Sexual Health

Many women who got a COVID-19 vaccine have reported heavier bleeding during their periods since they had the shots.

A team of researchers investigated the trend and set out to find out who among the vaccinated were more likely to experience the menstruation changes.

The researchers were led by Katharine M.N. Lee, PhD, MS, of the division of public health sciences at Washington University in St. Louis. Their findings were published ahead of print in Science Advances.

The investigators analyzed more than 139,000 responses from an online survey from both currently and formerly menstruating women.

They found that, among people who have regular periods, about the same percentage had heavier bleeding after they got a COVID vaccine as had no change in bleeding after the vaccine (44% vs. 42%, respectively).

“A much smaller portion had lighter periods,” they write.

The phenomenon has been difficult to study because questions about changes in menstruation are not a standard part of vaccine trials.

Date of last period is often tracked in clinical trials to make sure a participant is not pregnant, but the questions about periods often stop there.

Additionally, periods are different for everyone and can be influenced by all sorts of environmental factors, so making associations regarding exposures is problematic.
 

No changes found to fertility

The authors emphasized that, generally, changes to menstrual bleeding are not uncommon nor dangerous. They also emphasized that the changes in bleeding don’t mean changes to fertility.

The uterine reproductive system is flexible when the body is under stress, they note.

“We know that running a marathon may influence hormone concentrations in the short term while not rendering that person infertile,” the authors write.

However, they acknowledge that investigating these reports is critical in building trust in medicine.

This report includes information that hasn’t been available through the clinical trial follow-up process.

For instance, the authors write, “To the best of our knowledge, our work is the first to examine breakthrough bleeding after vaccination in either pre- or postmenopausal people.”

Reports of changes to periods after vaccination started emerging in 2021. But without data, reports were largely dismissed, fueling criticism from those waging campaigns against COVID vaccines.

Dr. Lee and colleagues gathered data from those who responded to the online survey and detailed some trends.

People who were bleeding more heavily after vaccination were more likely to be older, Hispanic, had vaccine side effects of fever and fatigue, had been pregnant at some point, or had given birth.

People with regular periods who had endometriosis, prolonged bleeding during their periods, polycystic ovarian syndrome (PCOS) or fibroids were also more likely to have increased bleeding after a COVID vaccine.
 

Breakthrough bleeding

For people who don’t menstruate, but have not reached menopause, breakthrough bleeding happened more often in women who had been pregnant and/or had given birth.

Among respondents who were postmenopausal, breakthrough bleeding happened more often in younger people and/or those who are Hispanic.

More than a third of the respondents (39%) who use gender-affirming hormones that eliminate menstruation reported breakthrough bleeding after vaccination.

The majority of premenopausal people on long-acting, reversible contraception (71%) and the majority of postmenopausal respondents (66%) had breakthrough bleeding as well.

The authors note that you can’t compare the percentages who report these experiences in the survey with the incidence of those who would experience changes in menstrual bleeding in the general population.

The nature of the online survey means it may be naturally biased because the people who responded may be more often those who noted some change in their own menstrual experiences, particularly if that involved discomfort, pain, or fear.

Researchers also acknowledge that Black, Indigenous, Latinx, and other respondents of color are underrepresented in this research and that represents a limitation in the work.

Alison Edelman, MD, MPH, with the department of obstetrics and gynecology at Oregon Health & Science University in Portland, was not involved with Dr. Lee and associates’ study but has also studied the relationship between COVID vaccines and menstruation.

Her team’s study found that COVID vaccination is associated with a small change in time between periods but not length of periods.

She said about the work by Dr. Lee and colleagues, “This work really elevates the voices of the public and what they’re experiencing.”

The association makes sense, Dr. Edelman says, in that the reproductive system and the immune system talk to each other and inflammation in the immune system is going to be noticed by the system governing periods.

Lack of data on the relationship between exposures and menstruation didn’t start with COVID. “There has been a signal in the population before with other vaccines that’s been dismissed,” she said.

Tracking menstruation information in clinical trials can help physicians counsel women on what may be coming with any vaccine and alleviate fears and vaccine hesitancy, Dr. Edelman explained. It can also help vaccine developers know what to include in information about their product.

“When you are counseled about what to expect, it’s not as scary. That provides trust in the system,” she said. She likened it to original lack of data on whether COVID-19 vaccines would affect pregnancy.

