a bull market, but we’re seeing concerning signs, such as an out-of-control housing market and rumblings about inflation and rising consumer costs. Sound familiar? If you hope to retire soon, take the time to objectively look around the corner so you can plan appropriately – whether your goal is to retire completely, stay in practice part-time, or even take on a new opportunity.

In an “it-depends” world, don’t be lured by a fictitious magic number, no matter what comes up when you Google: “When can I retire?” Instead, save early, imagine your dream retirement, and calculate expenses later to see what’s possible.

Dr. Greenwald is a graduate of the Albert Einstein College of Medicine, New York. Dr. Greenwald completed his internal medicine residency at the University of Minnesota, Minneapolis. He practiced internal medicine in the Twin Cities for 11 years before making the transition to financial planning for physicians, beginning in 1998.

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

“What’s my number?” When I hear this from my financial planning clients, I know they mean: “What investment net worth do I need to be financially independent and make practicing medicine optional?” In my 20-year career, this “magic number” is by far the most common thing physicians want to know.

Wiroj Sidhisoradej/EyeEm/Getty Images

If you look online, articles may recommend having a portfolio valued at $2 million, $5 million, and not uncommonly $10 million or more to retire. Really? $10 million? You might be thinking that surely not everyone needs that amount. Luckily, that’s true.

There’s no magic number your portfolio should be – just your number.

It’s human nature to want a simple, clear target to shoot for. But unfortunately, there’s no generic answer when it comes to saving for retirement. Even after a comprehensive hour-long review of a client’s financial plan – including insurance, investments, estate planning, and other items – the most honest answer I can give is: “It depends.” Not satisfying, I know. But there are still too many holes to fill.

By far the most important factor in getting beyond “it depends” is having an accurate estimate of annual retirement expenses. I have clients who live comfortably on $50,000 a year in retirement and others who need $250,000 or more. Knowing how much you need – your personal number – depends on the individual’s unique dream for retirement and calculating what that dream will cost.

Form a guesstimate based on savings and anticipated expenses

The total portfolio value needed to sustain an annual expense of $50,000 a year in retirement spending versus the portfolio size needed for $250,000 or more, blows apart the fiction of a universal “magic number.” It’s just not that simple. While it’s hard to gauge exactly what you will need, the right information can lead to a logical guesstimate about what size portfolio will provide you with financial independence.

In the end, it’s up to you to determine your desired retirement lifestyle. Then, the only way to get there is to calculate how much it will cost and save up for it by following a well-informed financial plan. This plan will be based on strategy that shifts from the middle to the later stages of your medical career and into retirement.

Let’s see how it works.
 

Early to mid-career: Focus on building up retirement savings

We ultimately want to save enough to meet our retirement expenses. But figuring out how much to save when you’re in your 40s and 50s is difficult. A mid-career physician likely has significant family- and child-related expenses. When we become empty-nesters, those expenses will decline. In retirement they may disappear entirely, but new expenses may arise.

With large variations in expenses at different life stages, it’s hard to calculate exactly how much you will need to save. Early on, the most sensible thing is putting aside a “reasonable” percentage of gross income for retirement savings.

What is a ‘reasonable’ savings goal for retirement?

As is often the case with high-income earners, many of our clients don’t have a budget or a clear picture of their current expenses and spending habits. That’s alright as long as they are building up a reasonable nest egg for the future – which begs the question of what is reasonable.

For mid-career docs, a reasonable goal to aim for is putting aside 20% of gross income for retirement. What you spend the rest of your money on is less important than how much you’re saving.

This is quite different from how you’ll handle expenses during retirement, when you no longer have a steady stream of income; rather, you have a pot of money that needs to last you another 20, 30, or even 40 years. At that point, thinking about specific expenses becomes more important (more on this topic later). That said, if you’re a mid-career doctor who is not meeting this 20% savings goal, it’s time to make a plan that will free up cash for retirement savings and investments.
 

Later-career docs: Calculate your spending level in retirement

Financial success means having a portfolio that can support your retirement dreams – with the confidence that your money will last and you won’t need to watch every dollar you spend. As you near retirement, your focus will shift away from accumulating savings to calculating the annual expenses you will have to meet in retirement.

A good place to start is figuring out which expenses will be necessary and which will be more flexible. To do this, separate your anticipated spending into these two categories:

• Fixed expenses: You can confidently forecast your “must-have” fixed expenses – such as property taxes, property/casualty insurance, health care costs, utilities, and groceries – because they remain steady from month to month.
• Discretionary expenses: These “like-to-have” expenses vary from month to month. This makes them harder to predict but easier to control. They might include dining out, travel, and charitable contributions.

As a retiree, understanding your fixed and discretionary expenses can help you prepare for a bear market, when the stock market can decline by 20% or more. Your portfolio won’t consist entirely of stocks, so it shouldn’t drop to that degree. Still, it will decline significantly. You may need to cut back on spending for a year or 2 to allow your portfolio to recover, particularly if the portfolio declines early in retirement.

Are you ready for retirement?

During the long bull market preceding the great recession of 2007 and 2009, many physicians retired –only to return to their practices when their portfolio values plummeted. In the exuberance of the moment, many failed to heed the warnings of many economists and got caught flat-footed.

Right now it’s a bull market, but we’re seeing concerning signs, such as an out-of-control housing market and rumblings about inflation and rising consumer costs. Sound familiar? If you hope to retire soon, take the time to objectively look around the corner so you can plan appropriately – whether your goal is to retire completely, stay in practice part-time, or even take on a new opportunity.

In an “it-depends” world, don’t be lured by a fictitious magic number, no matter what comes up when you Google: “When can I retire?” Instead, save early, imagine your dream retirement, and calculate expenses later to see what’s possible.

Dr. Greenwald is a graduate of the Albert Einstein College of Medicine, New York. Dr. Greenwald completed his internal medicine residency at the University of Minnesota, Minneapolis. He practiced internal medicine in the Twin Cities for 11 years before making the transition to financial planning for physicians, beginning in 1998.

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

The weekly number of 12- to 15-year-olds receiving a first dose of COVID-19 vaccine rose slightly, but the age group’s share of all first vaccinations continues to drop, according to data from the Centers for Disease Control and Prevention.

Almost 285,000 children aged 12-15 got their first dose of the COVID vaccine in the week ending July 4, stopping a trend that saw weekly vaccinations drop from 1.44 million for May 18-24 to 283,000 during June 22-28, the CDC reported on its COVID Data Tracker site.

As of July 5, not quite one-third (32.2%) of 12- to 15-year-olds had received at least one dose of the vaccine and 23.4% were fully vaccinated. For those aged 16-17 years, 44.5% have gotten at least one dose and 35.9% are fully vaccinated. Total numbers of fully vaccinated individuals in each age group are 4.9 million (12-15) and 3.4 million (16-17), the CDC said.

Looking at another measure, percentage of all vaccines initiated by each age group over the previous 14 days, shows that the decline has not stopped for those aged 12-15. They represented 12.1% of all first vaccines administered during the 2 weeks ending July 4, compared with 14.3% on June 28 and 23.4% (the highest proportion reached) on May 30. The 16- and 17-year olds were at 4.6% on July 4, but that figure has only ranged from 4.2% to 4.9% since late May, based on CDC data.

The numbers for full vaccination follow a similar trajectory. Children aged 12-15 represented 12.1% of all those completing the vaccine regimen over the 2 weeks ending July 4, down from 16.7% a week earlier (June 28) and from a high of 21.5% for the 2 weeks ending June 21. Full vaccination for 16- and 17-year-olds matched their pattern for first doses: nothing lower than 4.2% or higher than 4.6%, the COVID Data Tracker shows.

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The weekly number of 12- to 15-year-olds receiving a first dose of COVID-19 vaccine rose slightly, but the age group’s share of all first vaccinations continues to drop, according to data from the Centers for Disease Control and Prevention.

Almost 285,000 children aged 12-15 got their first dose of the COVID vaccine in the week ending July 4, stopping a trend that saw weekly vaccinations drop from 1.44 million for May 18-24 to 283,000 during June 22-28, the CDC reported on its COVID Data Tracker site.

As of July 5, not quite one-third (32.2%) of 12- to 15-year-olds had received at least one dose of the vaccine and 23.4% were fully vaccinated. For those aged 16-17 years, 44.5% have gotten at least one dose and 35.9% are fully vaccinated. Total numbers of fully vaccinated individuals in each age group are 4.9 million (12-15) and 3.4 million (16-17), the CDC said.

Looking at another measure, percentage of all vaccines initiated by each age group over the previous 14 days, shows that the decline has not stopped for those aged 12-15. They represented 12.1% of all first vaccines administered during the 2 weeks ending July 4, compared with 14.3% on June 28 and 23.4% (the highest proportion reached) on May 30. The 16- and 17-year olds were at 4.6% on July 4, but that figure has only ranged from 4.2% to 4.9% since late May, based on CDC data.

