Infectious Disease Practitioner

The majority of children with type 1 diabetes who tested positive for SARS-CoV-2 were cared for at home and did well, according to the first report of outcomes of pediatric patients with type 1 diabetes and COVID-19 from the United States.

Most children who were hospitalized had diabetic ketoacidosis (DKA) and high hemoglobin A1c levels, the new report from the T1D Exchange Quality Improvement Collaborative indicates. Fewer than 2% required respiratory support, and no deaths were recorded.

The greatest risk for adverse COVID-19 outcomes was among children with A1c levels >9%. In addition, children of certain ethnic minority groups and those with public health insurance were more likely to be hospitalized.

The study, conducted by G. Todd Alonso, MD, of the University of Colorado, Barbara Davis Center, Aurora, and colleagues, was published online April 14 in the Journal of Diabetes..

“As early reports identified diabetes as a risk factor for increased morbidity and mortality with COVID-19, the findings from this surveillance study should provide measured reassurance for families of children with type 1 diabetes as well as pediatric endocrinologists and their care teams,” say Dr. Alonso and colleagues.
 

Disproportionate rate of hospitalization, DKA among Black patients

Initiated in April 2020, the T1D Exchange Quality Improvement Collaborative comprises 56 diabetes centers, of which 52 submitted a total of 266 cases involving patients younger than 19 years who had type 1 diabetes and who tested positive for SARS-CoV-2 infection. Those with new-onset type 1 diabetes were excluded from this analysis and were reported separately. The data were collected between April 9, 2020, and Jan. 15, 2021.

Of the 266 patients, 23% (61) were hospitalized, and 205 were not. There were no differences by age, gender, or diabetes duration.

However, those hospitalized were more likely to be Black (34% vs. 13% among White patients; P < .001) and to have public health insurance (64% vs. 41%; P < .001). They also had higher A1c levels than patients who were not hospitalized (11% vs. 8.2%; P < .001), and fewer used insulin pumps (26% vs. 54%; P < .001) and continuous glucose monitors (39% vs. 75%; P < .001).

Those hospitalized were also more likely to have hyperglycemia (48% vs. 28%; P = .007), nausea (33% vs. 6%; P < .001), and vomiting (49% vs. 3%; P < .001). Rates of dry cough, excess fatigue, and body aches/headaches did not differ between those hospitalized and those who remained at home.

The most common adverse outcome was DKA, which occurred in 72% (44) of those hospitalized.

The most recent A1c level was less than 9% in 82% of those hospitalized vs. 31% of those who weren’t (P < .001) and in 38 of the 44 (86%) who had DKA.

“Our data reveal a disproportionate rate of hospitalization and DKA among racial and ethnic minority groups, children who were publicly insured, and those with higher A1c. It is essential to find pathways for the most vulnerable patients to have adequate, equitable access to medical care via in person and telehealth services, to obtain and successfully use diabetes technology, and to optimize sick day management,” say Dr. Alonso and colleagues.

One child, a 15-year-old White boy, underwent intubation and was placed on a ventilator. His most recent A1c was 8.9%. Another child, a 13-year-old boy whose most recent A1c level was 11.1%, developed multisystem inflammatory syndrome of childhood.

The registry remains open.

The T1D Exchange QI Collaborative is funded by the Helmsley Charitable Trust. The T1D Exchange received partial financial support for this study from Abbott Diabetes, Dexcom, Medtronic, Insulet Corporation, JDRF, Eli Lilly, and Tandem Diabetes Care. None of the sponsors were involved in initiating, designing, or preparing the manuscript for this study.

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

The majority of children with type 1 diabetes who tested positive for SARS-CoV-2 were cared for at home and did well, according to the first report of outcomes of pediatric patients with type 1 diabetes and COVID-19 from the United States.

Most children who were hospitalized had diabetic ketoacidosis (DKA) and high hemoglobin A1c levels, the new report from the T1D Exchange Quality Improvement Collaborative indicates. Fewer than 2% required respiratory support, and no deaths were recorded.

The greatest risk for adverse COVID-19 outcomes was among children with A1c levels >9%. In addition, children of certain ethnic minority groups and those with public health insurance were more likely to be hospitalized.

The study, conducted by G. Todd Alonso, MD, of the University of Colorado, Barbara Davis Center, Aurora, and colleagues, was published online April 14 in the Journal of Diabetes..

“As early reports identified diabetes as a risk factor for increased morbidity and mortality with COVID-19, the findings from this surveillance study should provide measured reassurance for families of children with type 1 diabetes as well as pediatric endocrinologists and their care teams,” say Dr. Alonso and colleagues.
 

Disproportionate rate of hospitalization, DKA among Black patients

Initiated in April 2020, the T1D Exchange Quality Improvement Collaborative comprises 56 diabetes centers, of which 52 submitted a total of 266 cases involving patients younger than 19 years who had type 1 diabetes and who tested positive for SARS-CoV-2 infection. Those with new-onset type 1 diabetes were excluded from this analysis and were reported separately. The data were collected between April 9, 2020, and Jan. 15, 2021.

Of the 266 patients, 23% (61) were hospitalized, and 205 were not. There were no differences by age, gender, or diabetes duration.

However, those hospitalized were more likely to be Black (34% vs. 13% among White patients; P < .001) and to have public health insurance (64% vs. 41%; P < .001). They also had higher A1c levels than patients who were not hospitalized (11% vs. 8.2%; P < .001), and fewer used insulin pumps (26% vs. 54%; P < .001) and continuous glucose monitors (39% vs. 75%; P < .001).

Those hospitalized were also more likely to have hyperglycemia (48% vs. 28%; P = .007), nausea (33% vs. 6%; P < .001), and vomiting (49% vs. 3%; P < .001). Rates of dry cough, excess fatigue, and body aches/headaches did not differ between those hospitalized and those who remained at home.

The most common adverse outcome was DKA, which occurred in 72% (44) of those hospitalized.

The most recent A1c level was less than 9% in 82% of those hospitalized vs. 31% of those who weren’t (P < .001) and in 38 of the 44 (86%) who had DKA.

“Our data reveal a disproportionate rate of hospitalization and DKA among racial and ethnic minority groups, children who were publicly insured, and those with higher A1c. It is essential to find pathways for the most vulnerable patients to have adequate, equitable access to medical care via in person and telehealth services, to obtain and successfully use diabetes technology, and to optimize sick day management,” say Dr. Alonso and colleagues.

One child, a 15-year-old White boy, underwent intubation and was placed on a ventilator. His most recent A1c was 8.9%. Another child, a 13-year-old boy whose most recent A1c level was 11.1%, developed multisystem inflammatory syndrome of childhood.

The registry remains open.

The T1D Exchange QI Collaborative is funded by the Helmsley Charitable Trust. The T1D Exchange received partial financial support for this study from Abbott Diabetes, Dexcom, Medtronic, Insulet Corporation, JDRF, Eli Lilly, and Tandem Diabetes Care. None of the sponsors were involved in initiating, designing, or preparing the manuscript for this study.

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

The majority of children with type 1 diabetes who tested positive for SARS-CoV-2 were cared for at home and did well, according to the first report of outcomes of pediatric patients with type 1 diabetes and COVID-19 from the United States.

Most children who were hospitalized had diabetic ketoacidosis (DKA) and high hemoglobin A1c levels, the new report from the T1D Exchange Quality Improvement Collaborative indicates. Fewer than 2% required respiratory support, and no deaths were recorded.

The greatest risk for adverse COVID-19 outcomes was among children with A1c levels >9%. In addition, children of certain ethnic minority groups and those with public health insurance were more likely to be hospitalized.

The study, conducted by G. Todd Alonso, MD, of the University of Colorado, Barbara Davis Center, Aurora, and colleagues, was published online April 14 in the Journal of Diabetes..

“As early reports identified diabetes as a risk factor for increased morbidity and mortality with COVID-19, the findings from this surveillance study should provide measured reassurance for families of children with type 1 diabetes as well as pediatric endocrinologists and their care teams,” say Dr. Alonso and colleagues.
 

Disproportionate rate of hospitalization, DKA among Black patients

Initiated in April 2020, the T1D Exchange Quality Improvement Collaborative comprises 56 diabetes centers, of which 52 submitted a total of 266 cases involving patients younger than 19 years who had type 1 diabetes and who tested positive for SARS-CoV-2 infection. Those with new-onset type 1 diabetes were excluded from this analysis and were reported separately. The data were collected between April 9, 2020, and Jan. 15, 2021.

Of the 266 patients, 23% (61) were hospitalized, and 205 were not. There were no differences by age, gender, or diabetes duration.

However, those hospitalized were more likely to be Black (34% vs. 13% among White patients; P < .001) and to have public health insurance (64% vs. 41%; P < .001). They also had higher A1c levels than patients who were not hospitalized (11% vs. 8.2%; P < .001), and fewer used insulin pumps (26% vs. 54%; P < .001) and continuous glucose monitors (39% vs. 75%; P < .001).

Those hospitalized were also more likely to have hyperglycemia (48% vs. 28%; P = .007), nausea (33% vs. 6%; P < .001), and vomiting (49% vs. 3%; P < .001). Rates of dry cough, excess fatigue, and body aches/headaches did not differ between those hospitalized and those who remained at home.