“We have great science now that COVID vaccine does not affect fertility and [vaccine] does not impact pregnancy.”

Another important aspect of this paper is that it included subgroups not studied before regarding menstruation and breakthrough bleeding, such as those taking gender-affirming hormones, she added.

Menstruation has been often overlooked as important in clinical trial exposures but Dr. Edelman hopes this recent attention and question will escalate and prompt more research.

“I’m hoping with the immense outpouring from the public about how important this is, that future studies will look at this a little bit better,” she says.

She said when the National Institutes of Health opened up funding for trials on COVID-19 vaccines and menstruation, researchers got flooded with requests from women to share their stories.

“As a researcher – I’ve been doing research for over 20 years – that’s not something that usually happens. I would love to have that happen for every research project.”

The authors and Dr. Edelman declare that they have no competing interests. This research was supported in part by the University of Illinois Beckman Institute for Advanced Science and Technology, the University of Illinois Interdisciplinary Health Sciences Institute, the National Institutes of Health, the Foundation for Barnes-Jewish Hospital, and the Siteman Cancer Center.

Many women who got a COVID-19 vaccine have reported heavier bleeding during their periods since they had the shots.

A team of researchers investigated the trend and set out to find out who among the vaccinated were more likely to experience the menstruation changes.

The researchers were led by Katharine M.N. Lee, PhD, MS, of the division of public health sciences at Washington University in St. Louis. Their findings were published ahead of print in Science Advances.

The investigators analyzed more than 139,000 responses from an online survey from both currently and formerly menstruating women.

They found that, among people who have regular periods, about the same percentage had heavier bleeding after they got a COVID vaccine as had no change in bleeding after the vaccine (44% vs. 42%, respectively).

“A much smaller portion had lighter periods,” they write.

The phenomenon has been difficult to study because questions about changes in menstruation are not a standard part of vaccine trials.

Date of last period is often tracked in clinical trials to make sure a participant is not pregnant, but the questions about periods often stop there.

Additionally, periods are different for everyone and can be influenced by all sorts of environmental factors, so making associations regarding exposures is problematic.
 

No changes found to fertility

The authors emphasized that, generally, changes to menstrual bleeding are not uncommon nor dangerous. They also emphasized that the changes in bleeding don’t mean changes to fertility.

The uterine reproductive system is flexible when the body is under stress, they note.

“We know that running a marathon may influence hormone concentrations in the short term while not rendering that person infertile,” the authors write.

However, they acknowledge that investigating these reports is critical in building trust in medicine.

This report includes information that hasn’t been available through the clinical trial follow-up process.

For instance, the authors write, “To the best of our knowledge, our work is the first to examine breakthrough bleeding after vaccination in either pre- or postmenopausal people.”

Reports of changes to periods after vaccination started emerging in 2021. But without data, reports were largely dismissed, fueling criticism from those waging campaigns against COVID vaccines.

Dr. Lee and colleagues gathered data from those who responded to the online survey and detailed some trends.

People who were bleeding more heavily after vaccination were more likely to be older, Hispanic, had vaccine side effects of fever and fatigue, had been pregnant at some point, or had given birth.

People with regular periods who had endometriosis, prolonged bleeding during their periods, polycystic ovarian syndrome (PCOS) or fibroids were also more likely to have increased bleeding after a COVID vaccine.
 

Breakthrough bleeding

For people who don’t menstruate, but have not reached menopause, breakthrough bleeding happened more often in women who had been pregnant and/or had given birth.

Among respondents who were postmenopausal, breakthrough bleeding happened more often in younger people and/or those who are Hispanic.

More than a third of the respondents (39%) who use gender-affirming hormones that eliminate menstruation reported breakthrough bleeding after vaccination.

The majority of premenopausal people on long-acting, reversible contraception (71%) and the majority of postmenopausal respondents (66%) had breakthrough bleeding as well.

The authors note that you can’t compare the percentages who report these experiences in the survey with the incidence of those who would experience changes in menstrual bleeding in the general population.

The nature of the online survey means it may be naturally biased because the people who responded may be more often those who noted some change in their own menstrual experiences, particularly if that involved discomfort, pain, or fear.

Researchers also acknowledge that Black, Indigenous, Latinx, and other respondents of color are underrepresented in this research and that represents a limitation in the work.

