HIV: failed viral suppression in CAB/RPV linked to three risk factors

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Tue, 07/27/2021 - 11:21

 

A body mass index (BMI) of at least 30 kg/m2, rilpivirine resistance–associated mutations, and the HIV-1 subtype A6/A1 can raise a person’s risk for confirmed virologic failure (CVF) of long-acting cabotegravir (CAB) and rilpivirine (RPV) therapy, new research suggests. A combination of at least two of these factors was necessary to increase risk.

Long-acting CAB/RPV (Cabenuva) is a Food and Drug Administration–approved antiretroviral therapy that is administered intramuscularly on a monthly basis. Although CVF was rare in all three clinical trials of the drug regimen, understanding the factors that may predispose patients to this outcome is necessary, the authors wrote. “This information will help inform clinicians and patients, allowing them to assess the potential benefits and risks of this novel long-acting therapy.” The results were published July 15, 2021, in AIDS.

In the study, researchers pooled the clinical data from the FLAIR, ATLAS, and ATLAS-2M trials for long-acting CAB/RPV. Using these data, they examined whether participant factors such as sex, body weight, resistance mutations, and dosing regimen influenced risk for CVF using a multivariable analysis.

Of the 1,039 participants included in the analysis, 13 (1.3%) experienced CVF; 272 participants (26%) in the study population had at least one of the three risk factors, but no single variable raised risk on its own.

“When we looked at the presence of only one baseline factor, it was no different than having no baseline factors,” Bill Spreen, PharmD, an author of the study, said in an interview. Dr. Spreen is the medicine development leader for cabotegravir at ViiV Healthcare, in Research Triangle Park, N.C. CVF rates for participants with no risk factors and those with only one risk factor were 0.4%.

In comparison, CVF occurred in 9 of the 35 participants (25.7%) who had at least two risk factors, and the 1 participant who had all three risk factors also experienced CVF. The HIV subtype A1/A6, a subtype largely limited to Russia, together with a BMI greater than 30 was the most common combination, occurring in 21 individuals. Ten participants had both RPV resistance mutations and a BMI greater than 30, and only three had HIV subtype A1/A6 and RPV resistance mutations.

“The higher the BMI, typically, the lower the absorption rate of the drug, so it was not surprising to see that come out,” Dr. Spreen said. Previous research has associated subtype A1/A6 with L74I polymorphism, which may lower the barrier to resistance to integrase strand transfer inhibitors such as CAB. In the current study, researchers found that the L74I polymorphism mutation was not associated with CVF, in particular among those individuals with non-A1/A6 subtypes.

Although A1/A6 was the most common risk factor in the study, testing patients for the subtype prior to initiating CAB/RPV is likely unnecessary in the United States, where the subtype is very rare, Susan Swindells, MBBS, an expert in HIV/AIDS therapeutics from the University of Nebraska Medical Center, Omaha, said in an interview. Dr. Swindells was not an author of this study but was involved in all three CAB/RPV clinical trials. The most common risk factors health care professionals will likely encounter are high BMI and resistance mutations.

In cases in which a patient may have both a high BMI and resistance mutations, Dr. Swindells would not recommend starting a CAB/RPV regimen “unless there was a very pressing reason to do it,” as, for example, in rare cases in which a patient can’t take medications orally. “It’s all a question of balancing the risk and benefit.”

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

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A body mass index (BMI) of at least 30 kg/m2, rilpivirine resistance–associated mutations, and the HIV-1 subtype A6/A1 can raise a person’s risk for confirmed virologic failure (CVF) of long-acting cabotegravir (CAB) and rilpivirine (RPV) therapy, new research suggests. A combination of at least two of these factors was necessary to increase risk.

Long-acting CAB/RPV (Cabenuva) is a Food and Drug Administration–approved antiretroviral therapy that is administered intramuscularly on a monthly basis. Although CVF was rare in all three clinical trials of the drug regimen, understanding the factors that may predispose patients to this outcome is necessary, the authors wrote. “This information will help inform clinicians and patients, allowing them to assess the potential benefits and risks of this novel long-acting therapy.” The results were published July 15, 2021, in AIDS.

In the study, researchers pooled the clinical data from the FLAIR, ATLAS, and ATLAS-2M trials for long-acting CAB/RPV. Using these data, they examined whether participant factors such as sex, body weight, resistance mutations, and dosing regimen influenced risk for CVF using a multivariable analysis.

Of the 1,039 participants included in the analysis, 13 (1.3%) experienced CVF; 272 participants (26%) in the study population had at least one of the three risk factors, but no single variable raised risk on its own.