The most common adverse outcome was DKA, which occurred in 72% (44) of those hospitalized.

The most recent A1c level was less than 9% in 82% of those hospitalized vs. 31% of those who weren’t (P < .001) and in 38 of the 44 (86%) who had DKA.

“Our data reveal a disproportionate rate of hospitalization and DKA among racial and ethnic minority groups, children who were publicly insured, and those with higher A1c. It is essential to find pathways for the most vulnerable patients to have adequate, equitable access to medical care via in person and telehealth services, to obtain and successfully use diabetes technology, and to optimize sick day management,” say Dr. Alonso and colleagues.

One child, a 15-year-old White boy, underwent intubation and was placed on a ventilator. His most recent A1c was 8.9%. Another child, a 13-year-old boy whose most recent A1c level was 11.1%, developed multisystem inflammatory syndrome of childhood.

The registry remains open.

The T1D Exchange QI Collaborative is funded by the Helmsley Charitable Trust. The T1D Exchange received partial financial support for this study from Abbott Diabetes, Dexcom, Medtronic, Insulet Corporation, JDRF, Eli Lilly, and Tandem Diabetes Care. None of the sponsors were involved in initiating, designing, or preparing the manuscript for this study.

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

Primary care for LGBTQ+ patients should focus on early identification and management of unique health risks, according to a leading expert.

Patients who are transgender, for instance, are nine times more likely to commit suicide than the general population (2015 U.S. Transgender Survey (USTS). Inter-university Consortium for Political and Social Research. 2019 May 22. doi: 10.3886/ICPSR37229.v1), and those who are also Black have an estimated HIV prevalence of 62%, demonstrating the cumulative, negative health effects of intersectionality (www.cdc.gov/hiv/group/gender/transgender/hiv-prevalence.html).

“Experiences with marginalization and stigma directly relate to some of the poor physical and mental health outcomes that these patients experience,” Megan McNamara, MD, said during a presentation at the American College of Physicians annual Internal Medicine meeting.

Dr. McNamara, who is director of the Gender Identity Veteran’s Experience (GIVE) Clinic, Veterans Affairs Northeast Ohio Healthcare System, Cleveland, offered a brief guide to managing LGBTQ+ patients. She emphasized increased rates of psychological distress and substance abuse, and encouraged familiarity with specific risks associated with three subgroups: men who have sex with men (MSM), women who have sex with women (WSW), and those who are transgender.

Men who have sex with men

According to Dr. McNamara, preexposure prophylaxis (PrEP) should be offered based on Centers for Disease Control and Prevention eligibility criteria, which require that the patient is HIV negative, has had a male sex partner in the past 6 months, is not in a monogamous relationship, and has had anal sex or a bacterial sexually transmitted infection in the past 6 months. The two PrEP options, emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir alafenamide, are equally effective and have similar safety profiles, Dr. McNamara said, but patients with impaired renal function should receive the alafenamide formulation.

Dr. McNamara also advised screening gay men for extragenital STIs, noting a 13.3% increased risk. When asked about anal Pap testing for HPV, Dr. McNamara called the subject “very controversial,” and ultimately recommended against it, citing a lack of data linking anal HPV infection and dysplasia with later development of rectal carcinoma, as well as the nonactionable impact of a positive result.

“For me, the issue is ... if [a positive anal Pap test] is not going to change my management, if I don’t know that the anal HPV that I diagnose will result in cancer, should I continue to monitor it?” Dr. McNamara said.

Women who have sex with women

Beyond higher rates of psychological distress and substance abuse among lesbian and bisexual women, Dr. McNamara described increased risks of overweight and obesity, higher rates of smoking, and lower rates of Pap testing, all of which should prompt clinicians to advise accordingly, with cervical cancer screening in alignment with guidelines. Clinicians should also discuss HPV vaccination with patients, taking care to weigh benefits and risks, as “catch-up” HPV vaccination is not unilaterally recommended for adults older than 26 years.

Transgender patients

Discussing transgender patients, Dr. McNamara focused on cross-sex hormone therapy (CSHT), first noting the significant psychological benefits, including improvements in depression, somatization, interpersonal sensitivity, hostility, anxiety, phobic anxiety/agoraphobia, and quality of life.

According to Dr. McNamara, CSHT is relatively simple and may be safely administered by primary care providers. For transmasculine patients, testosterone supplementation is all that is needed, whereas transfeminine patients will require spironolactone or GnRH agonists to reduce testosterone and estradiol to increase feminizing hormones to pubertal levels.

CSHT is not without risks, Dr. McNamara said, including “very high” risks of erythrocytosis among transmasculine patients and venous thromboembolic disease among transfeminine patients; but these risks need to be considered in the context of an approximate 40% suicide rate among transgender individuals.

“I can tell you in my own practice that these [suicide] data ring true,” Dr. McNamara said. “Many, many of my patients have attempted suicide, so [CSHT] is something that you really want to think about right away.”

Even when additional risk factors are present, such as preexisting cardiovascular disease, Dr. McNamara suggested that “there are very few absolute contraindications to CSHT,” and described it as a “life-sustaining treatment” that should be viewed analogously with any other long-term management strategy, such as therapy for diabetes or hypertension.

Fostering a transgender-friendly practice

In an interview, Nicole Nisly, MD, codirector of the LGBTQ+ Clinic at the University of Iowa Hospitals and Clinics, Iowa City, reflected upon Dr. McNamara’s presentation, noting that primary care providers – with a little education – are the best candidates to care for transgender patients.

“I think [primary care providers] do a better job [caring for transgender patients] than endocrinologists, honestly, because they can provide care for the whole person,” Dr. Nisly said. “They can do a Pap, they can do STI screening, they can assess mood, they can [evaluate] safety, and the whole person, as opposed to endocrinologists, who do hormone therapy, but somebody else does everything else.”

Dr. Nisly emphasized the importance of personalizing care for transgender individuals, which depends upon a welcoming practice environment, with careful attention to language.

Foremost, Dr. Nisly recommended asking patients for their preferred name, sexual orientation, and gender identity.

“One of the most difficult things [for transgender patients] is to see notes with the wrong name – the name that makes them feel uncomfortable – or the wrong pronoun,” Dr. Nisly said. “That’s very important to the community.”

Dr. Nisly also recommended an alternative term for cross-sex hormone therapy.

“I hate cross-sex hormone therapy terminology, honestly,” Dr. Nisly said. “I just think it’s so unwelcoming, and I think most of our patients don’t like the terminology, so we use ‘gender-affirming hormone therapy.’”

Dr. Nisly explained that the term “cross-sex” assumes a conventional definition of sex, which is inherently flawed.

When discussing certain medical risk factors, such as pregnancy or HIV, it is helpful to know “sex assigned at birth” for both patients and their sexual partners, Dr. Nisly said. It’s best to ask in this way, instead of using terms like “boyfriend” or “girlfriend,” as “sex assigned at birth” is “terminology the community recognizes, affirms, and feels comfortable with.”

Concerning management of medical risk factors, Dr. Nisly offered some additional perspectives.

For one, she recommended giving PrEP to any patient who has a desire to be on PrEP, noting that this desire can indicate a change in future sexual practices, which the CDC criteria do not anticipate. She also advised in-hospital self-swabbing for extragenital STIs, as this can increase patient comfort and adherence. And, in contrast with Dr. McNamara, Dr. Nisly recommended anal Pap screening for any man that has sex with men and anyone with HIV of any gender. She noted that rates of anal dysplasia are “pretty high” among men who have sex with men, and that detection may reduce cancer risk.

For clinicians who would like to learn more about caring for transgender patients, Dr. Nisly recommended that they start by reading the World Professional Association for Transgender Health guidelines.

“It’s about 300 pages,” Dr. Nisly said, “but it is great.”

Dr. McNamara and Dr. Nisly reported no conflicts of interest.

Primary care for LGBTQ+ patients should focus on early identification and management of unique health risks, according to a leading expert.

Patients who are transgender, for instance, are nine times more likely to commit suicide than the general population (2015 U.S. Transgender Survey (USTS). Inter-university Consortium for Political and Social Research. 2019 May 22. doi: 10.3886/ICPSR37229.v1), and those who are also Black have an estimated HIV prevalence of 62%, demonstrating the cumulative, negative health effects of intersectionality (www.cdc.gov/hiv/group/gender/transgender/hiv-prevalence.html).

“Experiences with marginalization and stigma directly relate to some of the poor physical and mental health outcomes that these patients experience,” Megan McNamara, MD, said during a presentation at the American College of Physicians annual Internal Medicine meeting.

Dr. McNamara, who is director of the Gender Identity Veteran’s Experience (GIVE) Clinic, Veterans Affairs Northeast Ohio Healthcare System, Cleveland, offered a brief guide to managing LGBTQ+ patients. She emphasized increased rates of psychological distress and substance abuse, and encouraged familiarity with specific risks associated with three subgroups: men who have sex with men (MSM), women who have sex with women (WSW), and those who are transgender.

