Infectious Diseases

People with HIV have an increased risk of breakthrough SARS-CoV-2 infections, a new study finds, and the authors say an additional primary vaccine dose should be considered for all who are living with the disease.

Currently, an additional primary dose administered 28 days after a second dose of the mRNA (Moderna or Pfizer) vaccines or after the first dose of the Johnson & Johnson (J&J) vaccine is recommended only for those with advanced or untreated HIV.

The Centers for Disease Control and Prevention recommends boosters for all adults with or without HIV.

Sally B. Coburn, PhD, of the department of epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, led the study, which was published online in JAMA Network Open. In their study, the researchers estimate the risk of breakthrough infections among fully vaccinated adults on the basis of HIV status in the United States.

Adults with HIV who were fully vaccinated before June 30, 2021, were matched with adults without HIV with regard to date of full vaccination, age, race/ethnicity, and sex. All were followed through Dec. 31, 2021.

Patients were considered fully vaccinated either 14 days after the second dose of the Pfizer or Moderna shots or 14 days after the single dose of the J&J shot.
 

Breakthrough risk 28% higher

In the study of 113,994 patients, researchers found that risk of breakthrough SARS-CoV-2 infection was low overall (3.8%) but was 28% higher among people with HIV in comparison with people without HIV (adjusted hazard ratio, 1.28; 95% confidence interval, 1.19-1.37).

The breakthrough rate was also higher in the HIV group (55 cases per 1,000 person-years, vs. 43 cases per 1,000 person-years in people without HIV).

Patients were drawn from the Corona-Infectious-Virus Epidemiology Team (CIVET)–II of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), which is part of the International Epidemiology Databases to Evaluate AIDS (IeDEA) collaboration involving four cohorts.

Among people with HIV, those younger than 45 years (vs. those aged 45-54) and those with a history of COVID-19 were more likely to experience breakthrough infections. Those who did not get any additional shots after the primary vaccination were more likely to have breakthrough infections, amplifying the need to get boosters, the authors wrote.

There was no link between breakthrough infections and HIV viral load suppression, but high CD4 counts (> 500 cells/mm³) were associated with fewer breakthrough cases among people with HIV, they noted.

Monica Gandhi, MD, professor of medicine and associate division chief of HIV, infectious diseases, and global medicine at the University of California, San Francisco, praised the study, noting that until now, large studies have not examined the rate of breakthrough infections among vaccinated people with HIV and people without HIV in the United States.

She told this news organization she agrees with the authors that a third dose for all who are living with HIV is needed because rates of breakthrough infections were high across all populations during the Omicron surge (which largely occurred after the period of this study).

She said she was not convinced the third shot was needed before Omicron, because breakthrough rates in both HIV and non-HIV groups were low.

“However, the most interesting part of this study for me was how well the vaccines worked in people with HIV with generally higher CD4 counts and virologic suppression, again telling us as HIV providers how well the HIV medicines work and how our patients with HIV have relatively normal immune systems if treated,” she said.

One limitation was that the study population was 92% male. Also, those without regular access to health care (who may be at greater risk for COVID-19) were less likely to be included in the study. People engaged in care may seek more frequent COVID-19 testing, which could lead to higher detection of breakthrough infections than in the general population.

“Future analyses should account for testing practices and include a larger proportion of women with HIV,” the authors wrote. “Ultimately, policy makers must determine the appropriate balance between preventing further COVID-19 infections and possibly unnecessary additional vaccinations.”

Coauthor Keri N. Althoff, PhD, told this news organization that there’s one unanswered question that would strengthen the call to action by the CDC: Do people with HIV have more severe postvaccination COVID-19 breakthrough illness?

“We have a second paper that is a preprint and currently under peer review,” she said. “In this paper, we found that people with HIV with a CD4 count less than 350 cells/mm³ were more likely to be hospitalized with postvaccination COVID-19 breakthrough illness compared to similar people without HIV. “

At a minimum, Dr. Althoff said, policymakers should consider including people with HIV with a CD4 less than 350 cells/mm³ (loosening the restriction to less than 200 cells/mm³) in their recommendations for people who are moderately or severely immunocompromised.

The research was funded with supplemental funds to the North American AIDS Cohort Collaboration on Research and Design. Dr. Coburn reports no relevant financial relationships. A coauthor has received grants from the Canadian Institutes of Health Research, Alberta Innovates, and University of Calgary/Alberta Health Services outside the submitted work. One coauthor reports serving as a consultant to Trio Health, Kennedy Dundas, and MedIQ outside the submitted work.

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

People with HIV have an increased risk of breakthrough SARS-CoV-2 infections, a new study finds, and the authors say an additional primary vaccine dose should be considered for all who are living with the disease.

Currently, an additional primary dose administered 28 days after a second dose of the mRNA (Moderna or Pfizer) vaccines or after the first dose of the Johnson & Johnson (J&J) vaccine is recommended only for those with advanced or untreated HIV.

The Centers for Disease Control and Prevention recommends boosters for all adults with or without HIV.

Sally B. Coburn, PhD, of the department of epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, led the study, which was published online in JAMA Network Open. In their study, the researchers estimate the risk of breakthrough infections among fully vaccinated adults on the basis of HIV status in the United States.

Adults with HIV who were fully vaccinated before June 30, 2021, were matched with adults without HIV with regard to date of full vaccination, age, race/ethnicity, and sex. All were followed through Dec. 31, 2021.

Patients were considered fully vaccinated either 14 days after the second dose of the Pfizer or Moderna shots or 14 days after the single dose of the J&J shot.
 

Breakthrough risk 28% higher

In the study of 113,994 patients, researchers found that risk of breakthrough SARS-CoV-2 infection was low overall (3.8%) but was 28% higher among people with HIV in comparison with people without HIV (adjusted hazard ratio, 1.28; 95% confidence interval, 1.19-1.37).

The breakthrough rate was also higher in the HIV group (55 cases per 1,000 person-years, vs. 43 cases per 1,000 person-years in people without HIV).

Patients were drawn from the Corona-Infectious-Virus Epidemiology Team (CIVET)–II of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), which is part of the International Epidemiology Databases to Evaluate AIDS (IeDEA) collaboration involving four cohorts.

Among people with HIV, those younger than 45 years (vs. those aged 45-54) and those with a history of COVID-19 were more likely to experience breakthrough infections. Those who did not get any additional shots after the primary vaccination were more likely to have breakthrough infections, amplifying the need to get boosters, the authors wrote.

There was no link between breakthrough infections and HIV viral load suppression, but high CD4 counts (> 500 cells/mm³) were associated with fewer breakthrough cases among people with HIV, they noted.

Monica Gandhi, MD, professor of medicine and associate division chief of HIV, infectious diseases, and global medicine at the University of California, San Francisco, praised the study, noting that until now, large studies have not examined the rate of breakthrough infections among vaccinated people with HIV and people without HIV in the United States.

She told this news organization she agrees with the authors that a third dose for all who are living with HIV is needed because rates of breakthrough infections were high across all populations during the Omicron surge (which largely occurred after the period of this study).

She said she was not convinced the third shot was needed before Omicron, because breakthrough rates in both HIV and non-HIV groups were low.

“However, the most interesting part of this study for me was how well the vaccines worked in people with HIV with generally higher CD4 counts and virologic suppression, again telling us as HIV providers how well the HIV medicines work and how our patients with HIV have relatively normal immune systems if treated,” she said.

One limitation was that the study population was 92% male. Also, those without regular access to health care (who may be at greater risk for COVID-19) were less likely to be included in the study. People engaged in care may seek more frequent COVID-19 testing, which could lead to higher detection of breakthrough infections than in the general population.

“Future analyses should account for testing practices and include a larger proportion of women with HIV,” the authors wrote. “Ultimately, policy makers must determine the appropriate balance between preventing further COVID-19 infections and possibly unnecessary additional vaccinations.”

Coauthor Keri N. Althoff, PhD, told this news organization that there’s one unanswered question that would strengthen the call to action by the CDC: Do people with HIV have more severe postvaccination COVID-19 breakthrough illness?

“We have a second paper that is a preprint and currently under peer review,” she said. “In this paper, we found that people with HIV with a CD4 count less than 350 cells/mm³ were more likely to be hospitalized with postvaccination COVID-19 breakthrough illness compared to similar people without HIV. “

At a minimum, Dr. Althoff said, policymakers should consider including people with HIV with a CD4 less than 350 cells/mm³ (loosening the restriction to less than 200 cells/mm³) in their recommendations for people who are moderately or severely immunocompromised.

The research was funded with supplemental funds to the North American AIDS Cohort Collaboration on Research and Design. Dr. Coburn reports no relevant financial relationships. A coauthor has received grants from the Canadian Institutes of Health Research, Alberta Innovates, and University of Calgary/Alberta Health Services outside the submitted work. One coauthor reports serving as a consultant to Trio Health, Kennedy Dundas, and MedIQ outside the submitted work.

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

People with HIV have an increased risk of breakthrough SARS-CoV-2 infections, a new study finds, and the authors say an additional primary vaccine dose should be considered for all who are living with the disease.

Currently, an additional primary dose administered 28 days after a second dose of the mRNA (Moderna or Pfizer) vaccines or after the first dose of the Johnson & Johnson (J&J) vaccine is recommended only for those with advanced or untreated HIV.

The Centers for Disease Control and Prevention recommends boosters for all adults with or without HIV.

Sally B. Coburn, PhD, of the department of epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, led the study, which was published online in JAMA Network Open. In their study, the researchers estimate the risk of breakthrough infections among fully vaccinated adults on the basis of HIV status in the United States.

Adults with HIV who were fully vaccinated before June 30, 2021, were matched with adults without HIV with regard to date of full vaccination, age, race/ethnicity, and sex. All were followed through Dec. 31, 2021.

Patients were considered fully vaccinated either 14 days after the second dose of the Pfizer or Moderna shots or 14 days after the single dose of the J&J shot.
 

Breakthrough risk 28% higher

In the study of 113,994 patients, researchers found that risk of breakthrough SARS-CoV-2 infection was low overall (3.8%) but was 28% higher among people with HIV in comparison with people without HIV (adjusted hazard ratio, 1.28; 95% confidence interval, 1.19-1.37).

The breakthrough rate was also higher in the HIV group (55 cases per 1,000 person-years, vs. 43 cases per 1,000 person-years in people without HIV).

Patients were drawn from the Corona-Infectious-Virus Epidemiology Team (CIVET)–II of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), which is part of the International Epidemiology Databases to Evaluate AIDS (IeDEA) collaboration involving four cohorts.

Among people with HIV, those younger than 45 years (vs. those aged 45-54) and those with a history of COVID-19 were more likely to experience breakthrough infections. Those who did not get any additional shots after the primary vaccination were more likely to have breakthrough infections, amplifying the need to get boosters, the authors wrote.

There was no link between breakthrough infections and HIV viral load suppression, but high CD4 counts (> 500 cells/mm³) were associated with fewer breakthrough cases among people with HIV, they noted.

Monica Gandhi, MD, professor of medicine and associate division chief of HIV, infectious diseases, and global medicine at the University of California, San Francisco, praised the study, noting that until now, large studies have not examined the rate of breakthrough infections among vaccinated people with HIV and people without HIV in the United States.

She told this news organization she agrees with the authors that a third dose for all who are living with HIV is needed because rates of breakthrough infections were high across all populations during the Omicron surge (which largely occurred after the period of this study).

She said she was not convinced the third shot was needed before Omicron, because breakthrough rates in both HIV and non-HIV groups were low.

“However, the most interesting part of this study for me was how well the vaccines worked in people with HIV with generally higher CD4 counts and virologic suppression, again telling us as HIV providers how well the HIV medicines work and how our patients with HIV have relatively normal immune systems if treated,” she said.

One limitation was that the study population was 92% male. Also, those without regular access to health care (who may be at greater risk for COVID-19) were less likely to be included in the study. People engaged in care may seek more frequent COVID-19 testing, which could lead to higher detection of breakthrough infections than in the general population.

“Future analyses should account for testing practices and include a larger proportion of women with HIV,” the authors wrote. “Ultimately, policy makers must determine the appropriate balance between preventing further COVID-19 infections and possibly unnecessary additional vaccinations.”

Coauthor Keri N. Althoff, PhD, told this news organization that there’s one unanswered question that would strengthen the call to action by the CDC: Do people with HIV have more severe postvaccination COVID-19 breakthrough illness?

“We have a second paper that is a preprint and currently under peer review,” she said. “In this paper, we found that people with HIV with a CD4 count less than 350 cells/mm³ were more likely to be hospitalized with postvaccination COVID-19 breakthrough illness compared to similar people without HIV. “

At a minimum, Dr. Althoff said, policymakers should consider including people with HIV with a CD4 less than 350 cells/mm³ (loosening the restriction to less than 200 cells/mm³) in their recommendations for people who are moderately or severely immunocompromised.

