Overdose deaths up 81% in pregnant, postpartum women

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Wed, 12/07/2022 - 13:24

Drug overdose deaths in pregnant and postpartum women rose by about 81% from 2017 to 2020, researchers report in a JAMA research letter published online Dec. 6.

Pregnancy-associated overdose deaths were highest in 2020 as the COVID pandemic began, according to the researchers, Emilie Bruzelius, MPH, and Silvia S. Martins, MD, PHD, with the department of epidemiology, Columbia University School of Public Health in New York.

The deaths were identified using International Statistical Classification of Diseases and Related Health Problems (ICD-10) pregnancy-related codes and death certificate pregnancy checkbox status.

The checkbox, part of all states’ death certificates, asks whether the person was pregnant at the time of death, within 42 days of death (early postpartum) or within 43-365 days of death (late postpartum).
 

Sharp increase at start of COVID pandemic

The authors note that pregnancy-related overdose deaths have been climbing from 2007 to 2019, but increased sharply in 2020.

“Pregnant and postpartum persons are known to face barriers to accessing drug treatment and harm-reduction services, which when compounded by pandemic-associated stressors, health care shutdowns, and increasingly volatile unregulated drug supply may have increased fatal overdose risk,” the authors write.

Of the 7,642 pregnancy-related deaths in the study period, 1,249 were overdose-related, leading to a cumulative overdose death rate of 8.35 per 100,000. From 2017 to 2020, pregnancy-related overdose deaths rose from 6.56 to 11.85 per 100,000. That translates to an absolute change rate of 5.30 per 100,000 and a relative increase of 81%.

The trend mirrors a pattern in people of reproductive age overall, the authors write.

Overdose mortality among reproductive age women similarly increased from 14.37 to 19.76 per 100,000 (absolute change rate, 5.39 [95% confidence interval, 4.94-5.85] per 100,000; relative increase of 38%).
 

Fentanyl deaths increase

The researchers found large increases in deaths involving fentanyl and other synthetics and psychostimulants (methamphetamine and cocaine, for example).

Pregnancy-associated overdose deaths involving benzodiazepines, heroin, and prescription opioids, however, were mostly stable from 2017 to 2020.

Numbers of late postpartum overdose deaths were notable in the paper.

In that group, there were 3.95 deaths per 100,000, compared with those pregnant at the time of death (2.99 per 100,000 or those identified as early postpartum (1.39 per 100 000).

Davida Schiff, MD, director of the Perinatal and Family-based Substance Use Disorder Care Massachusetts General Hospital substance use disorders initiative in Boston, told this publication it’s important to realize from this study that late postpartum period is the highest-risk period and also the time “when many states that have not expanded Medicaid cut off insurance needed to access life-saving health care services.”“Pregnancy is an important touch point of increased health care access, yet pregnant and parenting people face unique social and legal consequences from their substance use,” Dr. Schiff said.

She added, “I’m left wondering how many of the deaths reported could have been avoided if fear of a punitive response when engaging with our health care system had not prevented them from seeking out the care they needed.”

Dr. Schiff said the study highlights the importance of the pregnancy-checkbox addition to death records to better characterize pregnancy-associated deaths that previously were likely undercounted.

The authors and Dr. Schiff declare no relevant financial relationships.

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Drug overdose deaths in pregnant and postpartum women rose by about 81% from 2017 to 2020, researchers report in a JAMA research letter published online Dec. 6.

Pregnancy-associated overdose deaths were highest in 2020 as the COVID pandemic began, according to the researchers, Emilie Bruzelius, MPH, and Silvia S. Martins, MD, PHD, with the department of epidemiology, Columbia University School of Public Health in New York.

The deaths were identified using International Statistical Classification of Diseases and Related Health Problems (ICD-10) pregnancy-related codes and death certificate pregnancy checkbox status.

The checkbox, part of all states’ death certificates, asks whether the person was pregnant at the time of death, within 42 days of death (early postpartum) or within 43-365 days of death (late postpartum).
 

Sharp increase at start of COVID pandemic

The authors note that pregnancy-related overdose deaths have been climbing from 2007 to 2019, but increased sharply in 2020.

“Pregnant and postpartum persons are known to face barriers to accessing drug treatment and harm-reduction services, which when compounded by pandemic-associated stressors, health care shutdowns, and increasingly volatile unregulated drug supply may have increased fatal overdose risk,” the authors write.

Of the 7,642 pregnancy-related deaths in the study period, 1,249 were overdose-related, leading to a cumulative overdose death rate of 8.35 per 100,000. From 2017 to 2020, pregnancy-related overdose deaths rose from 6.56 to 11.85 per 100,000. That translates to an absolute change rate of 5.30 per 100,000 and a relative increase of 81%.

The trend mirrors a pattern in people of reproductive age overall, the authors write.

Overdose mortality among reproductive age women similarly increased from 14.37 to 19.76 per 100,000 (absolute change rate, 5.39 [95% confidence interval, 4.94-5.85] per 100,000; relative increase of 38%).
 

Fentanyl deaths increase

The researchers found large increases in deaths involving fentanyl and other synthetics and psychostimulants (methamphetamine and cocaine, for example).

Pregnancy-associated overdose deaths involving benzodiazepines, heroin, and prescription opioids, however, were mostly stable from 2017 to 2020.

Numbers of late postpartum overdose deaths were notable in the paper.

In that group, there were 3.95 deaths per 100,000, compared with those pregnant at the time of death (2.99 per 100,000 or those identified as early postpartum (1.39 per 100 000).

Davida Schiff, MD, director of the Perinatal and Family-based Substance Use Disorder Care Massachusetts General Hospital substance use disorders initiative in Boston, told this publication it’s important to realize from this study that late postpartum period is the highest-risk period and also the time “when many states that have not expanded Medicaid cut off insurance needed to access life-saving health care services.”“Pregnancy is an important touch point of increased health care access, yet pregnant and parenting people face unique social and legal consequences from their substance use,” Dr. Schiff said.

She added, “I’m left wondering how many of the deaths reported could have been avoided if fear of a punitive response when engaging with our health care system had not prevented them from seeking out the care they needed.”

Dr. Schiff said the study highlights the importance of the pregnancy-checkbox addition to death records to better characterize pregnancy-associated deaths that previously were likely undercounted.

The authors and Dr. Schiff declare no relevant financial relationships.

Drug overdose deaths in pregnant and postpartum women rose by about 81% from 2017 to 2020, researchers report in a JAMA research letter published online Dec. 6.

Pregnancy-associated overdose deaths were highest in 2020 as the COVID pandemic began, according to the researchers, Emilie Bruzelius, MPH, and Silvia S. Martins, MD, PHD, with the department of epidemiology, Columbia University School of Public Health in New York.

The deaths were identified using International Statistical Classification of Diseases and Related Health Problems (ICD-10) pregnancy-related codes and death certificate pregnancy checkbox status.

The checkbox, part of all states’ death certificates, asks whether the person was pregnant at the time of death, within 42 days of death (early postpartum) or within 43-365 days of death (late postpartum).
 

Sharp increase at start of COVID pandemic

The authors note that pregnancy-related overdose deaths have been climbing from 2007 to 2019, but increased sharply in 2020.

“Pregnant and postpartum persons are known to face barriers to accessing drug treatment and harm-reduction services, which when compounded by pandemic-associated stressors, health care shutdowns, and increasingly volatile unregulated drug supply may have increased fatal overdose risk,” the authors write.

Of the 7,642 pregnancy-related deaths in the study period, 1,249 were overdose-related, leading to a cumulative overdose death rate of 8.35 per 100,000. From 2017 to 2020, pregnancy-related overdose deaths rose from 6.56 to 11.85 per 100,000. That translates to an absolute change rate of 5.30 per 100,000 and a relative increase of 81%.

The trend mirrors a pattern in people of reproductive age overall, the authors write.

Overdose mortality among reproductive age women similarly increased from 14.37 to 19.76 per 100,000 (absolute change rate, 5.39 [95% confidence interval, 4.94-5.85] per 100,000; relative increase of 38%).
 

Fentanyl deaths increase

The researchers found large increases in deaths involving fentanyl and other synthetics and psychostimulants (methamphetamine and cocaine, for example).

Pregnancy-associated overdose deaths involving benzodiazepines, heroin, and prescription opioids, however, were mostly stable from 2017 to 2020.

Numbers of late postpartum overdose deaths were notable in the paper.

In that group, there were 3.95 deaths per 100,000, compared with those pregnant at the time of death (2.99 per 100,000 or those identified as early postpartum (1.39 per 100 000).

Davida Schiff, MD, director of the Perinatal and Family-based Substance Use Disorder Care Massachusetts General Hospital substance use disorders initiative in Boston, told this publication it’s important to realize from this study that late postpartum period is the highest-risk period and also the time “when many states that have not expanded Medicaid cut off insurance needed to access life-saving health care services.”“Pregnancy is an important touch point of increased health care access, yet pregnant and parenting people face unique social and legal consequences from their substance use,” Dr. Schiff said.

She added, “I’m left wondering how many of the deaths reported could have been avoided if fear of a punitive response when engaging with our health care system had not prevented them from seeking out the care they needed.”

Dr. Schiff said the study highlights the importance of the pregnancy-checkbox addition to death records to better characterize pregnancy-associated deaths that previously were likely undercounted.

The authors and Dr. Schiff declare no relevant financial relationships.

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Injury in pregnant women ups cerebral palsy risk in offspring

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Mon, 12/05/2022 - 16:22

The offspring of mothers who sustain unintentional injuries during pregnancy appear to have a modest 33% increased risk of developing cerebral palsy (CP) – higher when injuries are more severe, multiple, or lead to delivery soon afterward, a Canadian birth cohort study found.

Such children may benefit from long-term monitoring for neurodevelpmental issues, wrote a group led by Asma Ahmed, MD, PhD, MPH, a pediatric epidemiologist at the Hospital for Sick Children Research Institute in Toronto in JAMA Pediatrics.

“We need to provide better support for babies whose mothers have been injured in pregnancy, especially after severe injuries,” Dr. Ahmed said in a press release. “As well, these findings suggest the need for early monitoring of babies’ development, regular check-ups, and longer-term neurodevelopmental assessments.” Future studies should directly measure injury severity and its possible link to CP.

Current guidelines, however, focus on monitoring fetal condition immediately after injury with little attention to its long-term effects.

In their findings from the population-based linkage study of 2,110,177 children born in Ontario’s public health system during 2002-2017 and followed to 2018 with a median follow-up of 8 years:

  • A total of 81,281 fetuses were exposed in utero to unintentional maternal injury.
  • Overall, 0.3% children were diagnosed with CP, and the mean CP incidence rates were 4.36 per 10,000 child-years for the exposed versus 2.93 for the unexposed.
  • In those exposed, the hazard ratio was 1.33 (95% confidence interval, 1.18-1.50) after adjusting for maternal sociodemographic and clinical characteristics.
  • Injuries resulting in hospitalization or delivery within 1 week were linked to higher adjusted hazard ratios of 2.18 (95% CI, 1.29-3.68) and 3.40 (95% CI, 1.93-6.00), respectively.
  • Injuries most frequently resulted from transportation mishaps, falls, and being struck by a person or object. They were most commonly associated with age younger than 20 years, substance use disorder, residence in rural and under-resourced areas, and lower socioeconomic status.

The authors noted that complications after maternal injuries – which affect 6%-8% of pregnant women – include uterine rupture, preterm delivery, and placental abruption and are linked to fetal complications such as asphyxia. The association with an offspring’s neurodevelopment has been rarely investigated. One U.K. population study, however, suggested a link between vehicular crashes and higher CP risk in preterm infants.

A related editorial on the study noted that while CP affects about two to four children per 1,000 live births each year in high-income countries, the etiological causes of most cases remain unknown. “This large population-based cohort study ... should inspire more research into preventing and mitigating factors for maternal injuries and offspring CP development,” wrote Zeyan Liew, PhD, MPH, and Haoran Zhuo, MPH, of Yale University School of Public Health in New Haven, Conn.

This study was supported by Santé-Québec and ICES, a research institute funded by the Ontario Ministry of Health and the Ministry of Long-Term Care.

Dr. Ahmed and coauthor Seungmi Yang, PhD, reported research funding from Santé-Québec during the conduct of the study.

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The offspring of mothers who sustain unintentional injuries during pregnancy appear to have a modest 33% increased risk of developing cerebral palsy (CP) – higher when injuries are more severe, multiple, or lead to delivery soon afterward, a Canadian birth cohort study found.

Such children may benefit from long-term monitoring for neurodevelpmental issues, wrote a group led by Asma Ahmed, MD, PhD, MPH, a pediatric epidemiologist at the Hospital for Sick Children Research Institute in Toronto in JAMA Pediatrics.

“We need to provide better support for babies whose mothers have been injured in pregnancy, especially after severe injuries,” Dr. Ahmed said in a press release. “As well, these findings suggest the need for early monitoring of babies’ development, regular check-ups, and longer-term neurodevelopmental assessments.” Future studies should directly measure injury severity and its possible link to CP.

Current guidelines, however, focus on monitoring fetal condition immediately after injury with little attention to its long-term effects.

In their findings from the population-based linkage study of 2,110,177 children born in Ontario’s public health system during 2002-2017 and followed to 2018 with a median follow-up of 8 years:

  • A total of 81,281 fetuses were exposed in utero to unintentional maternal injury.
  • Overall, 0.3% children were diagnosed with CP, and the mean CP incidence rates were 4.36 per 10,000 child-years for the exposed versus 2.93 for the unexposed.
  • In those exposed, the hazard ratio was 1.33 (95% confidence interval, 1.18-1.50) after adjusting for maternal sociodemographic and clinical characteristics.
  • Injuries resulting in hospitalization or delivery within 1 week were linked to higher adjusted hazard ratios of 2.18 (95% CI, 1.29-3.68) and 3.40 (95% CI, 1.93-6.00), respectively.
  • Injuries most frequently resulted from transportation mishaps, falls, and being struck by a person or object. They were most commonly associated with age younger than 20 years, substance use disorder, residence in rural and under-resourced areas, and lower socioeconomic status.

The authors noted that complications after maternal injuries – which affect 6%-8% of pregnant women – include uterine rupture, preterm delivery, and placental abruption and are linked to fetal complications such as asphyxia. The association with an offspring’s neurodevelopment has been rarely investigated. One U.K. population study, however, suggested a link between vehicular crashes and higher CP risk in preterm infants.

A related editorial on the study noted that while CP affects about two to four children per 1,000 live births each year in high-income countries, the etiological causes of most cases remain unknown. “This large population-based cohort study ... should inspire more research into preventing and mitigating factors for maternal injuries and offspring CP development,” wrote Zeyan Liew, PhD, MPH, and Haoran Zhuo, MPH, of Yale University School of Public Health in New Haven, Conn.

This study was supported by Santé-Québec and ICES, a research institute funded by the Ontario Ministry of Health and the Ministry of Long-Term Care.

Dr. Ahmed and coauthor Seungmi Yang, PhD, reported research funding from Santé-Québec during the conduct of the study.

The offspring of mothers who sustain unintentional injuries during pregnancy appear to have a modest 33% increased risk of developing cerebral palsy (CP) – higher when injuries are more severe, multiple, or lead to delivery soon afterward, a Canadian birth cohort study found.