Men who have sex with men

According to Dr. McNamara, preexposure prophylaxis (PrEP) should be offered based on Centers for Disease Control and Prevention eligibility criteria, which require that the patient is HIV negative, has had a male sex partner in the past 6 months, is not in a monogamous relationship, and has had anal sex or a bacterial sexually transmitted infection in the past 6 months. The two PrEP options, emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir alafenamide, are equally effective and have similar safety profiles, Dr. McNamara said, but patients with impaired renal function should receive the alafenamide formulation.

Dr. McNamara also advised screening gay men for extragenital STIs, noting a 13.3% increased risk. When asked about anal Pap testing for HPV, Dr. McNamara called the subject “very controversial,” and ultimately recommended against it, citing a lack of data linking anal HPV infection and dysplasia with later development of rectal carcinoma, as well as the nonactionable impact of a positive result.

“For me, the issue is ... if [a positive anal Pap test] is not going to change my management, if I don’t know that the anal HPV that I diagnose will result in cancer, should I continue to monitor it?” Dr. McNamara said.

Women who have sex with women

Beyond higher rates of psychological distress and substance abuse among lesbian and bisexual women, Dr. McNamara described increased risks of overweight and obesity, higher rates of smoking, and lower rates of Pap testing, all of which should prompt clinicians to advise accordingly, with cervical cancer screening in alignment with guidelines. Clinicians should also discuss HPV vaccination with patients, taking care to weigh benefits and risks, as “catch-up” HPV vaccination is not unilaterally recommended for adults older than 26 years.

Transgender patients

Discussing transgender patients, Dr. McNamara focused on cross-sex hormone therapy (CSHT), first noting the significant psychological benefits, including improvements in depression, somatization, interpersonal sensitivity, hostility, anxiety, phobic anxiety/agoraphobia, and quality of life.

According to Dr. McNamara, CSHT is relatively simple and may be safely administered by primary care providers. For transmasculine patients, testosterone supplementation is all that is needed, whereas transfeminine patients will require spironolactone or GnRH agonists to reduce testosterone and estradiol to increase feminizing hormones to pubertal levels.

CSHT is not without risks, Dr. McNamara said, including “very high” risks of erythrocytosis among transmasculine patients and venous thromboembolic disease among transfeminine patients; but these risks need to be considered in the context of an approximate 40% suicide rate among transgender individuals.

“I can tell you in my own practice that these [suicide] data ring true,” Dr. McNamara said. “Many, many of my patients have attempted suicide, so [CSHT] is something that you really want to think about right away.”

Even when additional risk factors are present, such as preexisting cardiovascular disease, Dr. McNamara suggested that “there are very few absolute contraindications to CSHT,” and described it as a “life-sustaining treatment” that should be viewed analogously with any other long-term management strategy, such as therapy for diabetes or hypertension.

Fostering a transgender-friendly practice

In an interview, Nicole Nisly, MD, codirector of the LGBTQ+ Clinic at the University of Iowa Hospitals and Clinics, Iowa City, reflected upon Dr. McNamara’s presentation, noting that primary care providers – with a little education – are the best candidates to care for transgender patients.

“I think [primary care providers] do a better job [caring for transgender patients] than endocrinologists, honestly, because they can provide care for the whole person,” Dr. Nisly said. “They can do a Pap, they can do STI screening, they can assess mood, they can [evaluate] safety, and the whole person, as opposed to endocrinologists, who do hormone therapy, but somebody else does everything else.”

Dr. Nisly emphasized the importance of personalizing care for transgender individuals, which depends upon a welcoming practice environment, with careful attention to language.

Foremost, Dr. Nisly recommended asking patients for their preferred name, sexual orientation, and gender identity.

“One of the most difficult things [for transgender patients] is to see notes with the wrong name – the name that makes them feel uncomfortable – or the wrong pronoun,” Dr. Nisly said. “That’s very important to the community.”

Dr. Nisly also recommended an alternative term for cross-sex hormone therapy.

“I hate cross-sex hormone therapy terminology, honestly,” Dr. Nisly said. “I just think it’s so unwelcoming, and I think most of our patients don’t like the terminology, so we use ‘gender-affirming hormone therapy.’”

Dr. Nisly explained that the term “cross-sex” assumes a conventional definition of sex, which is inherently flawed.

When discussing certain medical risk factors, such as pregnancy or HIV, it is helpful to know “sex assigned at birth” for both patients and their sexual partners, Dr. Nisly said. It’s best to ask in this way, instead of using terms like “boyfriend” or “girlfriend,” as “sex assigned at birth” is “terminology the community recognizes, affirms, and feels comfortable with.”

Concerning management of medical risk factors, Dr. Nisly offered some additional perspectives.

For one, she recommended giving PrEP to any patient who has a desire to be on PrEP, noting that this desire can indicate a change in future sexual practices, which the CDC criteria do not anticipate. She also advised in-hospital self-swabbing for extragenital STIs, as this can increase patient comfort and adherence. And, in contrast with Dr. McNamara, Dr. Nisly recommended anal Pap screening for any man that has sex with men and anyone with HIV of any gender. She noted that rates of anal dysplasia are “pretty high” among men who have sex with men, and that detection may reduce cancer risk.

For clinicians who would like to learn more about caring for transgender patients, Dr. Nisly recommended that they start by reading the World Professional Association for Transgender Health guidelines.

“It’s about 300 pages,” Dr. Nisly said, “but it is great.”

Dr. McNamara and Dr. Nisly reported no conflicts of interest.

Primary care for LGBTQ+ patients should focus on early identification and management of unique health risks, according to a leading expert.

Patients who are transgender, for instance, are nine times more likely to commit suicide than the general population (2015 U.S. Transgender Survey (USTS). Inter-university Consortium for Political and Social Research. 2019 May 22. doi: 10.3886/ICPSR37229.v1), and those who are also Black have an estimated HIV prevalence of 62%, demonstrating the cumulative, negative health effects of intersectionality (www.cdc.gov/hiv/group/gender/transgender/hiv-prevalence.html).

“Experiences with marginalization and stigma directly relate to some of the poor physical and mental health outcomes that these patients experience,” Megan McNamara, MD, said during a presentation at the American College of Physicians annual Internal Medicine meeting.

Dr. McNamara, who is director of the Gender Identity Veteran’s Experience (GIVE) Clinic, Veterans Affairs Northeast Ohio Healthcare System, Cleveland, offered a brief guide to managing LGBTQ+ patients. She emphasized increased rates of psychological distress and substance abuse, and encouraged familiarity with specific risks associated with three subgroups: men who have sex with men (MSM), women who have sex with women (WSW), and those who are transgender.

Men who have sex with men

According to Dr. McNamara, preexposure prophylaxis (PrEP) should be offered based on Centers for Disease Control and Prevention eligibility criteria, which require that the patient is HIV negative, has had a male sex partner in the past 6 months, is not in a monogamous relationship, and has had anal sex or a bacterial sexually transmitted infection in the past 6 months. The two PrEP options, emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir alafenamide, are equally effective and have similar safety profiles, Dr. McNamara said, but patients with impaired renal function should receive the alafenamide formulation.

Dr. McNamara also advised screening gay men for extragenital STIs, noting a 13.3% increased risk. When asked about anal Pap testing for HPV, Dr. McNamara called the subject “very controversial,” and ultimately recommended against it, citing a lack of data linking anal HPV infection and dysplasia with later development of rectal carcinoma, as well as the nonactionable impact of a positive result.

“For me, the issue is ... if [a positive anal Pap test] is not going to change my management, if I don’t know that the anal HPV that I diagnose will result in cancer, should I continue to monitor it?” Dr. McNamara said.

Women who have sex with women

Beyond higher rates of psychological distress and substance abuse among lesbian and bisexual women, Dr. McNamara described increased risks of overweight and obesity, higher rates of smoking, and lower rates of Pap testing, all of which should prompt clinicians to advise accordingly, with cervical cancer screening in alignment with guidelines. Clinicians should also discuss HPV vaccination with patients, taking care to weigh benefits and risks, as “catch-up” HPV vaccination is not unilaterally recommended for adults older than 26 years.

Transgender patients

Discussing transgender patients, Dr. McNamara focused on cross-sex hormone therapy (CSHT), first noting the significant psychological benefits, including improvements in depression, somatization, interpersonal sensitivity, hostility, anxiety, phobic anxiety/agoraphobia, and quality of life.

According to Dr. McNamara, CSHT is relatively simple and may be safely administered by primary care providers. For transmasculine patients, testosterone supplementation is all that is needed, whereas transfeminine patients will require spironolactone or GnRH agonists to reduce testosterone and estradiol to increase feminizing hormones to pubertal levels.

CSHT is not without risks, Dr. McNamara said, including “very high” risks of erythrocytosis among transmasculine patients and venous thromboembolic disease among transfeminine patients; but these risks need to be considered in the context of an approximate 40% suicide rate among transgender individuals.

“I can tell you in my own practice that these [suicide] data ring true,” Dr. McNamara said. “Many, many of my patients have attempted suicide, so [CSHT] is something that you really want to think about right away.”

Even when additional risk factors are present, such as preexisting cardiovascular disease, Dr. McNamara suggested that “there are very few absolute contraindications to CSHT,” and described it as a “life-sustaining treatment” that should be viewed analogously with any other long-term management strategy, such as therapy for diabetes or hypertension.