The numbers for full vaccination follow a similar trajectory. Children aged 12-15 represented 12.1% of all those completing the vaccine regimen over the 2 weeks ending July 4, down from 16.7% a week earlier (June 28) and from a high of 21.5% for the 2 weeks ending June 21. Full vaccination for 16- and 17-year-olds matched their pattern for first doses: nothing lower than 4.2% or higher than 4.6%, the COVID Data Tracker shows.

[email protected]

The weekly number of 12- to 15-year-olds receiving a first dose of COVID-19 vaccine rose slightly, but the age group’s share of all first vaccinations continues to drop, according to data from the Centers for Disease Control and Prevention.

Almost 285,000 children aged 12-15 got their first dose of the COVID vaccine in the week ending July 4, stopping a trend that saw weekly vaccinations drop from 1.44 million for May 18-24 to 283,000 during June 22-28, the CDC reported on its COVID Data Tracker site.

As of July 5, not quite one-third (32.2%) of 12- to 15-year-olds had received at least one dose of the vaccine and 23.4% were fully vaccinated. For those aged 16-17 years, 44.5% have gotten at least one dose and 35.9% are fully vaccinated. Total numbers of fully vaccinated individuals in each age group are 4.9 million (12-15) and 3.4 million (16-17), the CDC said.

Looking at another measure, percentage of all vaccines initiated by each age group over the previous 14 days, shows that the decline has not stopped for those aged 12-15. They represented 12.1% of all first vaccines administered during the 2 weeks ending July 4, compared with 14.3% on June 28 and 23.4% (the highest proportion reached) on May 30. The 16- and 17-year olds were at 4.6% on July 4, but that figure has only ranged from 4.2% to 4.9% since late May, based on CDC data.

The numbers for full vaccination follow a similar trajectory. Children aged 12-15 represented 12.1% of all those completing the vaccine regimen over the 2 weeks ending July 4, down from 16.7% a week earlier (June 28) and from a high of 21.5% for the 2 weeks ending June 21. Full vaccination for 16- and 17-year-olds matched their pattern for first doses: nothing lower than 4.2% or higher than 4.6%, the COVID Data Tracker shows.

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The stark realities of antimicrobial resistance – including rising rates of difficult-to-treat infections, lack of a robust pipeline of future antimicrobials, and COVID-19 treatments that leave people more vulnerable to infections – remain urgent priorities, experts say.

For some patients, the pandemic and antimicrobial resistance (AMR) are intertwined.

“One patient I’m seeing now in service really underscores how the two interact,” Vance Fowler, MD, said during a June 30 media briefing sponsored by the Infectious Diseases Society of America (IDSA). A man in his mid-40s, married with a small child, developed COVID-19 in early January 2021. He was intubated, spent about 1 month in the ICU, and managed to survive.

“But since then he has been struck with a series of progressively more drug resistant bacteria,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C., and chair of the IDSA Antimicrobial Resistance Committee.

The patient acquired Pseudomonas ventilator-associated pneumonia. Although the infection initially responded to standard antibiotics, he has experienced relapses over the past few months. Through these multiple infections the Pseudomonas grew increasingly pan-resistant to treatment.

The only remaining antimicrobial agent for this patient, Dr. Fowler said, is “a case study in what we are describing ... a drug that is used relatively infrequently, that is fairly expensive, but for that particular patient is absolutely vital.”
 

A ‘terrifying’ personal experience

Tori Kinamon, a Duke University medical student and Food and Drug Administration antibacterial drug resistance fellow, joined Dr. Fowler at the IDSA briefing. She shared her personal journey of surviving a methicillin-resistant Staphylococcus aureus (MRSA) infection, one that sparked her interest in becoming a physician.

“I had a very frightening and unexpected confrontation with antimicrobial resistance when I was a freshman in college,” Ms. Kinamon said.

A few days after competing in a Division One gymnastics championship, she felt a gradual onset of pain in her left hamstring. The pain grew acutely worse and, within days, her leg become red, swollen, and painful to the touch.

Ms. Kinamon was admitted to the hospital for suspected cellulitis and put on intravenous antibiotics.

“However, my clinical condition continued to decline,” she recalled. “Imaging studies revealed a 15-cm abscess deep in my hamstring.”

The limb- and life-threatening infection left her wondering if she would come out of surgery with both legs.

“Ultimately, I had eight surgeries in 2 weeks,” she said.

“As a 19-year-old collegiate athlete, that’s terrifying. And I never imagined that something like that would happen to me – until it did,” said Ms. Kinamon, who is an NCAA infection prevention advocate.

When Ms. Kinamon’s kidneys could no longer tolerate vancomycin, she was switched to daptomycin.

“I reflect quite frequently on how having that one extra drug in the stockpile had a significant impact on my outcome,” she said.
 

Incentivizing new antimicrobial agents

A lack of new antimicrobials in development is not a new story.

“There’s been a chill that’s been sustained on the antibiotic development field. Most large pharmaceutical companies have left the area of anti-infectants and the bulk of research and development is now in small pharmaceutical companies,” Dr. Fowler said. “And they’re struggling.”

One potential solution is the Pasteur Act, a bipartisan bill reintroduced in Congress and supported by IDSA. The bill encourages pharmaceutical companies to develop new antimicrobial agents with funding not linked to sales or use of the drugs.

Furthermore, the bill emphasizes appropriate use of these agents through effective stewardship programs.

Although some institutions shifted resources away from AMR out of necessity when COVID-19 struck, “I can say certainly from our experience at Duke that at least stewardship was alive and well. It was not relegated to the side,” Dr. Fowler said.

“In fact,” he added, “if anything, COVID really emphasized the importance of stewardship” by helping clinicians with guidance on the use of remdesivir and other antivirals during the pandemic.

Also, in some instances, treatments used to keep people with COVID-19 alive can paradoxically place them at higher risk for other infections, Dr. Fowler said, citing corticosteroids as an example.
 

Everyone’s concern

AMR isn’t just an issue in hospital settings, either. Ms. Kinamon reiterated that she picked up the infection in an athletic environment.

“Antimicrobial resistance is not just a problem for ICU patients in the hospital. I was the healthiest I had ever been and just very nearly escaped death due to one of these infections,” she said. ”As rates of resistance rise as these pathogens become more virulent, AMR is becoming more and more of a community threat,” she added.

Furthermore, consumers are partially to blame as well, Dr. Fowler noted.

“It’s interesting when you look at the surveys of the numbers of patients that have used someone else’s antibiotics” or leftover antimicrobial agents from a prior infection.

“It’s really startling ... that’s the sort of antibiotic overuse that directly contributes to antibacterial resistance,” he said.
 

Reasons for optimism

Promising advances in diagnostics, treatment, and prevention of AMRs are underway, Dr. Fowler said.

“It always gets me really excited to talk about it. It’s amazing what technology and scientific discovery can bring to this discussion and to this threat,” he said.

For example, there is a “silent revolution” in diagnostics with the aim to rapidly provide life-saving actionable data on a real patient in nearly real time.

Traditionally, “you start off by treating what should be there” while awaiting results of tests to narrow down therapy, Dr. Fowler said. However, a whole host of new platforms are in development to reduce the time to susceptibility results. This kind of technology has “the potential to transform our ability to take care of patients, giving them the right drug at the right time and no more,” he said.

Another promising avenue of research involves bacteriophages. Dr. Fowler is principal investigator on a clinical trial underway to evaluate bacteriophages as adjunct therapy for MRSA bacteremia.

When it comes to prevention on AMR infections in the future, “I continue to be optimistic about the possibility of vaccines to prevent many of these infections,” Dr. Fowler said, adding that companies are working on vaccines against these kinds of infections caused by MRSA or Escherichia coli, for example.
 

Patient outcomes

The man in his 40s with the multidrug resistant Pseudomonas infections “is now to the point where he’s walking in the halls and I think he’ll get out of the hospital eventually,” Dr. Fowler said.

“But his life is forever changed,” he added.

Ms. Kinamon’s recovery from MRSA included time in the ICU, 1 month in a regular hospital setting, and 5 months at home.

“It sparked my interest in antibiotic research and development because I see myself as a direct beneficiary of the stockpile of antibiotics that were available to treat my infection,” Ms. Kinamon said. “Now as a medical student working with patients who have similar infections, I feel a deep empathy and connectedness to them because they ask the same questions that I did.”

A version of this article first appeared on WebMD.com.

The stark realities of antimicrobial resistance – including rising rates of difficult-to-treat infections, lack of a robust pipeline of future antimicrobials, and COVID-19 treatments that leave people more vulnerable to infections – remain urgent priorities, experts say.

For some patients, the pandemic and antimicrobial resistance (AMR) are intertwined.

“One patient I’m seeing now in service really underscores how the two interact,” Vance Fowler, MD, said during a June 30 media briefing sponsored by the Infectious Diseases Society of America (IDSA). A man in his mid-40s, married with a small child, developed COVID-19 in early January 2021. He was intubated, spent about 1 month in the ICU, and managed to survive.

“But since then he has been struck with a series of progressively more drug resistant bacteria,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C., and chair of the IDSA Antimicrobial Resistance Committee.