“When we looked at the presence of only one baseline factor, it was no different than having no baseline factors,” Bill Spreen, PharmD, an author of the study, said in an interview. Dr. Spreen is the medicine development leader for cabotegravir at ViiV Healthcare, in Research Triangle Park, N.C. CVF rates for participants with no risk factors and those with only one risk factor were 0.4%.

In comparison, CVF occurred in 9 of the 35 participants (25.7%) who had at least two risk factors, and the 1 participant who had all three risk factors also experienced CVF. The HIV subtype A1/A6, a subtype largely limited to Russia, together with a BMI greater than 30 was the most common combination, occurring in 21 individuals. Ten participants had both RPV resistance mutations and a BMI greater than 30, and only three had HIV subtype A1/A6 and RPV resistance mutations.

“The higher the BMI, typically, the lower the absorption rate of the drug, so it was not surprising to see that come out,” Dr. Spreen said. Previous research has associated subtype A1/A6 with L74I polymorphism, which may lower the barrier to resistance to integrase strand transfer inhibitors such as CAB. In the current study, researchers found that the L74I polymorphism mutation was not associated with CVF, in particular among those individuals with non-A1/A6 subtypes.

Although A1/A6 was the most common risk factor in the study, testing patients for the subtype prior to initiating CAB/RPV is likely unnecessary in the United States, where the subtype is very rare, Susan Swindells, MBBS, an expert in HIV/AIDS therapeutics from the University of Nebraska Medical Center, Omaha, said in an interview. Dr. Swindells was not an author of this study but was involved in all three CAB/RPV clinical trials. The most common risk factors health care professionals will likely encounter are high BMI and resistance mutations.

In cases in which a patient may have both a high BMI and resistance mutations, Dr. Swindells would not recommend starting a CAB/RPV regimen “unless there was a very pressing reason to do it,” as, for example, in rare cases in which a patient can’t take medications orally. “It’s all a question of balancing the risk and benefit.”

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

 

A body mass index (BMI) of at least 30 kg/m2, rilpivirine resistance–associated mutations, and the HIV-1 subtype A6/A1 can raise a person’s risk for confirmed virologic failure (CVF) of long-acting cabotegravir (CAB) and rilpivirine (RPV) therapy, new research suggests. A combination of at least two of these factors was necessary to increase risk.

Long-acting CAB/RPV (Cabenuva) is a Food and Drug Administration–approved antiretroviral therapy that is administered intramuscularly on a monthly basis. Although CVF was rare in all three clinical trials of the drug regimen, understanding the factors that may predispose patients to this outcome is necessary, the authors wrote. “This information will help inform clinicians and patients, allowing them to assess the potential benefits and risks of this novel long-acting therapy.” The results were published July 15, 2021, in AIDS.

In the study, researchers pooled the clinical data from the FLAIR, ATLAS, and ATLAS-2M trials for long-acting CAB/RPV. Using these data, they examined whether participant factors such as sex, body weight, resistance mutations, and dosing regimen influenced risk for CVF using a multivariable analysis.

Of the 1,039 participants included in the analysis, 13 (1.3%) experienced CVF; 272 participants (26%) in the study population had at least one of the three risk factors, but no single variable raised risk on its own.

“When we looked at the presence of only one baseline factor, it was no different than having no baseline factors,” Bill Spreen, PharmD, an author of the study, said in an interview. Dr. Spreen is the medicine development leader for cabotegravir at ViiV Healthcare, in Research Triangle Park, N.C. CVF rates for participants with no risk factors and those with only one risk factor were 0.4%.

In comparison, CVF occurred in 9 of the 35 participants (25.7%) who had at least two risk factors, and the 1 participant who had all three risk factors also experienced CVF. The HIV subtype A1/A6, a subtype largely limited to Russia, together with a BMI greater than 30 was the most common combination, occurring in 21 individuals. Ten participants had both RPV resistance mutations and a BMI greater than 30, and only three had HIV subtype A1/A6 and RPV resistance mutations.

“The higher the BMI, typically, the lower the absorption rate of the drug, so it was not surprising to see that come out,” Dr. Spreen said. Previous research has associated subtype A1/A6 with L74I polymorphism, which may lower the barrier to resistance to integrase strand transfer inhibitors such as CAB. In the current study, researchers found that the L74I polymorphism mutation was not associated with CVF, in particular among those individuals with non-A1/A6 subtypes.