Such children may benefit from long-term monitoring for neurodevelpmental issues, wrote a group led by Asma Ahmed, MD, PhD, MPH, a pediatric epidemiologist at the Hospital for Sick Children Research Institute in Toronto in JAMA Pediatrics.

“We need to provide better support for babies whose mothers have been injured in pregnancy, especially after severe injuries,” Dr. Ahmed said in a press release. “As well, these findings suggest the need for early monitoring of babies’ development, regular check-ups, and longer-term neurodevelopmental assessments.” Future studies should directly measure injury severity and its possible link to CP.

Current guidelines, however, focus on monitoring fetal condition immediately after injury with little attention to its long-term effects.

In their findings from the population-based linkage study of 2,110,177 children born in Ontario’s public health system during 2002-2017 and followed to 2018 with a median follow-up of 8 years:

  • A total of 81,281 fetuses were exposed in utero to unintentional maternal injury.
  • Overall, 0.3% children were diagnosed with CP, and the mean CP incidence rates were 4.36 per 10,000 child-years for the exposed versus 2.93 for the unexposed.
  • In those exposed, the hazard ratio was 1.33 (95% confidence interval, 1.18-1.50) after adjusting for maternal sociodemographic and clinical characteristics.
  • Injuries resulting in hospitalization or delivery within 1 week were linked to higher adjusted hazard ratios of 2.18 (95% CI, 1.29-3.68) and 3.40 (95% CI, 1.93-6.00), respectively.
  • Injuries most frequently resulted from transportation mishaps, falls, and being struck by a person or object. They were most commonly associated with age younger than 20 years, substance use disorder, residence in rural and under-resourced areas, and lower socioeconomic status.

The authors noted that complications after maternal injuries – which affect 6%-8% of pregnant women – include uterine rupture, preterm delivery, and placental abruption and are linked to fetal complications such as asphyxia. The association with an offspring’s neurodevelopment has been rarely investigated. One U.K. population study, however, suggested a link between vehicular crashes and higher CP risk in preterm infants.

A related editorial on the study noted that while CP affects about two to four children per 1,000 live births each year in high-income countries, the etiological causes of most cases remain unknown. “This large population-based cohort study ... should inspire more research into preventing and mitigating factors for maternal injuries and offspring CP development,” wrote Zeyan Liew, PhD, MPH, and Haoran Zhuo, MPH, of Yale University School of Public Health in New Haven, Conn.

This study was supported by Santé-Québec and ICES, a research institute funded by the Ontario Ministry of Health and the Ministry of Long-Term Care.

Dr. Ahmed and coauthor Seungmi Yang, PhD, reported research funding from Santé-Québec during the conduct of the study.

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Deductibles a threat to more imaging after abnormal mammogram

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Wed, 01/04/2023 - 16:39

– One in five women will skip further imaging after an abnormal mammogram if they have to pay out of pocket before their deductible is met, new data indicate.

“The ACA [Affordable Care Act] removed out-of-pocket costs for screening mammograms under most health plans to encourage women to partake in this important preventative health care measure,” Michael Ngo, MD, a radiology resident at Boston Medical Center and Boston University, said in a statement.

However, the screening mammogram is only the first step. If it’s abnormal, additional tests and a biopsy help determine whether the patient has cancer. The ACA does not mandate coverage for those, Dr. Ngo noted.

Dr. Ngo was lead author of the study presented at the annual meeting of the Radiological Society of North America.

Researchers collected 932 surveys. Asked whether they would skip follow-up imaging if they knew that they would have to pay a deductible, 151 of 714 (21.2%) said that they would skip the imaging; 424 (59.4%) said that they would not skip further imaging; and 139 (19.5%) were undecided. Responses differed by race, education level, household income, and insurance payer.
 

Groups most likely to forgo further tests

The groups with the highest percentage of persons who would skip additional imaging were Hispanic persons (33%); persons whose level of education was high school or less (31.0%); persons with a household income of less than $35,000 (27%); and those covered by Medicaid or who were uninsured (31.5%).

Wendie Berg, MD, PhD, professor of radiology at the University of Pittsburgh, who was not part of the study, said that because insurance companies had to cover initial mammograms fully under the ACA, “they generally increased deductibles. That resulted in more charges to patients when they came in for additional testing.

“It caught a lot of women by surprise,” she told this news organization.

The out-of-pocket charges can escalate with each step – more images, a biopsy, then more if they do have cancer, she said. This puts patients on the hook for hundreds, if not thousands, of dollars in medical bills.

However, Dr. Berg said, “The vast majority of women – 95% – who are called back for additional testing don’t have cancer. It is a problem that a lot of women will experience the cost and don’t have any benefit.”
 

Reducing false-positive recalls

The study highlights several things, she said. One is that “it’s incumbent on all of us to reduce false-positive recalls, which is one of the benefits of 3-D mammogram.”

Physicians who order additional tests must also consider the financial burden for patients, she said.

Some states have tackled the issue, she said. “Seven states do require insurance to cover diagnostic testing.” But those states differ in the extent of the coverage. DenseBreast-info.org, a website she helps with on a volunteer basis, explains the benefits by state.

Further compounding the problem is that not every insurer is subject to state law, she said.

Many states have programs that cover the cost for those who meet income requirements, although, she noted, some women make too much to qualify.

“It would be great to have a federal law that is inclusive,” she said.
 

 

 

Education efforts may help

Brian N. Dontchos, MD, with the University of Washington in Seattle, who was not part of the study, views the data another way. He told this news organization, “It is encouraging from the study that the majority of women would pursue additional imaging after an abnormal screening mammogram despite incurring more cost.”

He said that since direct patient education “has been shown to be effective in improving patient participation in screening programs, it is possible that, with more education of patients and providers, that advocacy could influence payers to support downstream imaging and biopsies that result from screening programs.”

Dr. Ngo, Dr. Berg, and Dr. Dontchos report no relevant financial relationships.

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

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– One in five women will skip further imaging after an abnormal mammogram if they have to pay out of pocket before their deductible is met, new data indicate.

“The ACA [Affordable Care Act] removed out-of-pocket costs for screening mammograms under most health plans to encourage women to partake in this important preventative health care measure,” Michael Ngo, MD, a radiology resident at Boston Medical Center and Boston University, said in a statement.

However, the screening mammogram is only the first step. If it’s abnormal, additional tests and a biopsy help determine whether the patient has cancer. The ACA does not mandate coverage for those, Dr. Ngo noted.

Dr. Ngo was lead author of the study presented at the annual meeting of the Radiological Society of North America.

Researchers collected 932 surveys. Asked whether they would skip follow-up imaging if they knew that they would have to pay a deductible, 151 of 714 (21.2%) said that they would skip the imaging; 424 (59.4%) said that they would not skip further imaging; and 139 (19.5%) were undecided. Responses differed by race, education level, household income, and insurance payer.
 

Groups most likely to forgo further tests

The groups with the highest percentage of persons who would skip additional imaging were Hispanic persons (33%); persons whose level of education was high school or less (31.0%); persons with a household income of less than $35,000 (27%); and those covered by Medicaid or who were uninsured (31.5%).

Wendie Berg, MD, PhD, professor of radiology at the University of Pittsburgh, who was not part of the study, said that because insurance companies had to cover initial mammograms fully under the ACA, “they generally increased deductibles. That resulted in more charges to patients when they came in for additional testing.

“It caught a lot of women by surprise,” she told this news organization.

The out-of-pocket charges can escalate with each step – more images, a biopsy, then more if they do have cancer, she said. This puts patients on the hook for hundreds, if not thousands, of dollars in medical bills.

However, Dr. Berg said, “The vast majority of women – 95% – who are called back for additional testing don’t have cancer. It is a problem that a lot of women will experience the cost and don’t have any benefit.”
 

Reducing false-positive recalls

The study highlights several things, she said. One is that “it’s incumbent on all of us to reduce false-positive recalls, which is one of the benefits of 3-D mammogram.”

Physicians who order additional tests must also consider the financial burden for patients, she said.

Some states have tackled the issue, she said. “Seven states do require insurance to cover diagnostic testing.” But those states differ in the extent of the coverage. DenseBreast-info.org, a website she helps with on a volunteer basis, explains the benefits by state.

Further compounding the problem is that not every insurer is subject to state law, she said.

Many states have programs that cover the cost for those who meet income requirements, although, she noted, some women make too much to qualify.

“It would be great to have a federal law that is inclusive,” she said.
 

 

 

Education efforts may help

Brian N. Dontchos, MD, with the University of Washington in Seattle, who was not part of the study, views the data another way. He told this news organization, “It is encouraging from the study that the majority of women would pursue additional imaging after an abnormal screening mammogram despite incurring more cost.”

He said that since direct patient education “has been shown to be effective in improving patient participation in screening programs, it is possible that, with more education of patients and providers, that advocacy could influence payers to support downstream imaging and biopsies that result from screening programs.”

Dr. Ngo, Dr. Berg, and Dr. Dontchos report no relevant financial relationships.

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

– One in five women will skip further imaging after an abnormal mammogram if they have to pay out of pocket before their deductible is met, new data indicate.

“The ACA [Affordable Care Act] removed out-of-pocket costs for screening mammograms under most health plans to encourage women to partake in this important preventative health care measure,” Michael Ngo, MD, a radiology resident at Boston Medical Center and Boston University, said in a statement.

However, the screening mammogram is only the first step. If it’s abnormal, additional tests and a biopsy help determine whether the patient has cancer. The ACA does not mandate coverage for those, Dr. Ngo noted.

Dr. Ngo was lead author of the study presented at the annual meeting of the Radiological Society of North America.

Researchers collected 932 surveys. Asked whether they would skip follow-up imaging if they knew that they would have to pay a deductible, 151 of 714 (21.2%) said that they would skip the imaging; 424 (59.4%) said that they would not skip further imaging; and 139 (19.5%) were undecided. Responses differed by race, education level, household income, and insurance payer.
 

Groups most likely to forgo further tests

The groups with the highest percentage of persons who would skip additional imaging were Hispanic persons (33%); persons whose level of education was high school or less (31.0%); persons with a household income of less than $35,000 (27%); and those covered by Medicaid or who were uninsured (31.5%).

Wendie Berg, MD, PhD, professor of radiology at the University of Pittsburgh, who was not part of the study, said that because insurance companies had to cover initial mammograms fully under the ACA, “they generally increased deductibles. That resulted in more charges to patients when they came in for additional testing.

“It caught a lot of women by surprise,” she told this news organization.

The out-of-pocket charges can escalate with each step – more images, a biopsy, then more if they do have cancer, she said. This puts patients on the hook for hundreds, if not thousands, of dollars in medical bills.

However, Dr. Berg said, “The vast majority of women – 95% – who are called back for additional testing don’t have cancer. It is a problem that a lot of women will experience the cost and don’t have any benefit.”
 

Reducing false-positive recalls

The study highlights several things, she said. One is that “it’s incumbent on all of us to reduce false-positive recalls, which is one of the benefits of 3-D mammogram.”

Physicians who order additional tests must also consider the financial burden for patients, she said.

Some states have tackled the issue, she said. “Seven states do require insurance to cover diagnostic testing.” But those states differ in the extent of the coverage. DenseBreast-info.org, a website she helps with on a volunteer basis, explains the benefits by state.

Further compounding the problem is that not every insurer is subject to state law, she said.

Many states have programs that cover the cost for those who meet income requirements, although, she noted, some women make too much to qualify.

“It would be great to have a federal law that is inclusive,” she said.
 

 

 

Education efforts may help

Brian N. Dontchos, MD, with the University of Washington in Seattle, who was not part of the study, views the data another way. He told this news organization, “It is encouraging from the study that the majority of women would pursue additional imaging after an abnormal screening mammogram despite incurring more cost.”

He said that since direct patient education “has been shown to be effective in improving patient participation in screening programs, it is possible that, with more education of patients and providers, that advocacy could influence payers to support downstream imaging and biopsies that result from screening programs.”

Dr. Ngo, Dr. Berg, and Dr. Dontchos report no relevant financial relationships.

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

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Consider quality of life, comorbidities in hidradenitis suppurativa

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Thu, 12/15/2022 - 16:47

The delay in the diagnosis of hidradenitis suppurativa (HS) often ranges from 7 to 10 years, which results in increased morbidity and disease severity, and an extended impact on quality of life, Robert G. Micheletti, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

Dr. Robert G. Micheletti

For patients with HS, “the quality-of-life impact is profound, greater than any other systematically studied dermatologic condition,” said Dr. Micheletti, associate professor of dermatology at the Hospital of the University of Pennsylavnia, and chief of hospital dermatology, and chief of dermatology at Pennsylvania Hospital, Philadelphia.

Two key aspects of quality of life that affect HS patients are sexual health and overall pain, he said. The female-to-male ratio of HS is approximately 3:1, and data show that approximately 40% of female HS patients experience fertility issues and have unaddressed questions about HS and pregnancy, said Dr. Micheletti. Additionally, data from a systematic review showed that 50%-60% of patients with HS reported sexual dysfunction. Impaired sexual function is also associated with both overall impaired quality of life ratings and the presence of mood disorders, he noted.

Wikimedia Commons/Creative Commons Attribution-Share Alike 4.0 International
Hidradenitis suppurativa lesions

Pain also has a significant impact on quality of life for HS patients. When these patients present in an emergency department, 70% report severe pain, and approximately 60% receive opioids, said Dr. Micheletti.

Data from a 2021 study showed that HS patients are significantly more likely to receive opioids compared with controls, and also more likely to be diagnosed with opioid use disorder than controls, especially if they are seen by nondermatologists, he noted.

For acute pain, Dr. Micheletti recommended starting with acetaminophen 500 mg every 4 to 6 hours as needed, and topical nonsteroidal anti-inflammatory drugs (NSAIDs). “It still makes sense to do topical care,” said Dr. Micheletti, but he added that he also prescribes medications for anxiety for these patients.

Patients with increased pain severity or refractory disease may benefit from systemic NSAIDs, or intralesional triamcinolone, he noted. Incision and draining of abscesses may provide temporary symptomatic relief, but keep in mind that lesions will recur, he noted.

For the most severe cases, Dr. Micheletti advised adding tramadol as a first-line opioid, or another short-acting opioid for breakthrough pain.

To manage patients with HS who have chronic pain, Dr. Micheletti recommended starting with HS disease–directed therapy, but also screening for pain severity and psychological comorbidities.

His strategies in these cases include nonpharmacological pain management in the form of physical therapy, wound care, and behavioral health. His algorithm for nociceptive pain is NSAIDs with or without acetaminophen; duloxetine or nortriptyline are other options. For neuropathic pain, gabapentin and/or duloxetine are top choices, but pregabalin, venlafaxine, and nortriptyline are on the list as well.

Topical NSAIDs or topical lidocaine may serve as add-ons to systemic therapy in more severe cases, or as first-line therapy for milder chronic pain, Dr. Micheletti noted. Patients who have failed treatment with at least two pharmacologic agents, suffer medically refractory HS with debilitating pain, or use opioids on an ongoing basis should be referred to a pain management specialist, he said.
 

 

 

Don’t forget lifestyle

Although data on the impact of diet on patients with HS are limited, “we know anecdotally that dairy and refined carbohydrates are associated with exacerbations,” said Dr. Micheletti.