The patient acquired Pseudomonas ventilator-associated pneumonia. Although the infection initially responded to standard antibiotics, he has experienced relapses over the past few months. Through these multiple infections the Pseudomonas grew increasingly pan-resistant to treatment.

The only remaining antimicrobial agent for this patient, Dr. Fowler said, is “a case study in what we are describing ... a drug that is used relatively infrequently, that is fairly expensive, but for that particular patient is absolutely vital.”
 

A ‘terrifying’ personal experience

Tori Kinamon, a Duke University medical student and Food and Drug Administration antibacterial drug resistance fellow, joined Dr. Fowler at the IDSA briefing. She shared her personal journey of surviving a methicillin-resistant Staphylococcus aureus (MRSA) infection, one that sparked her interest in becoming a physician.

“I had a very frightening and unexpected confrontation with antimicrobial resistance when I was a freshman in college,” Ms. Kinamon said.

A few days after competing in a Division One gymnastics championship, she felt a gradual onset of pain in her left hamstring. The pain grew acutely worse and, within days, her leg become red, swollen, and painful to the touch.

Ms. Kinamon was admitted to the hospital for suspected cellulitis and put on intravenous antibiotics.

“However, my clinical condition continued to decline,” she recalled. “Imaging studies revealed a 15-cm abscess deep in my hamstring.”

The limb- and life-threatening infection left her wondering if she would come out of surgery with both legs.

“Ultimately, I had eight surgeries in 2 weeks,” she said.

“As a 19-year-old collegiate athlete, that’s terrifying. And I never imagined that something like that would happen to me – until it did,” said Ms. Kinamon, who is an NCAA infection prevention advocate.

When Ms. Kinamon’s kidneys could no longer tolerate vancomycin, she was switched to daptomycin.

“I reflect quite frequently on how having that one extra drug in the stockpile had a significant impact on my outcome,” she said.
 

Incentivizing new antimicrobial agents

A lack of new antimicrobials in development is not a new story.

“There’s been a chill that’s been sustained on the antibiotic development field. Most large pharmaceutical companies have left the area of anti-infectants and the bulk of research and development is now in small pharmaceutical companies,” Dr. Fowler said. “And they’re struggling.”

One potential solution is the Pasteur Act, a bipartisan bill reintroduced in Congress and supported by IDSA. The bill encourages pharmaceutical companies to develop new antimicrobial agents with funding not linked to sales or use of the drugs.

Furthermore, the bill emphasizes appropriate use of these agents through effective stewardship programs.

Although some institutions shifted resources away from AMR out of necessity when COVID-19 struck, “I can say certainly from our experience at Duke that at least stewardship was alive and well. It was not relegated to the side,” Dr. Fowler said.

“In fact,” he added, “if anything, COVID really emphasized the importance of stewardship” by helping clinicians with guidance on the use of remdesivir and other antivirals during the pandemic.

Also, in some instances, treatments used to keep people with COVID-19 alive can paradoxically place them at higher risk for other infections, Dr. Fowler said, citing corticosteroids as an example.
 

Everyone’s concern

AMR isn’t just an issue in hospital settings, either. Ms. Kinamon reiterated that she picked up the infection in an athletic environment.

“Antimicrobial resistance is not just a problem for ICU patients in the hospital. I was the healthiest I had ever been and just very nearly escaped death due to one of these infections,” she said. ”As rates of resistance rise as these pathogens become more virulent, AMR is becoming more and more of a community threat,” she added.

Furthermore, consumers are partially to blame as well, Dr. Fowler noted.

“It’s interesting when you look at the surveys of the numbers of patients that have used someone else’s antibiotics” or leftover antimicrobial agents from a prior infection.

“It’s really startling ... that’s the sort of antibiotic overuse that directly contributes to antibacterial resistance,” he said.
 

Reasons for optimism

Promising advances in diagnostics, treatment, and prevention of AMRs are underway, Dr. Fowler said.

“It always gets me really excited to talk about it. It’s amazing what technology and scientific discovery can bring to this discussion and to this threat,” he said.

For example, there is a “silent revolution” in diagnostics with the aim to rapidly provide life-saving actionable data on a real patient in nearly real time.

Traditionally, “you start off by treating what should be there” while awaiting results of tests to narrow down therapy, Dr. Fowler said. However, a whole host of new platforms are in development to reduce the time to susceptibility results. This kind of technology has “the potential to transform our ability to take care of patients, giving them the right drug at the right time and no more,” he said.

Another promising avenue of research involves bacteriophages. Dr. Fowler is principal investigator on a clinical trial underway to evaluate bacteriophages as adjunct therapy for MRSA bacteremia.

When it comes to prevention on AMR infections in the future, “I continue to be optimistic about the possibility of vaccines to prevent many of these infections,” Dr. Fowler said, adding that companies are working on vaccines against these kinds of infections caused by MRSA or Escherichia coli, for example.
 

Patient outcomes

The man in his 40s with the multidrug resistant Pseudomonas infections “is now to the point where he’s walking in the halls and I think he’ll get out of the hospital eventually,” Dr. Fowler said.

“But his life is forever changed,” he added.

Ms. Kinamon’s recovery from MRSA included time in the ICU, 1 month in a regular hospital setting, and 5 months at home.

“It sparked my interest in antibiotic research and development because I see myself as a direct beneficiary of the stockpile of antibiotics that were available to treat my infection,” Ms. Kinamon said. “Now as a medical student working with patients who have similar infections, I feel a deep empathy and connectedness to them because they ask the same questions that I did.”

A version of this article first appeared on WebMD.com.

The stark realities of antimicrobial resistance – including rising rates of difficult-to-treat infections, lack of a robust pipeline of future antimicrobials, and COVID-19 treatments that leave people more vulnerable to infections – remain urgent priorities, experts say.

For some patients, the pandemic and antimicrobial resistance (AMR) are intertwined.

“One patient I’m seeing now in service really underscores how the two interact,” Vance Fowler, MD, said during a June 30 media briefing sponsored by the Infectious Diseases Society of America (IDSA). A man in his mid-40s, married with a small child, developed COVID-19 in early January 2021. He was intubated, spent about 1 month in the ICU, and managed to survive.

“But since then he has been struck with a series of progressively more drug resistant bacteria,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C., and chair of the IDSA Antimicrobial Resistance Committee.

The patient acquired Pseudomonas ventilator-associated pneumonia. Although the infection initially responded to standard antibiotics, he has experienced relapses over the past few months. Through these multiple infections the Pseudomonas grew increasingly pan-resistant to treatment.

The only remaining antimicrobial agent for this patient, Dr. Fowler said, is “a case study in what we are describing ... a drug that is used relatively infrequently, that is fairly expensive, but for that particular patient is absolutely vital.”
 

A ‘terrifying’ personal experience

Tori Kinamon, a Duke University medical student and Food and Drug Administration antibacterial drug resistance fellow, joined Dr. Fowler at the IDSA briefing. She shared her personal journey of surviving a methicillin-resistant Staphylococcus aureus (MRSA) infection, one that sparked her interest in becoming a physician.

“I had a very frightening and unexpected confrontation with antimicrobial resistance when I was a freshman in college,” Ms. Kinamon said.

A few days after competing in a Division One gymnastics championship, she felt a gradual onset of pain in her left hamstring. The pain grew acutely worse and, within days, her leg become red, swollen, and painful to the touch.

Ms. Kinamon was admitted to the hospital for suspected cellulitis and put on intravenous antibiotics.

“However, my clinical condition continued to decline,” she recalled. “Imaging studies revealed a 15-cm abscess deep in my hamstring.”

The limb- and life-threatening infection left her wondering if she would come out of surgery with both legs.

“Ultimately, I had eight surgeries in 2 weeks,” she said.

“As a 19-year-old collegiate athlete, that’s terrifying. And I never imagined that something like that would happen to me – until it did,” said Ms. Kinamon, who is an NCAA infection prevention advocate.

When Ms. Kinamon’s kidneys could no longer tolerate vancomycin, she was switched to daptomycin.

“I reflect quite frequently on how having that one extra drug in the stockpile had a significant impact on my outcome,” she said.
 

Incentivizing new antimicrobial agents

A lack of new antimicrobials in development is not a new story.

“There’s been a chill that’s been sustained on the antibiotic development field. Most large pharmaceutical companies have left the area of anti-infectants and the bulk of research and development is now in small pharmaceutical companies,” Dr. Fowler said. “And they’re struggling.”

One potential solution is the Pasteur Act, a bipartisan bill reintroduced in Congress and supported by IDSA. The bill encourages pharmaceutical companies to develop new antimicrobial agents with funding not linked to sales or use of the drugs.

Furthermore, the bill emphasizes appropriate use of these agents through effective stewardship programs.

Although some institutions shifted resources away from AMR out of necessity when COVID-19 struck, “I can say certainly from our experience at Duke that at least stewardship was alive and well. It was not relegated to the side,” Dr. Fowler said.