Although A1/A6 was the most common risk factor in the study, testing patients for the subtype prior to initiating CAB/RPV is likely unnecessary in the United States, where the subtype is very rare, Susan Swindells, MBBS, an expert in HIV/AIDS therapeutics from the University of Nebraska Medical Center, Omaha, said in an interview. Dr. Swindells was not an author of this study but was involved in all three CAB/RPV clinical trials. The most common risk factors health care professionals will likely encounter are high BMI and resistance mutations.

In cases in which a patient may have both a high BMI and resistance mutations, Dr. Swindells would not recommend starting a CAB/RPV regimen “unless there was a very pressing reason to do it,” as, for example, in rare cases in which a patient can’t take medications orally. “It’s all a question of balancing the risk and benefit.”

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

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CDC revamps STI treatment guidelines

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Tue, 07/27/2021 - 08:50

 

On July 22, the Centers for Disease Control and Prevention released updated sexually transmitted infection treatment guidelines to reflect current screening, testing, and treatment recommendations. The guidelines were last updated in 2015.

The new recommendations come at a pivotal moment in the field’s history, Kimberly Workowski, MD, a medical officer at the CDC’s Division of STD Prevention, told this news organization in an email. “The COVID-19 pandemic has caused decreased clinic capacity and drug and diagnostic test kit shortages,” she says. Many of these shortages have been resolved, she added, and it is important that health care professionals use the most current evidence-based recommendations for screening and management of STIs.

Updates to these guidelines were necessary to reflect “continued advances in research in the prevention of STIs, new interventions in terms of STI prevention, and thirdly, changing epidemiology,” Jeffrey Klausner, MD, MPH, an STI specialist with the Keck School of Medicine at the University of Southern California, Los Angeles, said in an interview. “There’s been increased concern about antimicrobial resistance, and that’s really driven some of the key changes in these new STI treatment guidelines.”

Notable updates to the guidelines include the following:

  • Updated treatment recommendations for gonorrhea, chlamydia, , and 
  • Two-step testing for diagnosing genital  virus
  • Expanded risk factors for  testing in pregnant women
  • Information on FDA-cleared rectal and oral tests to diagnose chlamydia and gonorrhea
  • A recommendation that universal  screening be conducted at least once in a lifetime for adults aged 18 years and older

Dr. Workowski emphasized updates to gonorrhea treatment that built on the recommendation published in December 2020 in Morbidity and Mortality Weekly Report. The CDC now recommends that gonorrhea be treated with a single 500-mg injection of ceftriaxone, and if chlamydial infection is not ruled out, treating with a regimen of 100 mg of oral doxycycline taken twice daily for 7 days. Other gonorrhea treatment recommendations include retesting patients 3 months after treatment and that a test of cure be conducted for people with pharyngeal gonorrhea 1 to 2 weeks after treatment, using either culture or nucleic-acid amplification tests.

“Effectively treating gonorrhea remains a public health priority,” Dr. Workowski said. “Gonorrhea can rapidly develop antibiotic resistance and is the second most commonly reported bacterial STI in the U.S., increasing 56% from 2015 to 2019.”

The updates to syphilis screening for pregnant women are also important, added Dr. Klausner. “We’ve seen a dramatic and shameful rise in congenital syphilis,” he said. In addition to screening all pregnant women at the first prenatal visit, the CDC recommends retesting for syphilis at 28 weeks’ gestation and at delivery if the mother lives in an area where the prevalence of syphilis is high or if she is at risk of acquiring syphilis during pregnancy. An expectant mother is at higher risk if she has multiple sex partners, has an STI during pregnancy, has a partner with an STI, has a new sex partner, or misuses drugs, the recommendations state.

Dr. Klausner also noted that the updates provide more robust guidelines for treating transgender individuals and incarcerated people.

The treatment guidelines are available online along with a wall chart and a pocket guide that summarizes these updates. The mobile app with the 2015 guidelines will be retired at the end of July 2021, Dr. Workowski said. An app with these updated treatment recommendations is in development and will be available later this year.

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

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On July 22, the Centers for Disease Control and Prevention released updated sexually transmitted infection treatment guidelines to reflect current screening, testing, and treatment recommendations. The guidelines were last updated in 2015.

The new recommendations come at a pivotal moment in the field’s history, Kimberly Workowski, MD, a medical officer at the CDC’s Division of STD Prevention, told this news organization in an email. “The COVID-19 pandemic has caused decreased clinic capacity and drug and diagnostic test kit shortages,” she says. Many of these shortages have been resolved, she added, and it is important that health care professionals use the most current evidence-based recommendations for screening and management of STIs.