Alison Edelman, MD, MPH, with the department of obstetrics and gynecology at Oregon Health & Science University in Portland, was not involved with Dr. Lee and associates’ study but has also studied the relationship between COVID vaccines and menstruation.

Her team’s study found that COVID vaccination is associated with a small change in time between periods but not length of periods.

She said about the work by Dr. Lee and colleagues, “This work really elevates the voices of the public and what they’re experiencing.”

The association makes sense, Dr. Edelman says, in that the reproductive system and the immune system talk to each other and inflammation in the immune system is going to be noticed by the system governing periods.

Lack of data on the relationship between exposures and menstruation didn’t start with COVID. “There has been a signal in the population before with other vaccines that’s been dismissed,” she said.

Tracking menstruation information in clinical trials can help physicians counsel women on what may be coming with any vaccine and alleviate fears and vaccine hesitancy, Dr. Edelman explained. It can also help vaccine developers know what to include in information about their product.

“When you are counseled about what to expect, it’s not as scary. That provides trust in the system,” she said. She likened it to original lack of data on whether COVID-19 vaccines would affect pregnancy.

“We have great science now that COVID vaccine does not affect fertility and [vaccine] does not impact pregnancy.”

Another important aspect of this paper is that it included subgroups not studied before regarding menstruation and breakthrough bleeding, such as those taking gender-affirming hormones, she added.

Menstruation has been often overlooked as important in clinical trial exposures but Dr. Edelman hopes this recent attention and question will escalate and prompt more research.

“I’m hoping with the immense outpouring from the public about how important this is, that future studies will look at this a little bit better,” she says.

She said when the National Institutes of Health opened up funding for trials on COVID-19 vaccines and menstruation, researchers got flooded with requests from women to share their stories.

“As a researcher – I’ve been doing research for over 20 years – that’s not something that usually happens. I would love to have that happen for every research project.”

The authors and Dr. Edelman declare that they have no competing interests. This research was supported in part by the University of Illinois Beckman Institute for Advanced Science and Technology, the University of Illinois Interdisciplinary Health Sciences Institute, the National Institutes of Health, the Foundation for Barnes-Jewish Hospital, and the Siteman Cancer Center.

Many women who got a COVID-19 vaccine have reported heavier bleeding during their periods since they had the shots.

A team of researchers investigated the trend and set out to find out who among the vaccinated were more likely to experience the menstruation changes.

The researchers were led by Katharine M.N. Lee, PhD, MS, of the division of public health sciences at Washington University in St. Louis. Their findings were published ahead of print in Science Advances.

The investigators analyzed more than 139,000 responses from an online survey from both currently and formerly menstruating women.

They found that, among people who have regular periods, about the same percentage had heavier bleeding after they got a COVID vaccine as had no change in bleeding after the vaccine (44% vs. 42%, respectively).

“A much smaller portion had lighter periods,” they write.

The phenomenon has been difficult to study because questions about changes in menstruation are not a standard part of vaccine trials.

Date of last period is often tracked in clinical trials to make sure a participant is not pregnant, but the questions about periods often stop there.

Additionally, periods are different for everyone and can be influenced by all sorts of environmental factors, so making associations regarding exposures is problematic.
 

No changes found to fertility

The authors emphasized that, generally, changes to menstrual bleeding are not uncommon nor dangerous. They also emphasized that the changes in bleeding don’t mean changes to fertility.

The uterine reproductive system is flexible when the body is under stress, they note.

“We know that running a marathon may influence hormone concentrations in the short term while not rendering that person infertile,” the authors write.

However, they acknowledge that investigating these reports is critical in building trust in medicine.

This report includes information that hasn’t been available through the clinical trial follow-up process.

For instance, the authors write, “To the best of our knowledge, our work is the first to examine breakthrough bleeding after vaccination in either pre- or postmenopausal people.”

Reports of changes to periods after vaccination started emerging in 2021. But without data, reports were largely dismissed, fueling criticism from those waging campaigns against COVID vaccines.

Dr. Lee and colleagues gathered data from those who responded to the online survey and detailed some trends.

People who were bleeding more heavily after vaccination were more likely to be older, Hispanic, had vaccine side effects of fever and fatigue, had been pregnant at some point, or had given birth.

People with regular periods who had endometriosis, prolonged bleeding during their periods, polycystic ovarian syndrome (PCOS) or fibroids were also more likely to have increased bleeding after a COVID vaccine.
 