“In fact,” he added, “if anything, COVID really emphasized the importance of stewardship” by helping clinicians with guidance on the use of remdesivir and other antivirals during the pandemic.

Also, in some instances, treatments used to keep people with COVID-19 alive can paradoxically place them at higher risk for other infections, Dr. Fowler said, citing corticosteroids as an example.
 

Everyone’s concern

AMR isn’t just an issue in hospital settings, either. Ms. Kinamon reiterated that she picked up the infection in an athletic environment.

“Antimicrobial resistance is not just a problem for ICU patients in the hospital. I was the healthiest I had ever been and just very nearly escaped death due to one of these infections,” she said. ”As rates of resistance rise as these pathogens become more virulent, AMR is becoming more and more of a community threat,” she added.

Furthermore, consumers are partially to blame as well, Dr. Fowler noted.

“It’s interesting when you look at the surveys of the numbers of patients that have used someone else’s antibiotics” or leftover antimicrobial agents from a prior infection.

“It’s really startling ... that’s the sort of antibiotic overuse that directly contributes to antibacterial resistance,” he said.
 

Reasons for optimism

Promising advances in diagnostics, treatment, and prevention of AMRs are underway, Dr. Fowler said.

“It always gets me really excited to talk about it. It’s amazing what technology and scientific discovery can bring to this discussion and to this threat,” he said.

For example, there is a “silent revolution” in diagnostics with the aim to rapidly provide life-saving actionable data on a real patient in nearly real time.

Traditionally, “you start off by treating what should be there” while awaiting results of tests to narrow down therapy, Dr. Fowler said. However, a whole host of new platforms are in development to reduce the time to susceptibility results. This kind of technology has “the potential to transform our ability to take care of patients, giving them the right drug at the right time and no more,” he said.

Another promising avenue of research involves bacteriophages. Dr. Fowler is principal investigator on a clinical trial underway to evaluate bacteriophages as adjunct therapy for MRSA bacteremia.

When it comes to prevention on AMR infections in the future, “I continue to be optimistic about the possibility of vaccines to prevent many of these infections,” Dr. Fowler said, adding that companies are working on vaccines against these kinds of infections caused by MRSA or Escherichia coli, for example.
 

Patient outcomes

The man in his 40s with the multidrug resistant Pseudomonas infections “is now to the point where he’s walking in the halls and I think he’ll get out of the hospital eventually,” Dr. Fowler said.

“But his life is forever changed,” he added.

Ms. Kinamon’s recovery from MRSA included time in the ICU, 1 month in a regular hospital setting, and 5 months at home.

“It sparked my interest in antibiotic research and development because I see myself as a direct beneficiary of the stockpile of antibiotics that were available to treat my infection,” Ms. Kinamon said. “Now as a medical student working with patients who have similar infections, I feel a deep empathy and connectedness to them because they ask the same questions that I did.”

A version of this article first appeared on WebMD.com.

The hashtag #BigHoopEnergy has sparked an online conversation about how women of color in the medical field are pressured to conform to traditional standards of professional appearance.

It started when a Latina doctor tweeted that she lost points on a practical exam in medical school because of her hoop earrings, with the evaluator writing “earrings, unprofessional.”

That led other female doctors to cite their own experiences, reported The Lily, a Washington Post publication aimed at millennial women. Many women posted photos of themselves wearing hoops, which have long been associated with Latina and African American women, the outlet said.

“There’s a big movement to police women of color and how they present themselves in medical spaces,” said Briana Christophers, an MD-PhD student at the Tri-Institutional MD-PhD Program in New York. “I think in part it’s a way of trying to make people who don’t usually fit the mold, fit the mold.”

Ms. Christophers, who identifies as Latina, said she was urged to wear a black or navy suit when interviewing for doctorate programs. She wore a black suit with a lavender blouse and received comments about that – some positive, some not, she said.

“Sometimes you don’t know how to interpret those sorts of comments,” Ms. Christophers said. “Do you remember because you like the shirt, or because you don’t think I should have done that?”

Doctors of color still stand out in American medicine. The Lily cited the Association of American Medical Colleges as saying that in 2018, Hispanics made up 5.8% of active American doctors and African Americans made up 5%.

Studies show that medical professionals of color often don’t receive the same respect as their White counterparts, with some people questioning whether they’re actually doctors.

“At work, wearing my white coat that has my name pretty big on it with a badge that says doctor on it, I still get asked if I’m the environmental services staff,” Alexandra Sims, MD, a pediatrician in Cincinnati, told The Lily. “I think it just demonstrates how deeply ingrained bias, racism, and sexism are in society and that we have a lot of work to do to disrupt that.”

Dr. Sims said the tweet about hoop earrings led her to wonder about daily decisions she makes about dress.

“Am I too much? Is this too much? Is this earring too big? Is this nail polish color too loud? And how will that be received at work?” she said, noting that she may opt not to wear hoops in certain situations, such as when she’s dealing with a grabby baby.

Monica Verduzco-Gutierrez, MD, professor and chair of the department of rehabilitation medicine at University of Texas Health, San Antonio, said doctors should be judged on the care they provide, not their appearance.

“Judging someone based on their earrings or their jumpsuit or whatever else that they’re noticing about the student is not an appropriate way to judge the student’s ability to take care of a patient,” Dr. Verduzco-Gutierrez said, noting that she was not speaking on behalf of the school.
 

A version of this article was first published on WebMD.com .

The hashtag #BigHoopEnergy has sparked an online conversation about how women of color in the medical field are pressured to conform to traditional standards of professional appearance.

It started when a Latina doctor tweeted that she lost points on a practical exam in medical school because of her hoop earrings, with the evaluator writing “earrings, unprofessional.”

That led other female doctors to cite their own experiences, reported The Lily, a Washington Post publication aimed at millennial women. Many women posted photos of themselves wearing hoops, which have long been associated with Latina and African American women, the outlet said.

“There’s a big movement to police women of color and how they present themselves in medical spaces,” said Briana Christophers, an MD-PhD student at the Tri-Institutional MD-PhD Program in New York. “I think in part it’s a way of trying to make people who don’t usually fit the mold, fit the mold.”

Ms. Christophers, who identifies as Latina, said she was urged to wear a black or navy suit when interviewing for doctorate programs. She wore a black suit with a lavender blouse and received comments about that – some positive, some not, she said.

“Sometimes you don’t know how to interpret those sorts of comments,” Ms. Christophers said. “Do you remember because you like the shirt, or because you don’t think I should have done that?”

Doctors of color still stand out in American medicine. The Lily cited the Association of American Medical Colleges as saying that in 2018, Hispanics made up 5.8% of active American doctors and African Americans made up 5%.

Studies show that medical professionals of color often don’t receive the same respect as their White counterparts, with some people questioning whether they’re actually doctors.

“At work, wearing my white coat that has my name pretty big on it with a badge that says doctor on it, I still get asked if I’m the environmental services staff,” Alexandra Sims, MD, a pediatrician in Cincinnati, told The Lily. “I think it just demonstrates how deeply ingrained bias, racism, and sexism are in society and that we have a lot of work to do to disrupt that.”

Dr. Sims said the tweet about hoop earrings led her to wonder about daily decisions she makes about dress.

“Am I too much? Is this too much? Is this earring too big? Is this nail polish color too loud? And how will that be received at work?” she said, noting that she may opt not to wear hoops in certain situations, such as when she’s dealing with a grabby baby.

Monica Verduzco-Gutierrez, MD, professor and chair of the department of rehabilitation medicine at University of Texas Health, San Antonio, said doctors should be judged on the care they provide, not their appearance.

“Judging someone based on their earrings or their jumpsuit or whatever else that they’re noticing about the student is not an appropriate way to judge the student’s ability to take care of a patient,” Dr. Verduzco-Gutierrez said, noting that she was not speaking on behalf of the school.
 

A version of this article was first published on WebMD.com .

The hashtag #BigHoopEnergy has sparked an online conversation about how women of color in the medical field are pressured to conform to traditional standards of professional appearance.

It started when a Latina doctor tweeted that she lost points on a practical exam in medical school because of her hoop earrings, with the evaluator writing “earrings, unprofessional.”

That led other female doctors to cite their own experiences, reported The Lily, a Washington Post publication aimed at millennial women. Many women posted photos of themselves wearing hoops, which have long been associated with Latina and African American women, the outlet said.

“There’s a big movement to police women of color and how they present themselves in medical spaces,” said Briana Christophers, an MD-PhD student at the Tri-Institutional MD-PhD Program in New York. “I think in part it’s a way of trying to make people who don’t usually fit the mold, fit the mold.”

Ms. Christophers, who identifies as Latina, said she was urged to wear a black or navy suit when interviewing for doctorate programs. She wore a black suit with a lavender blouse and received comments about that – some positive, some not, she said.

“Sometimes you don’t know how to interpret those sorts of comments,” Ms. Christophers said. “Do you remember because you like the shirt, or because you don’t think I should have done that?”