Fostering a transgender-friendly practice

In an interview, Nicole Nisly, MD, codirector of the LGBTQ+ Clinic at the University of Iowa Hospitals and Clinics, Iowa City, reflected upon Dr. McNamara’s presentation, noting that primary care providers – with a little education – are the best candidates to care for transgender patients.

“I think [primary care providers] do a better job [caring for transgender patients] than endocrinologists, honestly, because they can provide care for the whole person,” Dr. Nisly said. “They can do a Pap, they can do STI screening, they can assess mood, they can [evaluate] safety, and the whole person, as opposed to endocrinologists, who do hormone therapy, but somebody else does everything else.”

Dr. Nisly emphasized the importance of personalizing care for transgender individuals, which depends upon a welcoming practice environment, with careful attention to language.

Foremost, Dr. Nisly recommended asking patients for their preferred name, sexual orientation, and gender identity.

“One of the most difficult things [for transgender patients] is to see notes with the wrong name – the name that makes them feel uncomfortable – or the wrong pronoun,” Dr. Nisly said. “That’s very important to the community.”

Dr. Nisly also recommended an alternative term for cross-sex hormone therapy.

“I hate cross-sex hormone therapy terminology, honestly,” Dr. Nisly said. “I just think it’s so unwelcoming, and I think most of our patients don’t like the terminology, so we use ‘gender-affirming hormone therapy.’”

Dr. Nisly explained that the term “cross-sex” assumes a conventional definition of sex, which is inherently flawed.

When discussing certain medical risk factors, such as pregnancy or HIV, it is helpful to know “sex assigned at birth” for both patients and their sexual partners, Dr. Nisly said. It’s best to ask in this way, instead of using terms like “boyfriend” or “girlfriend,” as “sex assigned at birth” is “terminology the community recognizes, affirms, and feels comfortable with.”

Concerning management of medical risk factors, Dr. Nisly offered some additional perspectives.

For one, she recommended giving PrEP to any patient who has a desire to be on PrEP, noting that this desire can indicate a change in future sexual practices, which the CDC criteria do not anticipate. She also advised in-hospital self-swabbing for extragenital STIs, as this can increase patient comfort and adherence. And, in contrast with Dr. McNamara, Dr. Nisly recommended anal Pap screening for any man that has sex with men and anyone with HIV of any gender. She noted that rates of anal dysplasia are “pretty high” among men who have sex with men, and that detection may reduce cancer risk.

For clinicians who would like to learn more about caring for transgender patients, Dr. Nisly recommended that they start by reading the World Professional Association for Transgender Health guidelines.

“It’s about 300 pages,” Dr. Nisly said, “but it is great.”

Dr. McNamara and Dr. Nisly reported no conflicts of interest.

Oral corticosteroid bursts are associated with an increased risk of gastrointestinal bleeding, sepsis, and pneumonia during the month after treatment initiation, according to a nationwide cohort study of children in Taiwan.

The adverse events are rare, and the risk attenuates in subsequent months, the analysis shows. Still, the study “provides evidence that corticosteroid bursts are not innocuous but may pose potentially serious health risks,” study author Tsung-Chieh Yao, MD, PhD, and colleagues said. “Clinicians prescribing corticosteroid bursts to children need to weigh the benefits against the risks of severe adverse events.”

[email protected]

Oral corticosteroid bursts are associated with an increased risk of gastrointestinal bleeding, sepsis, and pneumonia during the month after treatment initiation, according to a nationwide cohort study of children in Taiwan.

The adverse events are rare, and the risk attenuates in subsequent months, the analysis shows. Still, the study “provides evidence that corticosteroid bursts are not innocuous but may pose potentially serious health risks,” study author Tsung-Chieh Yao, MD, PhD, and colleagues said. “Clinicians prescribing corticosteroid bursts to children need to weigh the benefits against the risks of severe adverse events.”

[email protected]

Oral corticosteroid bursts are associated with an increased risk of gastrointestinal bleeding, sepsis, and pneumonia during the month after treatment initiation, according to a nationwide cohort study of children in Taiwan.

The adverse events are rare, and the risk attenuates in subsequent months, the analysis shows. Still, the study “provides evidence that corticosteroid bursts are not innocuous but may pose potentially serious health risks,” study author Tsung-Chieh Yao, MD, PhD, and colleagues said. “Clinicians prescribing corticosteroid bursts to children need to weigh the benefits against the risks of severe adverse events.”

[email protected]

A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.

The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.

That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.

However, the new report noted that these conditions are very rare.

“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.

“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”

The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
 

Assessing 81 million patients

In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.

Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.

Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.

Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.

For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.

“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected. 
 

Rare events

The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.

An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.

An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.

A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.

“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”

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

A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.

The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.

That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.

However, the new report noted that these conditions are very rare.

“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.

“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”

The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
 

Assessing 81 million patients

In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.

Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.

Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.

Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.

For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.

“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected. 
 

Rare events

The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.

An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.

An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.

A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.

“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”

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

A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.

The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.

That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.

However, the new report noted that these conditions are very rare.

“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.

“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”

The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
 

Assessing 81 million patients

In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.

Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.

Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.

Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.

For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.

“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected. 
 

Rare events

The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.

An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.

An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.

A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.

“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”

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

Although vaccination rates against the human papillomavirus remain low for young adults across the United States, the number of self-reported HPV vaccinations among women and men aged between 18 and 21 years has markedly increased since 2010, according to new research findings.

The findings were published online April 27, 2021, as a research letter in JAMA.

In 2006, the Food and Drug Administration approved the HPV vaccine for the prevention of cervical cancer and genital warts in female patients. Three years later, the FDA approved the vaccine for the prevention of anogenital cancer and warts in male patients.

The Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention recommend two doses of the HPV vaccine for children aged 11-12 years. Adolescents and young adults may need three doses over the course of 6 months if they start their vaccine series on or following their 15th birthday.

For persons who have not previously received the HPV vaccine or who did not receive adequate doses, the HPV vaccine is recommended through age 26. Data on the rates of vaccination among young adults between 18 and 21 years of age in the United States are sparse, and it is not known how well vaccination programs are progressing in the country.

In the recently published JAMA research letter, investigators from the University of Michigan, Ann Arbor, examined data for the period 2010-2018 from the cross-sectional National Health Interview Survey. Respondents included in the analysis were aged 18-21 years. They were asked whether they had received the HPV vaccine before age 18 and at what age they had been vaccinated against the virus.

The researchers also assessed whether the respondents had received any HPV vaccine dose between the ages of 18 and 21 years. The findings were limited to self-reported vaccination status.

In total, 6,606 women and 6,038 men were included in the analysis. Approximately 42% of women and 16% of men said they had received at least one HPV vaccine dose at any age. The proportion of female patients who reported receiving an HPV vaccine dose significantly increased from 32% in 2010 to 55% in 2018 (P =.001). Similarly, among men, the percentage significantly increased from 2% in 2010 to 34% in 2018 (P <.001).

Approximately 4% of the female respondents and 3% of the male respondents reported that they had received an HPV vaccine between the ages of 18 and 21 years; 46% of women and 29% of men who received the vaccine between these ages completed the recommended vaccination series.

Findings from the study highlight the continual need for improving vaccination rates among vulnerable populations. Lead study author Michelle Chen, MD, MHS, a professor in the department of otolaryngology–head and neck surgery at the University of Michigan, explained in an interview that there are multiple barriers to HPV vaccination among young adults. “These barriers to vaccination among young adults primarily include cost, lack of knowledge and awareness, missed opportunities for vaccination, rapidly changing guidelines, and initial gender-based guidelines,” said Dr. Chen.

Clinicians play a large role in improving vaccination rates among young adults, who may lack awareness of the overall importance of inoculation against the potentially debilitating and deadly virus. Dr. Chen noted that clinicians can lead the way by increasing gender-inclusive awareness of HPV-associated diseases and HPV vaccination, by performing routine vaccine eligibility assessments for young adults regardless of sex, by developing robust reminder and recall strategies to improve series completion rates, and by offering patients resources regarding assistance programs to address cost barriers for uninsured patients.

“Young adult men are particularly vulnerable [to HPV], because they start to age out of pediatric health practices,” added Dr. Chen. “Thus, a multilevel gender-inclusive approach is needed to target clinicians, patients, parents, and community-based organizations.”

Gypsyamber D’Souza, PhD, professor of epidemiology at Johns Hopkins University, Baltimore, said in an interview that the initial uptake of HPV vaccination was slow in the United States but that progress has been made in recent years among persons in the targeted age range of 11-12 years. “However, catch-up vaccination has lagged behind, and sadly, we’re still seeing low uptake in those older ages that are still eligible and where we know there still is tremendous benefit,” she said.

Dr. D’Souza is a lead investigator in the MOUTH trial, which is currently enrolling patients. That trial will examine potential biomarkers for oropharyngeal cancer risk among people with known risk factors for HPV who came of age prior to the rollout of the vaccine.