In addition, many patients use complementary medicine “and they aren’t always telling us,” he emphasized. Smoking is prevalent among patients with HS, and is a risk factor for the disease in general, and for more severe and refractory disease, he added. Consequently, screening for tobacco smoking is recommended for patients with HS not only because of the impact on disease, but because it is a potentially modifiable cardiovascular risk factor, he explained.
 

Consider comorbidities

Cardiovascular disease is among several comorbidities associated with HS, said Dr. Micheletti. HS foundations in the United States and Canada recently published evidence-based recommendations for comorbidity screening. The recommendations included screening for 19 specific comorbidities: acne, dissecting cellulitis, pilonidal disease, pyoderma gangrenosum, depression, anxiety, suicide, smoking, substance abuse, polycystic ovary syndrome, obesity, dyslipidemia, diabetes mellitus, metabolic syndrome, hypertension, cardiovascular disease, inflammatory bowel disease, spondyloarthritis, and sexual dysfunction.

Dr. Micheletti highlighted cardiovascular comorbidities, and noted the association between HS and modifiable cardiovascular risk factors: smoking, obesity, diabetes mellitus, and dyslipidemia. “HS is also independently associated with cardiovascular disease leading to myocardial infarction, stroke, cardiovascular-associated death, and all-cause mortality compared to controls,” he said. Studies show an incidence rate ratio of 1.53 for major adverse cardiovascular events in patients with HS compared with controls, with the highest relative risk among those aged 18-29 years, he added.
 

Medical management

Depending on the patient, medical management of HS may involve antibiotics, hormonal agents, and biologics, said Dr. Micheletti. Some of the most commonly used antibiotic regimens for HS are those recommended in treatment guidelines, including doxycycline and a clindamycin/rifampin combination, he said. However, the use of trimethoprim-sulfamethoxazole or ciprofloxacin has been associated with increased antibiotic resistance and is not supported by available evidence, he noted.

Hormonal therapies may help some women with HS, said Dr. Micheletti. Options include spironolactone, metformin, or estrogen-containing hormonal contraceptives, he said.

When it comes to biologics, only 33% of HS patients meet criteria for their use (Hurley stage II or III, moderate or severe HS), he noted. However, research suggests “a huge gap” in the use of anti-TNF therapy even among patients for whom it is recommended, he said.

Of the TNF-alpha inhibitors, data on adalimumab, which is FDA-approved for HS, are the most recent. Adalimumab “is our gold standard biologic and our gateway biologic, for HS at this time,” Dr. Micheletti said.

However, those who respond to adalimumab “can continue to do better, but they can wax and wane and flare,” he cautioned. Infliximab, while not approved for HS, has been studied in patients with HS and is prescribed by some providers. Although no comparative studies have been done for infliximab versus adalimumab, “anecdotally, response to infliximab tends to be better, and it is the most effective biologic in common use for severe HS,” he noted.

Dr. Micheletti’s top treatment recommendations for using biologics start with considering biosimilars. Most patients on biosimilars do fine, but some patients who previously responded to infliximab will unpredictably lose efficacy or have reactions when switched to a biosimilar, he said.

Patients on biologics also may experience waning efficacy in the wake of an immune response stimulated by foreign antibodies, said Dr. Micheletti. “Anti-drug antibody formation is more likely to occur when treatment is interrupted,” he noted. Minimize the risk of antibody formation by paying attention to adherence issues and dosing frequency, he advised.

If patients fail both adalimumab and infliximab, Dr. Micheletti tells them not to lose hope, and that treatment is a trial-and-error process that may involve more than one therapy. Other biologics in active use for HS include ustekinumab, anakinra, secukinumab, brodalumab, golimumab, and JAK inhibitors, any of which might be effective in any given patient, he said.
 

 

 

Surgical solutions

For HS patients with chronic, recurring inflammation and drainage associated with a sinus tract, surgical deroofing may the best treatment option, Dr. Micheletti said. “Deroofing involves the use of a probe to trace the extent of the subcutaneous tract, followed by incision and removal of the tract ‘roof,’ ’’ he explained. The deroofing procedure involves local anesthesia and has a low morbidity rate, as well as a low recurrence rate and high levels of patient satisfaction, he said.

“The acute role for surgery is to remove active foci of inflammation and relieve pain,” which is achieved more effectively with deroofing, said Dr. Micheletti. By contrast, incision and drainage is associated with an almost 100% recurrence rate, he added.

When planning elective surgery for HS, Dr. Micheletti noted that holding infliximab for less than 4 weeks does not affect postoperative infection rates in patients with rheumatoid arthritis, and a recent randomized, controlled trial showed that adalimumab can be continued safely through HS surgeries.

In fact, “continuing TNF inhibitors through elective surgery does not increase infection risk and results in better disease control,” and dermatologists should work with surgery to balance infection and disease flare concerns in HS patients, he said.

Dr. Micheletti disclosed serving as a consultant or advisor for Adaptimmune and Vertex, and research funding from Amgen and Cabaletta Bio. MedscapeLive and this news organization are owned by the same parent company.

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The delay in the diagnosis of hidradenitis suppurativa (HS) often ranges from 7 to 10 years, which results in increased morbidity and disease severity, and an extended impact on quality of life, Robert G. Micheletti, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

Dr. Robert G. Micheletti

For patients with HS, “the quality-of-life impact is profound, greater than any other systematically studied dermatologic condition,” said Dr. Micheletti, associate professor of dermatology at the Hospital of the University of Pennsylavnia, and chief of hospital dermatology, and chief of dermatology at Pennsylvania Hospital, Philadelphia.

Two key aspects of quality of life that affect HS patients are sexual health and overall pain, he said. The female-to-male ratio of HS is approximately 3:1, and data show that approximately 40% of female HS patients experience fertility issues and have unaddressed questions about HS and pregnancy, said Dr. Micheletti. Additionally, data from a systematic review showed that 50%-60% of patients with HS reported sexual dysfunction. Impaired sexual function is also associated with both overall impaired quality of life ratings and the presence of mood disorders, he noted.

Wikimedia Commons/Creative Commons Attribution-Share Alike 4.0 International
Hidradenitis suppurativa lesions

Pain also has a significant impact on quality of life for HS patients. When these patients present in an emergency department, 70% report severe pain, and approximately 60% receive opioids, said Dr. Micheletti.

Data from a 2021 study showed that HS patients are significantly more likely to receive opioids compared with controls, and also more likely to be diagnosed with opioid use disorder than controls, especially if they are seen by nondermatologists, he noted.

For acute pain, Dr. Micheletti recommended starting with acetaminophen 500 mg every 4 to 6 hours as needed, and topical nonsteroidal anti-inflammatory drugs (NSAIDs). “It still makes sense to do topical care,” said Dr. Micheletti, but he added that he also prescribes medications for anxiety for these patients.

Patients with increased pain severity or refractory disease may benefit from systemic NSAIDs, or intralesional triamcinolone, he noted. Incision and draining of abscesses may provide temporary symptomatic relief, but keep in mind that lesions will recur, he noted.

For the most severe cases, Dr. Micheletti advised adding tramadol as a first-line opioid, or another short-acting opioid for breakthrough pain.

To manage patients with HS who have chronic pain, Dr. Micheletti recommended starting with HS disease–directed therapy, but also screening for pain severity and psychological comorbidities.

His strategies in these cases include nonpharmacological pain management in the form of physical therapy, wound care, and behavioral health. His algorithm for nociceptive pain is NSAIDs with or without acetaminophen; duloxetine or nortriptyline are other options. For neuropathic pain, gabapentin and/or duloxetine are top choices, but pregabalin, venlafaxine, and nortriptyline are on the list as well.

Topical NSAIDs or topical lidocaine may serve as add-ons to systemic therapy in more severe cases, or as first-line therapy for milder chronic pain, Dr. Micheletti noted. Patients who have failed treatment with at least two pharmacologic agents, suffer medically refractory HS with debilitating pain, or use opioids on an ongoing basis should be referred to a pain management specialist, he said.
 

 

 

Don’t forget lifestyle

Although data on the impact of diet on patients with HS are limited, “we know anecdotally that dairy and refined carbohydrates are associated with exacerbations,” said Dr. Micheletti.

In addition, many patients use complementary medicine “and they aren’t always telling us,” he emphasized. Smoking is prevalent among patients with HS, and is a risk factor for the disease in general, and for more severe and refractory disease, he added. Consequently, screening for tobacco smoking is recommended for patients with HS not only because of the impact on disease, but because it is a potentially modifiable cardiovascular risk factor, he explained.
 

Consider comorbidities

Cardiovascular disease is among several comorbidities associated with HS, said Dr. Micheletti. HS foundations in the United States and Canada recently published evidence-based recommendations for comorbidity screening. The recommendations included screening for 19 specific comorbidities: acne, dissecting cellulitis, pilonidal disease, pyoderma gangrenosum, depression, anxiety, suicide, smoking, substance abuse, polycystic ovary syndrome, obesity, dyslipidemia, diabetes mellitus, metabolic syndrome, hypertension, cardiovascular disease, inflammatory bowel disease, spondyloarthritis, and sexual dysfunction.

Dr. Micheletti highlighted cardiovascular comorbidities, and noted the association between HS and modifiable cardiovascular risk factors: smoking, obesity, diabetes mellitus, and dyslipidemia. “HS is also independently associated with cardiovascular disease leading to myocardial infarction, stroke, cardiovascular-associated death, and all-cause mortality compared to controls,” he said. Studies show an incidence rate ratio of 1.53 for major adverse cardiovascular events in patients with HS compared with controls, with the highest relative risk among those aged 18-29 years, he added.
 

Medical management

Depending on the patient, medical management of HS may involve antibiotics, hormonal agents, and biologics, said Dr. Micheletti. Some of the most commonly used antibiotic regimens for HS are those recommended in treatment guidelines, including doxycycline and a clindamycin/rifampin combination, he said. However, the use of trimethoprim-sulfamethoxazole or ciprofloxacin has been associated with increased antibiotic resistance and is not supported by available evidence, he noted.

Hormonal therapies may help some women with HS, said Dr. Micheletti. Options include spironolactone, metformin, or estrogen-containing hormonal contraceptives, he said.

When it comes to biologics, only 33% of HS patients meet criteria for their use (Hurley stage II or III, moderate or severe HS), he noted. However, research suggests “a huge gap” in the use of anti-TNF therapy even among patients for whom it is recommended, he said.

Of the TNF-alpha inhibitors, data on adalimumab, which is FDA-approved for HS, are the most recent. Adalimumab “is our gold standard biologic and our gateway biologic, for HS at this time,” Dr. Micheletti said.

However, those who respond to adalimumab “can continue to do better, but they can wax and wane and flare,” he cautioned. Infliximab, while not approved for HS, has been studied in patients with HS and is prescribed by some providers. Although no comparative studies have been done for infliximab versus adalimumab, “anecdotally, response to infliximab tends to be better, and it is the most effective biologic in common use for severe HS,” he noted.

Dr. Micheletti’s top treatment recommendations for using biologics start with considering biosimilars. Most patients on biosimilars do fine, but some patients who previously responded to infliximab will unpredictably lose efficacy or have reactions when switched to a biosimilar, he said.

Patients on biologics also may experience waning efficacy in the wake of an immune response stimulated by foreign antibodies, said Dr. Micheletti. “Anti-drug antibody formation is more likely to occur when treatment is interrupted,” he noted. Minimize the risk of antibody formation by paying attention to adherence issues and dosing frequency, he advised.

If patients fail both adalimumab and infliximab, Dr. Micheletti tells them not to lose hope, and that treatment is a trial-and-error process that may involve more than one therapy. Other biologics in active use for HS include ustekinumab, anakinra, secukinumab, brodalumab, golimumab, and JAK inhibitors, any of which might be effective in any given patient, he said.
 

 

 

Surgical solutions

For HS patients with chronic, recurring inflammation and drainage associated with a sinus tract, surgical deroofing may the best treatment option, Dr. Micheletti said. “Deroofing involves the use of a probe to trace the extent of the subcutaneous tract, followed by incision and removal of the tract ‘roof,’ ’’ he explained. The deroofing procedure involves local anesthesia and has a low morbidity rate, as well as a low recurrence rate and high levels of patient satisfaction, he said.

“The acute role for surgery is to remove active foci of inflammation and relieve pain,” which is achieved more effectively with deroofing, said Dr. Micheletti. By contrast, incision and drainage is associated with an almost 100% recurrence rate, he added.

When planning elective surgery for HS, Dr. Micheletti noted that holding infliximab for less than 4 weeks does not affect postoperative infection rates in patients with rheumatoid arthritis, and a recent randomized, controlled trial showed that adalimumab can be continued safely through HS surgeries.

In fact, “continuing TNF inhibitors through elective surgery does not increase infection risk and results in better disease control,” and dermatologists should work with surgery to balance infection and disease flare concerns in HS patients, he said.

Dr. Micheletti disclosed serving as a consultant or advisor for Adaptimmune and Vertex, and research funding from Amgen and Cabaletta Bio. MedscapeLive and this news organization are owned by the same parent company.

The delay in the diagnosis of hidradenitis suppurativa (HS) often ranges from 7 to 10 years, which results in increased morbidity and disease severity, and an extended impact on quality of life, Robert G. Micheletti, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

Dr. Robert G. Micheletti

For patients with HS, “the quality-of-life impact is profound, greater than any other systematically studied dermatologic condition,” said Dr. Micheletti, associate professor of dermatology at the Hospital of the University of Pennsylavnia, and chief of hospital dermatology, and chief of dermatology at Pennsylvania Hospital, Philadelphia.

Two key aspects of quality of life that affect HS patients are sexual health and overall pain, he said. The female-to-male ratio of HS is approximately 3:1, and data show that approximately 40% of female HS patients experience fertility issues and have unaddressed questions about HS and pregnancy, said Dr. Micheletti. Additionally, data from a systematic review showed that 50%-60% of patients with HS reported sexual dysfunction. Impaired sexual function is also associated with both overall impaired quality of life ratings and the presence of mood disorders, he noted.

Wikimedia Commons/Creative Commons Attribution-Share Alike 4.0 International
Hidradenitis suppurativa lesions

Pain also has a significant impact on quality of life for HS patients. When these patients present in an emergency department, 70% report severe pain, and approximately 60% receive opioids, said Dr. Micheletti.

Data from a 2021 study showed that HS patients are significantly more likely to receive opioids compared with controls, and also more likely to be diagnosed with opioid use disorder than controls, especially if they are seen by nondermatologists, he noted.

For acute pain, Dr. Micheletti recommended starting with acetaminophen 500 mg every 4 to 6 hours as needed, and topical nonsteroidal anti-inflammatory drugs (NSAIDs). “It still makes sense to do topical care,” said Dr. Micheletti, but he added that he also prescribes medications for anxiety for these patients.

Patients with increased pain severity or refractory disease may benefit from systemic NSAIDs, or intralesional triamcinolone, he noted. Incision and draining of abscesses may provide temporary symptomatic relief, but keep in mind that lesions will recur, he noted.

For the most severe cases, Dr. Micheletti advised adding tramadol as a first-line opioid, or another short-acting opioid for breakthrough pain.

To manage patients with HS who have chronic pain, Dr. Micheletti recommended starting with HS disease–directed therapy, but also screening for pain severity and psychological comorbidities.