Doctors of color still stand out in American medicine. The Lily cited the Association of American Medical Colleges as saying that in 2018, Hispanics made up 5.8% of active American doctors and African Americans made up 5%.

Studies show that medical professionals of color often don’t receive the same respect as their White counterparts, with some people questioning whether they’re actually doctors.

“At work, wearing my white coat that has my name pretty big on it with a badge that says doctor on it, I still get asked if I’m the environmental services staff,” Alexandra Sims, MD, a pediatrician in Cincinnati, told The Lily. “I think it just demonstrates how deeply ingrained bias, racism, and sexism are in society and that we have a lot of work to do to disrupt that.”

Dr. Sims said the tweet about hoop earrings led her to wonder about daily decisions she makes about dress.

“Am I too much? Is this too much? Is this earring too big? Is this nail polish color too loud? And how will that be received at work?” she said, noting that she may opt not to wear hoops in certain situations, such as when she’s dealing with a grabby baby.

Monica Verduzco-Gutierrez, MD, professor and chair of the department of rehabilitation medicine at University of Texas Health, San Antonio, said doctors should be judged on the care they provide, not their appearance.

“Judging someone based on their earrings or their jumpsuit or whatever else that they’re noticing about the student is not an appropriate way to judge the student’s ability to take care of a patient,” Dr. Verduzco-Gutierrez said, noting that she was not speaking on behalf of the school.
 

A version of this article was first published on WebMD.com .

The Food and Drug Administration has expanded the approval of secnidazole to include treatment of trichomoniasis in adults, according to a statement from manufacturer Lupin Pharmaceuticals.

Trichomoniasis vaginalis is a common, nonviral, curable sexually transmitted disease that affects approximately 3 million to 5 million adults in the United States each year; the infection can linger for months or years if left untreated, and may have a negative impact on reproductive health. The drug was approved for the treatment of bacterial vaginosis in 2017.

The availability of a single-dose oral treatment for both trichomoniasis and bacterial vaginosis may help improve adherence and reduce risk factors associated with these conditions, including pelvic inflammatory disease and other sexually transmitted infections, according to the statement.

The approval for the new indication was based primarily on data from a phase 3 clinical trial in which women with a confirmed trichomoniasis diagnosis were randomized to a single dose of 2 g oral secnidazole or a placebo. Secnidazole showed a 92.2% cure rate for patients with trichomoniasis, compared with placebo, based on cultures collected 6-12 days after dosing. Cure rates in subsets of patients with HIV and bacterial vaginosis were 100% and 95%, respectively.

The most common treatment-related adverse events were vulvovaginal candidiasis and nausea, each reported in 2.7% of study participants. The study findings were published in March 2021 in Clinical Infections Diseases.

Secnidazole also is approved for treatment of trichomoniasis in men, based on data from four open-label studies, one with men only and three including both men and women, according to the statement.

Full prescribing information for secnidazole is available here.

The Food and Drug Administration has expanded the approval of secnidazole to include treatment of trichomoniasis in adults, according to a statement from manufacturer Lupin Pharmaceuticals.

Trichomoniasis vaginalis is a common, nonviral, curable sexually transmitted disease that affects approximately 3 million to 5 million adults in the United States each year; the infection can linger for months or years if left untreated, and may have a negative impact on reproductive health. The drug was approved for the treatment of bacterial vaginosis in 2017.

The availability of a single-dose oral treatment for both trichomoniasis and bacterial vaginosis may help improve adherence and reduce risk factors associated with these conditions, including pelvic inflammatory disease and other sexually transmitted infections, according to the statement.

The approval for the new indication was based primarily on data from a phase 3 clinical trial in which women with a confirmed trichomoniasis diagnosis were randomized to a single dose of 2 g oral secnidazole or a placebo. Secnidazole showed a 92.2% cure rate for patients with trichomoniasis, compared with placebo, based on cultures collected 6-12 days after dosing. Cure rates in subsets of patients with HIV and bacterial vaginosis were 100% and 95%, respectively.

The most common treatment-related adverse events were vulvovaginal candidiasis and nausea, each reported in 2.7% of study participants. The study findings were published in March 2021 in Clinical Infections Diseases.

Secnidazole also is approved for treatment of trichomoniasis in men, based on data from four open-label studies, one with men only and three including both men and women, according to the statement.

Full prescribing information for secnidazole is available here.

The Food and Drug Administration has expanded the approval of secnidazole to include treatment of trichomoniasis in adults, according to a statement from manufacturer Lupin Pharmaceuticals.

Trichomoniasis vaginalis is a common, nonviral, curable sexually transmitted disease that affects approximately 3 million to 5 million adults in the United States each year; the infection can linger for months or years if left untreated, and may have a negative impact on reproductive health. The drug was approved for the treatment of bacterial vaginosis in 2017.

The availability of a single-dose oral treatment for both trichomoniasis and bacterial vaginosis may help improve adherence and reduce risk factors associated with these conditions, including pelvic inflammatory disease and other sexually transmitted infections, according to the statement.

The approval for the new indication was based primarily on data from a phase 3 clinical trial in which women with a confirmed trichomoniasis diagnosis were randomized to a single dose of 2 g oral secnidazole or a placebo. Secnidazole showed a 92.2% cure rate for patients with trichomoniasis, compared with placebo, based on cultures collected 6-12 days after dosing. Cure rates in subsets of patients with HIV and bacterial vaginosis were 100% and 95%, respectively.

The most common treatment-related adverse events were vulvovaginal candidiasis and nausea, each reported in 2.7% of study participants. The study findings were published in March 2021 in Clinical Infections Diseases.

Secnidazole also is approved for treatment of trichomoniasis in men, based on data from four open-label studies, one with men only and three including both men and women, according to the statement.

Full prescribing information for secnidazole is available here.

Further details from multiple cases of myocarditis linked to the Pfizer and Moderna mRNA COVID vaccines have been described in recent papers in the medical literature.

The cases appear to occur almost exclusively in males and most often in younger age groups. While symptoms and signs of myocarditis mostly resolved with a few days of supportive care, long-term effects are unknown at present.

The authors of all the reports and of two accompanying editorials in JAMA Cardiology are unanimous in their opinion that the benefits of vaccination still outweigh the risks.  

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices met June 23 to discuss this issue. At that meeting, it was reported that 323 cases of myocarditis or pericarditis in individuals aged 29 years and younger have been confirmed, but committee members delivered a strong endorsement for continuing to vaccinate young people with the mRNA vaccines.

The current case reports are published in two papers in JAMA Cardiology and in three in Circulation.
 

U.S. military reports 23 cases

In one report in JAMA Cardiology, authors led by Jay Montgomery, MD, from Walter Reed National Military Medical Center in Bethesda, Md., described 23 cases from the U.S. Military Health System of individuals with acute myocarditis who presented within 4 days after mRNA-based COVID-19 vaccination (7 Pfizer and 16 Moderna).

All patients were male, 22 of 23 were on active duty, and the median age was 25 years (range, 20-51); 20 of the 23 cases occurred after receipt of a second dose of an mRNA COVID-19 vaccine.

The patients all presented with acute onset of marked chest pain. All patients had significantly elevated cardiac troponin levels. Among eight patients who underwent cardiac MRI (cMRI), all had findings consistent with the clinical diagnosis of myocarditis.

Additional testing did not identify other possible causes of myocarditis. All patients received brief supportive care and were recovered or recovering.

The authors reported that the military administered more than 2.8 million doses of mRNA COVID-19 vaccine in this period, and while the observed number of myocarditis cases was small, the number was “substantially higher” than expected among male military members after a second vaccine dose.

They noted that, based on historical data, among the 544,000 second doses to military members there may have been 0-10 expected myocarditis cases, but they observed 19 cases.  

“All patients in this series reflect substantial similarities in demographic characteristics, proximate vaccine dose, onset interval, and character of vaccine-associated myocarditis. The consistent pattern of clinical presentation, rapid recovery, and absence of evidence of other causes support the diagnosis of hypersensitivity myocarditis,” they stated.

They added that presentation after a second vaccine dose or, in three patients, when vaccination followed SARS-CoV-2 infection, suggests that prior exposure was relevant in the hypersensitivity response.

“The spectrum of clinical presentation and reliance on patients seeking health care and on health care professionals recognizing a rare vaccine-associated adverse event limits determination of the true incidence of this condition,” the authors wrote.

They stressed that recognition of vaccine-associated myocarditis is clinically important because diagnosis impacts management, recommendations for exercise, and monitoring for cardiomyopathy.

But the authors also acknowledged that it is important to frame concerns about potential vaccine-associated myocarditis within the context of the current pandemic.

“Infection with SARS-CoV-2 is a clear cause of serious cardiac injury in many patients. ... Prevalence of cardiac injury may be as high as 60% in seriously ill patients. Notably, nearly 1% of highly fit athletes with mild COVID-19 infection have evidence of myocarditis on cMRI,” they wrote.

“Given that COVID-19 vaccines are remarkably effective at preventing infection, any risk of rare adverse events following immunization must be carefully weighed against the very substantial benefit of vaccination,” they concluded.
 