The research was funded with supplemental funds to the North American AIDS Cohort Collaboration on Research and Design. Dr. Coburn reports no relevant financial relationships. A coauthor has received grants from the Canadian Institutes of Health Research, Alberta Innovates, and University of Calgary/Alberta Health Services outside the submitted work. One coauthor reports serving as a consultant to Trio Health, Kennedy Dundas, and MedIQ outside the submitted work.

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

Pregnant women with monkeypox will be advised to give birth by C-section to avoid infecting their baby during delivery, according to a new paper in Ultrasound in Obstetrics & Gynecology.

The risk of monkeypox infection remains low for the general public, the authors wrote, though cases continue to grow worldwide, particularly in the United Kingdom.

“We are aware infants and children are at greater risk of becoming seriously ill if they do catch monkeypox,” Edward Morris, MBBS, one of the authors and president of the Royal College of Obstetricians and Gynecologists, said in a statement.

“Therefore, to minimize the risk of a baby contracting the virus, we recommend health care professionals discuss the benefits and risks of having a cesarean birth with a pregnant woman or person who has or is suspected of having the virus,” he said.

Dr. Morris and colleagues pulled together existing evidence on monkeypox diagnosis, treatment, and recommended modes of birth for mothers and babies.

“The World Health Organization states there could be adverse consequences for pregnant women and babies if they become infected, including congenital monkeypox, miscarriage, or stillbirth, which is why we have provided clear guidance for health care professionals in this paper,” Dr. Morris said.

The monkeypox virus typically spreads through direct contact, droplets, or contaminated surfaces and objects. But some limited evidence shows that the virus can be passed from a mother to a baby via the placenta, which can lead to congenital monkeypox.

What’s more, mothers may be able to transmit the virus during or after birth. Although no evidence exists around the optimal mode of birth, a pregnant woman with an active monkeypox infection may choose to avoid vaginal delivery to reduce direct contact.

“If genital lesions are identified on a pregnant woman, then a cesarean birth will be recommended,” the authors wrote. “If a pregnant woman or person has suspected or confirmed monkeypox, a caesarean birth will be offered following discussion of the possible risk of neonatal infection, which may be serious.”

After giving birth, close contact can spread the virus as well. To minimize the risk, the authors recommend isolating the baby from family members who have confirmed or suspected monkeypox and carefully monitoring for infection.

Mothers with an active monkeypox infection should also avoid breastfeeding to lower the risk of spreading the virus to their newborn, the authors wrote. But to support breastfeeding after infection, mothers can express and discard milk until the isolation period has passed.

Pregnant women who become infected may also consider getting vaccinated, the authors wrote. Vaccination up to 14 days after exposure doesn’t prevent the disease but can reduce the severity of symptoms. In the current outbreak, public health organizations advised doctors to vaccinate contacts of confirmed cases, including pregnant people.

The data for monkeypox vaccine use in pregnant women is small, the authors wrote, including fewer than 300 women. In previous studies, no adverse outcomes were found. The vaccine is also considered safe for breastfeeding.

“The decision whether to have the vaccine in pregnancy should be a personal choice,” the authors wrote. “Pregnant women and people should be encouraged to discuss the risks and benefits of vaccination, including possible side effects, with a health care professional before making their final decision.”

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

Pregnant women with monkeypox will be advised to give birth by C-section to avoid infecting their baby during delivery, according to a new paper in Ultrasound in Obstetrics & Gynecology.

The risk of monkeypox infection remains low for the general public, the authors wrote, though cases continue to grow worldwide, particularly in the United Kingdom.

“We are aware infants and children are at greater risk of becoming seriously ill if they do catch monkeypox,” Edward Morris, MBBS, one of the authors and president of the Royal College of Obstetricians and Gynecologists, said in a statement.

“Therefore, to minimize the risk of a baby contracting the virus, we recommend health care professionals discuss the benefits and risks of having a cesarean birth with a pregnant woman or person who has or is suspected of having the virus,” he said.

Dr. Morris and colleagues pulled together existing evidence on monkeypox diagnosis, treatment, and recommended modes of birth for mothers and babies.

“The World Health Organization states there could be adverse consequences for pregnant women and babies if they become infected, including congenital monkeypox, miscarriage, or stillbirth, which is why we have provided clear guidance for health care professionals in this paper,” Dr. Morris said.

The monkeypox virus typically spreads through direct contact, droplets, or contaminated surfaces and objects. But some limited evidence shows that the virus can be passed from a mother to a baby via the placenta, which can lead to congenital monkeypox.

What’s more, mothers may be able to transmit the virus during or after birth. Although no evidence exists around the optimal mode of birth, a pregnant woman with an active monkeypox infection may choose to avoid vaginal delivery to reduce direct contact.

“If genital lesions are identified on a pregnant woman, then a cesarean birth will be recommended,” the authors wrote. “If a pregnant woman or person has suspected or confirmed monkeypox, a caesarean birth will be offered following discussion of the possible risk of neonatal infection, which may be serious.”

After giving birth, close contact can spread the virus as well. To minimize the risk, the authors recommend isolating the baby from family members who have confirmed or suspected monkeypox and carefully monitoring for infection.

Mothers with an active monkeypox infection should also avoid breastfeeding to lower the risk of spreading the virus to their newborn, the authors wrote. But to support breastfeeding after infection, mothers can express and discard milk until the isolation period has passed.

Pregnant women who become infected may also consider getting vaccinated, the authors wrote. Vaccination up to 14 days after exposure doesn’t prevent the disease but can reduce the severity of symptoms. In the current outbreak, public health organizations advised doctors to vaccinate contacts of confirmed cases, including pregnant people.

The data for monkeypox vaccine use in pregnant women is small, the authors wrote, including fewer than 300 women. In previous studies, no adverse outcomes were found. The vaccine is also considered safe for breastfeeding.

“The decision whether to have the vaccine in pregnancy should be a personal choice,” the authors wrote. “Pregnant women and people should be encouraged to discuss the risks and benefits of vaccination, including possible side effects, with a health care professional before making their final decision.”

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

Pregnant women with monkeypox will be advised to give birth by C-section to avoid infecting their baby during delivery, according to a new paper in Ultrasound in Obstetrics & Gynecology.

The risk of monkeypox infection remains low for the general public, the authors wrote, though cases continue to grow worldwide, particularly in the United Kingdom.

“We are aware infants and children are at greater risk of becoming seriously ill if they do catch monkeypox,” Edward Morris, MBBS, one of the authors and president of the Royal College of Obstetricians and Gynecologists, said in a statement.

“Therefore, to minimize the risk of a baby contracting the virus, we recommend health care professionals discuss the benefits and risks of having a cesarean birth with a pregnant woman or person who has or is suspected of having the virus,” he said.

Dr. Morris and colleagues pulled together existing evidence on monkeypox diagnosis, treatment, and recommended modes of birth for mothers and babies.

“The World Health Organization states there could be adverse consequences for pregnant women and babies if they become infected, including congenital monkeypox, miscarriage, or stillbirth, which is why we have provided clear guidance for health care professionals in this paper,” Dr. Morris said.

The monkeypox virus typically spreads through direct contact, droplets, or contaminated surfaces and objects. But some limited evidence shows that the virus can be passed from a mother to a baby via the placenta, which can lead to congenital monkeypox.

What’s more, mothers may be able to transmit the virus during or after birth. Although no evidence exists around the optimal mode of birth, a pregnant woman with an active monkeypox infection may choose to avoid vaginal delivery to reduce direct contact.

“If genital lesions are identified on a pregnant woman, then a cesarean birth will be recommended,” the authors wrote. “If a pregnant woman or person has suspected or confirmed monkeypox, a caesarean birth will be offered following discussion of the possible risk of neonatal infection, which may be serious.”

After giving birth, close contact can spread the virus as well. To minimize the risk, the authors recommend isolating the baby from family members who have confirmed or suspected monkeypox and carefully monitoring for infection.

Mothers with an active monkeypox infection should also avoid breastfeeding to lower the risk of spreading the virus to their newborn, the authors wrote. But to support breastfeeding after infection, mothers can express and discard milk until the isolation period has passed.

Pregnant women who become infected may also consider getting vaccinated, the authors wrote. Vaccination up to 14 days after exposure doesn’t prevent the disease but can reduce the severity of symptoms. In the current outbreak, public health organizations advised doctors to vaccinate contacts of confirmed cases, including pregnant people.

The data for monkeypox vaccine use in pregnant women is small, the authors wrote, including fewer than 300 women. In previous studies, no adverse outcomes were found. The vaccine is also considered safe for breastfeeding.

“The decision whether to have the vaccine in pregnancy should be a personal choice,” the authors wrote. “Pregnant women and people should be encouraged to discuss the risks and benefits of vaccination, including possible side effects, with a health care professional before making their final decision.”

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

If you have bacteria in your urine but don’t have symptoms of a urinary tract infection (UTI), such as burning or frequent urination, you probably don’t need antibiotics. So why did you get that prescription?

The Infectious Diseases Society of America recommends against antibiotics in this scenario, with exceptions for patients who are pregnant or undergoing certain urologic procedures.

Antibiotics for asymptomatic bacteriuria (ASB) generally do not help; are costly; and can cause side effects, Clostridioides difficile infection, and antibiotic resistance.

Still, antibiotic treatment for asymptomatic bacteriuria remains common, despite guidelines.

And when researchers recently surveyed 551 primary care clinicians to see which ones would inappropriately prescribe antibiotics for a positive urine culture, the answer was most of them: 71%.

“Regardless of years in practice, training background, or professional degree, most clinicians indicated that they would prescribe antibiotics for asymptomatic bacteriuria,” the researchers reported in JAMA Network Open.

Some groups of clinicians seemed especially likely to prescribe antibiotics unnecessarily.

“Medical maximizers” – clinicians who prefer treatment even when its value is ambiguous – and family medicine clinicians were more likely to prescribe antibiotics in response to a hypothetical case.

What to do for Mr. Williams?

To examine clinician attitudes and characteristics associated with prescribing antibiotics for asymptomatic bacteriuria, Dr. Baghdadi and his colleagues analyzed survey responses from 490 physicians and 61 advanced practice clinicians.

Study participants completed tests that measure numeracy, risk-taking preferences, burnout, and tendency to maximize care. They were presented with four hypothetical clinical scenarios, including a case of asymptomatic bacteriuria: “Mr. Williams, a 65-year-old man, comes to the office for follow-up of his osteoarthritis. He has noted foul-smelling urine and no pain or difficulty with urination. A urine dipstick shows trace blood. He has no particular preference for testing and wants your advice.”

Clinicians who had been in practice for at least 10 years were more likely to prescribe antibiotics (82%) to “Mr. Williams” than were those with 3-9 years in practice (73%) or less than 3 years in practice (64%).

Breaking a habit

Some prescribers may know not to treat asymptomatic bacteriuria but mistakenly consider certain findings to be symptoms of UTI.

Bradley Langford, PharmD, an antimicrobial stewardship expert with Public Health Ontario, said in his experience, most clinicians who say they know not to treat ASB incorrectly believe that cloudy urine, altered cognition, and other nonspecific symptoms indicate a UTI.

“The fact that most clinicians would treat ASB suggests that there is still a lot of work to do to improve antimicrobial stewardship, particularly outside of the hospital setting,” Dr. Langford told this news organization.

Avoiding unnecessary antibiotics is important not just because of the lack of benefit, but also because of the potential harms, said Dr. Langford. He has created a list of rebuttals for commonly given reasons for testing and treating asymptomatic bacteriuria.

“Using antibiotics for ASB can counterintuitively increase the risk for symptomatic UTI due to the disruption of protective local microflora, allowing for the growth of more pathogenic/resistant organisms,” he said.

One approach to addressing the problem: Don’t test urine in the first place if patients are asymptomatic. Virtual learning sessions have been shown to reduce urine culturing and urinary antibiotic prescribing in long-term care homes, Dr. Langford noted.

Updated training for health care professionals from the outset may also be key, and the lower rate of prescribing intent among resident physicians is reassuring, he said.
 

A role for patients

Patients could also help decrease the inappropriate use of antibiotics.

“Be clear with your doctor about your expectations for the health care interaction, including whether you are expecting to receive antibiotics,” Dr. Baghdadi said. “Your doctor may assume you contacted them because you wanted a prescription. If you are not expecting antibiotics, you should feel free to say so. And if you are asymptomatic, you may not need antibiotics, even if the urine culture is positive.”

The study was funded by a grant from the National Institutes of Health, and Dr. Baghdadi received grant support from the University of Maryland, Baltimore Institute for Clinical and Translational Research. Coauthors disclosed government grants and ties to Memorial Sloan Kettering Cancer Center, Vedanta Biosciences, Opentrons, and Fimbrion. Dr. Langford reported no relevant financial conflicts of interest.

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

If you have bacteria in your urine but don’t have symptoms of a urinary tract infection (UTI), such as burning or frequent urination, you probably don’t need antibiotics. So why did you get that prescription?

The Infectious Diseases Society of America recommends against antibiotics in this scenario, with exceptions for patients who are pregnant or undergoing certain urologic procedures.

Antibiotics for asymptomatic bacteriuria (ASB) generally do not help; are costly; and can cause side effects, Clostridioides difficile infection, and antibiotic resistance.