Breakthrough bleeding

For people who don’t menstruate, but have not reached menopause, breakthrough bleeding happened more often in women who had been pregnant and/or had given birth.

Among respondents who were postmenopausal, breakthrough bleeding happened more often in younger people and/or those who are Hispanic.

More than a third of the respondents (39%) who use gender-affirming hormones that eliminate menstruation reported breakthrough bleeding after vaccination.

The majority of premenopausal people on long-acting, reversible contraception (71%) and the majority of postmenopausal respondents (66%) had breakthrough bleeding as well.

The authors note that you can’t compare the percentages who report these experiences in the survey with the incidence of those who would experience changes in menstrual bleeding in the general population.

The nature of the online survey means it may be naturally biased because the people who responded may be more often those who noted some change in their own menstrual experiences, particularly if that involved discomfort, pain, or fear.

Researchers also acknowledge that Black, Indigenous, Latinx, and other respondents of color are underrepresented in this research and that represents a limitation in the work.

Alison Edelman, MD, MPH, with the department of obstetrics and gynecology at Oregon Health & Science University in Portland, was not involved with Dr. Lee and associates’ study but has also studied the relationship between COVID vaccines and menstruation.

Her team’s study found that COVID vaccination is associated with a small change in time between periods but not length of periods.

She said about the work by Dr. Lee and colleagues, “This work really elevates the voices of the public and what they’re experiencing.”

The association makes sense, Dr. Edelman says, in that the reproductive system and the immune system talk to each other and inflammation in the immune system is going to be noticed by the system governing periods.

Lack of data on the relationship between exposures and menstruation didn’t start with COVID. “There has been a signal in the population before with other vaccines that’s been dismissed,” she said.

Tracking menstruation information in clinical trials can help physicians counsel women on what may be coming with any vaccine and alleviate fears and vaccine hesitancy, Dr. Edelman explained. It can also help vaccine developers know what to include in information about their product.

“When you are counseled about what to expect, it’s not as scary. That provides trust in the system,” she said. She likened it to original lack of data on whether COVID-19 vaccines would affect pregnancy.

“We have great science now that COVID vaccine does not affect fertility and [vaccine] does not impact pregnancy.”

Another important aspect of this paper is that it included subgroups not studied before regarding menstruation and breakthrough bleeding, such as those taking gender-affirming hormones, she added.

Menstruation has been often overlooked as important in clinical trial exposures but Dr. Edelman hopes this recent attention and question will escalate and prompt more research.

“I’m hoping with the immense outpouring from the public about how important this is, that future studies will look at this a little bit better,” she says.

She said when the National Institutes of Health opened up funding for trials on COVID-19 vaccines and menstruation, researchers got flooded with requests from women to share their stories.

“As a researcher – I’ve been doing research for over 20 years – that’s not something that usually happens. I would love to have that happen for every research project.”

The authors and Dr. Edelman declare that they have no competing interests. This research was supported in part by the University of Illinois Beckman Institute for Advanced Science and Technology, the University of Illinois Interdisciplinary Health Sciences Institute, the National Institutes of Health, the Foundation for Barnes-Jewish Hospital, and the Siteman Cancer Center.

A 5-year cervical screening interval is as safe and effective for women who test negative for human papillomavirus (HPV) as are 3-year intervals, according to a new ‘real life’ study led by King’s College London (KCL) with researchers from the University of Manchester, and the NHS, on behalf of the HPV pilot steering group.

The study, published in The BMJ, used data from the HPV screening pilot to assess rates of detection of high-grade cervical intraepithelial neoplasia (CIN3+) and of cervical cancer following a negative HPV test. It confirmed that 5-yearly screening prevents as many cancers as screening at 3-year intervals, even in women who are not vaccinated against HPV.
 

Change to primary HPV testing since 2019 

Before 2019, the NHS cervical screening program conducted cytology testing first, testing for HPV only if abnormalities were found. In 2019, following reporting of early results of the HPV pilot by the same researchers, the program in England switched to testing for HPV first, on the grounds that since having HPV infection comes before having abnormal cells, HPV testing would detect more women at risk of cervical cancer.

Following the switch to primary HPV testing, the same screening intervals were retained, meaning 3-yearly screening for those aged 24-49 years and testing every 5 years for women aged 50-64 years, or 3 years if they tested positive. However, the National Screening Committee had recommended that invites should be changed from 3 to 5 years for those in the under-50 age group found not to have high-risk HPV at their routine screening test.