Four cases at Duke

In the second paper in JAMA Cardiology, a group led by Han W. Kim, MD, reported four patients with acute myocarditis occurring within days of mRNA COVID-19 vaccination (two Pfizer and two Moderna) in patients treated at Duke University Medical Center, Durham, N.C. The hospital courses of the four patients with myocarditis following COVID-19 vaccination were uneventful, and they were discharged within 2-4 days.

The authors said that, although a causal relationship cannot be established, none of the patients had a viral prodrome or had coincident testing that revealed an alternative explanation.

They stated that these four patients represent the majority of patients with acute myocarditis identified in the past 3 months at their institution, and this led to the highest total number of patients with acute myocarditis, compared with the same 3-month period for the past 5 years. 

“Additionally, we identified only those patients with severe unremitting chest pain who sought medical attention. Those with mild or moderate chest pain might not seek medical attention, and it is possible that subclinical myocarditis may occur and could be detected by active surveillance, as has been described with smallpox vaccination,” they wrote.
 

Further case reports

In one of the papers in Circulation, a group led by Kathryn F. Larson, MD, from the Mayo Clinic in Rochester, Minn., described eight patients hospitalized with chest pain who were diagnosed with myocarditis within 2-4 days of receiving either the Pfizer or Moderna vaccine.

Two of the patients had previously been infected by SARS-CoV-2 without need for hospitalization. All individuals were otherwise healthy males between the ages of 21 and 56 years. All but one patient developed symptoms after their second dose, and the one patient who developed myocarditis after the first vaccine dose had previously been infected with SARS-CoV-2.  

Systemic symptoms began within 24 hours after vaccine administration in five of eight patients, with chest pain presenting between 48 and 96 hours later. Troponin values were elevated in all individuals and appeared to peak the day after admission, whereas none had eosinophilia.

Cardiac MRI revealed findings consistent with myocarditis in all patients. All patients had resolution of their chest pain and were discharged from the hospital in stable condition.

“The patients presented here demonstrated typical signs, symptoms, and diagnostic features of acute myocarditis. The temporal association between receiving an mRNA-based COVID-19 vaccine and the development of myocarditis is notable,” the authors said.  

They added that they would consider the use of corticosteroids in these patients but cautioned that this could reduce the specific immune response against SARS-COV-2 triggered by the vaccine. “Thus, the duration of corticosteroid administration should be limited to the resolution of the symptoms or ventricular arrhythmias or the recovery of the left ventricular ejection fraction.”

Pending publication of long-term outcome data after SARS-CoV-2 vaccine–related myocarditis, they suggest adherence to the current consensus recommendation to abstain from competitive sports for a period of 3-6 months with reevaluation prior to sports participation. 

In another of the Circulation papers, a group led by Carolyn M. Rosner, MSN,  presented a case series of seven patients hospitalized for acute myocarditis-like illness following COVID-19 vaccination, from two U.S. medical centers, in Falls Church, Va., and Dallas. All patients were males below the age of 40 years and of White or Hispanic race/ethnicity. Only one patient reported prior history of COVID-19 infection. Six patients received mRNA (Moderna or Pfizer) and one received the adenovirus (Johnson & Johnson) vaccine. All patients presented 3-7 days post vaccination with acute onset chest pain and biochemical evidence of myocardial injury.

Hospital length of stay was 3 days, and all patients’ symptoms resolved by hospital discharge.

And finally, the third paper in Circulation reported a detailed description of one patient – a 52-year-old, previously healthy male who presented with acute myocarditis 3 days after the administration of the second dose of Moderna’s COVID-19 vaccine. The symptoms resolved, and there was a gradual improvement in cMRI findings. Ischemic injury and other potential causes of acute myocardial injury were excluded, as were other potential infectious causes of myocarditis, and there was no evidence of systemic autoimmune disease.

“Clinicians should be aware that myocarditis may be present in patients exhibiting cardiac signs and symptoms 2-4 days after COVID-19 vaccination,” the authors said.

They added that additional surveillance of such adverse events post–COVID-19 vaccination will help identify subgroups at higher risk for this vaccine-related effect, and whether additional precautions are necessary.
 

‘Benefits outweigh risk’

In an accompanying editorial in JAMA Cardiology, three doctors from the CDC cite several other reports of myocarditis after mRNA COVID vaccination. These include a case report published in Pediatrics of seven male adolescents aged 14-19 years who presented with myocarditis or myopericarditis within 4 days after receipt of a second dose of the Pfizer vaccine.

But the editorialists noted that the most comprehensive data about the risk for myocarditis following immunization with mRNA vaccines comes from Israel.

The Israeli Ministry of Health recently posted data describing 121 myocarditis cases occurring within 30 days of a second dose of mRNA vaccine among 5,049,424 persons, suggesting a crude incidence rate of approximately 24 cases per million.

On the current case reports, the CDC doctors wrote: “The striking clinical similarities in the presentations of these patients, their recent vaccination with an mRNA-based COVID-19 vaccine, and the lack of any alternative etiologies for acute myocarditis suggest an association with immunization.”

They said that acute onset of chest pain 3-5 days after vaccine administration, usually after a second dose, is a typical feature of reported cases and suggests an immune-mediated mechanism.

But SARS-CoV-2 infection also causes cardiac injury which may result in severe outcomes, and based on currently available data, myocarditis following immunization with current mRNA-based vaccines is rare.

“At present, the benefits of immunization in preventing severe morbidity favors continued COVID-19 vaccination, particularly considering the increasing COVID-19 hospitalization rates among adolescents reported during spring 2021,” the editorialists stated.

But they added that many questions remain. These include whether modifications are needed to the vaccine schedule among persons with a history of possible or confirmed myocarditis after COVID vaccine, how should postvaccine myocarditis be managed, how often should follow-up assessments be performed, how might follow-up assessments affect recommendations to avoid vigorous physical activity following the diagnosis of myocarditis, and do all likely cases of acute myocarditis that appear to be uncomplicated require cardiac MRI for more definitive diagnosis?

“While the data needed to answer such questions are being collected, there is an opportunity for researchers with expertise in myocarditis to develop a comprehensive, national assessment of the natural history, pathogenesis, and treatment of acute myocarditis associated with receipt of mRNA-based COVID-19 vaccines,” they concluded.

In a second editorial in JAMA Cardiology, a group of editors from the journal acknowledged that publication of the current case reports may contribute to additional public concern regarding immunization. But they added that clinicians discussing immunization with patients should recognize that these case series suggest that the symptomatic events consistent with myocarditis are still very rare and appear to be self-limiting.

“Given the risks of COVID-19, including the risk of myocarditis from COVID-19 infection, the editors do not believe these case reports are sufficient to interrupt the march toward maximal vaccination against SARS-CoV-2 as expeditiously as possible,” they said.

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

Further details from multiple cases of myocarditis linked to the Pfizer and Moderna mRNA COVID vaccines have been described in recent papers in the medical literature.

The cases appear to occur almost exclusively in males and most often in younger age groups. While symptoms and signs of myocarditis mostly resolved with a few days of supportive care, long-term effects are unknown at present.

The authors of all the reports and of two accompanying editorials in JAMA Cardiology are unanimous in their opinion that the benefits of vaccination still outweigh the risks.  

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices met June 23 to discuss this issue. At that meeting, it was reported that 323 cases of myocarditis or pericarditis in individuals aged 29 years and younger have been confirmed, but committee members delivered a strong endorsement for continuing to vaccinate young people with the mRNA vaccines.

The current case reports are published in two papers in JAMA Cardiology and in three in Circulation.
 

U.S. military reports 23 cases

In one report in JAMA Cardiology, authors led by Jay Montgomery, MD, from Walter Reed National Military Medical Center in Bethesda, Md., described 23 cases from the U.S. Military Health System of individuals with acute myocarditis who presented within 4 days after mRNA-based COVID-19 vaccination (7 Pfizer and 16 Moderna).

All patients were male, 22 of 23 were on active duty, and the median age was 25 years (range, 20-51); 20 of the 23 cases occurred after receipt of a second dose of an mRNA COVID-19 vaccine.

The patients all presented with acute onset of marked chest pain. All patients had significantly elevated cardiac troponin levels. Among eight patients who underwent cardiac MRI (cMRI), all had findings consistent with the clinical diagnosis of myocarditis.

Additional testing did not identify other possible causes of myocarditis. All patients received brief supportive care and were recovered or recovering.

The authors reported that the military administered more than 2.8 million doses of mRNA COVID-19 vaccine in this period, and while the observed number of myocarditis cases was small, the number was “substantially higher” than expected among male military members after a second vaccine dose.

They noted that, based on historical data, among the 544,000 second doses to military members there may have been 0-10 expected myocarditis cases, but they observed 19 cases.  

“All patients in this series reflect substantial similarities in demographic characteristics, proximate vaccine dose, onset interval, and character of vaccine-associated myocarditis. The consistent pattern of clinical presentation, rapid recovery, and absence of evidence of other causes support the diagnosis of hypersensitivity myocarditis,” they stated.