She explained that many parents want their children to be vaccinated for HPV after they hear about the vaccine, but because the health care system in the United States is an “opt-in” system, rather than an “opt-out” one, parents need to actively seek out vaccination. Children then move toward adulthood without having received the recommended vaccine course. “There are individuals who did not get vaccinated at the ages of 11 and 12 and then forget to ask about it later, or the provider asks about it and the patients don’t have enough information,” Dr. D’Souza said.

She noted that one reason why HPV vaccination rates remain low among young adults is that the vaccine is not often kept in stock other than in pediatric clinics. “Because vaccines expire and clinics don’t have a lot of people in that age group getting vaccinated, they may not have it regularly in stock, making this one reason it might be hard for someone to get vaccinated.”

The HPV vaccine is not effective for clearing HPV once a patient acquires the infection, she added. “So young adulthood is a critical time where we have individuals who still can benefit from being vaccinated, but if we wait too long, they’ll age out of those ages where we see the highest efficacy.”

Ultimately, said Dr. D’Souza, clinicians need to catch people at multiple time points and work to remove barriers to vaccination, including letting patients know that HPV vaccination is covered by insurance. “There’s a lot of opportunity to prevent future cancers in young adults by having care providers for that age group talk about the vaccine and remember to offer it.”

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

Although vaccination rates against the human papillomavirus remain low for young adults across the United States, the number of self-reported HPV vaccinations among women and men aged between 18 and 21 years has markedly increased since 2010, according to new research findings.

The findings were published online April 27, 2021, as a research letter in JAMA.

In 2006, the Food and Drug Administration approved the HPV vaccine for the prevention of cervical cancer and genital warts in female patients. Three years later, the FDA approved the vaccine for the prevention of anogenital cancer and warts in male patients.

The Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention recommend two doses of the HPV vaccine for children aged 11-12 years. Adolescents and young adults may need three doses over the course of 6 months if they start their vaccine series on or following their 15th birthday.

For persons who have not previously received the HPV vaccine or who did not receive adequate doses, the HPV vaccine is recommended through age 26. Data on the rates of vaccination among young adults between 18 and 21 years of age in the United States are sparse, and it is not known how well vaccination programs are progressing in the country.

In the recently published JAMA research letter, investigators from the University of Michigan, Ann Arbor, examined data for the period 2010-2018 from the cross-sectional National Health Interview Survey. Respondents included in the analysis were aged 18-21 years. They were asked whether they had received the HPV vaccine before age 18 and at what age they had been vaccinated against the virus.

The researchers also assessed whether the respondents had received any HPV vaccine dose between the ages of 18 and 21 years. The findings were limited to self-reported vaccination status.

In total, 6,606 women and 6,038 men were included in the analysis. Approximately 42% of women and 16% of men said they had received at least one HPV vaccine dose at any age. The proportion of female patients who reported receiving an HPV vaccine dose significantly increased from 32% in 2010 to 55% in 2018 (P =.001). Similarly, among men, the percentage significantly increased from 2% in 2010 to 34% in 2018 (P <.001).

Approximately 4% of the female respondents and 3% of the male respondents reported that they had received an HPV vaccine between the ages of 18 and 21 years; 46% of women and 29% of men who received the vaccine between these ages completed the recommended vaccination series.

Findings from the study highlight the continual need for improving vaccination rates among vulnerable populations. Lead study author Michelle Chen, MD, MHS, a professor in the department of otolaryngology–head and neck surgery at the University of Michigan, explained in an interview that there are multiple barriers to HPV vaccination among young adults. “These barriers to vaccination among young adults primarily include cost, lack of knowledge and awareness, missed opportunities for vaccination, rapidly changing guidelines, and initial gender-based guidelines,” said Dr. Chen.

Clinicians play a large role in improving vaccination rates among young adults, who may lack awareness of the overall importance of inoculation against the potentially debilitating and deadly virus. Dr. Chen noted that clinicians can lead the way by increasing gender-inclusive awareness of HPV-associated diseases and HPV vaccination, by performing routine vaccine eligibility assessments for young adults regardless of sex, by developing robust reminder and recall strategies to improve series completion rates, and by offering patients resources regarding assistance programs to address cost barriers for uninsured patients.

“Young adult men are particularly vulnerable [to HPV], because they start to age out of pediatric health practices,” added Dr. Chen. “Thus, a multilevel gender-inclusive approach is needed to target clinicians, patients, parents, and community-based organizations.”

Gypsyamber D’Souza, PhD, professor of epidemiology at Johns Hopkins University, Baltimore, said in an interview that the initial uptake of HPV vaccination was slow in the United States but that progress has been made in recent years among persons in the targeted age range of 11-12 years. “However, catch-up vaccination has lagged behind, and sadly, we’re still seeing low uptake in those older ages that are still eligible and where we know there still is tremendous benefit,” she said.

Dr. D’Souza is a lead investigator in the MOUTH trial, which is currently enrolling patients. That trial will examine potential biomarkers for oropharyngeal cancer risk among people with known risk factors for HPV who came of age prior to the rollout of the vaccine.

She explained that many parents want their children to be vaccinated for HPV after they hear about the vaccine, but because the health care system in the United States is an “opt-in” system, rather than an “opt-out” one, parents need to actively seek out vaccination. Children then move toward adulthood without having received the recommended vaccine course. “There are individuals who did not get vaccinated at the ages of 11 and 12 and then forget to ask about it later, or the provider asks about it and the patients don’t have enough information,” Dr. D’Souza said.

She noted that one reason why HPV vaccination rates remain low among young adults is that the vaccine is not often kept in stock other than in pediatric clinics. “Because vaccines expire and clinics don’t have a lot of people in that age group getting vaccinated, they may not have it regularly in stock, making this one reason it might be hard for someone to get vaccinated.”

The HPV vaccine is not effective for clearing HPV once a patient acquires the infection, she added. “So young adulthood is a critical time where we have individuals who still can benefit from being vaccinated, but if we wait too long, they’ll age out of those ages where we see the highest efficacy.”

Ultimately, said Dr. D’Souza, clinicians need to catch people at multiple time points and work to remove barriers to vaccination, including letting patients know that HPV vaccination is covered by insurance. “There’s a lot of opportunity to prevent future cancers in young adults by having care providers for that age group talk about the vaccine and remember to offer it.”

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

Although vaccination rates against the human papillomavirus remain low for young adults across the United States, the number of self-reported HPV vaccinations among women and men aged between 18 and 21 years has markedly increased since 2010, according to new research findings.

The findings were published online April 27, 2021, as a research letter in JAMA.

In 2006, the Food and Drug Administration approved the HPV vaccine for the prevention of cervical cancer and genital warts in female patients. Three years later, the FDA approved the vaccine for the prevention of anogenital cancer and warts in male patients.

The Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention recommend two doses of the HPV vaccine for children aged 11-12 years. Adolescents and young adults may need three doses over the course of 6 months if they start their vaccine series on or following their 15th birthday.

For persons who have not previously received the HPV vaccine or who did not receive adequate doses, the HPV vaccine is recommended through age 26. Data on the rates of vaccination among young adults between 18 and 21 years of age in the United States are sparse, and it is not known how well vaccination programs are progressing in the country.

In the recently published JAMA research letter, investigators from the University of Michigan, Ann Arbor, examined data for the period 2010-2018 from the cross-sectional National Health Interview Survey. Respondents included in the analysis were aged 18-21 years. They were asked whether they had received the HPV vaccine before age 18 and at what age they had been vaccinated against the virus.

The researchers also assessed whether the respondents had received any HPV vaccine dose between the ages of 18 and 21 years. The findings were limited to self-reported vaccination status.

In total, 6,606 women and 6,038 men were included in the analysis. Approximately 42% of women and 16% of men said they had received at least one HPV vaccine dose at any age. The proportion of female patients who reported receiving an HPV vaccine dose significantly increased from 32% in 2010 to 55% in 2018 (P =.001). Similarly, among men, the percentage significantly increased from 2% in 2010 to 34% in 2018 (P <.001).

Approximately 4% of the female respondents and 3% of the male respondents reported that they had received an HPV vaccine between the ages of 18 and 21 years; 46% of women and 29% of men who received the vaccine between these ages completed the recommended vaccination series.

Findings from the study highlight the continual need for improving vaccination rates among vulnerable populations. Lead study author Michelle Chen, MD, MHS, a professor in the department of otolaryngology–head and neck surgery at the University of Michigan, explained in an interview that there are multiple barriers to HPV vaccination among young adults. “These barriers to vaccination among young adults primarily include cost, lack of knowledge and awareness, missed opportunities for vaccination, rapidly changing guidelines, and initial gender-based guidelines,” said Dr. Chen.

Clinicians play a large role in improving vaccination rates among young adults, who may lack awareness of the overall importance of inoculation against the potentially debilitating and deadly virus. Dr. Chen noted that clinicians can lead the way by increasing gender-inclusive awareness of HPV-associated diseases and HPV vaccination, by performing routine vaccine eligibility assessments for young adults regardless of sex, by developing robust reminder and recall strategies to improve series completion rates, and by offering patients resources regarding assistance programs to address cost barriers for uninsured patients.

“Young adult men are particularly vulnerable [to HPV], because they start to age out of pediatric health practices,” added Dr. Chen. “Thus, a multilevel gender-inclusive approach is needed to target clinicians, patients, parents, and community-based organizations.”