Still, antibiotic treatment for asymptomatic bacteriuria remains common, despite guidelines.

And when researchers recently surveyed 551 primary care clinicians to see which ones would inappropriately prescribe antibiotics for a positive urine culture, the answer was most of them: 71%.

“Regardless of years in practice, training background, or professional degree, most clinicians indicated that they would prescribe antibiotics for asymptomatic bacteriuria,” the researchers reported in JAMA Network Open.

Some groups of clinicians seemed especially likely to prescribe antibiotics unnecessarily.

“Medical maximizers” – clinicians who prefer treatment even when its value is ambiguous – and family medicine clinicians were more likely to prescribe antibiotics in response to a hypothetical case.

What to do for Mr. Williams?

To examine clinician attitudes and characteristics associated with prescribing antibiotics for asymptomatic bacteriuria, Dr. Baghdadi and his colleagues analyzed survey responses from 490 physicians and 61 advanced practice clinicians.

Study participants completed tests that measure numeracy, risk-taking preferences, burnout, and tendency to maximize care. They were presented with four hypothetical clinical scenarios, including a case of asymptomatic bacteriuria: “Mr. Williams, a 65-year-old man, comes to the office for follow-up of his osteoarthritis. He has noted foul-smelling urine and no pain or difficulty with urination. A urine dipstick shows trace blood. He has no particular preference for testing and wants your advice.”

Clinicians who had been in practice for at least 10 years were more likely to prescribe antibiotics (82%) to “Mr. Williams” than were those with 3-9 years in practice (73%) or less than 3 years in practice (64%).

Breaking a habit

Some prescribers may know not to treat asymptomatic bacteriuria but mistakenly consider certain findings to be symptoms of UTI.

Bradley Langford, PharmD, an antimicrobial stewardship expert with Public Health Ontario, said in his experience, most clinicians who say they know not to treat ASB incorrectly believe that cloudy urine, altered cognition, and other nonspecific symptoms indicate a UTI.

“The fact that most clinicians would treat ASB suggests that there is still a lot of work to do to improve antimicrobial stewardship, particularly outside of the hospital setting,” Dr. Langford told this news organization.

Avoiding unnecessary antibiotics is important not just because of the lack of benefit, but also because of the potential harms, said Dr. Langford. He has created a list of rebuttals for commonly given reasons for testing and treating asymptomatic bacteriuria.

“Using antibiotics for ASB can counterintuitively increase the risk for symptomatic UTI due to the disruption of protective local microflora, allowing for the growth of more pathogenic/resistant organisms,” he said.

One approach to addressing the problem: Don’t test urine in the first place if patients are asymptomatic. Virtual learning sessions have been shown to reduce urine culturing and urinary antibiotic prescribing in long-term care homes, Dr. Langford noted.

Updated training for health care professionals from the outset may also be key, and the lower rate of prescribing intent among resident physicians is reassuring, he said.
 

A role for patients

Patients could also help decrease the inappropriate use of antibiotics.

“Be clear with your doctor about your expectations for the health care interaction, including whether you are expecting to receive antibiotics,” Dr. Baghdadi said. “Your doctor may assume you contacted them because you wanted a prescription. If you are not expecting antibiotics, you should feel free to say so. And if you are asymptomatic, you may not need antibiotics, even if the urine culture is positive.”

The study was funded by a grant from the National Institutes of Health, and Dr. Baghdadi received grant support from the University of Maryland, Baltimore Institute for Clinical and Translational Research. Coauthors disclosed government grants and ties to Memorial Sloan Kettering Cancer Center, Vedanta Biosciences, Opentrons, and Fimbrion. Dr. Langford reported no relevant financial conflicts of interest.

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

If you have bacteria in your urine but don’t have symptoms of a urinary tract infection (UTI), such as burning or frequent urination, you probably don’t need antibiotics. So why did you get that prescription?

The Infectious Diseases Society of America recommends against antibiotics in this scenario, with exceptions for patients who are pregnant or undergoing certain urologic procedures.

Antibiotics for asymptomatic bacteriuria (ASB) generally do not help; are costly; and can cause side effects, Clostridioides difficile infection, and antibiotic resistance.

Still, antibiotic treatment for asymptomatic bacteriuria remains common, despite guidelines.

And when researchers recently surveyed 551 primary care clinicians to see which ones would inappropriately prescribe antibiotics for a positive urine culture, the answer was most of them: 71%.

“Regardless of years in practice, training background, or professional degree, most clinicians indicated that they would prescribe antibiotics for asymptomatic bacteriuria,” the researchers reported in JAMA Network Open.

Some groups of clinicians seemed especially likely to prescribe antibiotics unnecessarily.

“Medical maximizers” – clinicians who prefer treatment even when its value is ambiguous – and family medicine clinicians were more likely to prescribe antibiotics in response to a hypothetical case.

What to do for Mr. Williams?

To examine clinician attitudes and characteristics associated with prescribing antibiotics for asymptomatic bacteriuria, Dr. Baghdadi and his colleagues analyzed survey responses from 490 physicians and 61 advanced practice clinicians.

Study participants completed tests that measure numeracy, risk-taking preferences, burnout, and tendency to maximize care. They were presented with four hypothetical clinical scenarios, including a case of asymptomatic bacteriuria: “Mr. Williams, a 65-year-old man, comes to the office for follow-up of his osteoarthritis. He has noted foul-smelling urine and no pain or difficulty with urination. A urine dipstick shows trace blood. He has no particular preference for testing and wants your advice.”

Clinicians who had been in practice for at least 10 years were more likely to prescribe antibiotics (82%) to “Mr. Williams” than were those with 3-9 years in practice (73%) or less than 3 years in practice (64%).

Breaking a habit

Some prescribers may know not to treat asymptomatic bacteriuria but mistakenly consider certain findings to be symptoms of UTI.

Bradley Langford, PharmD, an antimicrobial stewardship expert with Public Health Ontario, said in his experience, most clinicians who say they know not to treat ASB incorrectly believe that cloudy urine, altered cognition, and other nonspecific symptoms indicate a UTI.

“The fact that most clinicians would treat ASB suggests that there is still a lot of work to do to improve antimicrobial stewardship, particularly outside of the hospital setting,” Dr. Langford told this news organization.

Avoiding unnecessary antibiotics is important not just because of the lack of benefit, but also because of the potential harms, said Dr. Langford. He has created a list of rebuttals for commonly given reasons for testing and treating asymptomatic bacteriuria.

“Using antibiotics for ASB can counterintuitively increase the risk for symptomatic UTI due to the disruption of protective local microflora, allowing for the growth of more pathogenic/resistant organisms,” he said.

One approach to addressing the problem: Don’t test urine in the first place if patients are asymptomatic. Virtual learning sessions have been shown to reduce urine culturing and urinary antibiotic prescribing in long-term care homes, Dr. Langford noted.

Updated training for health care professionals from the outset may also be key, and the lower rate of prescribing intent among resident physicians is reassuring, he said.
 

A role for patients

Patients could also help decrease the inappropriate use of antibiotics.

“Be clear with your doctor about your expectations for the health care interaction, including whether you are expecting to receive antibiotics,” Dr. Baghdadi said. “Your doctor may assume you contacted them because you wanted a prescription. If you are not expecting antibiotics, you should feel free to say so. And if you are asymptomatic, you may not need antibiotics, even if the urine culture is positive.”

The study was funded by a grant from the National Institutes of Health, and Dr. Baghdadi received grant support from the University of Maryland, Baltimore Institute for Clinical and Translational Research. Coauthors disclosed government grants and ties to Memorial Sloan Kettering Cancer Center, Vedanta Biosciences, Opentrons, and Fimbrion. Dr. Langford reported no relevant financial conflicts of interest.

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

The first decline in COVID-19 cases among children since early April may have been holiday related, but the shortened week also brought news about vaccination for the youngest children.

The Food and Drug Administration has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, so vaccination could begin as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.

“We know that many, many parents are eager to vaccinate their youngest kids and it’s important to do this right,” Dr. Jha said at a White House press briefing June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”

Decline may just be underreporting

Over on the incidence side of the pandemic, the total number of cases reported for the week of May 27 to June 2 was about 87,000, a drop of 22% from May 20-26 and the first decline after 7 straight weeks of increases. “Testing and reporting may have been affected by the holiday weekend [since] states may change their reporting schedules, which may cause irregularities in trends,” the American Academy of Pediatrics and the Children’s Hospital association said in their latest COVID report.

The decline in new cases was not spread uniformly across the four major regions of the United States. The count actually went up in the West for the week of May 27 to June 2, while the South saw the largest decline. The Midwest and Northeast, meanwhile, saw new cases drop for the second straight week, the AAP and CHA said.

The cumulative number of COVID-19 cases in children was up to 13.45 million as of June 2, with children representing 18.9% of all cases since the start of the pandemic, according to the two organizations. The Centers for Disease Control and Prevention reported figures of 13.14 million and 17.5% on June 6.

The AAP/CHA estimates, however, are based on state data that have become increasingly hard to obtain and subject to inconsistency. “Shortages of COVID-19 tests during surges and the increasing use of COVID-19 home tests likely affect the undercounting of COVID-19 cases,” they noted, and “at times when COVID-19 transmission is low, states might reduce the frequency information is updated.”
 

Vaccinations held steady over the holiday

The ongoing vaccination effort in children aged 5 years and older did not show a Memorial Day drop-off, as initial vaccinations held at 43,000 in 5- to 11-year-olds and at 27,000 in 12- to 17-year-olds for a second consecutive week. That number has ranged from 34,000 to 70,000 for the younger children and from 25,000 to 47,000 for the older group since mid-March, the AAP said in a separate weekly report.

Despite weekly vaccine initiations that have been roughly double those of the older children for months, the 5- to 11-year-olds are still only at 36.0% coverage with at least one dose, compared with 69.5% for the 12- to-17-year-olds. Full vaccination for the two age groups comes in at 29.3% and 59.6%, respectively, as of June 6, according to the CDC’s COVID Data Tracker.
 

The first decline in COVID-19 cases among children since early April may have been holiday related, but the shortened week also brought news about vaccination for the youngest children.

The Food and Drug Administration has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, so vaccination could begin as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.

“We know that many, many parents are eager to vaccinate their youngest kids and it’s important to do this right,” Dr. Jha said at a White House press briefing June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”

Decline may just be underreporting

Over on the incidence side of the pandemic, the total number of cases reported for the week of May 27 to June 2 was about 87,000, a drop of 22% from May 20-26 and the first decline after 7 straight weeks of increases. “Testing and reporting may have been affected by the holiday weekend [since] states may change their reporting schedules, which may cause irregularities in trends,” the American Academy of Pediatrics and the Children’s Hospital association said in their latest COVID report.

The decline in new cases was not spread uniformly across the four major regions of the United States. The count actually went up in the West for the week of May 27 to June 2, while the South saw the largest decline. The Midwest and Northeast, meanwhile, saw new cases drop for the second straight week, the AAP and CHA said.

The cumulative number of COVID-19 cases in children was up to 13.45 million as of June 2, with children representing 18.9% of all cases since the start of the pandemic, according to the two organizations. The Centers for Disease Control and Prevention reported figures of 13.14 million and 17.5% on June 6.

The AAP/CHA estimates, however, are based on state data that have become increasingly hard to obtain and subject to inconsistency. “Shortages of COVID-19 tests during surges and the increasing use of COVID-19 home tests likely affect the undercounting of COVID-19 cases,” they noted, and “at times when COVID-19 transmission is low, states might reduce the frequency information is updated.”
 

Vaccinations held steady over the holiday

The ongoing vaccination effort in children aged 5 years and older did not show a Memorial Day drop-off, as initial vaccinations held at 43,000 in 5- to 11-year-olds and at 27,000 in 12- to 17-year-olds for a second consecutive week. That number has ranged from 34,000 to 70,000 for the younger children and from 25,000 to 47,000 for the older group since mid-March, the AAP said in a separate weekly report.

Despite weekly vaccine initiations that have been roughly double those of the older children for months, the 5- to 11-year-olds are still only at 36.0% coverage with at least one dose, compared with 69.5% for the 12- to-17-year-olds. Full vaccination for the two age groups comes in at 29.3% and 59.6%, respectively, as of June 6, according to the CDC’s COVID Data Tracker.
 

The first decline in COVID-19 cases among children since early April may have been holiday related, but the shortened week also brought news about vaccination for the youngest children.

The Food and Drug Administration has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, so vaccination could begin as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.

“We know that many, many parents are eager to vaccinate their youngest kids and it’s important to do this right,” Dr. Jha said at a White House press briefing June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”

Decline may just be underreporting

Over on the incidence side of the pandemic, the total number of cases reported for the week of May 27 to June 2 was about 87,000, a drop of 22% from May 20-26 and the first decline after 7 straight weeks of increases. “Testing and reporting may have been affected by the holiday weekend [since] states may change their reporting schedules, which may cause irregularities in trends,” the American Academy of Pediatrics and the Children’s Hospital association said in their latest COVID report.