They added that presentation after a second vaccine dose or, in three patients, when vaccination followed SARS-CoV-2 infection, suggests that prior exposure was relevant in the hypersensitivity response.

“The spectrum of clinical presentation and reliance on patients seeking health care and on health care professionals recognizing a rare vaccine-associated adverse event limits determination of the true incidence of this condition,” the authors wrote.

They stressed that recognition of vaccine-associated myocarditis is clinically important because diagnosis impacts management, recommendations for exercise, and monitoring for cardiomyopathy.

But the authors also acknowledged that it is important to frame concerns about potential vaccine-associated myocarditis within the context of the current pandemic.

“Infection with SARS-CoV-2 is a clear cause of serious cardiac injury in many patients. ... Prevalence of cardiac injury may be as high as 60% in seriously ill patients. Notably, nearly 1% of highly fit athletes with mild COVID-19 infection have evidence of myocarditis on cMRI,” they wrote.

“Given that COVID-19 vaccines are remarkably effective at preventing infection, any risk of rare adverse events following immunization must be carefully weighed against the very substantial benefit of vaccination,” they concluded.
 

Four cases at Duke

In the second paper in JAMA Cardiology, a group led by Han W. Kim, MD, reported four patients with acute myocarditis occurring within days of mRNA COVID-19 vaccination (two Pfizer and two Moderna) in patients treated at Duke University Medical Center, Durham, N.C. The hospital courses of the four patients with myocarditis following COVID-19 vaccination were uneventful, and they were discharged within 2-4 days.

The authors said that, although a causal relationship cannot be established, none of the patients had a viral prodrome or had coincident testing that revealed an alternative explanation.

They stated that these four patients represent the majority of patients with acute myocarditis identified in the past 3 months at their institution, and this led to the highest total number of patients with acute myocarditis, compared with the same 3-month period for the past 5 years. 

“Additionally, we identified only those patients with severe unremitting chest pain who sought medical attention. Those with mild or moderate chest pain might not seek medical attention, and it is possible that subclinical myocarditis may occur and could be detected by active surveillance, as has been described with smallpox vaccination,” they wrote.
 

Further case reports

In one of the papers in Circulation, a group led by Kathryn F. Larson, MD, from the Mayo Clinic in Rochester, Minn., described eight patients hospitalized with chest pain who were diagnosed with myocarditis within 2-4 days of receiving either the Pfizer or Moderna vaccine.

Two of the patients had previously been infected by SARS-CoV-2 without need for hospitalization. All individuals were otherwise healthy males between the ages of 21 and 56 years. All but one patient developed symptoms after their second dose, and the one patient who developed myocarditis after the first vaccine dose had previously been infected with SARS-CoV-2.  

Systemic symptoms began within 24 hours after vaccine administration in five of eight patients, with chest pain presenting between 48 and 96 hours later. Troponin values were elevated in all individuals and appeared to peak the day after admission, whereas none had eosinophilia.

Cardiac MRI revealed findings consistent with myocarditis in all patients. All patients had resolution of their chest pain and were discharged from the hospital in stable condition.

“The patients presented here demonstrated typical signs, symptoms, and diagnostic features of acute myocarditis. The temporal association between receiving an mRNA-based COVID-19 vaccine and the development of myocarditis is notable,” the authors said.  

They added that they would consider the use of corticosteroids in these patients but cautioned that this could reduce the specific immune response against SARS-COV-2 triggered by the vaccine. “Thus, the duration of corticosteroid administration should be limited to the resolution of the symptoms or ventricular arrhythmias or the recovery of the left ventricular ejection fraction.”

Pending publication of long-term outcome data after SARS-CoV-2 vaccine–related myocarditis, they suggest adherence to the current consensus recommendation to abstain from competitive sports for a period of 3-6 months with reevaluation prior to sports participation. 

In another of the Circulation papers, a group led by Carolyn M. Rosner, MSN,  presented a case series of seven patients hospitalized for acute myocarditis-like illness following COVID-19 vaccination, from two U.S. medical centers, in Falls Church, Va., and Dallas. All patients were males below the age of 40 years and of White or Hispanic race/ethnicity. Only one patient reported prior history of COVID-19 infection. Six patients received mRNA (Moderna or Pfizer) and one received the adenovirus (Johnson & Johnson) vaccine. All patients presented 3-7 days post vaccination with acute onset chest pain and biochemical evidence of myocardial injury.

Hospital length of stay was 3 days, and all patients’ symptoms resolved by hospital discharge.

And finally, the third paper in Circulation reported a detailed description of one patient – a 52-year-old, previously healthy male who presented with acute myocarditis 3 days after the administration of the second dose of Moderna’s COVID-19 vaccine. The symptoms resolved, and there was a gradual improvement in cMRI findings. Ischemic injury and other potential causes of acute myocardial injury were excluded, as were other potential infectious causes of myocarditis, and there was no evidence of systemic autoimmune disease.

“Clinicians should be aware that myocarditis may be present in patients exhibiting cardiac signs and symptoms 2-4 days after COVID-19 vaccination,” the authors said.

They added that additional surveillance of such adverse events post–COVID-19 vaccination will help identify subgroups at higher risk for this vaccine-related effect, and whether additional precautions are necessary.
 

‘Benefits outweigh risk’

In an accompanying editorial in JAMA Cardiology, three doctors from the CDC cite several other reports of myocarditis after mRNA COVID vaccination. These include a case report published in Pediatrics of seven male adolescents aged 14-19 years who presented with myocarditis or myopericarditis within 4 days after receipt of a second dose of the Pfizer vaccine.

But the editorialists noted that the most comprehensive data about the risk for myocarditis following immunization with mRNA vaccines comes from Israel.

The Israeli Ministry of Health recently posted data describing 121 myocarditis cases occurring within 30 days of a second dose of mRNA vaccine among 5,049,424 persons, suggesting a crude incidence rate of approximately 24 cases per million.

On the current case reports, the CDC doctors wrote: “The striking clinical similarities in the presentations of these patients, their recent vaccination with an mRNA-based COVID-19 vaccine, and the lack of any alternative etiologies for acute myocarditis suggest an association with immunization.”

They said that acute onset of chest pain 3-5 days after vaccine administration, usually after a second dose, is a typical feature of reported cases and suggests an immune-mediated mechanism.

But SARS-CoV-2 infection also causes cardiac injury which may result in severe outcomes, and based on currently available data, myocarditis following immunization with current mRNA-based vaccines is rare.

“At present, the benefits of immunization in preventing severe morbidity favors continued COVID-19 vaccination, particularly considering the increasing COVID-19 hospitalization rates among adolescents reported during spring 2021,” the editorialists stated.

But they added that many questions remain. These include whether modifications are needed to the vaccine schedule among persons with a history of possible or confirmed myocarditis after COVID vaccine, how should postvaccine myocarditis be managed, how often should follow-up assessments be performed, how might follow-up assessments affect recommendations to avoid vigorous physical activity following the diagnosis of myocarditis, and do all likely cases of acute myocarditis that appear to be uncomplicated require cardiac MRI for more definitive diagnosis?

“While the data needed to answer such questions are being collected, there is an opportunity for researchers with expertise in myocarditis to develop a comprehensive, national assessment of the natural history, pathogenesis, and treatment of acute myocarditis associated with receipt of mRNA-based COVID-19 vaccines,” they concluded.

In a second editorial in JAMA Cardiology, a group of editors from the journal acknowledged that publication of the current case reports may contribute to additional public concern regarding immunization. But they added that clinicians discussing immunization with patients should recognize that these case series suggest that the symptomatic events consistent with myocarditis are still very rare and appear to be self-limiting.

“Given the risks of COVID-19, including the risk of myocarditis from COVID-19 infection, the editors do not believe these case reports are sufficient to interrupt the march toward maximal vaccination against SARS-CoV-2 as expeditiously as possible,” they said.

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

Further details from multiple cases of myocarditis linked to the Pfizer and Moderna mRNA COVID vaccines have been described in recent papers in the medical literature.

The cases appear to occur almost exclusively in males and most often in younger age groups. While symptoms and signs of myocarditis mostly resolved with a few days of supportive care, long-term effects are unknown at present.

The authors of all the reports and of two accompanying editorials in JAMA Cardiology are unanimous in their opinion that the benefits of vaccination still outweigh the risks.  

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices met June 23 to discuss this issue. At that meeting, it was reported that 323 cases of myocarditis or pericarditis in individuals aged 29 years and younger have been confirmed, but committee members delivered a strong endorsement for continuing to vaccinate young people with the mRNA vaccines.

The current case reports are published in two papers in JAMA Cardiology and in three in Circulation.
 

U.S. military reports 23 cases

In one report in JAMA Cardiology, authors led by Jay Montgomery, MD, from Walter Reed National Military Medical Center in Bethesda, Md., described 23 cases from the U.S. Military Health System of individuals with acute myocarditis who presented within 4 days after mRNA-based COVID-19 vaccination (7 Pfizer and 16 Moderna).