His strategies in these cases include nonpharmacological pain management in the form of physical therapy, wound care, and behavioral health. His algorithm for nociceptive pain is NSAIDs with or without acetaminophen; duloxetine or nortriptyline are other options. For neuropathic pain, gabapentin and/or duloxetine are top choices, but pregabalin, venlafaxine, and nortriptyline are on the list as well.

Topical NSAIDs or topical lidocaine may serve as add-ons to systemic therapy in more severe cases, or as first-line therapy for milder chronic pain, Dr. Micheletti noted. Patients who have failed treatment with at least two pharmacologic agents, suffer medically refractory HS with debilitating pain, or use opioids on an ongoing basis should be referred to a pain management specialist, he said.
 

 

 

Don’t forget lifestyle

Although data on the impact of diet on patients with HS are limited, “we know anecdotally that dairy and refined carbohydrates are associated with exacerbations,” said Dr. Micheletti.

In addition, many patients use complementary medicine “and they aren’t always telling us,” he emphasized. Smoking is prevalent among patients with HS, and is a risk factor for the disease in general, and for more severe and refractory disease, he added. Consequently, screening for tobacco smoking is recommended for patients with HS not only because of the impact on disease, but because it is a potentially modifiable cardiovascular risk factor, he explained.
 

Consider comorbidities

Cardiovascular disease is among several comorbidities associated with HS, said Dr. Micheletti. HS foundations in the United States and Canada recently published evidence-based recommendations for comorbidity screening. The recommendations included screening for 19 specific comorbidities: acne, dissecting cellulitis, pilonidal disease, pyoderma gangrenosum, depression, anxiety, suicide, smoking, substance abuse, polycystic ovary syndrome, obesity, dyslipidemia, diabetes mellitus, metabolic syndrome, hypertension, cardiovascular disease, inflammatory bowel disease, spondyloarthritis, and sexual dysfunction.

Dr. Micheletti highlighted cardiovascular comorbidities, and noted the association between HS and modifiable cardiovascular risk factors: smoking, obesity, diabetes mellitus, and dyslipidemia. “HS is also independently associated with cardiovascular disease leading to myocardial infarction, stroke, cardiovascular-associated death, and all-cause mortality compared to controls,” he said. Studies show an incidence rate ratio of 1.53 for major adverse cardiovascular events in patients with HS compared with controls, with the highest relative risk among those aged 18-29 years, he added.
 

Medical management

Depending on the patient, medical management of HS may involve antibiotics, hormonal agents, and biologics, said Dr. Micheletti. Some of the most commonly used antibiotic regimens for HS are those recommended in treatment guidelines, including doxycycline and a clindamycin/rifampin combination, he said. However, the use of trimethoprim-sulfamethoxazole or ciprofloxacin has been associated with increased antibiotic resistance and is not supported by available evidence, he noted.

Hormonal therapies may help some women with HS, said Dr. Micheletti. Options include spironolactone, metformin, or estrogen-containing hormonal contraceptives, he said.

When it comes to biologics, only 33% of HS patients meet criteria for their use (Hurley stage II or III, moderate or severe HS), he noted. However, research suggests “a huge gap” in the use of anti-TNF therapy even among patients for whom it is recommended, he said.

Of the TNF-alpha inhibitors, data on adalimumab, which is FDA-approved for HS, are the most recent. Adalimumab “is our gold standard biologic and our gateway biologic, for HS at this time,” Dr. Micheletti said.

However, those who respond to adalimumab “can continue to do better, but they can wax and wane and flare,” he cautioned. Infliximab, while not approved for HS, has been studied in patients with HS and is prescribed by some providers. Although no comparative studies have been done for infliximab versus adalimumab, “anecdotally, response to infliximab tends to be better, and it is the most effective biologic in common use for severe HS,” he noted.

Dr. Micheletti’s top treatment recommendations for using biologics start with considering biosimilars. Most patients on biosimilars do fine, but some patients who previously responded to infliximab will unpredictably lose efficacy or have reactions when switched to a biosimilar, he said.

Patients on biologics also may experience waning efficacy in the wake of an immune response stimulated by foreign antibodies, said Dr. Micheletti. “Anti-drug antibody formation is more likely to occur when treatment is interrupted,” he noted. Minimize the risk of antibody formation by paying attention to adherence issues and dosing frequency, he advised.

If patients fail both adalimumab and infliximab, Dr. Micheletti tells them not to lose hope, and that treatment is a trial-and-error process that may involve more than one therapy. Other biologics in active use for HS include ustekinumab, anakinra, secukinumab, brodalumab, golimumab, and JAK inhibitors, any of which might be effective in any given patient, he said.
 

 

 

Surgical solutions

For HS patients with chronic, recurring inflammation and drainage associated with a sinus tract, surgical deroofing may the best treatment option, Dr. Micheletti said. “Deroofing involves the use of a probe to trace the extent of the subcutaneous tract, followed by incision and removal of the tract ‘roof,’ ’’ he explained. The deroofing procedure involves local anesthesia and has a low morbidity rate, as well as a low recurrence rate and high levels of patient satisfaction, he said.

“The acute role for surgery is to remove active foci of inflammation and relieve pain,” which is achieved more effectively with deroofing, said Dr. Micheletti. By contrast, incision and drainage is associated with an almost 100% recurrence rate, he added.

When planning elective surgery for HS, Dr. Micheletti noted that holding infliximab for less than 4 weeks does not affect postoperative infection rates in patients with rheumatoid arthritis, and a recent randomized, controlled trial showed that adalimumab can be continued safely through HS surgeries.

In fact, “continuing TNF inhibitors through elective surgery does not increase infection risk and results in better disease control,” and dermatologists should work with surgery to balance infection and disease flare concerns in HS patients, he said.

Dr. Micheletti disclosed serving as a consultant or advisor for Adaptimmune and Vertex, and research funding from Amgen and Cabaletta Bio. MedscapeLive and this news organization are owned by the same parent company.

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Gestational hypertension-diabetes combo signals CVD risk

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Thu, 12/15/2022 - 14:23

Women who develop transient hypertensive disorders during their pregnancy are at risk for developing subsequent cardiovascular disease (CVD), particularly if this experienced at the same time as gestational diabetes.

In a large population-based study, the adjusted hazard ratios for developing CVD following a gestational hypertensive disorder (GHTD) alone were 1.90 (95% confidence interval, 1.151-2.25) within 5 years and 1.41 (95% CI, 1.12-1.76) after 5 years or more.

Vesnaandjic/E+/Getty Images

When gestational diabetes was added into the mix, however, the risk for CVD after 5 years more than doubled (aHR, 2.43; 95% CI, 1.60-3.67). Risk in the earlier postpartum period was also raised by the combination, but this was not significant (aHR, 1.42; 95% CI, 0.78-2.58).

Having gestational diabetes by itself did not seem to increase the risk for later CVD in the analysis, despite being linked to higher heart disease risk in other studies.

“These are women coming out of a pregnancy – young women of reproductive age – so this is not a group that typically has cardiovascular events,” said Ravi Retnakaran, MD, in an interview, an investigator in the new study, which is published in JAMA Network Open.

“If they are somebody who has both disorders concurrently in their pregnancy, they may be at even greater risk than a woman with one or the other disorder,” added Dr. Retnakaran, who is professor of medicine at the University of Toronto and an endocrinologist at the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, also in Toronto. “In other words, amongst already high-risk patients. This is identifying a subset at maybe an even higher risk.”

It doesn’t mean that there is a huge absolute risk, Dr. Retnakaran said, but it is showing that there is a heightened risk such that women and their clinicians need to be aware of and potentially the need for greater preventative care in the future.

“It is allowing you to identify future lifetime risk of cardiovascular disease,” he said.
 

Study rationale and design

GHTD is “a forerunner of hypertension,” and gestational diabetes is “a precursor of diabetes” – each associated with a high risk of developing CVD in the years after pregnancy, the investigators said. While studies have looked at their individual contributions to future CVD risk, not many had looked to see what risks having both may confer in the postpregnancy years.

For the analysis, data on 886,295 women with GHTD (43,861), gestational diabetes (54,061), both (4,975), or neither (783,398) were obtained from several Canadian administrative health databases.

The mean age was around 30 years across the groups, with those with both conditions or gestational diabetes alone more likely to be older than those with GTHD alone or neither condition (32 vs. 29 years, respectively, P < .001).

After a total follow-up period of 12 years, 1,999 CVD events were recorded, most of them (1,162) 5 years after the pregnancy.
 

Pregnancy is a stress test for the heart

“We know that what we call adverse pregnancy outcomes – things like gestational hypertension, and gestational diabetes, and preeclampsia – are on the rise globally,” Natalie A. Bello, MD, director of hypertension research at the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, commented in an interview.

Dr. Natalie Bello


“People who are younger and of childbearing age who are going into pregnancy now are less healthy than they perhaps were in the past,” Dr. Bello suggested, with more hypertension, more obesity, and people being less physically active. “We think that’s translating into some of the pregnancy complications.”

That’s concerning for a number of reasons, said Dr. Bello, who is also the cochair of the American College of Cardiology’s Cardio-Obstetrics Workgroup, and the biggest one perhaps is the stress that these may conditions may be placing on the heart.

“We know that when individuals have an adverse pregnancy outcome like gestational hypertension, or gestational diabetes, their risk for heart disease is increased in the future compared to someone who has an uncomplicated pregnancy,” she said. “So, we sort of say pregnancy is like a stress test for your heart.”

Dr. Bello added that “these situations, these adverse pregnancy outcomes are an indicator for us as physicians, but also they should be for patients as well, to sort of make sure they’re talking to their doctor about their risk factors and modifying them whenever possible.”

The population studied came from quite a racially, ethnically, and economically diverse area of Canada, Dr. Bello pointed out, although because of the nature of an administrative database there wasn’t information on individual level risk factors.

“We don’t know things like smoking, or if individuals were obese when they were pregnant. So, there are some limitations that should be noted,” she said.

Also, the results don’t mean that isolated gestational diabetes “isn’t something we need to be concerned about,” Dr. Bello observed, adding that the study may have been underpowered to look at this association. “It may just be that it will take a longer time for individuals who have gestational diabetes who don’t make lifestyle changes to develop diabetes, and then develop heart disease.”

The main message is that the women who have a co-occurrence of gestational hypertension and gestational diabetes are at particularly high risk of cardiovascular disease in the future,” said Dr. Retnakaran.

“The way to look at it from a patient standpoint is that we are all on different tracks in terms of our cardiometabolic destiny,” and that these data give “some understanding of what kind of tracks they are on for future risk,” Dr. Retnakaran said.

“A history of either gestational hypertension, and/or gestational diabetes should be really a warning sign for physicians and for patients that they have a higher risk of heart disease,” said Dr. Bello.

She added that this is a signal “that we need to do things to modify their risk, because we know that about 80% of heart disease is modifiable and preventable with proper risk factor management.”

The study was funded by the Ontario Ministry of Health and Long-Term Care. Dr. Retnakaran has received grants and personal fees from Novo Nordisk and Merck, grants from Boehringer Ingelheim, and personal fees from Eli Lily Takeda, and Sanofi. Dr. Bello had no conflicts of interest to disclose.



 

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Women who develop transient hypertensive disorders during their pregnancy are at risk for developing subsequent cardiovascular disease (CVD), particularly if this experienced at the same time as gestational diabetes.

In a large population-based study, the adjusted hazard ratios for developing CVD following a gestational hypertensive disorder (GHTD) alone were 1.90 (95% confidence interval, 1.151-2.25) within 5 years and 1.41 (95% CI, 1.12-1.76) after 5 years or more.

Vesnaandjic/E+/Getty Images

When gestational diabetes was added into the mix, however, the risk for CVD after 5 years more than doubled (aHR, 2.43; 95% CI, 1.60-3.67). Risk in the earlier postpartum period was also raised by the combination, but this was not significant (aHR, 1.42; 95% CI, 0.78-2.58).

Having gestational diabetes by itself did not seem to increase the risk for later CVD in the analysis, despite being linked to higher heart disease risk in other studies.

“These are women coming out of a pregnancy – young women of reproductive age – so this is not a group that typically has cardiovascular events,” said Ravi Retnakaran, MD, in an interview, an investigator in the new study, which is published in JAMA Network Open.

“If they are somebody who has both disorders concurrently in their pregnancy, they may be at even greater risk than a woman with one or the other disorder,” added Dr. Retnakaran, who is professor of medicine at the University of Toronto and an endocrinologist at the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, also in Toronto. “In other words, amongst already high-risk patients. This is identifying a subset at maybe an even higher risk.”

It doesn’t mean that there is a huge absolute risk, Dr. Retnakaran said, but it is showing that there is a heightened risk such that women and their clinicians need to be aware of and potentially the need for greater preventative care in the future.

“It is allowing you to identify future lifetime risk of cardiovascular disease,” he said.
 

Study rationale and design

GHTD is “a forerunner of hypertension,” and gestational diabetes is “a precursor of diabetes” – each associated with a high risk of developing CVD in the years after pregnancy, the investigators said. While studies have looked at their individual contributions to future CVD risk, not many had looked to see what risks having both may confer in the postpregnancy years.

For the analysis, data on 886,295 women with GHTD (43,861), gestational diabetes (54,061), both (4,975), or neither (783,398) were obtained from several Canadian administrative health databases.

The mean age was around 30 years across the groups, with those with both conditions or gestational diabetes alone more likely to be older than those with GTHD alone or neither condition (32 vs. 29 years, respectively, P < .001).

After a total follow-up period of 12 years, 1,999 CVD events were recorded, most of them (1,162) 5 years after the pregnancy.
 

Pregnancy is a stress test for the heart

“We know that what we call adverse pregnancy outcomes – things like gestational hypertension, and gestational diabetes, and preeclampsia – are on the rise globally,” Natalie A. Bello, MD, director of hypertension research at the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, commented in an interview.

Dr. Natalie Bello


“People who are younger and of childbearing age who are going into pregnancy now are less healthy than they perhaps were in the past,” Dr. Bello suggested, with more hypertension, more obesity, and people being less physically active. “We think that’s translating into some of the pregnancy complications.”

That’s concerning for a number of reasons, said Dr. Bello, who is also the cochair of the American College of Cardiology’s Cardio-Obstetrics Workgroup, and the biggest one perhaps is the stress that these may conditions may be placing on the heart.

“We know that when individuals have an adverse pregnancy outcome like gestational hypertension, or gestational diabetes, their risk for heart disease is increased in the future compared to someone who has an uncomplicated pregnancy,” she said. “So, we sort of say pregnancy is like a stress test for your heart.”

Dr. Bello added that “these situations, these adverse pregnancy outcomes are an indicator for us as physicians, but also they should be for patients as well, to sort of make sure they’re talking to their doctor about their risk factors and modifying them whenever possible.”

The population studied came from quite a racially, ethnically, and economically diverse area of Canada, Dr. Bello pointed out, although because of the nature of an administrative database there wasn’t information on individual level risk factors.

“We don’t know things like smoking, or if individuals were obese when they were pregnant. So, there are some limitations that should be noted,” she said.

Also, the results don’t mean that isolated gestational diabetes “isn’t something we need to be concerned about,” Dr. Bello observed, adding that the study may have been underpowered to look at this association. “It may just be that it will take a longer time for individuals who have gestational diabetes who don’t make lifestyle changes to develop diabetes, and then develop heart disease.”