For the latest study, funded by Cancer Research UK, the steering group researchers analyzed details for more than 1.3 million women who had attended screening for two rounds of the HPV screening pilot, the first from 2013 to 2016, with a follow-up to the end of 2019. By this time, the data set had doubled in size from the pilot study, and results had been linked with the national cancer registry.

They confirmed that HPV testing was more accurate than a cytology test, irrespective of whether the HPV test assay was DNA- or mRNA-based. With HPV testing, the risk of subsequent cytological changes more than halved overall. Eligible women under 50 who had a negative HPV screen in the first round had a much lower risk of detection of CIN3+ in the second round, with a rate of 1.21 in 1,000, compared with 4.52 in 1,000 after a negative cytology test.
 

Data support extension of the testing interval

“The study confirms that women in this age group are much less likely to develop clinically relevant cervical lesions and cervical cancer, 3 years after a negative HPV screen, compared with a negative smear test,” the researchers said.

They suggested that most women do not need to be screened as frequently as the current program allows, and that the data support an extension of the screening intervals, regardless of the test assay used, to 5 years after a negative HPV test in women aged 25-49 years, and even longer for women aged 50 years and older.

However, the screening interval for HPV-positive women who have negative HPV tests at early recall should be kept at 3 years, they said.

“These results are very reassuring,” said lead author Matejka Rebolj, PhD, senior epidemiologist at KCL. “They build on previous research that shows that following the introduction of HPV testing for cervical screening, a 5-year interval is at least as safe as the previous 3-year interval. Changing to 5-yearly screening will mean we can prevent just as many cancers as before, while allowing for fewer screens.”

Michelle Mitchell, Cancer Research UK’s chief executive, said: “This large study shows that offering cervical screening using HPV testing effectively prevents cervical cancer, without having to be screened as often. This builds on findings from years of research showing HPV testing is more accurate at predicting who is at risk of developing cervical cancer compared to the previous way of testing. As changes to the screening [programs] are made, they will be monitored to help ensure that cervical screening is as effective as possible for all who take part.”
 

If HPV is present, testing interval should remain every 3 years

Responding to the study, Theresa Freeman-Wang, MBChB, consultant gynecologist, president of the British Society for Colposcopy and Cervical Pathology, and spokesperson for the Royal College of Obstetricians and Gynaecologists, told this news organization: “England, Scotland, and Wales and many other countries now use HPV primary screening, which is much better at assessing risk than previous methods. HPV testing is more sensitive and accurate, so changes are picked up earlier.

“Studies have confirmed that if someone is HPV negative (i.e., HPV is not present in the screen test), intervals between tests can very safely be increased from 3 to 5 years. 

“If HPV is present, then the program will automatically look for any abnormal cells. If there are no abnormalities, the woman will be advised to have a repeat screen test in a year. If the HPV remains present over 3 successive years or if abnormal cells are detected at any stage, she will be referred for a more detailed screening examination called a colposcopy.

“It’s important that with any change like this, there is clear information available to explain what these changes mean.

“We have an effective cervical screening program in the UK that has significantly reduced the number of cases and deaths from this preventable cancer. 

“HPV screening every 5 years is safe and to be fully effective it is vital that women take up the invitation for cervical screening when called.”

A version of this article first appeared on Medscape UK.

A 5-year cervical screening interval is as safe and effective for women who test negative for human papillomavirus (HPV) as are 3-year intervals, according to a new ‘real life’ study led by King’s College London (KCL) with researchers from the University of Manchester, and the NHS, on behalf of the HPV pilot steering group.

The study, published in The BMJ, used data from the HPV screening pilot to assess rates of detection of high-grade cervical intraepithelial neoplasia (CIN3+) and of cervical cancer following a negative HPV test. It confirmed that 5-yearly screening prevents as many cancers as screening at 3-year intervals, even in women who are not vaccinated against HPV.
 

Change to primary HPV testing since 2019 

Before 2019, the NHS cervical screening program conducted cytology testing first, testing for HPV only if abnormalities were found. In 2019, following reporting of early results of the HPV pilot by the same researchers, the program in England switched to testing for HPV first, on the grounds that since having HPV infection comes before having abnormal cells, HPV testing would detect more women at risk of cervical cancer.