The decline in new cases was not spread uniformly across the four major regions of the United States. The count actually went up in the West for the week of May 27 to June 2, while the South saw the largest decline. The Midwest and Northeast, meanwhile, saw new cases drop for the second straight week, the AAP and CHA said.

The cumulative number of COVID-19 cases in children was up to 13.45 million as of June 2, with children representing 18.9% of all cases since the start of the pandemic, according to the two organizations. The Centers for Disease Control and Prevention reported figures of 13.14 million and 17.5% on June 6.

The AAP/CHA estimates, however, are based on state data that have become increasingly hard to obtain and subject to inconsistency. “Shortages of COVID-19 tests during surges and the increasing use of COVID-19 home tests likely affect the undercounting of COVID-19 cases,” they noted, and “at times when COVID-19 transmission is low, states might reduce the frequency information is updated.”
 

Vaccinations held steady over the holiday

The ongoing vaccination effort in children aged 5 years and older did not show a Memorial Day drop-off, as initial vaccinations held at 43,000 in 5- to 11-year-olds and at 27,000 in 12- to 17-year-olds for a second consecutive week. That number has ranged from 34,000 to 70,000 for the younger children and from 25,000 to 47,000 for the older group since mid-March, the AAP said in a separate weekly report.

Despite weekly vaccine initiations that have been roughly double those of the older children for months, the 5- to 11-year-olds are still only at 36.0% coverage with at least one dose, compared with 69.5% for the 12- to-17-year-olds. Full vaccination for the two age groups comes in at 29.3% and 59.6%, respectively, as of June 6, according to the CDC’s COVID Data Tracker.
 

Among an estimated 87% of people with HIV (PWH) whose condition has been diagnosed, roughly 66% have received medication. But only half are retained in care, leaving substantial risk for viral rebound and further HIV transmission.

A variety of factors contribute to falling out of care (OOC), a primary reason why a team from the Centers for Disease Control and Prevention reviewed over three decades of studies with the goal of identifying best practices for re-engagement.

The research, which was published  in the journal AIDS, underscores the need for more customized strategies, rather than a one-size-fits-all approach, especially for historically underserved communities.

“Many study participants across the studies included in this review represented communities who have the largest challenges with remaining in care,” Darrel H. Higa, PhD, MSW, lead study author and a behavioral scientist at the CDC in Atlanta, told this news organization.

For example, “Some face barriers that may limit their access to care ... including not having health insurance or being unable to pay for doctor visits or medication, HIV-related stigma, racism, homophobia, transphobia, health literacy, and a lack of providers who specialize in HIV care,” he said.

Other challenges relate to personal barriers, such as competing priorities (for example, work or childcare), substance use, mental health disorders, transportation problems, or a lack of social support.

Even with improvements that address some of these barriers, such as expanded access to health care insurance and broader provision of medical care and HIV medications through the national Ryan White program, structural challenges and social barriers persist.
 

Better versus best practices

In their analysis, the CDC team expanded the scope of prior reviews by including literature published between 2000 and 2020 and further conducted meta-analyses to assess the effectiveness of five common, non mutually exclusive interventions:

• patient navigation
• appointment help/alerts
• psychosocial support
• transportation/appointment reminders
• data-to-care HIV care outcomes (using health department surveillance data and/or patient health records to identify and re-engage OOC PWH)

The majority of the 26,154 participants in 39 included studies (incorporating 42 unique interventions) were male (71%) and Black (64%); the most common time frame for OOC was between 6 and 12 months, but some studies used a time frame of 3-4 months, and others more than 12 months.

Definitions for re-engagement and retention were likewise inconsistent across studies but most commonly involved having an HIV medical visit or viral load test record between 2 and 6 months (re-engagement), and ≥ 1 medical visits in each 6-month period a minimum of 60 days apart for a period of over 2 years (retention).

This is notable, as it points to the role played – at least in part – by the care fragmentation inherent in the United States health care system. Without national indicators or thresholds for clinical outcomes, services are unlikely to reach scale.

“You can’t expect retention in care until you have a close to seamless, less fragmented safety net in the United States,” said Mary Jane Rotheram-Borus, PhD, distinguished professor of clinical psychology and director of the Global Center for Children and Families at the Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles. (Dr. Rotheram-Borus authored an accompanying editorial but was not involved in the study.)

Nevertheless, review findings highlighted that overall, the five interventions appeared to improve care re-engagement (odds ratio = 1.79, 95% confidence interval, 1.36-2.36), care retention (OR = 2.01; 95% CI, 1.64-2.46), and viral suppression (OR = 2.50; 95% CI, 1.87-2.24).

Overall, the five strategies were associated with optimal re-engagement and retention in care. In addition, four of them were associated with viral suppression for PWH who were OOC during the study time frame. The one exception was data-to-care, for which the evidence supporting an association with viral suppression was unclear.

Because of the similarities between patient navigation and transportation/appointment accompaniment, the researchers also compared PWH who received combined strategies to those who did not.

“The findings suggest that patient navigation services that often include helping with transportation to appointments or accompanying PWH to appointments may be more effective compared to interventions without the combination,” explained Dr. Higa, “especially for communities with the largest challenges remaining in care.”

He added that, moving forward, many of the same strategies that help re-engage out-of-care PWH may be useful for retention. These include co-locating services, outreach, mental health services, clinical care models, telemedicine, and financial incentives.

Despite its financial investments toward ending the HIV epidemic, the United States arguably still has a long way to go to improve retention and care.

Still, Dr. Rotheram-Borus underscores the silver lining.

“The breakthroughs in medication are substantial,” she said, pointing to her own research, which has shown that at least 60% of newly infected, poor, LGBTQ+ young people up to age 24 have been linked to care and are adherent enough to be virally suppressed.

For PWH who are out of care, perhaps treatment advances – including long-acting injectables – may ultimately fill in the gaps.

Dr. Higa and Dr. Rotherum-Borus report no relevant financial relationships.

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

Among an estimated 87% of people with HIV (PWH) whose condition has been diagnosed, roughly 66% have received medication. But only half are retained in care, leaving substantial risk for viral rebound and further HIV transmission.

A variety of factors contribute to falling out of care (OOC), a primary reason why a team from the Centers for Disease Control and Prevention reviewed over three decades of studies with the goal of identifying best practices for re-engagement.

The research, which was published  in the journal AIDS, underscores the need for more customized strategies, rather than a one-size-fits-all approach, especially for historically underserved communities.

“Many study participants across the studies included in this review represented communities who have the largest challenges with remaining in care,” Darrel H. Higa, PhD, MSW, lead study author and a behavioral scientist at the CDC in Atlanta, told this news organization.

For example, “Some face barriers that may limit their access to care ... including not having health insurance or being unable to pay for doctor visits or medication, HIV-related stigma, racism, homophobia, transphobia, health literacy, and a lack of providers who specialize in HIV care,” he said.

Other challenges relate to personal barriers, such as competing priorities (for example, work or childcare), substance use, mental health disorders, transportation problems, or a lack of social support.

Even with improvements that address some of these barriers, such as expanded access to health care insurance and broader provision of medical care and HIV medications through the national Ryan White program, structural challenges and social barriers persist.
 

Better versus best practices

In their analysis, the CDC team expanded the scope of prior reviews by including literature published between 2000 and 2020 and further conducted meta-analyses to assess the effectiveness of five common, non mutually exclusive interventions:

• patient navigation
• appointment help/alerts
• psychosocial support
• transportation/appointment reminders
• data-to-care HIV care outcomes (using health department surveillance data and/or patient health records to identify and re-engage OOC PWH)

The majority of the 26,154 participants in 39 included studies (incorporating 42 unique interventions) were male (71%) and Black (64%); the most common time frame for OOC was between 6 and 12 months, but some studies used a time frame of 3-4 months, and others more than 12 months.

Definitions for re-engagement and retention were likewise inconsistent across studies but most commonly involved having an HIV medical visit or viral load test record between 2 and 6 months (re-engagement), and ≥ 1 medical visits in each 6-month period a minimum of 60 days apart for a period of over 2 years (retention).

This is notable, as it points to the role played – at least in part – by the care fragmentation inherent in the United States health care system. Without national indicators or thresholds for clinical outcomes, services are unlikely to reach scale.

“You can’t expect retention in care until you have a close to seamless, less fragmented safety net in the United States,” said Mary Jane Rotheram-Borus, PhD, distinguished professor of clinical psychology and director of the Global Center for Children and Families at the Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles. (Dr. Rotheram-Borus authored an accompanying editorial but was not involved in the study.)

Nevertheless, review findings highlighted that overall, the five interventions appeared to improve care re-engagement (odds ratio = 1.79, 95% confidence interval, 1.36-2.36), care retention (OR = 2.01; 95% CI, 1.64-2.46), and viral suppression (OR = 2.50; 95% CI, 1.87-2.24).

Overall, the five strategies were associated with optimal re-engagement and retention in care. In addition, four of them were associated with viral suppression for PWH who were OOC during the study time frame. The one exception was data-to-care, for which the evidence supporting an association with viral suppression was unclear.

Because of the similarities between patient navigation and transportation/appointment accompaniment, the researchers also compared PWH who received combined strategies to those who did not.

“The findings suggest that patient navigation services that often include helping with transportation to appointments or accompanying PWH to appointments may be more effective compared to interventions without the combination,” explained Dr. Higa, “especially for communities with the largest challenges remaining in care.”

He added that, moving forward, many of the same strategies that help re-engage out-of-care PWH may be useful for retention. These include co-locating services, outreach, mental health services, clinical care models, telemedicine, and financial incentives.

Despite its financial investments toward ending the HIV epidemic, the United States arguably still has a long way to go to improve retention and care.

Still, Dr. Rotheram-Borus underscores the silver lining.

“The breakthroughs in medication are substantial,” she said, pointing to her own research, which has shown that at least 60% of newly infected, poor, LGBTQ+ young people up to age 24 have been linked to care and are adherent enough to be virally suppressed.

For PWH who are out of care, perhaps treatment advances – including long-acting injectables – may ultimately fill in the gaps.

Dr. Higa and Dr. Rotherum-Borus report no relevant financial relationships.

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

Among an estimated 87% of people with HIV (PWH) whose condition has been diagnosed, roughly 66% have received medication. But only half are retained in care, leaving substantial risk for viral rebound and further HIV transmission.

A variety of factors contribute to falling out of care (OOC), a primary reason why a team from the Centers for Disease Control and Prevention reviewed over three decades of studies with the goal of identifying best practices for re-engagement.

The research, which was published  in the journal AIDS, underscores the need for more customized strategies, rather than a one-size-fits-all approach, especially for historically underserved communities.

“Many study participants across the studies included in this review represented communities who have the largest challenges with remaining in care,” Darrel H. Higa, PhD, MSW, lead study author and a behavioral scientist at the CDC in Atlanta, told this news organization.

For example, “Some face barriers that may limit their access to care ... including not having health insurance or being unable to pay for doctor visits or medication, HIV-related stigma, racism, homophobia, transphobia, health literacy, and a lack of providers who specialize in HIV care,” he said.

Other challenges relate to personal barriers, such as competing priorities (for example, work or childcare), substance use, mental health disorders, transportation problems, or a lack of social support.

Even with improvements that address some of these barriers, such as expanded access to health care insurance and broader provision of medical care and HIV medications through the national Ryan White program, structural challenges and social barriers persist.
 

Better versus best practices

In their analysis, the CDC team expanded the scope of prior reviews by including literature published between 2000 and 2020 and further conducted meta-analyses to assess the effectiveness of five common, non mutually exclusive interventions:

• patient navigation
• appointment help/alerts
• psychosocial support
• transportation/appointment reminders
• data-to-care HIV care outcomes (using health department surveillance data and/or patient health records to identify and re-engage OOC PWH)

The majority of the 26,154 participants in 39 included studies (incorporating 42 unique interventions) were male (71%) and Black (64%); the most common time frame for OOC was between 6 and 12 months, but some studies used a time frame of 3-4 months, and others more than 12 months.

Definitions for re-engagement and retention were likewise inconsistent across studies but most commonly involved having an HIV medical visit or viral load test record between 2 and 6 months (re-engagement), and ≥ 1 medical visits in each 6-month period a minimum of 60 days apart for a period of over 2 years (retention).

This is notable, as it points to the role played – at least in part – by the care fragmentation inherent in the United States health care system. Without national indicators or thresholds for clinical outcomes, services are unlikely to reach scale.

“You can’t expect retention in care until you have a close to seamless, less fragmented safety net in the United States,” said Mary Jane Rotheram-Borus, PhD, distinguished professor of clinical psychology and director of the Global Center for Children and Families at the Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles. (Dr. Rotheram-Borus authored an accompanying editorial but was not involved in the study.)

Nevertheless, review findings highlighted that overall, the five interventions appeared to improve care re-engagement (odds ratio = 1.79, 95% confidence interval, 1.36-2.36), care retention (OR = 2.01; 95% CI, 1.64-2.46), and viral suppression (OR = 2.50; 95% CI, 1.87-2.24).