The main message is that the women who have a co-occurrence of gestational hypertension and gestational diabetes are at particularly high risk of cardiovascular disease in the future,” said Dr. Retnakaran.

“The way to look at it from a patient standpoint is that we are all on different tracks in terms of our cardiometabolic destiny,” and that these data give “some understanding of what kind of tracks they are on for future risk,” Dr. Retnakaran said.

“A history of either gestational hypertension, and/or gestational diabetes should be really a warning sign for physicians and for patients that they have a higher risk of heart disease,” said Dr. Bello.

She added that this is a signal “that we need to do things to modify their risk, because we know that about 80% of heart disease is modifiable and preventable with proper risk factor management.”

The study was funded by the Ontario Ministry of Health and Long-Term Care. Dr. Retnakaran has received grants and personal fees from Novo Nordisk and Merck, grants from Boehringer Ingelheim, and personal fees from Eli Lily Takeda, and Sanofi. Dr. Bello had no conflicts of interest to disclose.



 

Women who develop transient hypertensive disorders during their pregnancy are at risk for developing subsequent cardiovascular disease (CVD), particularly if this experienced at the same time as gestational diabetes.

In a large population-based study, the adjusted hazard ratios for developing CVD following a gestational hypertensive disorder (GHTD) alone were 1.90 (95% confidence interval, 1.151-2.25) within 5 years and 1.41 (95% CI, 1.12-1.76) after 5 years or more.

Vesnaandjic/E+/Getty Images

When gestational diabetes was added into the mix, however, the risk for CVD after 5 years more than doubled (aHR, 2.43; 95% CI, 1.60-3.67). Risk in the earlier postpartum period was also raised by the combination, but this was not significant (aHR, 1.42; 95% CI, 0.78-2.58).

Having gestational diabetes by itself did not seem to increase the risk for later CVD in the analysis, despite being linked to higher heart disease risk in other studies.

“These are women coming out of a pregnancy – young women of reproductive age – so this is not a group that typically has cardiovascular events,” said Ravi Retnakaran, MD, in an interview, an investigator in the new study, which is published in JAMA Network Open.

“If they are somebody who has both disorders concurrently in their pregnancy, they may be at even greater risk than a woman with one or the other disorder,” added Dr. Retnakaran, who is professor of medicine at the University of Toronto and an endocrinologist at the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, also in Toronto. “In other words, amongst already high-risk patients. This is identifying a subset at maybe an even higher risk.”

It doesn’t mean that there is a huge absolute risk, Dr. Retnakaran said, but it is showing that there is a heightened risk such that women and their clinicians need to be aware of and potentially the need for greater preventative care in the future.

“It is allowing you to identify future lifetime risk of cardiovascular disease,” he said.
 

Study rationale and design

GHTD is “a forerunner of hypertension,” and gestational diabetes is “a precursor of diabetes” – each associated with a high risk of developing CVD in the years after pregnancy, the investigators said. While studies have looked at their individual contributions to future CVD risk, not many had looked to see what risks having both may confer in the postpregnancy years.

For the analysis, data on 886,295 women with GHTD (43,861), gestational diabetes (54,061), both (4,975), or neither (783,398) were obtained from several Canadian administrative health databases.

The mean age was around 30 years across the groups, with those with both conditions or gestational diabetes alone more likely to be older than those with GTHD alone or neither condition (32 vs. 29 years, respectively, P < .001).

After a total follow-up period of 12 years, 1,999 CVD events were recorded, most of them (1,162) 5 years after the pregnancy.
 

Pregnancy is a stress test for the heart

“We know that what we call adverse pregnancy outcomes – things like gestational hypertension, and gestational diabetes, and preeclampsia – are on the rise globally,” Natalie A. Bello, MD, director of hypertension research at the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, commented in an interview.

Dr. Natalie Bello


“People who are younger and of childbearing age who are going into pregnancy now are less healthy than they perhaps were in the past,” Dr. Bello suggested, with more hypertension, more obesity, and people being less physically active. “We think that’s translating into some of the pregnancy complications.”

That’s concerning for a number of reasons, said Dr. Bello, who is also the cochair of the American College of Cardiology’s Cardio-Obstetrics Workgroup, and the biggest one perhaps is the stress that these may conditions may be placing on the heart.

“We know that when individuals have an adverse pregnancy outcome like gestational hypertension, or gestational diabetes, their risk for heart disease is increased in the future compared to someone who has an uncomplicated pregnancy,” she said. “So, we sort of say pregnancy is like a stress test for your heart.”

Dr. Bello added that “these situations, these adverse pregnancy outcomes are an indicator for us as physicians, but also they should be for patients as well, to sort of make sure they’re talking to their doctor about their risk factors and modifying them whenever possible.”

The population studied came from quite a racially, ethnically, and economically diverse area of Canada, Dr. Bello pointed out, although because of the nature of an administrative database there wasn’t information on individual level risk factors.

“We don’t know things like smoking, or if individuals were obese when they were pregnant. So, there are some limitations that should be noted,” she said.

Also, the results don’t mean that isolated gestational diabetes “isn’t something we need to be concerned about,” Dr. Bello observed, adding that the study may have been underpowered to look at this association. “It may just be that it will take a longer time for individuals who have gestational diabetes who don’t make lifestyle changes to develop diabetes, and then develop heart disease.”

The main message is that the women who have a co-occurrence of gestational hypertension and gestational diabetes are at particularly high risk of cardiovascular disease in the future,” said Dr. Retnakaran.

“The way to look at it from a patient standpoint is that we are all on different tracks in terms of our cardiometabolic destiny,” and that these data give “some understanding of what kind of tracks they are on for future risk,” Dr. Retnakaran said.

“A history of either gestational hypertension, and/or gestational diabetes should be really a warning sign for physicians and for patients that they have a higher risk of heart disease,” said Dr. Bello.

She added that this is a signal “that we need to do things to modify their risk, because we know that about 80% of heart disease is modifiable and preventable with proper risk factor management.”

The study was funded by the Ontario Ministry of Health and Long-Term Care. Dr. Retnakaran has received grants and personal fees from Novo Nordisk and Merck, grants from Boehringer Ingelheim, and personal fees from Eli Lily Takeda, and Sanofi. Dr. Bello had no conflicts of interest to disclose.



 

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A new use for dating apps: Chasing STDs

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Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.

Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.

A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.

“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”

Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.

Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.

So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.

Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.

Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.

When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.

Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.

“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.

Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.

But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.

What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.

Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.

Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.

During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.

That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.

There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.

That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)

Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.

Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”

But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.

The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”

Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.

That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.

Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.

But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.

Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.

A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.

“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”

Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.

Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.

So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.

Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.

Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.

When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.

Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.

“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.

Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.

But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.

What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.

Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.

Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.

During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.

That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.

There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.

That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)

Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.

Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”

But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.

The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”

Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.

That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.

Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.

But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.

Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.

A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.

“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”

Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.

Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.

So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.

Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.

Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.

When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.

Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.

“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.

Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.

But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.

What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.

Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.

Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.

During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.

That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.

There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.

That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)

Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.

Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”

But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.

The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”

Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.

That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.

Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.

But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Buprenorphine linked with lower risk for neonatal harms than methadone

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Changed
Wed, 11/30/2022 - 12:13

Using buprenorphine for opioid use disorder in pregnancy was linked with a lower risk of neonatal side effects than using methadone, but the risk of adverse maternal outcomes was similar between the two treatments, according to new research.

Elizabeth A. Suarez, PhD, MPH, with Brigham and Women’s Hospital in Boston, led the study published online in the New England Journal of Medicine.

Opioid use disorder in pregnant women has increased steadily in the United States since 2000, the authors write. As of 2017, about 8.2 per 1,000 deliveries were estimated to be affected by the disorder. The numbers were particularly high in people insured by Medicaid. In that group, an estimated 14.6 per 1,000 deliveries were affected.

Researchers studied pregnant women enrolled in public insurance programs in the United States from 2000 through 2018 in a dataset of 2,548,372 pregnancies that ended in live births. They analyzed outcomes in those who received buprenorphine as compared with those who received methadone.

They looked at different periods of exposure to the two medications: early pregnancy (through gestational week 19); late pregnancy (week 20 through the day before delivery); and the 30 days before delivery.

Highlighted differences in infants included:

  • Neonatal abstinence syndrome in 52% of the infants who were exposed to buprenorphine in the 30 days before delivery as compared with 69.2% of those exposed to methadone (adjusted relative risk, 0.73).
  • Preterm birth in 14.4% of infants exposed to buprenorphine in early pregnancy and in 24.9% of those exposed to methadone (ARR, 0.58).
  • Small size for gestational age in 12.1% (buprenorphine) and 15.3% (methadone) (ARR, 0.72).
  • Low birth weight in 8.3% (buprenorphine) and 14.9% (methadone) (ARR, 0.56).
  • Delivery by cesarean section occurred in 33.6% of pregnant women exposed to buprenorphine in early pregnancy and 33.1% of those exposed to methadone (ARR, 1.02.).

Severe maternal complications developed in 3.3% of the women exposed to buprenorphine and 3.5% of those on methadone (ARR, 0.91.) Exposures in late pregnancy and early pregnancy yielded similar results, the authors say.

Dr. Michael Caucci

Michael Caucci, MD, of the department of psychiatry at Vanderbilt University Medical Center in Nashville, Tenn. who also runs the Women’s Mental Health Clinic at the university, said this paper supports preliminary findings from the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study that suggested infants exposed to buprenorphine (compared with methadone) appeared to have lower rates of neonatal complications.

“It also supports buprenorphine as a relatively safe option for treatment of opioid use disorder during pregnancy,” said Dr. Caucci, who was not part of the study by Dr. Suarez and associates. “Reducing the fear of harming the fetus or neonate will help eliminate this barrier to perinatal substance use disorder treatment.”

But he cautions against concluding that, because buprenorphine has lower risks of fetal/neonatal complications, it is safer and therefore better than methadone in pregnancy. 

“Some women do not tolerate buprenorphine and do much better on methadone, Dr. Caucci said. “Current recommendations are that both buprenorphine and methadone are relatively safe options for treatment of OUD [opioid use disorder] in pregnancy.”

Among the differences between the treatments is that while methadone is administered daily during in-person visits to federally regulated opioid treatment programs, buprenorphine can be prescribed by approved providers, which allows patients to administer buprenorphine themselves.

Dr. Caucci said he was intrigued by the finding that there was no difference in pregnancy, neonatal, and maternal outcomes depending on the time of exposure to the agents.  

“I would have expected higher rates of neonatal abstinence syndrome (NAS) or poor fetal growth in those exposed later in pregnancy vs. those with early exposure,” he said. 

The work was supported by the National Institute on Drug Abuse. Dr. Caucci reports no relevant financial relationships. The authors’ disclosures are available with the full text.

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Using buprenorphine for opioid use disorder in pregnancy was linked with a lower risk of neonatal side effects than using methadone, but the risk of adverse maternal outcomes was similar between the two treatments, according to new research.

Elizabeth A. Suarez, PhD, MPH, with Brigham and Women’s Hospital in Boston, led the study published online in the New England Journal of Medicine.

Opioid use disorder in pregnant women has increased steadily in the United States since 2000, the authors write. As of 2017, about 8.2 per 1,000 deliveries were estimated to be affected by the disorder. The numbers were particularly high in people insured by Medicaid. In that group, an estimated 14.6 per 1,000 deliveries were affected.

Researchers studied pregnant women enrolled in public insurance programs in the United States from 2000 through 2018 in a dataset of 2,548,372 pregnancies that ended in live births. They analyzed outcomes in those who received buprenorphine as compared with those who received methadone.

They looked at different periods of exposure to the two medications: early pregnancy (through gestational week 19); late pregnancy (week 20 through the day before delivery); and the 30 days before delivery.

Highlighted differences in infants included:

  • Neonatal abstinence syndrome in 52% of the infants who were exposed to buprenorphine in the 30 days before delivery as compared with 69.2% of those exposed to methadone (adjusted relative risk, 0.73).
  • Preterm birth in 14.4% of infants exposed to buprenorphine in early pregnancy and in 24.9% of those exposed to methadone (ARR, 0.58).
  • Small size for gestational age in 12.1% (buprenorphine) and 15.3% (methadone) (ARR, 0.72).
  • Low birth weight in 8.3% (buprenorphine) and 14.9% (methadone) (ARR, 0.56).
  • Delivery by cesarean section occurred in 33.6% of pregnant women exposed to buprenorphine in early pregnancy and 33.1% of those exposed to methadone (ARR, 1.02.).

Severe maternal complications developed in 3.3% of the women exposed to buprenorphine and 3.5% of those on methadone (ARR, 0.91.) Exposures in late pregnancy and early pregnancy yielded similar results, the authors say.

Dr. Michael Caucci

Michael Caucci, MD, of the department of psychiatry at Vanderbilt University Medical Center in Nashville, Tenn. who also runs the Women’s Mental Health Clinic at the university, said this paper supports preliminary findings from the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study that suggested infants exposed to buprenorphine (compared with methadone) appeared to have lower rates of neonatal complications.

“It also supports buprenorphine as a relatively safe option for treatment of opioid use disorder during pregnancy,” said Dr. Caucci, who was not part of the study by Dr. Suarez and associates. “Reducing the fear of harming the fetus or neonate will help eliminate this barrier to perinatal substance use disorder treatment.”

But he cautions against concluding that, because buprenorphine has lower risks of fetal/neonatal complications, it is safer and therefore better than methadone in pregnancy. 

“Some women do not tolerate buprenorphine and do much better on methadone, Dr. Caucci said. “Current recommendations are that both buprenorphine and methadone are relatively safe options for treatment of OUD [opioid use disorder] in pregnancy.”

Among the differences between the treatments is that while methadone is administered daily during in-person visits to federally regulated opioid treatment programs, buprenorphine can be prescribed by approved providers, which allows patients to administer buprenorphine themselves.

Dr. Caucci said he was intrigued by the finding that there was no difference in pregnancy, neonatal, and maternal outcomes depending on the time of exposure to the agents.  

“I would have expected higher rates of neonatal abstinence syndrome (NAS) or poor fetal growth in those exposed later in pregnancy vs. those with early exposure,” he said. 

The work was supported by the National Institute on Drug Abuse. Dr. Caucci reports no relevant financial relationships. The authors’ disclosures are available with the full text.

Using buprenorphine for opioid use disorder in pregnancy was linked with a lower risk of neonatal side effects than using methadone, but the risk of adverse maternal outcomes was similar between the two treatments, according to new research.

Elizabeth A. Suarez, PhD, MPH, with Brigham and Women’s Hospital in Boston, led the study published online in the New England Journal of Medicine.

Opioid use disorder in pregnant women has increased steadily in the United States since 2000, the authors write. As of 2017, about 8.2 per 1,000 deliveries were estimated to be affected by the disorder. The numbers were particularly high in people insured by Medicaid. In that group, an estimated 14.6 per 1,000 deliveries were affected.

Researchers studied pregnant women enrolled in public insurance programs in the United States from 2000 through 2018 in a dataset of 2,548,372 pregnancies that ended in live births. They analyzed outcomes in those who received buprenorphine as compared with those who received methadone.