Updates to these guidelines were necessary to reflect “continued advances in research in the prevention of STIs, new interventions in terms of STI prevention, and thirdly, changing epidemiology,” Jeffrey Klausner, MD, MPH, an STI specialist with the Keck School of Medicine at the University of Southern California, Los Angeles, said in an interview. “There’s been increased concern about antimicrobial resistance, and that’s really driven some of the key changes in these new STI treatment guidelines.”

Notable updates to the guidelines include the following:

  • Updated treatment recommendations for gonorrhea, chlamydia, , and 
  • Two-step testing for diagnosing genital  virus
  • Expanded risk factors for  testing in pregnant women
  • Information on FDA-cleared rectal and oral tests to diagnose chlamydia and gonorrhea
  • A recommendation that universal  screening be conducted at least once in a lifetime for adults aged 18 years and older

Dr. Workowski emphasized updates to gonorrhea treatment that built on the recommendation published in December 2020 in Morbidity and Mortality Weekly Report. The CDC now recommends that gonorrhea be treated with a single 500-mg injection of ceftriaxone, and if chlamydial infection is not ruled out, treating with a regimen of 100 mg of oral doxycycline taken twice daily for 7 days. Other gonorrhea treatment recommendations include retesting patients 3 months after treatment and that a test of cure be conducted for people with pharyngeal gonorrhea 1 to 2 weeks after treatment, using either culture or nucleic-acid amplification tests.

“Effectively treating gonorrhea remains a public health priority,” Dr. Workowski said. “Gonorrhea can rapidly develop antibiotic resistance and is the second most commonly reported bacterial STI in the U.S., increasing 56% from 2015 to 2019.”

The updates to syphilis screening for pregnant women are also important, added Dr. Klausner. “We’ve seen a dramatic and shameful rise in congenital syphilis,” he said. In addition to screening all pregnant women at the first prenatal visit, the CDC recommends retesting for syphilis at 28 weeks’ gestation and at delivery if the mother lives in an area where the prevalence of syphilis is high or if she is at risk of acquiring syphilis during pregnancy. An expectant mother is at higher risk if she has multiple sex partners, has an STI during pregnancy, has a partner with an STI, has a new sex partner, or misuses drugs, the recommendations state.

Dr. Klausner also noted that the updates provide more robust guidelines for treating transgender individuals and incarcerated people.

The treatment guidelines are available online along with a wall chart and a pocket guide that summarizes these updates. The mobile app with the 2015 guidelines will be retired at the end of July 2021, Dr. Workowski said. An app with these updated treatment recommendations is in development and will be available later this year.

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

 

On July 22, the Centers for Disease Control and Prevention released updated sexually transmitted infection treatment guidelines to reflect current screening, testing, and treatment recommendations. The guidelines were last updated in 2015.

The new recommendations come at a pivotal moment in the field’s history, Kimberly Workowski, MD, a medical officer at the CDC’s Division of STD Prevention, told this news organization in an email. “The COVID-19 pandemic has caused decreased clinic capacity and drug and diagnostic test kit shortages,” she says. Many of these shortages have been resolved, she added, and it is important that health care professionals use the most current evidence-based recommendations for screening and management of STIs.

Updates to these guidelines were necessary to reflect “continued advances in research in the prevention of STIs, new interventions in terms of STI prevention, and thirdly, changing epidemiology,” Jeffrey Klausner, MD, MPH, an STI specialist with the Keck School of Medicine at the University of Southern California, Los Angeles, said in an interview. “There’s been increased concern about antimicrobial resistance, and that’s really driven some of the key changes in these new STI treatment guidelines.”

Notable updates to the guidelines include the following:

  • Updated treatment recommendations for gonorrhea, chlamydia, , and 
  • Two-step testing for diagnosing genital  virus
  • Expanded risk factors for  testing in pregnant women
  • Information on FDA-cleared rectal and oral tests to diagnose chlamydia and gonorrhea
  • A recommendation that universal  screening be conducted at least once in a lifetime for adults aged 18 years and older

Dr. Workowski emphasized updates to gonorrhea treatment that built on the recommendation published in December 2020 in Morbidity and Mortality Weekly Report. The CDC now recommends that gonorrhea be treated with a single 500-mg injection of ceftriaxone, and if chlamydial infection is not ruled out, treating with a regimen of 100 mg of oral doxycycline taken twice daily for 7 days. Other gonorrhea treatment recommendations include retesting patients 3 months after treatment and that a test of cure be conducted for people with pharyngeal gonorrhea 1 to 2 weeks after treatment, using either culture or nucleic-acid amplification tests.