Overall, the five strategies were associated with optimal re-engagement and retention in care. In addition, four of them were associated with viral suppression for PWH who were OOC during the study time frame. The one exception was data-to-care, for which the evidence supporting an association with viral suppression was unclear.

Because of the similarities between patient navigation and transportation/appointment accompaniment, the researchers also compared PWH who received combined strategies to those who did not.

“The findings suggest that patient navigation services that often include helping with transportation to appointments or accompanying PWH to appointments may be more effective compared to interventions without the combination,” explained Dr. Higa, “especially for communities with the largest challenges remaining in care.”

He added that, moving forward, many of the same strategies that help re-engage out-of-care PWH may be useful for retention. These include co-locating services, outreach, mental health services, clinical care models, telemedicine, and financial incentives.

Despite its financial investments toward ending the HIV epidemic, the United States arguably still has a long way to go to improve retention and care.

Still, Dr. Rotheram-Borus underscores the silver lining.

“The breakthroughs in medication are substantial,” she said, pointing to her own research, which has shown that at least 60% of newly infected, poor, LGBTQ+ young people up to age 24 have been linked to care and are adherent enough to be virally suppressed.

For PWH who are out of care, perhaps treatment advances – including long-acting injectables – may ultimately fill in the gaps.

Dr. Higa and Dr. Rotherum-Borus report no relevant financial relationships.

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

With monkeypox now circulating in the United States, expecting mothers may worry about what might happen if they contract the infection while pregnant.

As of today, 25 cases of monkeypox have been confirmed in the United States since the outbreak began in early May, according to the U.S. Centers for Disease Control and Prevention. Although none of those cases has involved a pregnant person, the World Health Organization says monkeypox can pass from mother to fetus before delivery or to newborns by close contact during and after birth.

The case count could grow as the agency continues to investigate potential infections of the virus. In a conference call Friday, health officials stressed the importance of contact tracing, testing, and vaccine treatment.

As physicians in the United States are scrambling for information on ways to treat patients, a new study, published in Ultrasound in Obstetrics & Gynecology, could help clinicians better care for pregnant people infected with monkeypox. The authors advise consistently monitoring the fetus for infection and conducting regular ultrasounds, among other precautions. 

Asma Khalil, MBBCh, MD, a professor of obstetrics and fetal medicine at St. George’s University, London, and lead author of the new study, said the monkeypox outbreak outside Africa caught many clinicians by surprise.

“We quickly realized very few physicians caring for pregnant women knew anything at all about monkeypox and how it affects pregnancy,” Dr. Khalil told this news organization. “Clinicians caring for pregnant women are likely to be faced soon with pregnant women concerned they may have the infection – because they have a rash, for example – or indeed pregnant women who do have the infection.”

According to the CDC, monkeypox can be transmitted through direct contact with the rash, sores, or scabs caused by the virus, as well as contact with clothing, bedding, towels, or other surfaces used by an infected person. Respiratory droplets and oral fluids from a person with monkeypox have also been linked to spread of the virus, as has sexual activity.

Although the condition is rarely fatal, infants and young children are at the greatest risk of developing severe symptoms, health officials said. 

The U.S. Food and Drug Administration has approved a monkeypox vaccine, Jynneos (Bavarian Nordic A/S), for general use, but it has not been specifically approved for pregnant people. However, a study of 300 pregnant women who received the vaccine reported no adverse reactions or failed pregnancies linked to the shots.

The new review suggests that women who have a confirmed infection during pregnancy should have a doctor closely monitor the fetus until birth.

If the fetus is over 26 weeks or if the mother is unwell, the fetus should be cared for with heart monitoring, either by a doctor or remotely every 2-3 days. Ultrasounds should be performed regularly to confirm that the fetus is still growing well and that the placenta is functioning properly.

Further into the pregnancy, monitoring should include measurements of the fetus and detailed assessment of the fetal organs and the amniotic fluid. Once the infection is resolved, the risk to the fetus is small, according to Dr. Khalil. However, since data are limited, she recommended an ultrasound scan every 2-4 weeks. At birth, for the protection of the infant and the mother, the baby should be isolated until infection is no longer a risk.

The Royal College of Obstetricians & Gynaecologists is preparing guidance on the management of monkeypox in pregnant people, Dr. Khalil said. The American College of Obstetricians and Gynecologists said it is “relying on the CDC for the time being,” according to a spokesperson for ACOG. 

“There is a clear need for further research in this area,” Dr. Khalil said. “The current outbreak is an ideal opportunity to make this happen.”

Dr. Khalil has disclosed no relevant financial relationships.

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

With monkeypox now circulating in the United States, expecting mothers may worry about what might happen if they contract the infection while pregnant.

As of today, 25 cases of monkeypox have been confirmed in the United States since the outbreak began in early May, according to the U.S. Centers for Disease Control and Prevention. Although none of those cases has involved a pregnant person, the World Health Organization says monkeypox can pass from mother to fetus before delivery or to newborns by close contact during and after birth.

The case count could grow as the agency continues to investigate potential infections of the virus. In a conference call Friday, health officials stressed the importance of contact tracing, testing, and vaccine treatment.

As physicians in the United States are scrambling for information on ways to treat patients, a new study, published in Ultrasound in Obstetrics & Gynecology, could help clinicians better care for pregnant people infected with monkeypox. The authors advise consistently monitoring the fetus for infection and conducting regular ultrasounds, among other precautions. 

Asma Khalil, MBBCh, MD, a professor of obstetrics and fetal medicine at St. George’s University, London, and lead author of the new study, said the monkeypox outbreak outside Africa caught many clinicians by surprise.

“We quickly realized very few physicians caring for pregnant women knew anything at all about monkeypox and how it affects pregnancy,” Dr. Khalil told this news organization. “Clinicians caring for pregnant women are likely to be faced soon with pregnant women concerned they may have the infection – because they have a rash, for example – or indeed pregnant women who do have the infection.”

According to the CDC, monkeypox can be transmitted through direct contact with the rash, sores, or scabs caused by the virus, as well as contact with clothing, bedding, towels, or other surfaces used by an infected person. Respiratory droplets and oral fluids from a person with monkeypox have also been linked to spread of the virus, as has sexual activity.

Although the condition is rarely fatal, infants and young children are at the greatest risk of developing severe symptoms, health officials said. 

The U.S. Food and Drug Administration has approved a monkeypox vaccine, Jynneos (Bavarian Nordic A/S), for general use, but it has not been specifically approved for pregnant people. However, a study of 300 pregnant women who received the vaccine reported no adverse reactions or failed pregnancies linked to the shots.

The new review suggests that women who have a confirmed infection during pregnancy should have a doctor closely monitor the fetus until birth.

If the fetus is over 26 weeks or if the mother is unwell, the fetus should be cared for with heart monitoring, either by a doctor or remotely every 2-3 days. Ultrasounds should be performed regularly to confirm that the fetus is still growing well and that the placenta is functioning properly.

Further into the pregnancy, monitoring should include measurements of the fetus and detailed assessment of the fetal organs and the amniotic fluid. Once the infection is resolved, the risk to the fetus is small, according to Dr. Khalil. However, since data are limited, she recommended an ultrasound scan every 2-4 weeks. At birth, for the protection of the infant and the mother, the baby should be isolated until infection is no longer a risk.

The Royal College of Obstetricians & Gynaecologists is preparing guidance on the management of monkeypox in pregnant people, Dr. Khalil said. The American College of Obstetricians and Gynecologists said it is “relying on the CDC for the time being,” according to a spokesperson for ACOG. 

“There is a clear need for further research in this area,” Dr. Khalil said. “The current outbreak is an ideal opportunity to make this happen.”

Dr. Khalil has disclosed no relevant financial relationships.

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

With monkeypox now circulating in the United States, expecting mothers may worry about what might happen if they contract the infection while pregnant.

As of today, 25 cases of monkeypox have been confirmed in the United States since the outbreak began in early May, according to the U.S. Centers for Disease Control and Prevention. Although none of those cases has involved a pregnant person, the World Health Organization says monkeypox can pass from mother to fetus before delivery or to newborns by close contact during and after birth.

The case count could grow as the agency continues to investigate potential infections of the virus. In a conference call Friday, health officials stressed the importance of contact tracing, testing, and vaccine treatment.

As physicians in the United States are scrambling for information on ways to treat patients, a new study, published in Ultrasound in Obstetrics & Gynecology, could help clinicians better care for pregnant people infected with monkeypox. The authors advise consistently monitoring the fetus for infection and conducting regular ultrasounds, among other precautions. 

Asma Khalil, MBBCh, MD, a professor of obstetrics and fetal medicine at St. George’s University, London, and lead author of the new study, said the monkeypox outbreak outside Africa caught many clinicians by surprise.

“We quickly realized very few physicians caring for pregnant women knew anything at all about monkeypox and how it affects pregnancy,” Dr. Khalil told this news organization. “Clinicians caring for pregnant women are likely to be faced soon with pregnant women concerned they may have the infection – because they have a rash, for example – or indeed pregnant women who do have the infection.”

According to the CDC, monkeypox can be transmitted through direct contact with the rash, sores, or scabs caused by the virus, as well as contact with clothing, bedding, towels, or other surfaces used by an infected person. Respiratory droplets and oral fluids from a person with monkeypox have also been linked to spread of the virus, as has sexual activity.

Although the condition is rarely fatal, infants and young children are at the greatest risk of developing severe symptoms, health officials said. 

The U.S. Food and Drug Administration has approved a monkeypox vaccine, Jynneos (Bavarian Nordic A/S), for general use, but it has not been specifically approved for pregnant people. However, a study of 300 pregnant women who received the vaccine reported no adverse reactions or failed pregnancies linked to the shots.

The new review suggests that women who have a confirmed infection during pregnancy should have a doctor closely monitor the fetus until birth.

If the fetus is over 26 weeks or if the mother is unwell, the fetus should be cared for with heart monitoring, either by a doctor or remotely every 2-3 days. Ultrasounds should be performed regularly to confirm that the fetus is still growing well and that the placenta is functioning properly.

Further into the pregnancy, monitoring should include measurements of the fetus and detailed assessment of the fetal organs and the amniotic fluid. Once the infection is resolved, the risk to the fetus is small, according to Dr. Khalil. However, since data are limited, she recommended an ultrasound scan every 2-4 weeks. At birth, for the protection of the infant and the mother, the baby should be isolated until infection is no longer a risk.

The Royal College of Obstetricians & Gynaecologists is preparing guidance on the management of monkeypox in pregnant people, Dr. Khalil said. The American College of Obstetricians and Gynecologists said it is “relying on the CDC for the time being,” according to a spokesperson for ACOG. 

“There is a clear need for further research in this area,” Dr. Khalil said. “The current outbreak is an ideal opportunity to make this happen.”

Dr. Khalil has disclosed no relevant financial relationships.

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

In a new risk-assessment document, the European Centre for Disease Prevention and Control summarizes what we currently know about monkeypox and recommends that European countries focus on the identification and management of the disease as well as contract tracing and prompt reporting of new cases of the virus.

Recent developments

From May 15 to May 23, in eight European Union member states (Belgium, France, Germany, Italy, the Netherlands, Portugal, Spain, and Sweden) a total of 85 cases of monkeypox were reported; they were acquired through autochthonous transmission. Current diagnosed cases of monkeypox have mainly been recorded in men who have sexual relations with other men, suggesting that transmission may occur during sexual intercourse, through infectious material coming into contact with mucosa or damaged skin, or via large respiratory droplets during prolonged face-to-face contact.

Andrea Ammon, MD, director of the ECDC, stated that “most current cases have presented with mild symptoms of the disease, and for the general population, the chance of diffusion is very low. However, the likelihood of a further spread of the virus through close contact, for example during sexual activities among people with multiple sexual partners, is considerably increased.”

Stella Kyriakides, European commissioner for health and food safety, added, “I am worried about the increase of cases of monkeypox in the EU and worldwide. We are currently monitoring the situation and, although, at the moment, the probability of it spreading to the general population is low, the situation is evolving. We should all remain alert, making sure that contact tracing and a sufficient diagnostic capacity are in place and guarantee that vaccines and antiviral drugs are available, as well as sufficient personal protective equipment [PPE] for health care professionals.”
 

Routes of transmission

Monkeypox is not easily spread among people. Person-to-person transmission occurs through close contact with infectious material, coming from skin lesions of an infected person, through air droplets in the case of prolonged face-to-face contact, and through fomites. So far, diagnosed cases suggest that transmission can occur through sexual intercourse.

The incubation period is 5-21 days, and patients are symptomatic for 2-4 weeks.

According to the ECDC, the likelihood of this infection spreading is increased among people who have more than one sexual partner. Although most current cases present with mild symptoms, monkeypox can cause severe disease in some groups (such as young children, pregnant women, and immunosuppressed people). However, the probability of severe disease cannot yet be estimated precisely.

The overall risk is considered moderate for people who have multiple sexual partners and low for the general population.
 