They looked at different periods of exposure to the two medications: early pregnancy (through gestational week 19); late pregnancy (week 20 through the day before delivery); and the 30 days before delivery.

Highlighted differences in infants included:

  • Neonatal abstinence syndrome in 52% of the infants who were exposed to buprenorphine in the 30 days before delivery as compared with 69.2% of those exposed to methadone (adjusted relative risk, 0.73).
  • Preterm birth in 14.4% of infants exposed to buprenorphine in early pregnancy and in 24.9% of those exposed to methadone (ARR, 0.58).
  • Small size for gestational age in 12.1% (buprenorphine) and 15.3% (methadone) (ARR, 0.72).
  • Low birth weight in 8.3% (buprenorphine) and 14.9% (methadone) (ARR, 0.56).
  • Delivery by cesarean section occurred in 33.6% of pregnant women exposed to buprenorphine in early pregnancy and 33.1% of those exposed to methadone (ARR, 1.02.).

Severe maternal complications developed in 3.3% of the women exposed to buprenorphine and 3.5% of those on methadone (ARR, 0.91.) Exposures in late pregnancy and early pregnancy yielded similar results, the authors say.

Dr. Michael Caucci

Michael Caucci, MD, of the department of psychiatry at Vanderbilt University Medical Center in Nashville, Tenn. who also runs the Women’s Mental Health Clinic at the university, said this paper supports preliminary findings from the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study that suggested infants exposed to buprenorphine (compared with methadone) appeared to have lower rates of neonatal complications.

“It also supports buprenorphine as a relatively safe option for treatment of opioid use disorder during pregnancy,” said Dr. Caucci, who was not part of the study by Dr. Suarez and associates. “Reducing the fear of harming the fetus or neonate will help eliminate this barrier to perinatal substance use disorder treatment.”

But he cautions against concluding that, because buprenorphine has lower risks of fetal/neonatal complications, it is safer and therefore better than methadone in pregnancy. 

“Some women do not tolerate buprenorphine and do much better on methadone, Dr. Caucci said. “Current recommendations are that both buprenorphine and methadone are relatively safe options for treatment of OUD [opioid use disorder] in pregnancy.”

Among the differences between the treatments is that while methadone is administered daily during in-person visits to federally regulated opioid treatment programs, buprenorphine can be prescribed by approved providers, which allows patients to administer buprenorphine themselves.

Dr. Caucci said he was intrigued by the finding that there was no difference in pregnancy, neonatal, and maternal outcomes depending on the time of exposure to the agents.  

“I would have expected higher rates of neonatal abstinence syndrome (NAS) or poor fetal growth in those exposed later in pregnancy vs. those with early exposure,” he said. 

The work was supported by the National Institute on Drug Abuse. Dr. Caucci reports no relevant financial relationships. The authors’ disclosures are available with the full text.

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Women need not wait to conceive after miscarriage, abortion

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Changed
Wed, 11/30/2022 - 09:49

Women who conceived within 6 months of having a miscarriage or an induced abortion did not appear to be at an increased risk of a problematic pregnancy, a new study of more than 70,000 live births in Norway has found.

The findings, published online in PLOS Medicine, should help women and clinicians navigate conflicting guidance over how soon it is safe to conceive again after a pregnancy loss, said Gizachew Tessema, PhD, senior research fellow at Curtin University, Perth, Australia, and the lead author of the research.

“Especially after a miscarriage, women want to conceive again,” Dr. Tessema told this news organization. “Why should they wait if there’s no increased risk?”

On the international front, the World Health Organization advises patients not to attempt to become pregnant until a minimum of 6 months after an abortion or miscarriage. Those 2007 recommendations spurred Dr. Tessema and his colleagues to take a deeper dive into risk factors associated with pregnancies following a shorter interval. 

Two-thirds of women in the study conceived again within 6 months of having a miscarriage. Only a quarter of women who had an induced abortion were pregnant again within that same timeframe.

Using Norway’s national health registries, the researchers examined the outcomes of 49,058 births following a miscarriage and 23,707 births after an induced abortion between 2008 and 2016. The birth registry includes information on livebirths, stillbirths, miscarriages, and induced abortions, with detailed descriptions provided around how a miscarriage or abortion is identified. The study included only miscarriages reported through the health care system.

Expanding on other studies that have shown no adverse outcomes with those pregnancy intervals, Dr. Tessema and colleagues found that women who became pregnant shortly after a miscarriage or abortion were not at a higher risk for delivering preterm, having newborns that were small for gestational age (SGA) or large for gestational age (LGA), or developing preeclampsia or gestational diabetes.

Dr. Tessema and his colleagues found a slightly smaller percentage of women who conceived within 3 months, compared with those who became pregnant within 6-11 months after a miscarriage (8.6% to 10.1%). Women who conceived within 3 months of an induced abortion had a slightly, but statistically nonsignificant (P = .07), increased risk for SGA, compared with those who conceived between 6 and 11 months (11.5% to 10%).

No greater risk was shown for the other adverse outcomes – preterm births, LGA, preeclampsia, and GDM – for women who became pregnant within 6 months of an abortion or miscarriage.

The results should reassure women who want to get pregnant again soon after abortions or miscarriage, according to Scott Sullivan, MD, the director of high-risk ob.gyn. at Inova Health, Fairfax, Va.

Often, patients hear conflicting advice from doctors, friends, or medical associations about the best time to try for a baby following a miscarriage or abortion, in part because there are differences in various guidelines. Adding to the confusion is a lack of robust research and data on pregnancy loss, especially in the United States, he said.

“The entire topic of pregnancy loss is underappreciated by the public at large – how painful this is for people, how common it is,” Dr. Sullivan said in an interview. “We need research and resources on it. It’s not even tracked routinely in the United States like it is in other countries.”

Dr. Sullivan said he typically tells patients they can try to get pregnant again right away, following recommendations from the American College of Obstetricians and Gynecologists, which say that patients can conceive as quickly as 2 weeks after an early pregnancy loss.

But he cautions that not all patients are mentally ready to make another attempt that soon, especially if they are still grieving their pregnancy loss.

“Even if you’re physically ready, a lot of people are not emotionally ready, because there’s a grieving process,” Dr. Sullivan said. “That’s very different for people.”
 

 

 

The WHO’s guidelines for developed countries

The WHO developed its guidelines based on research from lower income countries, including one study across Latin America that concluded pregnancy outcomes were worse for women who waited less than 6 months to conceive following an abortion or miscarriage.

Dr. Tessema noted his research is limited because it focused on Norway, a high-income country where women have guaranteed access to health care. Outcomes may be worse in developing countries where incomes are lower and health care inequality is greater, he said.

“The issue is when this international guideline was developed, most of the evidence is from low- and middle-income countries,” Dr. Tessema said. “No studies were conducted from high income cities. We said: ‘This is a different context.’ These recommendations may not be appropriate for this setting.”

The study was supported with funding by the Research Council of Norway through its Centres of Excellence funding program, the National Health and Medical Research Council, the Raine Medical Research Foundation, and the European Research Council under the European Union’s Horizon 2020 Research and Innovation Programme. None of the authors report relevant financial relationships.

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

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Women who conceived within 6 months of having a miscarriage or an induced abortion did not appear to be at an increased risk of a problematic pregnancy, a new study of more than 70,000 live births in Norway has found.

The findings, published online in PLOS Medicine, should help women and clinicians navigate conflicting guidance over how soon it is safe to conceive again after a pregnancy loss, said Gizachew Tessema, PhD, senior research fellow at Curtin University, Perth, Australia, and the lead author of the research.

“Especially after a miscarriage, women want to conceive again,” Dr. Tessema told this news organization. “Why should they wait if there’s no increased risk?”

On the international front, the World Health Organization advises patients not to attempt to become pregnant until a minimum of 6 months after an abortion or miscarriage. Those 2007 recommendations spurred Dr. Tessema and his colleagues to take a deeper dive into risk factors associated with pregnancies following a shorter interval. 

Two-thirds of women in the study conceived again within 6 months of having a miscarriage. Only a quarter of women who had an induced abortion were pregnant again within that same timeframe.

Using Norway’s national health registries, the researchers examined the outcomes of 49,058 births following a miscarriage and 23,707 births after an induced abortion between 2008 and 2016. The birth registry includes information on livebirths, stillbirths, miscarriages, and induced abortions, with detailed descriptions provided around how a miscarriage or abortion is identified. The study included only miscarriages reported through the health care system.

Expanding on other studies that have shown no adverse outcomes with those pregnancy intervals, Dr. Tessema and colleagues found that women who became pregnant shortly after a miscarriage or abortion were not at a higher risk for delivering preterm, having newborns that were small for gestational age (SGA) or large for gestational age (LGA), or developing preeclampsia or gestational diabetes.

Dr. Tessema and his colleagues found a slightly smaller percentage of women who conceived within 3 months, compared with those who became pregnant within 6-11 months after a miscarriage (8.6% to 10.1%). Women who conceived within 3 months of an induced abortion had a slightly, but statistically nonsignificant (P = .07), increased risk for SGA, compared with those who conceived between 6 and 11 months (11.5% to 10%).

No greater risk was shown for the other adverse outcomes – preterm births, LGA, preeclampsia, and GDM – for women who became pregnant within 6 months of an abortion or miscarriage.

The results should reassure women who want to get pregnant again soon after abortions or miscarriage, according to Scott Sullivan, MD, the director of high-risk ob.gyn. at Inova Health, Fairfax, Va.

Often, patients hear conflicting advice from doctors, friends, or medical associations about the best time to try for a baby following a miscarriage or abortion, in part because there are differences in various guidelines. Adding to the confusion is a lack of robust research and data on pregnancy loss, especially in the United States, he said.

“The entire topic of pregnancy loss is underappreciated by the public at large – how painful this is for people, how common it is,” Dr. Sullivan said in an interview. “We need research and resources on it. It’s not even tracked routinely in the United States like it is in other countries.”

Dr. Sullivan said he typically tells patients they can try to get pregnant again right away, following recommendations from the American College of Obstetricians and Gynecologists, which say that patients can conceive as quickly as 2 weeks after an early pregnancy loss.

But he cautions that not all patients are mentally ready to make another attempt that soon, especially if they are still grieving their pregnancy loss.

“Even if you’re physically ready, a lot of people are not emotionally ready, because there’s a grieving process,” Dr. Sullivan said. “That’s very different for people.”
 

 

 

The WHO’s guidelines for developed countries

The WHO developed its guidelines based on research from lower income countries, including one study across Latin America that concluded pregnancy outcomes were worse for women who waited less than 6 months to conceive following an abortion or miscarriage.

Dr. Tessema noted his research is limited because it focused on Norway, a high-income country where women have guaranteed access to health care. Outcomes may be worse in developing countries where incomes are lower and health care inequality is greater, he said.

“The issue is when this international guideline was developed, most of the evidence is from low- and middle-income countries,” Dr. Tessema said. “No studies were conducted from high income cities. We said: ‘This is a different context.’ These recommendations may not be appropriate for this setting.”

The study was supported with funding by the Research Council of Norway through its Centres of Excellence funding program, the National Health and Medical Research Council, the Raine Medical Research Foundation, and the European Research Council under the European Union’s Horizon 2020 Research and Innovation Programme. None of the authors report relevant financial relationships.

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

Women who conceived within 6 months of having a miscarriage or an induced abortion did not appear to be at an increased risk of a problematic pregnancy, a new study of more than 70,000 live births in Norway has found.

The findings, published online in PLOS Medicine, should help women and clinicians navigate conflicting guidance over how soon it is safe to conceive again after a pregnancy loss, said Gizachew Tessema, PhD, senior research fellow at Curtin University, Perth, Australia, and the lead author of the research.

“Especially after a miscarriage, women want to conceive again,” Dr. Tessema told this news organization. “Why should they wait if there’s no increased risk?”

On the international front, the World Health Organization advises patients not to attempt to become pregnant until a minimum of 6 months after an abortion or miscarriage. Those 2007 recommendations spurred Dr. Tessema and his colleagues to take a deeper dive into risk factors associated with pregnancies following a shorter interval. 

Two-thirds of women in the study conceived again within 6 months of having a miscarriage. Only a quarter of women who had an induced abortion were pregnant again within that same timeframe.

Using Norway’s national health registries, the researchers examined the outcomes of 49,058 births following a miscarriage and 23,707 births after an induced abortion between 2008 and 2016. The birth registry includes information on livebirths, stillbirths, miscarriages, and induced abortions, with detailed descriptions provided around how a miscarriage or abortion is identified. The study included only miscarriages reported through the health care system.

Expanding on other studies that have shown no adverse outcomes with those pregnancy intervals, Dr. Tessema and colleagues found that women who became pregnant shortly after a miscarriage or abortion were not at a higher risk for delivering preterm, having newborns that were small for gestational age (SGA) or large for gestational age (LGA), or developing preeclampsia or gestational diabetes.

Dr. Tessema and his colleagues found a slightly smaller percentage of women who conceived within 3 months, compared with those who became pregnant within 6-11 months after a miscarriage (8.6% to 10.1%). Women who conceived within 3 months of an induced abortion had a slightly, but statistically nonsignificant (P = .07), increased risk for SGA, compared with those who conceived between 6 and 11 months (11.5% to 10%).

No greater risk was shown for the other adverse outcomes – preterm births, LGA, preeclampsia, and GDM – for women who became pregnant within 6 months of an abortion or miscarriage.

The results should reassure women who want to get pregnant again soon after abortions or miscarriage, according to Scott Sullivan, MD, the director of high-risk ob.gyn. at Inova Health, Fairfax, Va.

Often, patients hear conflicting advice from doctors, friends, or medical associations about the best time to try for a baby following a miscarriage or abortion, in part because there are differences in various guidelines. Adding to the confusion is a lack of robust research and data on pregnancy loss, especially in the United States, he said.

“The entire topic of pregnancy loss is underappreciated by the public at large – how painful this is for people, how common it is,” Dr. Sullivan said in an interview. “We need research and resources on it. It’s not even tracked routinely in the United States like it is in other countries.”

Dr. Sullivan said he typically tells patients they can try to get pregnant again right away, following recommendations from the American College of Obstetricians and Gynecologists, which say that patients can conceive as quickly as 2 weeks after an early pregnancy loss.

But he cautions that not all patients are mentally ready to make another attempt that soon, especially if they are still grieving their pregnancy loss.

“Even if you’re physically ready, a lot of people are not emotionally ready, because there’s a grieving process,” Dr. Sullivan said. “That’s very different for people.”
 

 

 

The WHO’s guidelines for developed countries

The WHO developed its guidelines based on research from lower income countries, including one study across Latin America that concluded pregnancy outcomes were worse for women who waited less than 6 months to conceive following an abortion or miscarriage.

Dr. Tessema noted his research is limited because it focused on Norway, a high-income country where women have guaranteed access to health care. Outcomes may be worse in developing countries where incomes are lower and health care inequality is greater, he said.

“The issue is when this international guideline was developed, most of the evidence is from low- and middle-income countries,” Dr. Tessema said. “No studies were conducted from high income cities. We said: ‘This is a different context.’ These recommendations may not be appropriate for this setting.”

The study was supported with funding by the Research Council of Norway through its Centres of Excellence funding program, the National Health and Medical Research Council, the Raine Medical Research Foundation, and the European Research Council under the European Union’s Horizon 2020 Research and Innovation Programme. None of the authors report relevant financial relationships.