“Effectively treating gonorrhea remains a public health priority,” Dr. Workowski said. “Gonorrhea can rapidly develop antibiotic resistance and is the second most commonly reported bacterial STI in the U.S., increasing 56% from 2015 to 2019.”

The updates to syphilis screening for pregnant women are also important, added Dr. Klausner. “We’ve seen a dramatic and shameful rise in congenital syphilis,” he said. In addition to screening all pregnant women at the first prenatal visit, the CDC recommends retesting for syphilis at 28 weeks’ gestation and at delivery if the mother lives in an area where the prevalence of syphilis is high or if she is at risk of acquiring syphilis during pregnancy. An expectant mother is at higher risk if she has multiple sex partners, has an STI during pregnancy, has a partner with an STI, has a new sex partner, or misuses drugs, the recommendations state.

Dr. Klausner also noted that the updates provide more robust guidelines for treating transgender individuals and incarcerated people.

The treatment guidelines are available online along with a wall chart and a pocket guide that summarizes these updates. The mobile app with the 2015 guidelines will be retired at the end of July 2021, Dr. Workowski said. An app with these updated treatment recommendations is in development and will be available later this year.

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

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FDA warns of potential mechanical concerns with MAGEC devices

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Tue, 02/14/2023 - 12:59

The Food and Drug Administration has issued a notice about potential mechanical failures and biocompatibility concerns with MAGEC system devices from NuVasive.

MAGEC is a surgical magnetic rod system used to treat early-onset scoliosis (EOS) in children under 10 years of age. The magnetic system can help avoid invasive surgeries, as growth rods can be adjusted with an external remote control. MAGEC is the only FDA-approved pure distraction-based system for EOS and is the most-used technology for EOS treatment in the United States, Aakash Agarwal, PhD, director of research and clinical affairs at Spinal Balance in Swanton, Ohio, said in an interview.

According to the notice, there are reports of endcap separation and O-ring seal failure in the following six MAGEC devices:

  • MAGEC Spinal Bracing and Distraction System
  • MAGEC 2 Spinal Bracing and Distraction System
  • MAGEC System
  • MAGEC System Model X Device
  • MAGEC System Model X Rod
  • MAGEC System Rods

Endcap separation can potentially expose the patient’s tissue to internal components of the device that have not been completely tested for biocompatibility.

In February 2020, NuVasive recalled its MAGEC System Model X rods to address reports of endcap separation issues. The FDA cleared a modified version of the device designed to mitigate these events in July 2020. In April 2021, NuVasive informed providers of potential biocompatibility concerns and placed a voluntary shipping hold on the MAGEC device system. The shipping hold was lifted July 15, the company announced.

The FDA is currently not recommending removal of functioning MAGEC devices, noting that it is “in the best interest of patients” to continue to make the system available. The overall benefits of the device outweigh the known risks, and the restricted use for a 2-year implantation time for children under 10 years of age will further mitigate these risks, the FDA said in the statement.

To report adverse events related to MAGEC devices, patients, caregivers, and providers can submit a report through MedWatch, the FDA safety information and adverse event reporting program.

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

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The Food and Drug Administration has issued a notice about potential mechanical failures and biocompatibility concerns with MAGEC system devices from NuVasive.

MAGEC is a surgical magnetic rod system used to treat early-onset scoliosis (EOS) in children under 10 years of age. The magnetic system can help avoid invasive surgeries, as growth rods can be adjusted with an external remote control. MAGEC is the only FDA-approved pure distraction-based system for EOS and is the most-used technology for EOS treatment in the United States, Aakash Agarwal, PhD, director of research and clinical affairs at Spinal Balance in Swanton, Ohio, said in an interview.

According to the notice, there are reports of endcap separation and O-ring seal failure in the following six MAGEC devices:

  • MAGEC Spinal Bracing and Distraction System
  • MAGEC 2 Spinal Bracing and Distraction System
  • MAGEC System
  • MAGEC System Model X Device
  • MAGEC System Model X Rod
  • MAGEC System Rods

Endcap separation can potentially expose the patient’s tissue to internal components of the device that have not been completely tested for biocompatibility.

In February 2020, NuVasive recalled its MAGEC System Model X rods to address reports of endcap separation issues. The FDA cleared a modified version of the device designed to mitigate these events in July 2020. In April 2021, NuVasive informed providers of potential biocompatibility concerns and placed a voluntary shipping hold on the MAGEC device system. The shipping hold was lifted July 15, the company announced.