All patients were male, 22 of 23 were on active duty, and the median age was 25 years (range, 20-51); 20 of the 23 cases occurred after receipt of a second dose of an mRNA COVID-19 vaccine.

The patients all presented with acute onset of marked chest pain. All patients had significantly elevated cardiac troponin levels. Among eight patients who underwent cardiac MRI (cMRI), all had findings consistent with the clinical diagnosis of myocarditis.

Additional testing did not identify other possible causes of myocarditis. All patients received brief supportive care and were recovered or recovering.

The authors reported that the military administered more than 2.8 million doses of mRNA COVID-19 vaccine in this period, and while the observed number of myocarditis cases was small, the number was “substantially higher” than expected among male military members after a second vaccine dose.

They noted that, based on historical data, among the 544,000 second doses to military members there may have been 0-10 expected myocarditis cases, but they observed 19 cases.  

“All patients in this series reflect substantial similarities in demographic characteristics, proximate vaccine dose, onset interval, and character of vaccine-associated myocarditis. The consistent pattern of clinical presentation, rapid recovery, and absence of evidence of other causes support the diagnosis of hypersensitivity myocarditis,” they stated.

They added that presentation after a second vaccine dose or, in three patients, when vaccination followed SARS-CoV-2 infection, suggests that prior exposure was relevant in the hypersensitivity response.

“The spectrum of clinical presentation and reliance on patients seeking health care and on health care professionals recognizing a rare vaccine-associated adverse event limits determination of the true incidence of this condition,” the authors wrote.

They stressed that recognition of vaccine-associated myocarditis is clinically important because diagnosis impacts management, recommendations for exercise, and monitoring for cardiomyopathy.

But the authors also acknowledged that it is important to frame concerns about potential vaccine-associated myocarditis within the context of the current pandemic.

“Infection with SARS-CoV-2 is a clear cause of serious cardiac injury in many patients. ... Prevalence of cardiac injury may be as high as 60% in seriously ill patients. Notably, nearly 1% of highly fit athletes with mild COVID-19 infection have evidence of myocarditis on cMRI,” they wrote.

“Given that COVID-19 vaccines are remarkably effective at preventing infection, any risk of rare adverse events following immunization must be carefully weighed against the very substantial benefit of vaccination,” they concluded.
 

Four cases at Duke

In the second paper in JAMA Cardiology, a group led by Han W. Kim, MD, reported four patients with acute myocarditis occurring within days of mRNA COVID-19 vaccination (two Pfizer and two Moderna) in patients treated at Duke University Medical Center, Durham, N.C. The hospital courses of the four patients with myocarditis following COVID-19 vaccination were uneventful, and they were discharged within 2-4 days.

The authors said that, although a causal relationship cannot be established, none of the patients had a viral prodrome or had coincident testing that revealed an alternative explanation.

They stated that these four patients represent the majority of patients with acute myocarditis identified in the past 3 months at their institution, and this led to the highest total number of patients with acute myocarditis, compared with the same 3-month period for the past 5 years. 

“Additionally, we identified only those patients with severe unremitting chest pain who sought medical attention. Those with mild or moderate chest pain might not seek medical attention, and it is possible that subclinical myocarditis may occur and could be detected by active surveillance, as has been described with smallpox vaccination,” they wrote.
 

Further case reports

In one of the papers in Circulation, a group led by Kathryn F. Larson, MD, from the Mayo Clinic in Rochester, Minn., described eight patients hospitalized with chest pain who were diagnosed with myocarditis within 2-4 days of receiving either the Pfizer or Moderna vaccine.

Two of the patients had previously been infected by SARS-CoV-2 without need for hospitalization. All individuals were otherwise healthy males between the ages of 21 and 56 years. All but one patient developed symptoms after their second dose, and the one patient who developed myocarditis after the first vaccine dose had previously been infected with SARS-CoV-2.  

Systemic symptoms began within 24 hours after vaccine administration in five of eight patients, with chest pain presenting between 48 and 96 hours later. Troponin values were elevated in all individuals and appeared to peak the day after admission, whereas none had eosinophilia.

Cardiac MRI revealed findings consistent with myocarditis in all patients. All patients had resolution of their chest pain and were discharged from the hospital in stable condition.

“The patients presented here demonstrated typical signs, symptoms, and diagnostic features of acute myocarditis. The temporal association between receiving an mRNA-based COVID-19 vaccine and the development of myocarditis is notable,” the authors said.  

They added that they would consider the use of corticosteroids in these patients but cautioned that this could reduce the specific immune response against SARS-COV-2 triggered by the vaccine. “Thus, the duration of corticosteroid administration should be limited to the resolution of the symptoms or ventricular arrhythmias or the recovery of the left ventricular ejection fraction.”

Pending publication of long-term outcome data after SARS-CoV-2 vaccine–related myocarditis, they suggest adherence to the current consensus recommendation to abstain from competitive sports for a period of 3-6 months with reevaluation prior to sports participation. 

In another of the Circulation papers, a group led by Carolyn M. Rosner, MSN,  presented a case series of seven patients hospitalized for acute myocarditis-like illness following COVID-19 vaccination, from two U.S. medical centers, in Falls Church, Va., and Dallas. All patients were males below the age of 40 years and of White or Hispanic race/ethnicity. Only one patient reported prior history of COVID-19 infection. Six patients received mRNA (Moderna or Pfizer) and one received the adenovirus (Johnson & Johnson) vaccine. All patients presented 3-7 days post vaccination with acute onset chest pain and biochemical evidence of myocardial injury.

Hospital length of stay was 3 days, and all patients’ symptoms resolved by hospital discharge.

And finally, the third paper in Circulation reported a detailed description of one patient – a 52-year-old, previously healthy male who presented with acute myocarditis 3 days after the administration of the second dose of Moderna’s COVID-19 vaccine. The symptoms resolved, and there was a gradual improvement in cMRI findings. Ischemic injury and other potential causes of acute myocardial injury were excluded, as were other potential infectious causes of myocarditis, and there was no evidence of systemic autoimmune disease.

“Clinicians should be aware that myocarditis may be present in patients exhibiting cardiac signs and symptoms 2-4 days after COVID-19 vaccination,” the authors said.

They added that additional surveillance of such adverse events post–COVID-19 vaccination will help identify subgroups at higher risk for this vaccine-related effect, and whether additional precautions are necessary.
 

‘Benefits outweigh risk’

In an accompanying editorial in JAMA Cardiology, three doctors from the CDC cite several other reports of myocarditis after mRNA COVID vaccination. These include a case report published in Pediatrics of seven male adolescents aged 14-19 years who presented with myocarditis or myopericarditis within 4 days after receipt of a second dose of the Pfizer vaccine.

But the editorialists noted that the most comprehensive data about the risk for myocarditis following immunization with mRNA vaccines comes from Israel.

The Israeli Ministry of Health recently posted data describing 121 myocarditis cases occurring within 30 days of a second dose of mRNA vaccine among 5,049,424 persons, suggesting a crude incidence rate of approximately 24 cases per million.

On the current case reports, the CDC doctors wrote: “The striking clinical similarities in the presentations of these patients, their recent vaccination with an mRNA-based COVID-19 vaccine, and the lack of any alternative etiologies for acute myocarditis suggest an association with immunization.”

They said that acute onset of chest pain 3-5 days after vaccine administration, usually after a second dose, is a typical feature of reported cases and suggests an immune-mediated mechanism.

But SARS-CoV-2 infection also causes cardiac injury which may result in severe outcomes, and based on currently available data, myocarditis following immunization with current mRNA-based vaccines is rare.

“At present, the benefits of immunization in preventing severe morbidity favors continued COVID-19 vaccination, particularly considering the increasing COVID-19 hospitalization rates among adolescents reported during spring 2021,” the editorialists stated.

But they added that many questions remain. These include whether modifications are needed to the vaccine schedule among persons with a history of possible or confirmed myocarditis after COVID vaccine, how should postvaccine myocarditis be managed, how often should follow-up assessments be performed, how might follow-up assessments affect recommendations to avoid vigorous physical activity following the diagnosis of myocarditis, and do all likely cases of acute myocarditis that appear to be uncomplicated require cardiac MRI for more definitive diagnosis?

“While the data needed to answer such questions are being collected, there is an opportunity for researchers with expertise in myocarditis to develop a comprehensive, national assessment of the natural history, pathogenesis, and treatment of acute myocarditis associated with receipt of mRNA-based COVID-19 vaccines,” they concluded.

In a second editorial in JAMA Cardiology, a group of editors from the journal acknowledged that publication of the current case reports may contribute to additional public concern regarding immunization. But they added that clinicians discussing immunization with patients should recognize that these case series suggest that the symptomatic events consistent with myocarditis are still very rare and appear to be self-limiting.

“Given the risks of COVID-19, including the risk of myocarditis from COVID-19 infection, the editors do not believe these case reports are sufficient to interrupt the march toward maximal vaccination against SARS-CoV-2 as expeditiously as possible,” they said.

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