Clinical course

The disease initially presents with fever, myalgia, fatigue, and headache. Within 3 days of the onset of the prodromal symptoms, a centrifugal maculopapular rash appears on the site of primary infection and rapidly spreads to other parts of the body. The palms of the hands and bottoms of the feet are involved in cases where the rash has spread, which is a characteristic of the disease. Usually within 12 days, the lesions progress, simultaneously changing from macules to papules, blisters, pustules, and scabs before falling off. The lesions may have a central depression and be extremely itchy.

If the patient scratches them, a secondary bacterial infection may take hold (for which treatment with oral antihistamines is indicated). Lesions may also be present in the oral or ocular mucous membrane. Either before or at the same time as onset of the rash, patients may experience swelling of the lymph nodes, which usually is not seen with smallpox or chickenpox.

The onset of the rash is considered the start of the infectious period; however, people with prodromal symptoms may also transmit the virus.

Most cases in people present with mild or moderate symptoms. Complications seen in endemic countries include encephalitis, secondary bacterial skin infections, dehydration, conjunctivitis, keratitis, and pneumonia. The death rate ranges from 0% to 11% in endemic areas, with fatalities from the disease mostly occurring in younger children.

There is not a lot of information available on the disease in immunosuppressed individuals. In the 2017 Nigerian epidemic, patients with a concomitant HIV infection presented with more severe disease, with a greater number of skin lesions and genital ulcers, compared with HIV-negative individuals. No deaths were reported among seropositive patients. The main sequelae from the disease are usually disfiguring scars and permanent corneal lesions.
 

Treatment

No smallpox vaccines are authorized for use against monkeypox, however the third-generation smallpox vaccine Imvanex (Modified Vaccinia Ankara) has been authorized by the European Medicines Agency (EMA) for the EU market against smallpox and has demonstrated to provide protection in primates.

Old-generation smallpox vaccines have significant side effects, are no longer authorized, and should no longer be used. It is also important to note the lack of safety data for the use of Imvanex in immunocompromised people.

For this reason, National Immunization Technical Advisory Groups have been asked to develop specific guidelines for vaccination in close contacts of patients with monkeypox. The use of a smallpox vaccine for preexposure prophylaxis cannot be considered now, when taking into account the risk-benefit ratio.

In regard to treatment, tecovirimat is the only antiviral drug with an EMA-authorized indication for orthopoxvirus infection.

Brincidofovir is not authorized in the EU but has been authorized by the US Food and Drug Administration. However, availability on the European market is limited somewhat by the number of doses.

According to the ECDC, health care authorities should provide information about which groups should have priority access to treatment.

The use of antivirals for postexposure prophylaxis should be investigated further. Cidofovir is active in vitro for smallpox but has a pronounced nephrotoxicity profile that makes it unsuitable for first-line treatment.

The ECDC document also proposes an interim case definition for epidemiologic reporting. Further indications will also be provided for the management of monkeypox cases and close contacts. Those infected should remain in isolation until the scabs have fallen off and should, above all, avoid close contact with at-risk or immunosuppressed people as well as pets.

Most infected people can remain at home with supportive care.
 

Prevention

Close contacts for cases of monkeypox should monitor the development of their symptoms until 21 days have passed from their most recent exposure to the virus.

Health care workers should wear appropriate PPE (gloves, water-resistant gowns, FFP2 masks) during screening for suspected cases or when working with confirmed cases. Laboratory staff should also take precautions to avoid exposure in the workplace.

Close contacts of an infected person should not donate blood, organs, or bone marrow for at least 21 days from the last day of exposure.

Finally, the ECDC recommends increasing proactive communication of the risks to increase awareness and provide updates and indications to individuals who are at a greater risk, as well as to the general public. These messages should highlight that monkeypox is spread through close person-to-person contact, especially within the family unit, and also potentially through sexual intercourse. A balance, however, should be maintained between informing the individuals who are at greater risk and communicating that the virus is not easily spread and that the risk for the general population is low.
 

Human-to-animal transmission

A potential risk for human-to-animal transmission exists in Europe; therefore, a close collaboration is required between human and veterinary health care authorities, working together to manage domestic animals exposed to the virus and to prevent transmission of the disease to wildlife. To date, the European Food Safety Authority is not aware of any reports of animal infections (domestic or wild) within the EU.

There are still many unknown factors about this outbreak. The ECDC continues to closely monitor any developments and will update the risk assessment as soon as new data and information become available.

If human-to-animal transmission occurs and the virus spreads among animal populations, there is a risk that the disease could become an endemic in Europe. Therefore, human and veterinary health care authorities should work together closely to manage cases of domestic animals exposed to the virus and prevent transmission of the disease to wildlife.

A version of this article appeared on Medscape.com. This article was translated from Univadis Italy.

In a new risk-assessment document, the European Centre for Disease Prevention and Control summarizes what we currently know about monkeypox and recommends that European countries focus on the identification and management of the disease as well as contract tracing and prompt reporting of new cases of the virus.

Recent developments

From May 15 to May 23, in eight European Union member states (Belgium, France, Germany, Italy, the Netherlands, Portugal, Spain, and Sweden) a total of 85 cases of monkeypox were reported; they were acquired through autochthonous transmission. Current diagnosed cases of monkeypox have mainly been recorded in men who have sexual relations with other men, suggesting that transmission may occur during sexual intercourse, through infectious material coming into contact with mucosa or damaged skin, or via large respiratory droplets during prolonged face-to-face contact.

Andrea Ammon, MD, director of the ECDC, stated that “most current cases have presented with mild symptoms of the disease, and for the general population, the chance of diffusion is very low. However, the likelihood of a further spread of the virus through close contact, for example during sexual activities among people with multiple sexual partners, is considerably increased.”

Stella Kyriakides, European commissioner for health and food safety, added, “I am worried about the increase of cases of monkeypox in the EU and worldwide. We are currently monitoring the situation and, although, at the moment, the probability of it spreading to the general population is low, the situation is evolving. We should all remain alert, making sure that contact tracing and a sufficient diagnostic capacity are in place and guarantee that vaccines and antiviral drugs are available, as well as sufficient personal protective equipment [PPE] for health care professionals.”
 

Routes of transmission

Monkeypox is not easily spread among people. Person-to-person transmission occurs through close contact with infectious material, coming from skin lesions of an infected person, through air droplets in the case of prolonged face-to-face contact, and through fomites. So far, diagnosed cases suggest that transmission can occur through sexual intercourse.

The incubation period is 5-21 days, and patients are symptomatic for 2-4 weeks.

According to the ECDC, the likelihood of this infection spreading is increased among people who have more than one sexual partner. Although most current cases present with mild symptoms, monkeypox can cause severe disease in some groups (such as young children, pregnant women, and immunosuppressed people). However, the probability of severe disease cannot yet be estimated precisely.

The overall risk is considered moderate for people who have multiple sexual partners and low for the general population.
 

Clinical course

The disease initially presents with fever, myalgia, fatigue, and headache. Within 3 days of the onset of the prodromal symptoms, a centrifugal maculopapular rash appears on the site of primary infection and rapidly spreads to other parts of the body. The palms of the hands and bottoms of the feet are involved in cases where the rash has spread, which is a characteristic of the disease. Usually within 12 days, the lesions progress, simultaneously changing from macules to papules, blisters, pustules, and scabs before falling off. The lesions may have a central depression and be extremely itchy.

If the patient scratches them, a secondary bacterial infection may take hold (for which treatment with oral antihistamines is indicated). Lesions may also be present in the oral or ocular mucous membrane. Either before or at the same time as onset of the rash, patients may experience swelling of the lymph nodes, which usually is not seen with smallpox or chickenpox.

The onset of the rash is considered the start of the infectious period; however, people with prodromal symptoms may also transmit the virus.

Most cases in people present with mild or moderate symptoms. Complications seen in endemic countries include encephalitis, secondary bacterial skin infections, dehydration, conjunctivitis, keratitis, and pneumonia. The death rate ranges from 0% to 11% in endemic areas, with fatalities from the disease mostly occurring in younger children.

There is not a lot of information available on the disease in immunosuppressed individuals. In the 2017 Nigerian epidemic, patients with a concomitant HIV infection presented with more severe disease, with a greater number of skin lesions and genital ulcers, compared with HIV-negative individuals. No deaths were reported among seropositive patients. The main sequelae from the disease are usually disfiguring scars and permanent corneal lesions.
 

Treatment

No smallpox vaccines are authorized for use against monkeypox, however the third-generation smallpox vaccine Imvanex (Modified Vaccinia Ankara) has been authorized by the European Medicines Agency (EMA) for the EU market against smallpox and has demonstrated to provide protection in primates.

Old-generation smallpox vaccines have significant side effects, are no longer authorized, and should no longer be used. It is also important to note the lack of safety data for the use of Imvanex in immunocompromised people.

For this reason, National Immunization Technical Advisory Groups have been asked to develop specific guidelines for vaccination in close contacts of patients with monkeypox. The use of a smallpox vaccine for preexposure prophylaxis cannot be considered now, when taking into account the risk-benefit ratio.

In regard to treatment, tecovirimat is the only antiviral drug with an EMA-authorized indication for orthopoxvirus infection.

Brincidofovir is not authorized in the EU but has been authorized by the US Food and Drug Administration. However, availability on the European market is limited somewhat by the number of doses.

According to the ECDC, health care authorities should provide information about which groups should have priority access to treatment.

The use of antivirals for postexposure prophylaxis should be investigated further. Cidofovir is active in vitro for smallpox but has a pronounced nephrotoxicity profile that makes it unsuitable for first-line treatment.

The ECDC document also proposes an interim case definition for epidemiologic reporting. Further indications will also be provided for the management of monkeypox cases and close contacts. Those infected should remain in isolation until the scabs have fallen off and should, above all, avoid close contact with at-risk or immunosuppressed people as well as pets.

Most infected people can remain at home with supportive care.
 

Prevention

Close contacts for cases of monkeypox should monitor the development of their symptoms until 21 days have passed from their most recent exposure to the virus.

Health care workers should wear appropriate PPE (gloves, water-resistant gowns, FFP2 masks) during screening for suspected cases or when working with confirmed cases. Laboratory staff should also take precautions to avoid exposure in the workplace.

Close contacts of an infected person should not donate blood, organs, or bone marrow for at least 21 days from the last day of exposure.

Finally, the ECDC recommends increasing proactive communication of the risks to increase awareness and provide updates and indications to individuals who are at a greater risk, as well as to the general public. These messages should highlight that monkeypox is spread through close person-to-person contact, especially within the family unit, and also potentially through sexual intercourse. A balance, however, should be maintained between informing the individuals who are at greater risk and communicating that the virus is not easily spread and that the risk for the general population is low.
 

Human-to-animal transmission

A potential risk for human-to-animal transmission exists in Europe; therefore, a close collaboration is required between human and veterinary health care authorities, working together to manage domestic animals exposed to the virus and to prevent transmission of the disease to wildlife. To date, the European Food Safety Authority is not aware of any reports of animal infections (domestic or wild) within the EU.

There are still many unknown factors about this outbreak. The ECDC continues to closely monitor any developments and will update the risk assessment as soon as new data and information become available.

If human-to-animal transmission occurs and the virus spreads among animal populations, there is a risk that the disease could become an endemic in Europe. Therefore, human and veterinary health care authorities should work together closely to manage cases of domestic animals exposed to the virus and prevent transmission of the disease to wildlife.

A version of this article appeared on Medscape.com. This article was translated from Univadis Italy.

In a new risk-assessment document, the European Centre for Disease Prevention and Control summarizes what we currently know about monkeypox and recommends that European countries focus on the identification and management of the disease as well as contract tracing and prompt reporting of new cases of the virus.

Recent developments

From May 15 to May 23, in eight European Union member states (Belgium, France, Germany, Italy, the Netherlands, Portugal, Spain, and Sweden) a total of 85 cases of monkeypox were reported; they were acquired through autochthonous transmission. Current diagnosed cases of monkeypox have mainly been recorded in men who have sexual relations with other men, suggesting that transmission may occur during sexual intercourse, through infectious material coming into contact with mucosa or damaged skin, or via large respiratory droplets during prolonged face-to-face contact.

Andrea Ammon, MD, director of the ECDC, stated that “most current cases have presented with mild symptoms of the disease, and for the general population, the chance of diffusion is very low. However, the likelihood of a further spread of the virus through close contact, for example during sexual activities among people with multiple sexual partners, is considerably increased.”

Stella Kyriakides, European commissioner for health and food safety, added, “I am worried about the increase of cases of monkeypox in the EU and worldwide. We are currently monitoring the situation and, although, at the moment, the probability of it spreading to the general population is low, the situation is evolving. We should all remain alert, making sure that contact tracing and a sufficient diagnostic capacity are in place and guarantee that vaccines and antiviral drugs are available, as well as sufficient personal protective equipment [PPE] for health care professionals.”
 

Routes of transmission

Monkeypox is not easily spread among people. Person-to-person transmission occurs through close contact with infectious material, coming from skin lesions of an infected person, through air droplets in the case of prolonged face-to-face contact, and through fomites. So far, diagnosed cases suggest that transmission can occur through sexual intercourse.

The incubation period is 5-21 days, and patients are symptomatic for 2-4 weeks.