The FDA is currently not recommending removal of functioning MAGEC devices, noting that it is “in the best interest of patients” to continue to make the system available. The overall benefits of the device outweigh the known risks, and the restricted use for a 2-year implantation time for children under 10 years of age will further mitigate these risks, the FDA said in the statement.

To report adverse events related to MAGEC devices, patients, caregivers, and providers can submit a report through MedWatch, the FDA safety information and adverse event reporting program.

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

The Food and Drug Administration has issued a notice about potential mechanical failures and biocompatibility concerns with MAGEC system devices from NuVasive.

MAGEC is a surgical magnetic rod system used to treat early-onset scoliosis (EOS) in children under 10 years of age. The magnetic system can help avoid invasive surgeries, as growth rods can be adjusted with an external remote control. MAGEC is the only FDA-approved pure distraction-based system for EOS and is the most-used technology for EOS treatment in the United States, Aakash Agarwal, PhD, director of research and clinical affairs at Spinal Balance in Swanton, Ohio, said in an interview.

According to the notice, there are reports of endcap separation and O-ring seal failure in the following six MAGEC devices:

  • MAGEC Spinal Bracing and Distraction System
  • MAGEC 2 Spinal Bracing and Distraction System
  • MAGEC System
  • MAGEC System Model X Device
  • MAGEC System Model X Rod
  • MAGEC System Rods

Endcap separation can potentially expose the patient’s tissue to internal components of the device that have not been completely tested for biocompatibility.

In February 2020, NuVasive recalled its MAGEC System Model X rods to address reports of endcap separation issues. The FDA cleared a modified version of the device designed to mitigate these events in July 2020. In April 2021, NuVasive informed providers of potential biocompatibility concerns and placed a voluntary shipping hold on the MAGEC device system. The shipping hold was lifted July 15, the company announced.

The FDA is currently not recommending removal of functioning MAGEC devices, noting that it is “in the best interest of patients” to continue to make the system available. The overall benefits of the device outweigh the known risks, and the restricted use for a 2-year implantation time for children under 10 years of age will further mitigate these risks, the FDA said in the statement.

To report adverse events related to MAGEC devices, patients, caregivers, and providers can submit a report through MedWatch, the FDA safety information and adverse event reporting program.

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

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Syphilis prevalence in MSM 15 times higher than in general population

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Mon, 07/19/2021 - 10:01

 

Worldwide, nearly 8% of men who have sex with men (MSM) may have syphilis, a new systematic review and meta-analysis suggests. This estimate, generated from 275 studies across 77 countries, is 15 times greater than the most recent estimates of syphilis prevalence in men in a general population.

“That disparity is absolutely unacceptable,” Matthew Chico, PhD, associate professor at the London School of Hygiene and Tropical Medicine, and senior author of the review, said in an interview.

Although the World Health Organization (WHO) aims to reduce the global prevalence of syphilis by 90% by 2030, an ambitious goal set in 2016, recent research suggests syphilis numbers are moving in the opposite direction. Cases in the United States rose 74% between 2015 and 2019, and other nations, such as Australia, South Korea, and the United Kingdom, are seeing similar trends.

Syphilis prevalence is generally higher in MSM, largely in subpopulations of men who have multiple sexual partners, Kenneth Mayer, MD, said in an interview. Dr. Mayer is medical research director at the Fenway Institute, Boston, and was not involved with the study.

Health literacy, lack of access to care, and medical mistrust can all be challenges to screening, identifying, and treating the infection in this population.

Reducing syphilis cases will require focusing interventions on higher-risk groups such as MSM, said Dr. Chico; however, there was “a real dearth in knowledge about the most likely prevalence of syphilis among MSM on a global level,” he said.

To help fill in the gaps, Dr. Chico and his research team collected studies that included syphilis prevalence data for MSM published between Jan. 1, 2000, and Feb. 1, 2020. Researchers excluded studies that included only MSM living with HIV, injection drug users, patients who routinely visit sexually transmitted infection (STI) clinics, and people seeking care only for STIs or other genital symptoms, because these studies would have skewed global syphilis prevalence estimates higher.

Their review, published July 8 in The Lancet Global Health, found that the pooled global prevalence of syphilis from 2000-2020 in MSM was 7.5%. It ranged from 1.9% in Australia and New Zealand to 10.6% in Latin America and the Caribbean. In comparison, the WHO estimates that globally, 0.5% of men in a general population have syphilis, a 15-fold difference.