Gypsyamber D’Souza, PhD, professor of epidemiology at Johns Hopkins University, Baltimore, said in an interview that the initial uptake of HPV vaccination was slow in the United States but that progress has been made in recent years among persons in the targeted age range of 11-12 years. “However, catch-up vaccination has lagged behind, and sadly, we’re still seeing low uptake in those older ages that are still eligible and where we know there still is tremendous benefit,” she said.

Dr. D’Souza is a lead investigator in the MOUTH trial, which is currently enrolling patients. That trial will examine potential biomarkers for oropharyngeal cancer risk among people with known risk factors for HPV who came of age prior to the rollout of the vaccine.

She explained that many parents want their children to be vaccinated for HPV after they hear about the vaccine, but because the health care system in the United States is an “opt-in” system, rather than an “opt-out” one, parents need to actively seek out vaccination. Children then move toward adulthood without having received the recommended vaccine course. “There are individuals who did not get vaccinated at the ages of 11 and 12 and then forget to ask about it later, or the provider asks about it and the patients don’t have enough information,” Dr. D’Souza said.

She noted that one reason why HPV vaccination rates remain low among young adults is that the vaccine is not often kept in stock other than in pediatric clinics. “Because vaccines expire and clinics don’t have a lot of people in that age group getting vaccinated, they may not have it regularly in stock, making this one reason it might be hard for someone to get vaccinated.”

The HPV vaccine is not effective for clearing HPV once a patient acquires the infection, she added. “So young adulthood is a critical time where we have individuals who still can benefit from being vaccinated, but if we wait too long, they’ll age out of those ages where we see the highest efficacy.”

Ultimately, said Dr. D’Souza, clinicians need to catch people at multiple time points and work to remove barriers to vaccination, including letting patients know that HPV vaccination is covered by insurance. “There’s a lot of opportunity to prevent future cancers in young adults by having care providers for that age group talk about the vaccine and remember to offer it.”

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

The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.

In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.

“They should be coming out very shortly,” Dr. Brooks said.

The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.

For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.

National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.

“I can’t overstate how serious this issue is for the health of our nation,” he said.

Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.

“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.

Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.

“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”

Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.

“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
 

Patients testify

Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.

Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”

Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.

“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”

She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.

“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”

Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.

“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”

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

The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.

In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.

“They should be coming out very shortly,” Dr. Brooks said.

The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.

For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.

National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.

“I can’t overstate how serious this issue is for the health of our nation,” he said.

Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.

“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.

Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.

“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”

Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.

“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
 

Patients testify

Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.

Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”

Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.

“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”

She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.

“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”

Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.

“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”

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

The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.

In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.

“They should be coming out very shortly,” Dr. Brooks said.

The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.

For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.

National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.

“I can’t overstate how serious this issue is for the health of our nation,” he said.

Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.

“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.

Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.

“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”

Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.

“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
 

Patients testify

Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.

Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”

Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.

“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”

She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.

“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”

Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.

“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”

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

Accelerated brain aging among HIV-infected adults might be caused in part by altered deep sleep patterns, new research suggests.

Using a measure known as the brain age index (BAI) – a machine-learning model that measures deviations in brain activity during sleep relative to healthy individuals – investigators identified 34 sleep electroencephalogram features that were significantly altered by HIV infection. The most notable of these was the decline in slow-wave activity during non-REM sleep, which has been previously associated with MRI markers of brain aging in healthy adults.

“One of the functions of slow-wave sleep appears to be its association with the glymphatic system, which clears [metabolic] waste products and supports memory consolidation,” study coauthor Brandon Westover, MD, PhD, associate professor of neurology at Massachusetts General Hospital/Harvard Medical School, Boston, said in an interview. “It’s also believed to be associated with an accelerated risk for dementia and other cognitive issues.”

Previous work conducted at Johns Hopkins and other institutions confirm Dr. Westerson’s hypothesis. Charlene Gamaldo, MD, medical director of Johns Hopkins Sleep Disorders Center in Baltimore, pointed to other study findings in patients with neurodegenerative disease that have shown a link between predominant habitual sleep positions and dementia, potentially driven by inefficient glymphatic transport. Dr. Gamaldo was not involved in the current study.
 

Threefold acceleration vs. healthy volunteers

“We’ve been grappling with whether people with HIV on ART experience accelerated aging or accentuated aging,” coauthor Shibani Mukerji, MD, PhD, associate director of the neuroinfectious diseases unit at Massachusetts General, said in an interview. “We have yet to have biomarkers to address this question, and most of the tools are limited to invasive or expensive diagnostics. “In general, sleep and its influence on health have been understudied in the HIV population.”

To address this question, the researchers retrospectively examined a Massachusetts General Hospital database of diagnostic sleep study participants from 2008 to 2018, identifying 3,155 healthy, HIV-negative control subjects and 43 HIV-positive participants. Thirty-four (79%) of the HIV-positive participants were men, 30 (70%) were White, and 38 (93%) were virally suppressed at the time of their sleep study. Four patients were taking efavirenz, 13 were taking an integrase strand transfer inhibitor, and all were adherent to antiretroviral therapy (ART) at the time of their sleep study.

None of the HIV-positive participants had a history of secondary brain infection or brain tumor, although one patient had recovered fully from a previous HIV-associated encephalitis.

The study findings, which were published online March 30, 2021, in Sleep, first showed that HIV-positive participants had an average BAI of 3.19 years (standard error of the mean,1.43 years), compared with the control participants, who had an average BAI of –0.16 (SEM, 0.18 years).

These findings held after adjustment for potential confounders (age, sex, race, tobacco use disorder, and alcohol use disorder), yielding a total effect of HIV on BAI of 3.35 years (P < .01).

“Despite being well controlled on ART, HIV-positive individuals who had participated in the sleep studies still had elevated brain age,” said Dr. Westover. “We didn’t have enough information to determine the pathways by which HIV increases the BAI, but chronic inflammation appears to be an important factor.”

The findings also demonstrated that comorbidities accounted for roughly a quarter of the effect of HIV on BAI. However, the lack of statistical significance (in part because of the limited sample size) precluded the ability to determine if treating or preventing them might influence the degree to which HIV affects BAI and, in turn, cognitive decline.
 

HIV, sleep EEG, and brain aging

To estimate the effect of HIV on specific EEG features, the investigators again evaluated the total effect, this time replacing BAI with individual sleep EEG as the primary outcome. Among the 34 EEG features significantly altered by HIV, none were observed in the wake state and three were altered in REM (each associated with reduced delta band power). The rest were distributed in non-REM sleep, most notably in the deepest phase, corresponding to relative reductions in delta wave power.

The study findings build on the investigators’ previous research, which demonstrated an association between greater mean BAI and dementia, psychotic disorders, and anxiety/mood disorders in HIV-negative subjects, all of which correlated to attenuated slow-wave sleep.

More research is needed to determine if BAI, as it relates to sleep EEG, can effectively track the risk for cognitive decline among HIV-positive people, and if certain confounders might attenuate or accelerate this risk.

“While our team has not specifically looked at BAI, the findings in this study seem perfectly in line with what we have found with our own research,” Dr. Gamaldo said in an interview. “Not only have we observed a robust association between minimal cognitive deficits and patients’ sleep complaints (despite being virally controlled), but also, the potential value of measuring the architectural sleep features by ambulatory EEG to identify HIV patients’ vulnerability to cognitive decline.”

“BAI is a physiologic, easily repeatable measurement that can be used to track if an intervention is having a good effect,” Dr. Westover said.

Dr. Mukerji concurred, adding that “having a tool that can be used in resource-challenged settings and also be incorporated into longitudinal studies in a patient population with substantial age-related comorbidities, like HIV, would be really helpful.”

Dr. Westover and Dr. Mukerji disclosed no relevant financial relationships. Dr. Gamaldo is a consultant for Jazz Pharmaceuticals, and has received author royalties from UpToDate and honoraria from Medscape CME for content contribution.

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

Accelerated brain aging among HIV-infected adults might be caused in part by altered deep sleep patterns, new research suggests.

Using a measure known as the brain age index (BAI) – a machine-learning model that measures deviations in brain activity during sleep relative to healthy individuals – investigators identified 34 sleep electroencephalogram features that were significantly altered by HIV infection. The most notable of these was the decline in slow-wave activity during non-REM sleep, which has been previously associated with MRI markers of brain aging in healthy adults.

“One of the functions of slow-wave sleep appears to be its association with the glymphatic system, which clears [metabolic] waste products and supports memory consolidation,” study coauthor Brandon Westover, MD, PhD, associate professor of neurology at Massachusetts General Hospital/Harvard Medical School, Boston, said in an interview. “It’s also believed to be associated with an accelerated risk for dementia and other cognitive issues.”

Previous work conducted at Johns Hopkins and other institutions confirm Dr. Westerson’s hypothesis. Charlene Gamaldo, MD, medical director of Johns Hopkins Sleep Disorders Center in Baltimore, pointed to other study findings in patients with neurodegenerative disease that have shown a link between predominant habitual sleep positions and dementia, potentially driven by inefficient glymphatic transport. Dr. Gamaldo was not involved in the current study.
 