According to the ECDC, the likelihood of this infection spreading is increased among people who have more than one sexual partner. Although most current cases present with mild symptoms, monkeypox can cause severe disease in some groups (such as young children, pregnant women, and immunosuppressed people). However, the probability of severe disease cannot yet be estimated precisely.

The overall risk is considered moderate for people who have multiple sexual partners and low for the general population.
 

Clinical course

The disease initially presents with fever, myalgia, fatigue, and headache. Within 3 days of the onset of the prodromal symptoms, a centrifugal maculopapular rash appears on the site of primary infection and rapidly spreads to other parts of the body. The palms of the hands and bottoms of the feet are involved in cases where the rash has spread, which is a characteristic of the disease. Usually within 12 days, the lesions progress, simultaneously changing from macules to papules, blisters, pustules, and scabs before falling off. The lesions may have a central depression and be extremely itchy.

If the patient scratches them, a secondary bacterial infection may take hold (for which treatment with oral antihistamines is indicated). Lesions may also be present in the oral or ocular mucous membrane. Either before or at the same time as onset of the rash, patients may experience swelling of the lymph nodes, which usually is not seen with smallpox or chickenpox.

The onset of the rash is considered the start of the infectious period; however, people with prodromal symptoms may also transmit the virus.

Most cases in people present with mild or moderate symptoms. Complications seen in endemic countries include encephalitis, secondary bacterial skin infections, dehydration, conjunctivitis, keratitis, and pneumonia. The death rate ranges from 0% to 11% in endemic areas, with fatalities from the disease mostly occurring in younger children.

There is not a lot of information available on the disease in immunosuppressed individuals. In the 2017 Nigerian epidemic, patients with a concomitant HIV infection presented with more severe disease, with a greater number of skin lesions and genital ulcers, compared with HIV-negative individuals. No deaths were reported among seropositive patients. The main sequelae from the disease are usually disfiguring scars and permanent corneal lesions.
 

Treatment

No smallpox vaccines are authorized for use against monkeypox, however the third-generation smallpox vaccine Imvanex (Modified Vaccinia Ankara) has been authorized by the European Medicines Agency (EMA) for the EU market against smallpox and has demonstrated to provide protection in primates.

Old-generation smallpox vaccines have significant side effects, are no longer authorized, and should no longer be used. It is also important to note the lack of safety data for the use of Imvanex in immunocompromised people.

For this reason, National Immunization Technical Advisory Groups have been asked to develop specific guidelines for vaccination in close contacts of patients with monkeypox. The use of a smallpox vaccine for preexposure prophylaxis cannot be considered now, when taking into account the risk-benefit ratio.

In regard to treatment, tecovirimat is the only antiviral drug with an EMA-authorized indication for orthopoxvirus infection.

Brincidofovir is not authorized in the EU but has been authorized by the US Food and Drug Administration. However, availability on the European market is limited somewhat by the number of doses.

According to the ECDC, health care authorities should provide information about which groups should have priority access to treatment.

The use of antivirals for postexposure prophylaxis should be investigated further. Cidofovir is active in vitro for smallpox but has a pronounced nephrotoxicity profile that makes it unsuitable for first-line treatment.

The ECDC document also proposes an interim case definition for epidemiologic reporting. Further indications will also be provided for the management of monkeypox cases and close contacts. Those infected should remain in isolation until the scabs have fallen off and should, above all, avoid close contact with at-risk or immunosuppressed people as well as pets.

Most infected people can remain at home with supportive care.
 

Prevention

Close contacts for cases of monkeypox should monitor the development of their symptoms until 21 days have passed from their most recent exposure to the virus.

Health care workers should wear appropriate PPE (gloves, water-resistant gowns, FFP2 masks) during screening for suspected cases or when working with confirmed cases. Laboratory staff should also take precautions to avoid exposure in the workplace.

Close contacts of an infected person should not donate blood, organs, or bone marrow for at least 21 days from the last day of exposure.

Finally, the ECDC recommends increasing proactive communication of the risks to increase awareness and provide updates and indications to individuals who are at a greater risk, as well as to the general public. These messages should highlight that monkeypox is spread through close person-to-person contact, especially within the family unit, and also potentially through sexual intercourse. A balance, however, should be maintained between informing the individuals who are at greater risk and communicating that the virus is not easily spread and that the risk for the general population is low.
 

Human-to-animal transmission

A potential risk for human-to-animal transmission exists in Europe; therefore, a close collaboration is required between human and veterinary health care authorities, working together to manage domestic animals exposed to the virus and to prevent transmission of the disease to wildlife. To date, the European Food Safety Authority is not aware of any reports of animal infections (domestic or wild) within the EU.

There are still many unknown factors about this outbreak. The ECDC continues to closely monitor any developments and will update the risk assessment as soon as new data and information become available.

If human-to-animal transmission occurs and the virus spreads among animal populations, there is a risk that the disease could become an endemic in Europe. Therefore, human and veterinary health care authorities should work together closely to manage cases of domestic animals exposed to the virus and prevent transmission of the disease to wildlife.

A version of this article appeared on Medscape.com. This article was translated from Univadis Italy.

The FDA has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, which clears the way for approval and distribution in June.

Pfizer announced June 1 that it completed the application for a three-dose vaccine for kids between 6 months and 5 years old, and the FDA said it received the emergency use application.

Children in this age group – the last to be eligible for COVID-19 vaccines – could begin getting shots as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.

Meanwhile, COVID-19 cases are still high – an average of 100,000 cases a day – but death numbers are about 90% lower than they were when President Joe Biden first took office, Dr. Jha said. 

The FDA’s advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet June 14 and June 15 to discuss data submitted by both Pfizer and Moderna.  

If the FDA gives them the green light, the CDC will then weigh in.

“We know that many, many parents are eager to vaccinate their youngest kids, and it’s important to do this right,” Dr. Jha said at a White House press briefing on June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”

States can place their orders as early as June 3, Dr. Jha said, and there will initially be 10 million doses available. If the FDA gives emergency use authorization for the vaccines, the government will begin shipping doses to thousands of sites across the country.

“The good news is we have plenty of supply of Pfizer and Moderna vaccines,” Dr. Jha said. “We’ve asked states to distribute to their highest priority sites, serving the highest risk and hardest to reach areas.”

Pfizer’s clinical trials found that three doses of the vaccine for children 6 months to under 5 years were safe and effective and proved to be 80% effective against Omicron.

The FDA announced its meeting information with a conversation about the Moderna vaccine for ages 6-17 scheduled for June 14 and a conversation about the Pfizer and Moderna vaccines for young children scheduled for June 15.

Moderna applied for FDA authorization of its two-dose vaccine for children under age 6 on April 28. The company said the vaccine was 51% effective against infections with symptoms for children ages 6 months to 2 years and 37% effective for ages 2-5.

Pfizer’s 3-microgram dose is one-tenth of its adult dose. Moderna’s 25-microgram dose is one-quarter of its adult dose.

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

The FDA has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, which clears the way for approval and distribution in June.

Pfizer announced June 1 that it completed the application for a three-dose vaccine for kids between 6 months and 5 years old, and the FDA said it received the emergency use application.

Children in this age group – the last to be eligible for COVID-19 vaccines – could begin getting shots as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.

Meanwhile, COVID-19 cases are still high – an average of 100,000 cases a day – but death numbers are about 90% lower than they were when President Joe Biden first took office, Dr. Jha said. 

The FDA’s advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet June 14 and June 15 to discuss data submitted by both Pfizer and Moderna.  

If the FDA gives them the green light, the CDC will then weigh in.

“We know that many, many parents are eager to vaccinate their youngest kids, and it’s important to do this right,” Dr. Jha said at a White House press briefing on June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”

States can place their orders as early as June 3, Dr. Jha said, and there will initially be 10 million doses available. If the FDA gives emergency use authorization for the vaccines, the government will begin shipping doses to thousands of sites across the country.

“The good news is we have plenty of supply of Pfizer and Moderna vaccines,” Dr. Jha said. “We’ve asked states to distribute to their highest priority sites, serving the highest risk and hardest to reach areas.”

Pfizer’s clinical trials found that three doses of the vaccine for children 6 months to under 5 years were safe and effective and proved to be 80% effective against Omicron.

The FDA announced its meeting information with a conversation about the Moderna vaccine for ages 6-17 scheduled for June 14 and a conversation about the Pfizer and Moderna vaccines for young children scheduled for June 15.

Moderna applied for FDA authorization of its two-dose vaccine for children under age 6 on April 28. The company said the vaccine was 51% effective against infections with symptoms for children ages 6 months to 2 years and 37% effective for ages 2-5.

Pfizer’s 3-microgram dose is one-tenth of its adult dose. Moderna’s 25-microgram dose is one-quarter of its adult dose.

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

The FDA has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, which clears the way for approval and distribution in June.

Pfizer announced June 1 that it completed the application for a three-dose vaccine for kids between 6 months and 5 years old, and the FDA said it received the emergency use application.

Children in this age group – the last to be eligible for COVID-19 vaccines – could begin getting shots as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.

Meanwhile, COVID-19 cases are still high – an average of 100,000 cases a day – but death numbers are about 90% lower than they were when President Joe Biden first took office, Dr. Jha said. 

The FDA’s advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet June 14 and June 15 to discuss data submitted by both Pfizer and Moderna.  

If the FDA gives them the green light, the CDC will then weigh in.

“We know that many, many parents are eager to vaccinate their youngest kids, and it’s important to do this right,” Dr. Jha said at a White House press briefing on June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”

States can place their orders as early as June 3, Dr. Jha said, and there will initially be 10 million doses available. If the FDA gives emergency use authorization for the vaccines, the government will begin shipping doses to thousands of sites across the country.

“The good news is we have plenty of supply of Pfizer and Moderna vaccines,” Dr. Jha said. “We’ve asked states to distribute to their highest priority sites, serving the highest risk and hardest to reach areas.”

Pfizer’s clinical trials found that three doses of the vaccine for children 6 months to under 5 years were safe and effective and proved to be 80% effective against Omicron.

The FDA announced its meeting information with a conversation about the Moderna vaccine for ages 6-17 scheduled for June 14 and a conversation about the Pfizer and Moderna vaccines for young children scheduled for June 15.

Moderna applied for FDA authorization of its two-dose vaccine for children under age 6 on April 28. The company said the vaccine was 51% effective against infections with symptoms for children ages 6 months to 2 years and 37% effective for ages 2-5.

Pfizer’s 3-microgram dose is one-tenth of its adult dose. Moderna’s 25-microgram dose is one-quarter of its adult dose.

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

Patients coinfected with hepatitis B virus (HBV) and human immunodeficiency virus who take tenofovir disoproxil fumarate (TDF) may have worsening renal function and bone turnover, according to a small, prospective cohort study in HIV Medicine.

“In this HBV-HIV cohort of adults with high prevalence of tenofovir use, several biomarkers of renal function and bone turnover indicated worsening status over approximately 4 years, highlighting the importance of clinicians’ awareness,” lead author Richard K. Sterling, MD, MSc, assistant chair of research in the department of internal medicine of Virginia Commonwealth University, Richmond, told this news organization in an email.

TDF is a common component of antiretroviral therapy (ART) in adults coinfected with HBV and HIV. The drug is known to adversely affect kidney function and bone turnover, but few studies have evaluated these issues, the authors write.

Dr. Sterling and colleagues enrolled adults coinfected with HBV and HIV who were taking any type of ART in their study at eight sites in North America.

The authors assessed demographics, medical history, current health status reports, physical exams, and blood and urine tests. They extracted clinical, laboratory, and radiologic data from medical records, and they processed whole blood, stored serum at -70 °C (-94 °F) at each site, and tested specimens in central laboratories.

The researchers assessed the participants at baseline and every 24 weeks for up to 192 weeks (3.7 years). They tested bone markers from stored serum at baseline, week 96, and week 192. And they recorded changes in renal function markers and bone turnover over time.

At baseline, the median age of the 115 patients was 49 years; 91% were male, and 52% were non-Hispanic Black. Their median body mass index was 26 kg/m², with 6.3% of participants underweight and 59% overweight or obese. The participants had been living with HIV for a median of about 20 years.

Overall, 84% of participants reported tenofovir use, 3% reported no HBV therapy, and 80% had HBV/HIV suppression. In addition, 13% had stage 2 liver fibrosis and 23% had stage 3 to 4 liver fibrosis. No participants reported using immunosuppressants, 4% reported using an anticoagulant, 3% reported taking calcium plus vitamin D, and 33% reported taking multivitamins.

Throughout the follow-up period, TDF use ranged from 80% to 92%. Estimated glomerular filtration rate (eGFR) dropped from 87.1 to 79.9 ml/min/1.73m² over 192 weeks (P < .001); but eGFR prevalence < 60 ml/min/1.73m² did not appear to change over time (always < 16%; P = .43).

From baseline to week 192, procollagen type 1 N-terminal propeptide (P1NP) dropped from 146.7 to 130.5 ng/ml (P = .001), osteocalcin dropped from 14.4 to 10.2 ng/ml (P < .001), and C-terminal telopeptides of type I collagen (CTX-1) dropped from 373 to 273 pg/ml (P < .001).