This elevated estimate is not surprising, and the review provides a more international view of syphilis. Earlier attempts to estimate the prevalence of syphilis among MSM were generally conducted in higher-income countries such as the United States, Dr. Mayer said. “It’s important that clinicians recognize that this is a global health issue, so they can do the appropriate screening.”

The review found that regions in which the prevalence of HIV was above 5% had higher rates of syphilis (8.7%) compared to regions in which the prevalence of HIV was below 5% (6.6%). Pooled syphilis prevalence estimates were also higher for lower-middle-income and upper-middle-income countries (8.7% and 8.6%, respectively).

Global syphilis prevalence dipped from 8.9% in studies from 2000 to 2009 to 6.6% in studies from 2010 to 2020. In Europe, Northern America, Latin America, the Caribbean, and Oceania (excluding Australia and New Zealand), syphilis prevalence estimates for 2015-2020 were higher compared with 2010-2014.

The authors acknowledged that there were some limitations to the study, particularly that regions of Eastern and Southeastern Asia contributed more than half (54.5%) of the global data points used in the study and accounted for more than 82% of the study’s participants. This highlights the lack of data from other regions around the world, Dr. Chico said.

Dr. Chico said these findings “serve as a clarion call to action” to focus interventions on groups at higher risk for syphilis, such as MSM, in the effort to drastically reduce syphilis cases around the world. Dr. Mayer agrees. “[Syphilis] is a readily diagnosable and treatable infection,” he said. “It definitely is something that we should be able to get a handle on, but that requires paying attention to the different subgroups who have particularly high rates of the infection.”

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

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Worldwide, nearly 8% of men who have sex with men (MSM) may have syphilis, a new systematic review and meta-analysis suggests. This estimate, generated from 275 studies across 77 countries, is 15 times greater than the most recent estimates of syphilis prevalence in men in a general population.

“That disparity is absolutely unacceptable,” Matthew Chico, PhD, associate professor at the London School of Hygiene and Tropical Medicine, and senior author of the review, said in an interview.

Although the World Health Organization (WHO) aims to reduce the global prevalence of syphilis by 90% by 2030, an ambitious goal set in 2016, recent research suggests syphilis numbers are moving in the opposite direction. Cases in the United States rose 74% between 2015 and 2019, and other nations, such as Australia, South Korea, and the United Kingdom, are seeing similar trends.

Syphilis prevalence is generally higher in MSM, largely in subpopulations of men who have multiple sexual partners, Kenneth Mayer, MD, said in an interview. Dr. Mayer is medical research director at the Fenway Institute, Boston, and was not involved with the study.

Health literacy, lack of access to care, and medical mistrust can all be challenges to screening, identifying, and treating the infection in this population.

Reducing syphilis cases will require focusing interventions on higher-risk groups such as MSM, said Dr. Chico; however, there was “a real dearth in knowledge about the most likely prevalence of syphilis among MSM on a global level,” he said.

To help fill in the gaps, Dr. Chico and his research team collected studies that included syphilis prevalence data for MSM published between Jan. 1, 2000, and Feb. 1, 2020. Researchers excluded studies that included only MSM living with HIV, injection drug users, patients who routinely visit sexually transmitted infection (STI) clinics, and people seeking care only for STIs or other genital symptoms, because these studies would have skewed global syphilis prevalence estimates higher.

Their review, published July 8 in The Lancet Global Health, found that the pooled global prevalence of syphilis from 2000-2020 in MSM was 7.5%. It ranged from 1.9% in Australia and New Zealand to 10.6% in Latin America and the Caribbean. In comparison, the WHO estimates that globally, 0.5% of men in a general population have syphilis, a 15-fold difference.

This elevated estimate is not surprising, and the review provides a more international view of syphilis. Earlier attempts to estimate the prevalence of syphilis among MSM were generally conducted in higher-income countries such as the United States, Dr. Mayer said. “It’s important that clinicians recognize that this is a global health issue, so they can do the appropriate screening.”

The review found that regions in which the prevalence of HIV was above 5% had higher rates of syphilis (8.7%) compared to regions in which the prevalence of HIV was below 5% (6.6%). Pooled syphilis prevalence estimates were also higher for lower-middle-income and upper-middle-income countries (8.7% and 8.6%, respectively).