Threefold acceleration vs. healthy volunteers

“We’ve been grappling with whether people with HIV on ART experience accelerated aging or accentuated aging,” coauthor Shibani Mukerji, MD, PhD, associate director of the neuroinfectious diseases unit at Massachusetts General, said in an interview. “We have yet to have biomarkers to address this question, and most of the tools are limited to invasive or expensive diagnostics. “In general, sleep and its influence on health have been understudied in the HIV population.”

To address this question, the researchers retrospectively examined a Massachusetts General Hospital database of diagnostic sleep study participants from 2008 to 2018, identifying 3,155 healthy, HIV-negative control subjects and 43 HIV-positive participants. Thirty-four (79%) of the HIV-positive participants were men, 30 (70%) were White, and 38 (93%) were virally suppressed at the time of their sleep study. Four patients were taking efavirenz, 13 were taking an integrase strand transfer inhibitor, and all were adherent to antiretroviral therapy (ART) at the time of their sleep study.

None of the HIV-positive participants had a history of secondary brain infection or brain tumor, although one patient had recovered fully from a previous HIV-associated encephalitis.

The study findings, which were published online March 30, 2021, in Sleep, first showed that HIV-positive participants had an average BAI of 3.19 years (standard error of the mean,1.43 years), compared with the control participants, who had an average BAI of –0.16 (SEM, 0.18 years).

These findings held after adjustment for potential confounders (age, sex, race, tobacco use disorder, and alcohol use disorder), yielding a total effect of HIV on BAI of 3.35 years (P < .01).

“Despite being well controlled on ART, HIV-positive individuals who had participated in the sleep studies still had elevated brain age,” said Dr. Westover. “We didn’t have enough information to determine the pathways by which HIV increases the BAI, but chronic inflammation appears to be an important factor.”

The findings also demonstrated that comorbidities accounted for roughly a quarter of the effect of HIV on BAI. However, the lack of statistical significance (in part because of the limited sample size) precluded the ability to determine if treating or preventing them might influence the degree to which HIV affects BAI and, in turn, cognitive decline.
 

HIV, sleep EEG, and brain aging

To estimate the effect of HIV on specific EEG features, the investigators again evaluated the total effect, this time replacing BAI with individual sleep EEG as the primary outcome. Among the 34 EEG features significantly altered by HIV, none were observed in the wake state and three were altered in REM (each associated with reduced delta band power). The rest were distributed in non-REM sleep, most notably in the deepest phase, corresponding to relative reductions in delta wave power.

The study findings build on the investigators’ previous research, which demonstrated an association between greater mean BAI and dementia, psychotic disorders, and anxiety/mood disorders in HIV-negative subjects, all of which correlated to attenuated slow-wave sleep.

More research is needed to determine if BAI, as it relates to sleep EEG, can effectively track the risk for cognitive decline among HIV-positive people, and if certain confounders might attenuate or accelerate this risk.

“While our team has not specifically looked at BAI, the findings in this study seem perfectly in line with what we have found with our own research,” Dr. Gamaldo said in an interview. “Not only have we observed a robust association between minimal cognitive deficits and patients’ sleep complaints (despite being virally controlled), but also, the potential value of measuring the architectural sleep features by ambulatory EEG to identify HIV patients’ vulnerability to cognitive decline.”

“BAI is a physiologic, easily repeatable measurement that can be used to track if an intervention is having a good effect,” Dr. Westover said.

Dr. Mukerji concurred, adding that “having a tool that can be used in resource-challenged settings and also be incorporated into longitudinal studies in a patient population with substantial age-related comorbidities, like HIV, would be really helpful.”

Dr. Westover and Dr. Mukerji disclosed no relevant financial relationships. Dr. Gamaldo is a consultant for Jazz Pharmaceuticals, and has received author royalties from UpToDate and honoraria from Medscape CME for content contribution.

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

Accelerated brain aging among HIV-infected adults might be caused in part by altered deep sleep patterns, new research suggests.

Using a measure known as the brain age index (BAI) – a machine-learning model that measures deviations in brain activity during sleep relative to healthy individuals – investigators identified 34 sleep electroencephalogram features that were significantly altered by HIV infection. The most notable of these was the decline in slow-wave activity during non-REM sleep, which has been previously associated with MRI markers of brain aging in healthy adults.

“One of the functions of slow-wave sleep appears to be its association with the glymphatic system, which clears [metabolic] waste products and supports memory consolidation,” study coauthor Brandon Westover, MD, PhD, associate professor of neurology at Massachusetts General Hospital/Harvard Medical School, Boston, said in an interview. “It’s also believed to be associated with an accelerated risk for dementia and other cognitive issues.”

Previous work conducted at Johns Hopkins and other institutions confirm Dr. Westerson’s hypothesis. Charlene Gamaldo, MD, medical director of Johns Hopkins Sleep Disorders Center in Baltimore, pointed to other study findings in patients with neurodegenerative disease that have shown a link between predominant habitual sleep positions and dementia, potentially driven by inefficient glymphatic transport. Dr. Gamaldo was not involved in the current study.
 

Threefold acceleration vs. healthy volunteers

“We’ve been grappling with whether people with HIV on ART experience accelerated aging or accentuated aging,” coauthor Shibani Mukerji, MD, PhD, associate director of the neuroinfectious diseases unit at Massachusetts General, said in an interview. “We have yet to have biomarkers to address this question, and most of the tools are limited to invasive or expensive diagnostics. “In general, sleep and its influence on health have been understudied in the HIV population.”

To address this question, the researchers retrospectively examined a Massachusetts General Hospital database of diagnostic sleep study participants from 2008 to 2018, identifying 3,155 healthy, HIV-negative control subjects and 43 HIV-positive participants. Thirty-four (79%) of the HIV-positive participants were men, 30 (70%) were White, and 38 (93%) were virally suppressed at the time of their sleep study. Four patients were taking efavirenz, 13 were taking an integrase strand transfer inhibitor, and all were adherent to antiretroviral therapy (ART) at the time of their sleep study.

None of the HIV-positive participants had a history of secondary brain infection or brain tumor, although one patient had recovered fully from a previous HIV-associated encephalitis.

The study findings, which were published online March 30, 2021, in Sleep, first showed that HIV-positive participants had an average BAI of 3.19 years (standard error of the mean,1.43 years), compared with the control participants, who had an average BAI of –0.16 (SEM, 0.18 years).

These findings held after adjustment for potential confounders (age, sex, race, tobacco use disorder, and alcohol use disorder), yielding a total effect of HIV on BAI of 3.35 years (P < .01).

“Despite being well controlled on ART, HIV-positive individuals who had participated in the sleep studies still had elevated brain age,” said Dr. Westover. “We didn’t have enough information to determine the pathways by which HIV increases the BAI, but chronic inflammation appears to be an important factor.”

The findings also demonstrated that comorbidities accounted for roughly a quarter of the effect of HIV on BAI. However, the lack of statistical significance (in part because of the limited sample size) precluded the ability to determine if treating or preventing them might influence the degree to which HIV affects BAI and, in turn, cognitive decline.
 

HIV, sleep EEG, and brain aging

To estimate the effect of HIV on specific EEG features, the investigators again evaluated the total effect, this time replacing BAI with individual sleep EEG as the primary outcome. Among the 34 EEG features significantly altered by HIV, none were observed in the wake state and three were altered in REM (each associated with reduced delta band power). The rest were distributed in non-REM sleep, most notably in the deepest phase, corresponding to relative reductions in delta wave power.

The study findings build on the investigators’ previous research, which demonstrated an association between greater mean BAI and dementia, psychotic disorders, and anxiety/mood disorders in HIV-negative subjects, all of which correlated to attenuated slow-wave sleep.

More research is needed to determine if BAI, as it relates to sleep EEG, can effectively track the risk for cognitive decline among HIV-positive people, and if certain confounders might attenuate or accelerate this risk.

“While our team has not specifically looked at BAI, the findings in this study seem perfectly in line with what we have found with our own research,” Dr. Gamaldo said in an interview. “Not only have we observed a robust association between minimal cognitive deficits and patients’ sleep complaints (despite being virally controlled), but also, the potential value of measuring the architectural sleep features by ambulatory EEG to identify HIV patients’ vulnerability to cognitive decline.”

“BAI is a physiologic, easily repeatable measurement that can be used to track if an intervention is having a good effect,” Dr. Westover said.

Dr. Mukerji concurred, adding that “having a tool that can be used in resource-challenged settings and also be incorporated into longitudinal studies in a patient population with substantial age-related comorbidities, like HIV, would be really helpful.”

Dr. Westover and Dr. Mukerji disclosed no relevant financial relationships. Dr. Gamaldo is a consultant for Jazz Pharmaceuticals, and has received author royalties from UpToDate and honoraria from Medscape CME for content contribution.

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

Pfizer CEO Albert Bourla, DVM, PhD, says an oral drug the company is developing to treat COVID-19 symptoms could be available to the public by the end of the year.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.

So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.

An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.

“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”

The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.

Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.

The company announced in late March that it was starting clinical trials on the oral drug.

In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.

A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.