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

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Future HIV PrEP innovations aim to address adherence, women’s health, and combination treatments

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Tue, 11/29/2022 - 09:26

– Pre-exposure prophylaxis (PrEP) has shown to be effective in many clinical and real-world studies, but concerns remain, according to research presented at the annual meeting of the Association of Nurses in AIDS Care (ANAC).

Only about 20% of people who could benefit from PrEP use the preventative medication, for example. Another concern is adherence, as regular use generally drops off over time, rarely lasting more than a few months for most people.

Furthermore, most studies to date evaluated safety and effectiveness of PrEP options among men who have sex with men. Now the focus is increasing on other populations, including women at risk of HIV exposure.  

Researchers working on new forms and formulations of PrEP are looking for ways to address those challenges.

No matter the target population, new options are needed that fit more seamlessly into people’s sex lives, said Craig W. Hendrix, MD, professor and director of the Division of Clinical Pharmacology at Johns Hopkins University School of Medicine, Baltimore.

“What I hear a lot of folks say [is] there are two or three options for PrEP, so why do we need more? We need choices that fit into a broader range of lifestyles,” Dr. Hendrix said.

For example, a medically fortified douche containing PrEP might be more likely to be used by people who use a douche before or after sex on a regular basis. This is called a “behaviorally congruent” strategy, Dr. Hendrix said.

In addition to a medical douche, formulations designed to continuously deliver PrEP, such as a subdermal implant, are in the works as well.

Another option for women, the dapivirine vaginal ring, is available internationally but not in the United States. “It was withdrawn from [Food and Drug Administration] consideration by the sponsor. I think it’s a huge loss not to have that,” Dr. Hendrix said.

During development, “frequent expulsions forced reformulation to a less stiff ring,” Dr. Hendrix said. “I don’t imagine that’s terrific, but it shows how important it is to have something that fits the anatomy and the lifestyle.”

“Currently, we have in the U.S. three licensed, really terrific options for PrEP, and they’re all for men that have sex with men and transgender women,” Dr. Hendrix said.
 

Three current options

The three current PrEP regimens in the United States often go by their abbreviations: F/TDF, F/TAF, and CAB-IM.

  • F/TDF is emtricitabine (F) 200 mg in combination with tenofovir disoproxil fumarate (TDF) 300 mg (Truvada, Gilead or generics)
  • F/TAF is emtricitabine (F) 200 mg in combination with tenofovir alafenamide (TAF) 25 mg (Descovy, Gilead)
  • CAB-IM is cabotegravir (CAB) 600 mg injection (Apretude, GlaxoSmithKline)

There is an important distinction: Daily oral PrEP with F/TDF is recommended to prevent HIV infection among all people at risk through sex or injection drug use. Daily oral PrEP with F/TAF is recommended to prevent HIV infection among people at risk through sex, excluding people at risk through receptive vaginal sex, the CDC notes.

The cost-effectiveness of the injection remains a potential issue, Dr. Hendrix said. On the other hand, “cost-effectiveness goes out the window if there is no adherence.”
 

 

 

An active pipeline

There are 24 new PrEP products in development, as well as 24 other multipurpose prevention technologies (MPTs), which are combination products containing PrEP and one or two other medications.

These 48 products include 28 unique antiviral and contraceptive drugs and 12 delivery methods or formulations. “Why so many?” Dr. Hendrix asked. “Many will not make it through development.”

Pills that include HIV PrEP and contraception or PrEP and sexually transmitted infection (STI) treatment are being evaluated, for example. “HIV risk, pregnancy risk, and other viral STIs overlap. Ideally, you can have one target for all three. That would increase efficiency of dosing and adherence,” Dr. Hendrix said.

Dual prevention pills (DPPs) hypothetically provide HIV PrEP and contraception better than either product alone, Dr. Hendrix said. Plans are to market them as family planning or women’s health products to avoid any stigma or distrust associated with HIV PrEP. An initial rollout is planned in 2024 in sub-Saharan Africa where the unmet need is highest, he added.

“Imagine how effective this could be in women in the United States,” Dr. Hendrix said. “My hope is fourth-quarter 2024” availability in the United States.

A way to prevent STIs and HIV in an all-in-one product “would be terrific,” Dr. Hendrix said.

“I think we’re going to see a lot more innovation going in that direction. The pill is close. The other things are going to be further off because the regulatory pathway is a little more complicated.”
 

Longer lasting protection?

All of the innovations have gone one of two directions, Dr. Hendrix said. One direction is to make PrEP even longer acting, “so that you have even less to worry [about] in terms of adherence.”

Going forward, “most of the focus has all been on continuously acting or long-active PrEP. It’s getting longer and longer: We’ve got 2 months, and they’re looking at a 6-month subcutaneous injection,” Dr. Hendrix said. The investigational agent lenacapavir is in development as PrEP, as well as for HIV treatment.

“This could get us from 2 to 6 months,” Dr. Hendrix said.

Some of the subcutaneous implants look as if they could provide PrEP for up to 12 months, he added. “An implant could also avoid peaks and troughs with bi-monthly injections.”
 

On-demand PrEP

The other direction is on-demand. “This is for the folks that don’t want drug in their body all the time. They only want it when they need it. And a twist on that ... is actually using products that are already used with sex now but medicating them.”

On-demand rectal options include a medicated douche and a fast-dissolving insert or suppository.

Fast-dissolving vaginal inserts are also in development. “These inserts are small, easy to store, inexpensive, and possibly inapparent to a partner,” Dr. Hendrix said.

Phase 2 studies will need to determine if these products “fit into folks’ active sex lives,” he said. “There’s still a need for human-friendly, human-designed products.”

A rectal microbicide that got as far as Phase 2 research provides a cautionary tale. The concentrations and the biology worked fine, Dr. Hendrix said. “It was a gel with an applicator, and it just was not liked by the folks in the study.” He added, “Your adherence is going to be in the tank if you’ve got a product that people don’t like to use.”
 

 

 

‘Extremely excited’

Asked for her perspective on Dr. Hendrix’s presentation, session moderator Rasheeta D. Chandler, PhD, RN, an associate professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said: “I am extremely excited, because I work with cisgender women, particularly with underserved women and women of color, and there’s a tendency to focus on men who have sex with men.”

“I understand, because they are the population that is most affected, but Black women are also extremely affected by this disease,” Dr. Chandler told this news organization.

Dr. Chandler applauded Dr. Hendrix for addressing women’s health needs as well and not treating PrEP in women “as an afterthought.”

“Finally, our voices are being heard that [PrEP] should be equitable across all different types of individuals who identify differently in a sexual context,” Dr. Chandler said.

More work is warranted to evaluate PrEP in other populations, including transgender men and individuals who inject drugs, Dr. Hendrix said.

For more information and updates on HIV PrEP and MPTs, visit the website of the nonprofit AIDS Vaccine Advocacy Coalition.

Dr. Hendrix has disclosed receiving research grants from Gilead and Merck. Dr. Chandler has reported no relevant financial relationships.

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

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– Pre-exposure prophylaxis (PrEP) has shown to be effective in many clinical and real-world studies, but concerns remain, according to research presented at the annual meeting of the Association of Nurses in AIDS Care (ANAC).

Only about 20% of people who could benefit from PrEP use the preventative medication, for example. Another concern is adherence, as regular use generally drops off over time, rarely lasting more than a few months for most people.

Furthermore, most studies to date evaluated safety and effectiveness of PrEP options among men who have sex with men. Now the focus is increasing on other populations, including women at risk of HIV exposure.  

Researchers working on new forms and formulations of PrEP are looking for ways to address those challenges.

No matter the target population, new options are needed that fit more seamlessly into people’s sex lives, said Craig W. Hendrix, MD, professor and director of the Division of Clinical Pharmacology at Johns Hopkins University School of Medicine, Baltimore.

“What I hear a lot of folks say [is] there are two or three options for PrEP, so why do we need more? We need choices that fit into a broader range of lifestyles,” Dr. Hendrix said.

For example, a medically fortified douche containing PrEP might be more likely to be used by people who use a douche before or after sex on a regular basis. This is called a “behaviorally congruent” strategy, Dr. Hendrix said.

In addition to a medical douche, formulations designed to continuously deliver PrEP, such as a subdermal implant, are in the works as well.

Another option for women, the dapivirine vaginal ring, is available internationally but not in the United States. “It was withdrawn from [Food and Drug Administration] consideration by the sponsor. I think it’s a huge loss not to have that,” Dr. Hendrix said.

During development, “frequent expulsions forced reformulation to a less stiff ring,” Dr. Hendrix said. “I don’t imagine that’s terrific, but it shows how important it is to have something that fits the anatomy and the lifestyle.”

“Currently, we have in the U.S. three licensed, really terrific options for PrEP, and they’re all for men that have sex with men and transgender women,” Dr. Hendrix said.
 

Three current options

The three current PrEP regimens in the United States often go by their abbreviations: F/TDF, F/TAF, and CAB-IM.

  • F/TDF is emtricitabine (F) 200 mg in combination with tenofovir disoproxil fumarate (TDF) 300 mg (Truvada, Gilead or generics)
  • F/TAF is emtricitabine (F) 200 mg in combination with tenofovir alafenamide (TAF) 25 mg (Descovy, Gilead)
  • CAB-IM is cabotegravir (CAB) 600 mg injection (Apretude, GlaxoSmithKline)

There is an important distinction: Daily oral PrEP with F/TDF is recommended to prevent HIV infection among all people at risk through sex or injection drug use. Daily oral PrEP with F/TAF is recommended to prevent HIV infection among people at risk through sex, excluding people at risk through receptive vaginal sex, the CDC notes.

The cost-effectiveness of the injection remains a potential issue, Dr. Hendrix said. On the other hand, “cost-effectiveness goes out the window if there is no adherence.”
 

 

 

An active pipeline

There are 24 new PrEP products in development, as well as 24 other multipurpose prevention technologies (MPTs), which are combination products containing PrEP and one or two other medications.

These 48 products include 28 unique antiviral and contraceptive drugs and 12 delivery methods or formulations. “Why so many?” Dr. Hendrix asked. “Many will not make it through development.”

Pills that include HIV PrEP and contraception or PrEP and sexually transmitted infection (STI) treatment are being evaluated, for example. “HIV risk, pregnancy risk, and other viral STIs overlap. Ideally, you can have one target for all three. That would increase efficiency of dosing and adherence,” Dr. Hendrix said.

Dual prevention pills (DPPs) hypothetically provide HIV PrEP and contraception better than either product alone, Dr. Hendrix said. Plans are to market them as family planning or women’s health products to avoid any stigma or distrust associated with HIV PrEP. An initial rollout is planned in 2024 in sub-Saharan Africa where the unmet need is highest, he added.

“Imagine how effective this could be in women in the United States,” Dr. Hendrix said. “My hope is fourth-quarter 2024” availability in the United States.

A way to prevent STIs and HIV in an all-in-one product “would be terrific,” Dr. Hendrix said.

“I think we’re going to see a lot more innovation going in that direction. The pill is close. The other things are going to be further off because the regulatory pathway is a little more complicated.”
 

Longer lasting protection?

All of the innovations have gone one of two directions, Dr. Hendrix said. One direction is to make PrEP even longer acting, “so that you have even less to worry [about] in terms of adherence.”

Going forward, “most of the focus has all been on continuously acting or long-active PrEP. It’s getting longer and longer: We’ve got 2 months, and they’re looking at a 6-month subcutaneous injection,” Dr. Hendrix said. The investigational agent lenacapavir is in development as PrEP, as well as for HIV treatment.

“This could get us from 2 to 6 months,” Dr. Hendrix said.

Some of the subcutaneous implants look as if they could provide PrEP for up to 12 months, he added. “An implant could also avoid peaks and troughs with bi-monthly injections.”
 

On-demand PrEP

The other direction is on-demand. “This is for the folks that don’t want drug in their body all the time. They only want it when they need it. And a twist on that ... is actually using products that are already used with sex now but medicating them.”

On-demand rectal options include a medicated douche and a fast-dissolving insert or suppository.

Fast-dissolving vaginal inserts are also in development. “These inserts are small, easy to store, inexpensive, and possibly inapparent to a partner,” Dr. Hendrix said.

Phase 2 studies will need to determine if these products “fit into folks’ active sex lives,” he said. “There’s still a need for human-friendly, human-designed products.”

A rectal microbicide that got as far as Phase 2 research provides a cautionary tale. The concentrations and the biology worked fine, Dr. Hendrix said. “It was a gel with an applicator, and it just was not liked by the folks in the study.” He added, “Your adherence is going to be in the tank if you’ve got a product that people don’t like to use.”
 

 

 

‘Extremely excited’

Asked for her perspective on Dr. Hendrix’s presentation, session moderator Rasheeta D. Chandler, PhD, RN, an associate professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said: “I am extremely excited, because I work with cisgender women, particularly with underserved women and women of color, and there’s a tendency to focus on men who have sex with men.”

“I understand, because they are the population that is most affected, but Black women are also extremely affected by this disease,” Dr. Chandler told this news organization.

Dr. Chandler applauded Dr. Hendrix for addressing women’s health needs as well and not treating PrEP in women “as an afterthought.”

“Finally, our voices are being heard that [PrEP] should be equitable across all different types of individuals who identify differently in a sexual context,” Dr. Chandler said.

More work is warranted to evaluate PrEP in other populations, including transgender men and individuals who inject drugs, Dr. Hendrix said.

For more information and updates on HIV PrEP and MPTs, visit the website of the nonprofit AIDS Vaccine Advocacy Coalition.

Dr. Hendrix has disclosed receiving research grants from Gilead and Merck. Dr. Chandler has reported no relevant financial relationships.

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

– Pre-exposure prophylaxis (PrEP) has shown to be effective in many clinical and real-world studies, but concerns remain, according to research presented at the annual meeting of the Association of Nurses in AIDS Care (ANAC).

Only about 20% of people who could benefit from PrEP use the preventative medication, for example. Another concern is adherence, as regular use generally drops off over time, rarely lasting more than a few months for most people.

Furthermore, most studies to date evaluated safety and effectiveness of PrEP options among men who have sex with men. Now the focus is increasing on other populations, including women at risk of HIV exposure.  

Researchers working on new forms and formulations of PrEP are looking for ways to address those challenges.

No matter the target population, new options are needed that fit more seamlessly into people’s sex lives, said Craig W. Hendrix, MD, professor and director of the Division of Clinical Pharmacology at Johns Hopkins University School of Medicine, Baltimore.

“What I hear a lot of folks say [is] there are two or three options for PrEP, so why do we need more? We need choices that fit into a broader range of lifestyles,” Dr. Hendrix said.

For example, a medically fortified douche containing PrEP might be more likely to be used by people who use a douche before or after sex on a regular basis. This is called a “behaviorally congruent” strategy, Dr. Hendrix said.

In addition to a medical douche, formulations designed to continuously deliver PrEP, such as a subdermal implant, are in the works as well.

Another option for women, the dapivirine vaginal ring, is available internationally but not in the United States. “It was withdrawn from [Food and Drug Administration] consideration by the sponsor. I think it’s a huge loss not to have that,” Dr. Hendrix said.