Predictors of decrease in eGFR included younger age, male sex, and overweight or obesity. Predictors of worsening bone turnover included Black race, healthy weight, advanced fibrosis, undetectable HBV DNA, and lower parathyroid hormone level.
 

Monitor patients with HBV and HIV closely

“The long-term effects of TDF on renal and bone health are important to monitor,” Dr. Sterling advised. “For renal health, physicians should monitor GFR as well as creatinine. For bone health, monitoring serum calcium, vitamin D, parathyroid hormone, and phosphate may not catch increased bone turnover.”

“We knew that TDF can cause renal dysfunction; however, we were surprised that we did not observe significant rise in serum creatinine but did observe decline in glomerular filtration rate and several markers of increased bone turnover,” he added.

Dr. Sterling acknowledged that limitations of the study include its small cohort, short follow-up, and lack of control participants who were taking TDF while mono-infected with either HBV or HIV. He added that strengths include close follow-up, use of bone turnover markers, and control for severity of liver disease.

Joseph Alvarnas, MD, a hematologist and oncologist in the department of hematology & hematopoietic cell transplant at City of Hope Comprehensive Cancer Center, Duarte, California, told this news organization that he welcomes the rigor of the study. “This study provides an important reminder of the complexities of taking a comprehensive management approach to the care of patients with long-term HIV infection,” Dr. Alvarnas wrote in an email. He was not involved in the study.

“More than 6 million people worldwide live with coinfection,” he added. “Patients coinfected with HBV and HIV have additional care needs over those living with only chronic HIV infection. With more HIV-infected patients becoming long-term survivors who are managed through the use of effective ART, fully understanding the differentiated long-term care needs of this population is important.”

Debika Bhattacharya, MD, a specialist in HIV and viral hepatitis coinfection in the Division of Infectious Diseases at UCLA Health, Los Angeles, joined Dr. Sterling and Dr. Alvarnas in advising clinicians to regularly evaluate the kidney and bone health of their coinfected patients.

“While this study focuses the very common antiretroviral agent TDF, it will be important to see the impact of a similar drug, tenofovir alafenamide (TAF) – which has been associated with less impact on bone and kidney health – on clinical outcomes in HBV-HIV coinfection,” Dr. Bhattacharya, who also was not involved in the study, wrote in an email.

The National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. Sterling has served on boards for Pfizer and AskBio, and he reports research grants from Gilead, Abbott, AbbVie, and Roche to his institution. Most other authors report financial relationships with pharmaceutical companies. Dr. Alvarnas reports no relevant financial relationships. Dr. Bhattacharya has received a research grant from Gilead Sciences, paid to her institution.

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

Patients coinfected with hepatitis B virus (HBV) and human immunodeficiency virus who take tenofovir disoproxil fumarate (TDF) may have worsening renal function and bone turnover, according to a small, prospective cohort study in HIV Medicine.

“In this HBV-HIV cohort of adults with high prevalence of tenofovir use, several biomarkers of renal function and bone turnover indicated worsening status over approximately 4 years, highlighting the importance of clinicians’ awareness,” lead author Richard K. Sterling, MD, MSc, assistant chair of research in the department of internal medicine of Virginia Commonwealth University, Richmond, told this news organization in an email.

TDF is a common component of antiretroviral therapy (ART) in adults coinfected with HBV and HIV. The drug is known to adversely affect kidney function and bone turnover, but few studies have evaluated these issues, the authors write.

Dr. Sterling and colleagues enrolled adults coinfected with HBV and HIV who were taking any type of ART in their study at eight sites in North America.

The authors assessed demographics, medical history, current health status reports, physical exams, and blood and urine tests. They extracted clinical, laboratory, and radiologic data from medical records, and they processed whole blood, stored serum at -70 °C (-94 °F) at each site, and tested specimens in central laboratories.

The researchers assessed the participants at baseline and every 24 weeks for up to 192 weeks (3.7 years). They tested bone markers from stored serum at baseline, week 96, and week 192. And they recorded changes in renal function markers and bone turnover over time.

At baseline, the median age of the 115 patients was 49 years; 91% were male, and 52% were non-Hispanic Black. Their median body mass index was 26 kg/m², with 6.3% of participants underweight and 59% overweight or obese. The participants had been living with HIV for a median of about 20 years.

Overall, 84% of participants reported tenofovir use, 3% reported no HBV therapy, and 80% had HBV/HIV suppression. In addition, 13% had stage 2 liver fibrosis and 23% had stage 3 to 4 liver fibrosis. No participants reported using immunosuppressants, 4% reported using an anticoagulant, 3% reported taking calcium plus vitamin D, and 33% reported taking multivitamins.

Throughout the follow-up period, TDF use ranged from 80% to 92%. Estimated glomerular filtration rate (eGFR) dropped from 87.1 to 79.9 ml/min/1.73m² over 192 weeks (P < .001); but eGFR prevalence < 60 ml/min/1.73m² did not appear to change over time (always < 16%; P = .43).

From baseline to week 192, procollagen type 1 N-terminal propeptide (P1NP) dropped from 146.7 to 130.5 ng/ml (P = .001), osteocalcin dropped from 14.4 to 10.2 ng/ml (P < .001), and C-terminal telopeptides of type I collagen (CTX-1) dropped from 373 to 273 pg/ml (P < .001).

Predictors of decrease in eGFR included younger age, male sex, and overweight or obesity. Predictors of worsening bone turnover included Black race, healthy weight, advanced fibrosis, undetectable HBV DNA, and lower parathyroid hormone level.
 

Monitor patients with HBV and HIV closely

“The long-term effects of TDF on renal and bone health are important to monitor,” Dr. Sterling advised. “For renal health, physicians should monitor GFR as well as creatinine. For bone health, monitoring serum calcium, vitamin D, parathyroid hormone, and phosphate may not catch increased bone turnover.”

“We knew that TDF can cause renal dysfunction; however, we were surprised that we did not observe significant rise in serum creatinine but did observe decline in glomerular filtration rate and several markers of increased bone turnover,” he added.

Dr. Sterling acknowledged that limitations of the study include its small cohort, short follow-up, and lack of control participants who were taking TDF while mono-infected with either HBV or HIV. He added that strengths include close follow-up, use of bone turnover markers, and control for severity of liver disease.

Joseph Alvarnas, MD, a hematologist and oncologist in the department of hematology & hematopoietic cell transplant at City of Hope Comprehensive Cancer Center, Duarte, California, told this news organization that he welcomes the rigor of the study. “This study provides an important reminder of the complexities of taking a comprehensive management approach to the care of patients with long-term HIV infection,” Dr. Alvarnas wrote in an email. He was not involved in the study.

“More than 6 million people worldwide live with coinfection,” he added. “Patients coinfected with HBV and HIV have additional care needs over those living with only chronic HIV infection. With more HIV-infected patients becoming long-term survivors who are managed through the use of effective ART, fully understanding the differentiated long-term care needs of this population is important.”

Debika Bhattacharya, MD, a specialist in HIV and viral hepatitis coinfection in the Division of Infectious Diseases at UCLA Health, Los Angeles, joined Dr. Sterling and Dr. Alvarnas in advising clinicians to regularly evaluate the kidney and bone health of their coinfected patients.

“While this study focuses the very common antiretroviral agent TDF, it will be important to see the impact of a similar drug, tenofovir alafenamide (TAF) – which has been associated with less impact on bone and kidney health – on clinical outcomes in HBV-HIV coinfection,” Dr. Bhattacharya, who also was not involved in the study, wrote in an email.

The National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. Sterling has served on boards for Pfizer and AskBio, and he reports research grants from Gilead, Abbott, AbbVie, and Roche to his institution. Most other authors report financial relationships with pharmaceutical companies. Dr. Alvarnas reports no relevant financial relationships. Dr. Bhattacharya has received a research grant from Gilead Sciences, paid to her institution.

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

Patients coinfected with hepatitis B virus (HBV) and human immunodeficiency virus who take tenofovir disoproxil fumarate (TDF) may have worsening renal function and bone turnover, according to a small, prospective cohort study in HIV Medicine.

“In this HBV-HIV cohort of adults with high prevalence of tenofovir use, several biomarkers of renal function and bone turnover indicated worsening status over approximately 4 years, highlighting the importance of clinicians’ awareness,” lead author Richard K. Sterling, MD, MSc, assistant chair of research in the department of internal medicine of Virginia Commonwealth University, Richmond, told this news organization in an email.

TDF is a common component of antiretroviral therapy (ART) in adults coinfected with HBV and HIV. The drug is known to adversely affect kidney function and bone turnover, but few studies have evaluated these issues, the authors write.

Dr. Sterling and colleagues enrolled adults coinfected with HBV and HIV who were taking any type of ART in their study at eight sites in North America.

The authors assessed demographics, medical history, current health status reports, physical exams, and blood and urine tests. They extracted clinical, laboratory, and radiologic data from medical records, and they processed whole blood, stored serum at -70 °C (-94 °F) at each site, and tested specimens in central laboratories.

The researchers assessed the participants at baseline and every 24 weeks for up to 192 weeks (3.7 years). They tested bone markers from stored serum at baseline, week 96, and week 192. And they recorded changes in renal function markers and bone turnover over time.

At baseline, the median age of the 115 patients was 49 years; 91% were male, and 52% were non-Hispanic Black. Their median body mass index was 26 kg/m², with 6.3% of participants underweight and 59% overweight or obese. The participants had been living with HIV for a median of about 20 years.

Overall, 84% of participants reported tenofovir use, 3% reported no HBV therapy, and 80% had HBV/HIV suppression. In addition, 13% had stage 2 liver fibrosis and 23% had stage 3 to 4 liver fibrosis. No participants reported using immunosuppressants, 4% reported using an anticoagulant, 3% reported taking calcium plus vitamin D, and 33% reported taking multivitamins.

Throughout the follow-up period, TDF use ranged from 80% to 92%. Estimated glomerular filtration rate (eGFR) dropped from 87.1 to 79.9 ml/min/1.73m² over 192 weeks (P < .001); but eGFR prevalence < 60 ml/min/1.73m² did not appear to change over time (always < 16%; P = .43).

From baseline to week 192, procollagen type 1 N-terminal propeptide (P1NP) dropped from 146.7 to 130.5 ng/ml (P = .001), osteocalcin dropped from 14.4 to 10.2 ng/ml (P < .001), and C-terminal telopeptides of type I collagen (CTX-1) dropped from 373 to 273 pg/ml (P < .001).

Predictors of decrease in eGFR included younger age, male sex, and overweight or obesity. Predictors of worsening bone turnover included Black race, healthy weight, advanced fibrosis, undetectable HBV DNA, and lower parathyroid hormone level.
 

Monitor patients with HBV and HIV closely

“The long-term effects of TDF on renal and bone health are important to monitor,” Dr. Sterling advised. “For renal health, physicians should monitor GFR as well as creatinine. For bone health, monitoring serum calcium, vitamin D, parathyroid hormone, and phosphate may not catch increased bone turnover.”

“We knew that TDF can cause renal dysfunction; however, we were surprised that we did not observe significant rise in serum creatinine but did observe decline in glomerular filtration rate and several markers of increased bone turnover,” he added.

Dr. Sterling acknowledged that limitations of the study include its small cohort, short follow-up, and lack of control participants who were taking TDF while mono-infected with either HBV or HIV. He added that strengths include close follow-up, use of bone turnover markers, and control for severity of liver disease.

Joseph Alvarnas, MD, a hematologist and oncologist in the department of hematology & hematopoietic cell transplant at City of Hope Comprehensive Cancer Center, Duarte, California, told this news organization that he welcomes the rigor of the study. “This study provides an important reminder of the complexities of taking a comprehensive management approach to the care of patients with long-term HIV infection,” Dr. Alvarnas wrote in an email. He was not involved in the study.

“More than 6 million people worldwide live with coinfection,” he added. “Patients coinfected with HBV and HIV have additional care needs over those living with only chronic HIV infection. With more HIV-infected patients becoming long-term survivors who are managed through the use of effective ART, fully understanding the differentiated long-term care needs of this population is important.”

Debika Bhattacharya, MD, a specialist in HIV and viral hepatitis coinfection in the Division of Infectious Diseases at UCLA Health, Los Angeles, joined Dr. Sterling and Dr. Alvarnas in advising clinicians to regularly evaluate the kidney and bone health of their coinfected patients.

“While this study focuses the very common antiretroviral agent TDF, it will be important to see the impact of a similar drug, tenofovir alafenamide (TAF) – which has been associated with less impact on bone and kidney health – on clinical outcomes in HBV-HIV coinfection,” Dr. Bhattacharya, who also was not involved in the study, wrote in an email.

The National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. Sterling has served on boards for Pfizer and AskBio, and he reports research grants from Gilead, Abbott, AbbVie, and Roche to his institution. Most other authors report financial relationships with pharmaceutical companies. Dr. Alvarnas reports no relevant financial relationships. Dr. Bhattacharya has received a research grant from Gilead Sciences, paid to her institution.

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