Following the switch to primary HPV testing, the same screening intervals were retained, meaning 3-yearly screening for those aged 24-49 years and testing every 5 years for women aged 50-64 years, or 3 years if they tested positive. However, the National Screening Committee had recommended that invites should be changed from 3 to 5 years for those in the under-50 age group found not to have high-risk HPV at their routine screening test.

For the latest study, funded by Cancer Research UK, the steering group researchers analyzed details for more than 1.3 million women who had attended screening for two rounds of the HPV screening pilot, the first from 2013 to 2016, with a follow-up to the end of 2019. By this time, the data set had doubled in size from the pilot study, and results had been linked with the national cancer registry.

They confirmed that HPV testing was more accurate than a cytology test, irrespective of whether the HPV test assay was DNA- or mRNA-based. With HPV testing, the risk of subsequent cytological changes more than halved overall. Eligible women under 50 who had a negative HPV screen in the first round had a much lower risk of detection of CIN3+ in the second round, with a rate of 1.21 in 1,000, compared with 4.52 in 1,000 after a negative cytology test.
 

Data support extension of the testing interval

“The study confirms that women in this age group are much less likely to develop clinically relevant cervical lesions and cervical cancer, 3 years after a negative HPV screen, compared with a negative smear test,” the researchers said.

They suggested that most women do not need to be screened as frequently as the current program allows, and that the data support an extension of the screening intervals, regardless of the test assay used, to 5 years after a negative HPV test in women aged 25-49 years, and even longer for women aged 50 years and older.

However, the screening interval for HPV-positive women who have negative HPV tests at early recall should be kept at 3 years, they said.

“These results are very reassuring,” said lead author Matejka Rebolj, PhD, senior epidemiologist at KCL. “They build on previous research that shows that following the introduction of HPV testing for cervical screening, a 5-year interval is at least as safe as the previous 3-year interval. Changing to 5-yearly screening will mean we can prevent just as many cancers as before, while allowing for fewer screens.”

Michelle Mitchell, Cancer Research UK’s chief executive, said: “This large study shows that offering cervical screening using HPV testing effectively prevents cervical cancer, without having to be screened as often. This builds on findings from years of research showing HPV testing is more accurate at predicting who is at risk of developing cervical cancer compared to the previous way of testing. As changes to the screening [programs] are made, they will be monitored to help ensure that cervical screening is as effective as possible for all who take part.”
 

If HPV is present, testing interval should remain every 3 years

Responding to the study, Theresa Freeman-Wang, MBChB, consultant gynecologist, president of the British Society for Colposcopy and Cervical Pathology, and spokesperson for the Royal College of Obstetricians and Gynaecologists, told this news organization: “England, Scotland, and Wales and many other countries now use HPV primary screening, which is much better at assessing risk than previous methods. HPV testing is more sensitive and accurate, so changes are picked up earlier.

“Studies have confirmed that if someone is HPV negative (i.e., HPV is not present in the screen test), intervals between tests can very safely be increased from 3 to 5 years. 

“If HPV is present, then the program will automatically look for any abnormal cells. If there are no abnormalities, the woman will be advised to have a repeat screen test in a year. If the HPV remains present over 3 successive years or if abnormal cells are detected at any stage, she will be referred for a more detailed screening examination called a colposcopy.

“It’s important that with any change like this, there is clear information available to explain what these changes mean.

“We have an effective cervical screening program in the UK that has significantly reduced the number of cases and deaths from this preventable cancer. 

“HPV screening every 5 years is safe and to be fully effective it is vital that women take up the invitation for cervical screening when called.”

A version of this article first appeared on Medscape UK.

A 5-year cervical screening interval is as safe and effective for women who test negative for human papillomavirus (HPV) as are 3-year intervals, according to a new ‘real life’ study led by King’s College London (KCL) with researchers from the University of Manchester, and the NHS, on behalf of the HPV pilot steering group.

The study, published in The BMJ, used data from the HPV screening pilot to assess rates of detection of high-grade cervical intraepithelial neoplasia (CIN3+) and of cervical cancer following a negative HPV test. It confirmed that 5-yearly screening prevents as many cancers as screening at 3-year intervals, even in women who are not vaccinated against HPV.
 