During development, “frequent expulsions forced reformulation to a less stiff ring,” Dr. Hendrix said. “I don’t imagine that’s terrific, but it shows how important it is to have something that fits the anatomy and the lifestyle.”

“Currently, we have in the U.S. three licensed, really terrific options for PrEP, and they’re all for men that have sex with men and transgender women,” Dr. Hendrix said.
 

Three current options

The three current PrEP regimens in the United States often go by their abbreviations: F/TDF, F/TAF, and CAB-IM.

  • F/TDF is emtricitabine (F) 200 mg in combination with tenofovir disoproxil fumarate (TDF) 300 mg (Truvada, Gilead or generics)
  • F/TAF is emtricitabine (F) 200 mg in combination with tenofovir alafenamide (TAF) 25 mg (Descovy, Gilead)
  • CAB-IM is cabotegravir (CAB) 600 mg injection (Apretude, GlaxoSmithKline)

There is an important distinction: Daily oral PrEP with F/TDF is recommended to prevent HIV infection among all people at risk through sex or injection drug use. Daily oral PrEP with F/TAF is recommended to prevent HIV infection among people at risk through sex, excluding people at risk through receptive vaginal sex, the CDC notes.

The cost-effectiveness of the injection remains a potential issue, Dr. Hendrix said. On the other hand, “cost-effectiveness goes out the window if there is no adherence.”
 

 

 

An active pipeline

There are 24 new PrEP products in development, as well as 24 other multipurpose prevention technologies (MPTs), which are combination products containing PrEP and one or two other medications.

These 48 products include 28 unique antiviral and contraceptive drugs and 12 delivery methods or formulations. “Why so many?” Dr. Hendrix asked. “Many will not make it through development.”

Pills that include HIV PrEP and contraception or PrEP and sexually transmitted infection (STI) treatment are being evaluated, for example. “HIV risk, pregnancy risk, and other viral STIs overlap. Ideally, you can have one target for all three. That would increase efficiency of dosing and adherence,” Dr. Hendrix said.

Dual prevention pills (DPPs) hypothetically provide HIV PrEP and contraception better than either product alone, Dr. Hendrix said. Plans are to market them as family planning or women’s health products to avoid any stigma or distrust associated with HIV PrEP. An initial rollout is planned in 2024 in sub-Saharan Africa where the unmet need is highest, he added.

“Imagine how effective this could be in women in the United States,” Dr. Hendrix said. “My hope is fourth-quarter 2024” availability in the United States.

A way to prevent STIs and HIV in an all-in-one product “would be terrific,” Dr. Hendrix said.

“I think we’re going to see a lot more innovation going in that direction. The pill is close. The other things are going to be further off because the regulatory pathway is a little more complicated.”
 

Longer lasting protection?

All of the innovations have gone one of two directions, Dr. Hendrix said. One direction is to make PrEP even longer acting, “so that you have even less to worry [about] in terms of adherence.”

Going forward, “most of the focus has all been on continuously acting or long-active PrEP. It’s getting longer and longer: We’ve got 2 months, and they’re looking at a 6-month subcutaneous injection,” Dr. Hendrix said. The investigational agent lenacapavir is in development as PrEP, as well as for HIV treatment.

“This could get us from 2 to 6 months,” Dr. Hendrix said.

Some of the subcutaneous implants look as if they could provide PrEP for up to 12 months, he added. “An implant could also avoid peaks and troughs with bi-monthly injections.”
 

On-demand PrEP

The other direction is on-demand. “This is for the folks that don’t want drug in their body all the time. They only want it when they need it. And a twist on that ... is actually using products that are already used with sex now but medicating them.”

On-demand rectal options include a medicated douche and a fast-dissolving insert or suppository.

Fast-dissolving vaginal inserts are also in development. “These inserts are small, easy to store, inexpensive, and possibly inapparent to a partner,” Dr. Hendrix said.

Phase 2 studies will need to determine if these products “fit into folks’ active sex lives,” he said. “There’s still a need for human-friendly, human-designed products.”

A rectal microbicide that got as far as Phase 2 research provides a cautionary tale. The concentrations and the biology worked fine, Dr. Hendrix said. “It was a gel with an applicator, and it just was not liked by the folks in the study.” He added, “Your adherence is going to be in the tank if you’ve got a product that people don’t like to use.”
 

 

 

‘Extremely excited’

Asked for her perspective on Dr. Hendrix’s presentation, session moderator Rasheeta D. Chandler, PhD, RN, an associate professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said: “I am extremely excited, because I work with cisgender women, particularly with underserved women and women of color, and there’s a tendency to focus on men who have sex with men.”

“I understand, because they are the population that is most affected, but Black women are also extremely affected by this disease,” Dr. Chandler told this news organization.

Dr. Chandler applauded Dr. Hendrix for addressing women’s health needs as well and not treating PrEP in women “as an afterthought.”

“Finally, our voices are being heard that [PrEP] should be equitable across all different types of individuals who identify differently in a sexual context,” Dr. Chandler said.

More work is warranted to evaluate PrEP in other populations, including transgender men and individuals who inject drugs, Dr. Hendrix said.

For more information and updates on HIV PrEP and MPTs, visit the website of the nonprofit AIDS Vaccine Advocacy Coalition.

Dr. Hendrix has disclosed receiving research grants from Gilead and Merck. Dr. Chandler has reported no relevant financial relationships.

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

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Why you (still) shouldn’t prescribe hormone therapy for disease prevention

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Why you (still) shouldn’t prescribe hormone therapy for disease prevention

On November 1, the US Preventive Services Task Force (USPSTF) published updated recommendations (and a supporting evidence report) for the use of hormone therapy in postmenopausal women for the prevention of chronic medical conditions, such as heart disease, cancer, and osteoporosis.1,2 The USPSTF continues to recommend against the use of either estrogen or combined estrogen plus progesterone for this purpose.

A bit of context. These recommendations apply to asymptomatic postmenopausal women and do not apply to those who are unable to manage menopausal symptoms (eg, hot flashes or vaginal dryness) with other interventions, or to those who have premature or surgically caused menopause.

This update is a reconfirmation of USPSTF’s 2017 recommendations on this topic. These recommendations are consistent with those of multiple other organizations, including the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American College of Physicians, and the American Heart Association.

A look at the evidence. The evidence report included data from 20 randomized clinical trials and 3 cohort studies that examined the use of oral or transdermal hormone therapy. The most commonly used therapy was oral conjugated equine estrogen 0.625 mg/d, with or without medroxyprogesterone acetate 2.5 mg/d. The strongest evidence is from the Women’s Health Initiative, which included postmenopausal women ages 50 to 79 years and had follow-up of 7.2 years for the estrogen-only trial, 5.6 years for the estrogen plus progestin trial, and a long-term follow-up of up to 20.7 years.2,3

Benefits and harms of hormone therapy. Among postmenopausal women, use of estrogen alone was associated with absolute reduction in risk for fractures (–388 per 10,000 women), diabetes (–134), and breast cancer (–52) and an absolute increase in risk for urinary incontinence (+ 885 per 10,000 women), gallbladder disease (+ 377), stroke (+ 79), and venous thromboembolism (+ 77). Use of estrogen plus progestin was associated with reduced risk for fractures (–230 per 10,000 women), diabetes (–78), and colorectal cancer (–34) and an increased risk for urinary incontinence ( + 562 per 10,000 women), gallbladder disease (+ 260), venous thromboembolism (+ 120), dementia (+ 88), stroke (+ 52), and breast cancer (+ 51).2,3

Lingering questions. The USPSTF felt that the evidence is too limited to answer the following: (1) Are the potential benefits and harms of hormone therapy affected by participants’ age or by the timing of therapy initiation in relation to menopause onset? and (2) Do different types, doses, or delivery modes of hormone therapy affect benefits and harms?1

The bottom line. In asymptomatic, healthy, postmenopausal women, do not prescribe hormone therapy to try to prevent chronic conditions.

References

1. USPSTF. Hormone therapy in postmenopausal persons: primary prevention of chronic conditions. Final recommendation statement. Published November 1, 2022. Accessed November 14, 2022. https://uspreventiveservicestaskforce.org/uspstf/recommendation/menopausal-hormone-therapy-preventive-medication

2. USPSTF. Hormone therapy in postmenopausal persons: primary prevention of chronic conditions. Evidence summary. Published November 1, 2022. Accessed November 14, 2022. https://uspreventiveservicestaskforce.org/uspstf/document/final-evidence-summary28/menopausal-hormone-therapy-preventive-medication

3. Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013;310:1353-1368. doi: 10.1001/jama.2013.278040

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Doug Campos-Outcalt, MD, MPA, is a clinical professor at the University of Arizona College of Medicine and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The author is a paid consultant to the CDC’s Advisory Committee on Immunization Practices.

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Doug Campos-Outcalt, MD, MPA, is a clinical professor at the University of Arizona College of Medicine and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The author is a paid consultant to the CDC’s Advisory Committee on Immunization Practices.

Author and Disclosure Information

Doug Campos-Outcalt, MD, MPA, is a clinical professor at the University of Arizona College of Medicine and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The author is a paid consultant to the CDC’s Advisory Committee on Immunization Practices.

On November 1, the US Preventive Services Task Force (USPSTF) published updated recommendations (and a supporting evidence report) for the use of hormone therapy in postmenopausal women for the prevention of chronic medical conditions, such as heart disease, cancer, and osteoporosis.1,2 The USPSTF continues to recommend against the use of either estrogen or combined estrogen plus progesterone for this purpose.

A bit of context. These recommendations apply to asymptomatic postmenopausal women and do not apply to those who are unable to manage menopausal symptoms (eg, hot flashes or vaginal dryness) with other interventions, or to those who have premature or surgically caused menopause.

This update is a reconfirmation of USPSTF’s 2017 recommendations on this topic. These recommendations are consistent with those of multiple other organizations, including the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American College of Physicians, and the American Heart Association.

A look at the evidence. The evidence report included data from 20 randomized clinical trials and 3 cohort studies that examined the use of oral or transdermal hormone therapy. The most commonly used therapy was oral conjugated equine estrogen 0.625 mg/d, with or without medroxyprogesterone acetate 2.5 mg/d. The strongest evidence is from the Women’s Health Initiative, which included postmenopausal women ages 50 to 79 years and had follow-up of 7.2 years for the estrogen-only trial, 5.6 years for the estrogen plus progestin trial, and a long-term follow-up of up to 20.7 years.2,3

Benefits and harms of hormone therapy. Among postmenopausal women, use of estrogen alone was associated with absolute reduction in risk for fractures (–388 per 10,000 women), diabetes (–134), and breast cancer (–52) and an absolute increase in risk for urinary incontinence (+ 885 per 10,000 women), gallbladder disease (+ 377), stroke (+ 79), and venous thromboembolism (+ 77). Use of estrogen plus progestin was associated with reduced risk for fractures (–230 per 10,000 women), diabetes (–78), and colorectal cancer (–34) and an increased risk for urinary incontinence ( + 562 per 10,000 women), gallbladder disease (+ 260), venous thromboembolism (+ 120), dementia (+ 88), stroke (+ 52), and breast cancer (+ 51).2,3

Lingering questions. The USPSTF felt that the evidence is too limited to answer the following: (1) Are the potential benefits and harms of hormone therapy affected by participants’ age or by the timing of therapy initiation in relation to menopause onset? and (2) Do different types, doses, or delivery modes of hormone therapy affect benefits and harms?1

The bottom line. In asymptomatic, healthy, postmenopausal women, do not prescribe hormone therapy to try to prevent chronic conditions.

On November 1, the US Preventive Services Task Force (USPSTF) published updated recommendations (and a supporting evidence report) for the use of hormone therapy in postmenopausal women for the prevention of chronic medical conditions, such as heart disease, cancer, and osteoporosis.1,2 The USPSTF continues to recommend against the use of either estrogen or combined estrogen plus progesterone for this purpose.

A bit of context. These recommendations apply to asymptomatic postmenopausal women and do not apply to those who are unable to manage menopausal symptoms (eg, hot flashes or vaginal dryness) with other interventions, or to those who have premature or surgically caused menopause.

This update is a reconfirmation of USPSTF’s 2017 recommendations on this topic. These recommendations are consistent with those of multiple other organizations, including the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American College of Physicians, and the American Heart Association.

A look at the evidence. The evidence report included data from 20 randomized clinical trials and 3 cohort studies that examined the use of oral or transdermal hormone therapy. The most commonly used therapy was oral conjugated equine estrogen 0.625 mg/d, with or without medroxyprogesterone acetate 2.5 mg/d. The strongest evidence is from the Women’s Health Initiative, which included postmenopausal women ages 50 to 79 years and had follow-up of 7.2 years for the estrogen-only trial, 5.6 years for the estrogen plus progestin trial, and a long-term follow-up of up to 20.7 years.2,3

Benefits and harms of hormone therapy. Among postmenopausal women, use of estrogen alone was associated with absolute reduction in risk for fractures (–388 per 10,000 women), diabetes (–134), and breast cancer (–52) and an absolute increase in risk for urinary incontinence (+ 885 per 10,000 women), gallbladder disease (+ 377), stroke (+ 79), and venous thromboembolism (+ 77). Use of estrogen plus progestin was associated with reduced risk for fractures (–230 per 10,000 women), diabetes (–78), and colorectal cancer (–34) and an increased risk for urinary incontinence ( + 562 per 10,000 women), gallbladder disease (+ 260), venous thromboembolism (+ 120), dementia (+ 88), stroke (+ 52), and breast cancer (+ 51).2,3

Lingering questions. The USPSTF felt that the evidence is too limited to answer the following: (1) Are the potential benefits and harms of hormone therapy affected by participants’ age or by the timing of therapy initiation in relation to menopause onset? and (2) Do different types, doses, or delivery modes of hormone therapy affect benefits and harms?1

The bottom line. In asymptomatic, healthy, postmenopausal women, do not prescribe hormone therapy to try to prevent chronic conditions.

References

1. USPSTF. Hormone therapy in postmenopausal persons: primary prevention of chronic conditions. Final recommendation statement. Published November 1, 2022. Accessed November 14, 2022. https://uspreventiveservicestaskforce.org/uspstf/recommendation/menopausal-hormone-therapy-preventive-medication

2. USPSTF. Hormone therapy in postmenopausal persons: primary prevention of chronic conditions. Evidence summary. Published November 1, 2022. Accessed November 14, 2022. https://uspreventiveservicestaskforce.org/uspstf/document/final-evidence-summary28/menopausal-hormone-therapy-preventive-medication

3. Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013;310:1353-1368. doi: 10.1001/jama.2013.278040

References

1. USPSTF. Hormone therapy in postmenopausal persons: primary prevention of chronic conditions. Final recommendation statement. Published November 1, 2022. Accessed November 14, 2022. https://uspreventiveservicestaskforce.org/uspstf/recommendation/menopausal-hormone-therapy-preventive-medication

2. USPSTF. Hormone therapy in postmenopausal persons: primary prevention of chronic conditions. Evidence summary. Published November 1, 2022. Accessed November 14, 2022. https://uspreventiveservicestaskforce.org/uspstf/document/final-evidence-summary28/menopausal-hormone-therapy-preventive-medication

3. Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013;310:1353-1368. doi: 10.1001/jama.2013.278040

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The Journal of Family Practice - 71(10)
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The Journal of Family Practice - 71(10)
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