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

Pfizer CEO Albert Bourla, DVM, PhD, says an oral drug the company is developing to treat COVID-19 symptoms could be available to the public by the end of the year.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.

So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.

An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.

“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”

The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.

Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.

The company announced in late March that it was starting clinical trials on the oral drug.

In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.

A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.

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

Pfizer CEO Albert Bourla, DVM, PhD, says an oral drug the company is developing to treat COVID-19 symptoms could be available to the public by the end of the year.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.

So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.

An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.

“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”

The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.

Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.

The company announced in late March that it was starting clinical trials on the oral drug.

In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.

A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.

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

People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

The Pfizer and Moderna COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary findings published in the New England Journal of Medicine.

The Centers for Disease Control and Prevention have said pregnant people have an increased risk of being severely ill from COVID-19; however, this group was excluded from major clinical trials that led up to the current vaccine approvals.

But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant people receive the COVID-19 vaccine.

The new study, which analyzed data between Dec. 14, 2020, and Feb. 28, 2021, from three federal databases, adds to a pool of limited data about the safety and efficacy of the vaccine in pregnant persons. Researchers did not include people who received the Johnson & Johnson vaccine because it received emergency use authorization on Feb. 27, just 1 day before they study’s cutoff.

“Our hope is that these initial data will be reassuring to pregnant people and their health care providers as well as the public, and contribute to increasing vaccination rates,” study author Christine Olson, MD, said in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”

For the study, Dr. Olson and colleagues analyzed v-safe survey data, data from those enrolled in the v-safe pregnancy registry, and Vaccine Adverse Event Reporting System (VAERS) reports.

Researchers found that 86% of pregnancies resulted in a live birth, 12.6 % resulted in spontaneous abortions, and 0.1% resulted in stillbirth. They also found that, among the live births, 9.4% were preterm, 3.2% of babies were small for their gestational age, and 2.2% had congenital anomalies.

Researchers also found that injection-site pain, fatigue, and headaches were reported more frequently in pregnant patients than among those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were nonpregnancy specific. Nearly 30% involved pregnancy- or neonatal-specific adverse events. The most frequently reported pregnancy-related events were spontaneous abortions, followed by stillbirths, premature rupture of membranes and vaginal bleeding.

“I think the results are actually quite reassuring as the proportion of the pregnancy outcomes, such as pregnancy loss and health effects to the newborns, are really quite consistent with what we’d expect in the background rate of the population,” Dr. Walensky said in a podcast accompanying the study. “So this study adds to growing evidence confirming that pregnant people develop a robust immune response to COVID-19 vaccination without so far seeing any adverse events to the mom or the fetus.”

Researchers said limitations of the study include the accuracy of self-reported data, and there being limited information on other potential risk factors for adverse pregnancies and neonatal outcomes. They acknowledged that continuous monitoring is needed to look at maternal safety and pregnancy outcomes in earlier stages of pregnancy and during the preconception period.

David Jaspan, DO, chair of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, who was not involved with the study, said in an interview that, despite the limitations, the study provides much-needed insight on the vaccine’s safety and efficacy in pregnant patients.

“In December we had no data for any pregnant patient,” Dr. Jaspan said. “And now just 4 short months later, this paper [has data from] at least had 35,000 people. We can’t answer every question, but we have more answers today than we had just 4 months ago.”

Dr. Olson hopes the present data is enough to help inform decision-making of pregnant patients and their health care providers when it comes to deciding to get the COVID-19 vaccination.

The study author and experts interviewed disclosed no relevant financial relationships.

The Pfizer and Moderna COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary findings published in the New England Journal of Medicine.

The Centers for Disease Control and Prevention have said pregnant people have an increased risk of being severely ill from COVID-19; however, this group was excluded from major clinical trials that led up to the current vaccine approvals.

But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant people receive the COVID-19 vaccine.

The new study, which analyzed data between Dec. 14, 2020, and Feb. 28, 2021, from three federal databases, adds to a pool of limited data about the safety and efficacy of the vaccine in pregnant persons. Researchers did not include people who received the Johnson & Johnson vaccine because it received emergency use authorization on Feb. 27, just 1 day before they study’s cutoff.

“Our hope is that these initial data will be reassuring to pregnant people and their health care providers as well as the public, and contribute to increasing vaccination rates,” study author Christine Olson, MD, said in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”

For the study, Dr. Olson and colleagues analyzed v-safe survey data, data from those enrolled in the v-safe pregnancy registry, and Vaccine Adverse Event Reporting System (VAERS) reports.

Researchers found that 86% of pregnancies resulted in a live birth, 12.6 % resulted in spontaneous abortions, and 0.1% resulted in stillbirth. They also found that, among the live births, 9.4% were preterm, 3.2% of babies were small for their gestational age, and 2.2% had congenital anomalies.

Researchers also found that injection-site pain, fatigue, and headaches were reported more frequently in pregnant patients than among those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were nonpregnancy specific. Nearly 30% involved pregnancy- or neonatal-specific adverse events. The most frequently reported pregnancy-related events were spontaneous abortions, followed by stillbirths, premature rupture of membranes and vaginal bleeding.

“I think the results are actually quite reassuring as the proportion of the pregnancy outcomes, such as pregnancy loss and health effects to the newborns, are really quite consistent with what we’d expect in the background rate of the population,” Dr. Walensky said in a podcast accompanying the study. “So this study adds to growing evidence confirming that pregnant people develop a robust immune response to COVID-19 vaccination without so far seeing any adverse events to the mom or the fetus.”

Researchers said limitations of the study include the accuracy of self-reported data, and there being limited information on other potential risk factors for adverse pregnancies and neonatal outcomes. They acknowledged that continuous monitoring is needed to look at maternal safety and pregnancy outcomes in earlier stages of pregnancy and during the preconception period.

David Jaspan, DO, chair of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, who was not involved with the study, said in an interview that, despite the limitations, the study provides much-needed insight on the vaccine’s safety and efficacy in pregnant patients.

“In December we had no data for any pregnant patient,” Dr. Jaspan said. “And now just 4 short months later, this paper [has data from] at least had 35,000 people. We can’t answer every question, but we have more answers today than we had just 4 months ago.”

Dr. Olson hopes the present data is enough to help inform decision-making of pregnant patients and their health care providers when it comes to deciding to get the COVID-19 vaccination.

The study author and experts interviewed disclosed no relevant financial relationships.

The Pfizer and Moderna COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary findings published in the New England Journal of Medicine.

The Centers for Disease Control and Prevention have said pregnant people have an increased risk of being severely ill from COVID-19; however, this group was excluded from major clinical trials that led up to the current vaccine approvals.

But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant people receive the COVID-19 vaccine.

The new study, which analyzed data between Dec. 14, 2020, and Feb. 28, 2021, from three federal databases, adds to a pool of limited data about the safety and efficacy of the vaccine in pregnant persons. Researchers did not include people who received the Johnson & Johnson vaccine because it received emergency use authorization on Feb. 27, just 1 day before they study’s cutoff.

“Our hope is that these initial data will be reassuring to pregnant people and their health care providers as well as the public, and contribute to increasing vaccination rates,” study author Christine Olson, MD, said in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”

For the study, Dr. Olson and colleagues analyzed v-safe survey data, data from those enrolled in the v-safe pregnancy registry, and Vaccine Adverse Event Reporting System (VAERS) reports.

Researchers found that 86% of pregnancies resulted in a live birth, 12.6 % resulted in spontaneous abortions, and 0.1% resulted in stillbirth. They also found that, among the live births, 9.4% were preterm, 3.2% of babies were small for their gestational age, and 2.2% had congenital anomalies.

Researchers also found that injection-site pain, fatigue, and headaches were reported more frequently in pregnant patients than among those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were nonpregnancy specific. Nearly 30% involved pregnancy- or neonatal-specific adverse events. The most frequently reported pregnancy-related events were spontaneous abortions, followed by stillbirths, premature rupture of membranes and vaginal bleeding.

“I think the results are actually quite reassuring as the proportion of the pregnancy outcomes, such as pregnancy loss and health effects to the newborns, are really quite consistent with what we’d expect in the background rate of the population,” Dr. Walensky said in a podcast accompanying the study. “So this study adds to growing evidence confirming that pregnant people develop a robust immune response to COVID-19 vaccination without so far seeing any adverse events to the mom or the fetus.”

Researchers said limitations of the study include the accuracy of self-reported data, and there being limited information on other potential risk factors for adverse pregnancies and neonatal outcomes. They acknowledged that continuous monitoring is needed to look at maternal safety and pregnancy outcomes in earlier stages of pregnancy and during the preconception period.

David Jaspan, DO, chair of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, who was not involved with the study, said in an interview that, despite the limitations, the study provides much-needed insight on the vaccine’s safety and efficacy in pregnant patients.

“In December we had no data for any pregnant patient,” Dr. Jaspan said. “And now just 4 short months later, this paper [has data from] at least had 35,000 people. We can’t answer every question, but we have more answers today than we had just 4 months ago.”

Dr. Olson hopes the present data is enough to help inform decision-making of pregnant patients and their health care providers when it comes to deciding to get the COVID-19 vaccination.

The study author and experts interviewed disclosed no relevant financial relationships.