Global syphilis prevalence dipped from 8.9% in studies from 2000 to 2009 to 6.6% in studies from 2010 to 2020. In Europe, Northern America, Latin America, the Caribbean, and Oceania (excluding Australia and New Zealand), syphilis prevalence estimates for 2015-2020 were higher compared with 2010-2014.

The authors acknowledged that there were some limitations to the study, particularly that regions of Eastern and Southeastern Asia contributed more than half (54.5%) of the global data points used in the study and accounted for more than 82% of the study’s participants. This highlights the lack of data from other regions around the world, Dr. Chico said.

Dr. Chico said these findings “serve as a clarion call to action” to focus interventions on groups at higher risk for syphilis, such as MSM, in the effort to drastically reduce syphilis cases around the world. Dr. Mayer agrees. “[Syphilis] is a readily diagnosable and treatable infection,” he said. “It definitely is something that we should be able to get a handle on, but that requires paying attention to the different subgroups who have particularly high rates of the infection.”

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

 

Worldwide, nearly 8% of men who have sex with men (MSM) may have syphilis, a new systematic review and meta-analysis suggests. This estimate, generated from 275 studies across 77 countries, is 15 times greater than the most recent estimates of syphilis prevalence in men in a general population.

“That disparity is absolutely unacceptable,” Matthew Chico, PhD, associate professor at the London School of Hygiene and Tropical Medicine, and senior author of the review, said in an interview.

Although the World Health Organization (WHO) aims to reduce the global prevalence of syphilis by 90% by 2030, an ambitious goal set in 2016, recent research suggests syphilis numbers are moving in the opposite direction. Cases in the United States rose 74% between 2015 and 2019, and other nations, such as Australia, South Korea, and the United Kingdom, are seeing similar trends.

Syphilis prevalence is generally higher in MSM, largely in subpopulations of men who have multiple sexual partners, Kenneth Mayer, MD, said in an interview. Dr. Mayer is medical research director at the Fenway Institute, Boston, and was not involved with the study.

Health literacy, lack of access to care, and medical mistrust can all be challenges to screening, identifying, and treating the infection in this population.

Reducing syphilis cases will require focusing interventions on higher-risk groups such as MSM, said Dr. Chico; however, there was “a real dearth in knowledge about the most likely prevalence of syphilis among MSM on a global level,” he said.

To help fill in the gaps, Dr. Chico and his research team collected studies that included syphilis prevalence data for MSM published between Jan. 1, 2000, and Feb. 1, 2020. Researchers excluded studies that included only MSM living with HIV, injection drug users, patients who routinely visit sexually transmitted infection (STI) clinics, and people seeking care only for STIs or other genital symptoms, because these studies would have skewed global syphilis prevalence estimates higher.

Their review, published July 8 in The Lancet Global Health, found that the pooled global prevalence of syphilis from 2000-2020 in MSM was 7.5%. It ranged from 1.9% in Australia and New Zealand to 10.6% in Latin America and the Caribbean. In comparison, the WHO estimates that globally, 0.5% of men in a general population have syphilis, a 15-fold difference.

This elevated estimate is not surprising, and the review provides a more international view of syphilis. Earlier attempts to estimate the prevalence of syphilis among MSM were generally conducted in higher-income countries such as the United States, Dr. Mayer said. “It’s important that clinicians recognize that this is a global health issue, so they can do the appropriate screening.”

The review found that regions in which the prevalence of HIV was above 5% had higher rates of syphilis (8.7%) compared to regions in which the prevalence of HIV was below 5% (6.6%). Pooled syphilis prevalence estimates were also higher for lower-middle-income and upper-middle-income countries (8.7% and 8.6%, respectively).

Global syphilis prevalence dipped from 8.9% in studies from 2000 to 2009 to 6.6% in studies from 2010 to 2020. In Europe, Northern America, Latin America, the Caribbean, and Oceania (excluding Australia and New Zealand), syphilis prevalence estimates for 2015-2020 were higher compared with 2010-2014.

The authors acknowledged that there were some limitations to the study, particularly that regions of Eastern and Southeastern Asia contributed more than half (54.5%) of the global data points used in the study and accounted for more than 82% of the study’s participants. This highlights the lack of data from other regions around the world, Dr. Chico said.

Dr. Chico said these findings “serve as a clarion call to action” to focus interventions on groups at higher risk for syphilis, such as MSM, in the effort to drastically reduce syphilis cases around the world. Dr. Mayer agrees. “[Syphilis] is a readily diagnosable and treatable infection,” he said. “It definitely is something that we should be able to get a handle on, but that requires paying attention to the different subgroups who have particularly high rates of the infection.”

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

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