Change to primary HPV testing since 2019 

Before 2019, the NHS cervical screening program conducted cytology testing first, testing for HPV only if abnormalities were found. In 2019, following reporting of early results of the HPV pilot by the same researchers, the program in England switched to testing for HPV first, on the grounds that since having HPV infection comes before having abnormal cells, HPV testing would detect more women at risk of cervical cancer.

Following the switch to primary HPV testing, the same screening intervals were retained, meaning 3-yearly screening for those aged 24-49 years and testing every 5 years for women aged 50-64 years, or 3 years if they tested positive. However, the National Screening Committee had recommended that invites should be changed from 3 to 5 years for those in the under-50 age group found not to have high-risk HPV at their routine screening test.

For the latest study, funded by Cancer Research UK, the steering group researchers analyzed details for more than 1.3 million women who had attended screening for two rounds of the HPV screening pilot, the first from 2013 to 2016, with a follow-up to the end of 2019. By this time, the data set had doubled in size from the pilot study, and results had been linked with the national cancer registry.

They confirmed that HPV testing was more accurate than a cytology test, irrespective of whether the HPV test assay was DNA- or mRNA-based. With HPV testing, the risk of subsequent cytological changes more than halved overall. Eligible women under 50 who had a negative HPV screen in the first round had a much lower risk of detection of CIN3+ in the second round, with a rate of 1.21 in 1,000, compared with 4.52 in 1,000 after a negative cytology test.
 

Data support extension of the testing interval

“The study confirms that women in this age group are much less likely to develop clinically relevant cervical lesions and cervical cancer, 3 years after a negative HPV screen, compared with a negative smear test,” the researchers said.

They suggested that most women do not need to be screened as frequently as the current program allows, and that the data support an extension of the screening intervals, regardless of the test assay used, to 5 years after a negative HPV test in women aged 25-49 years, and even longer for women aged 50 years and older.

However, the screening interval for HPV-positive women who have negative HPV tests at early recall should be kept at 3 years, they said.

“These results are very reassuring,” said lead author Matejka Rebolj, PhD, senior epidemiologist at KCL. “They build on previous research that shows that following the introduction of HPV testing for cervical screening, a 5-year interval is at least as safe as the previous 3-year interval. Changing to 5-yearly screening will mean we can prevent just as many cancers as before, while allowing for fewer screens.”

Michelle Mitchell, Cancer Research UK’s chief executive, said: “This large study shows that offering cervical screening using HPV testing effectively prevents cervical cancer, without having to be screened as often. This builds on findings from years of research showing HPV testing is more accurate at predicting who is at risk of developing cervical cancer compared to the previous way of testing. As changes to the screening [programs] are made, they will be monitored to help ensure that cervical screening is as effective as possible for all who take part.”
 

If HPV is present, testing interval should remain every 3 years

Responding to the study, Theresa Freeman-Wang, MBChB, consultant gynecologist, president of the British Society for Colposcopy and Cervical Pathology, and spokesperson for the Royal College of Obstetricians and Gynaecologists, told this news organization: “England, Scotland, and Wales and many other countries now use HPV primary screening, which is much better at assessing risk than previous methods. HPV testing is more sensitive and accurate, so changes are picked up earlier.

“Studies have confirmed that if someone is HPV negative (i.e., HPV is not present in the screen test), intervals between tests can very safely be increased from 3 to 5 years. 

“If HPV is present, then the program will automatically look for any abnormal cells. If there are no abnormalities, the woman will be advised to have a repeat screen test in a year. If the HPV remains present over 3 successive years or if abnormal cells are detected at any stage, she will be referred for a more detailed screening examination called a colposcopy.

“It’s important that with any change like this, there is clear information available to explain what these changes mean.

“We have an effective cervical screening program in the UK that has significantly reduced the number of cases and deaths from this preventable cancer. 

“HPV screening every 5 years is safe and to be fully effective it is vital that women take up the invitation for cervical screening when called.”

A version of this article first appeared on Medscape UK.

A new study suggests that, at least for certain male patients, the answer to infertility might lie with epigenetics.

According to the study, a commercially available test of epigenetic anomalies – factors that affect how genes express themselves – can grade the likelihood that sperm are viable for conception.

“The uniqueness of epigenetics is that some of the abnormalities detected have the potential to be modified with lifestyle,” said Larry I. Lipshultz, MD, head of the Division of Male Reproductive Medicine and Surgery at Baylor College of Medicine, Houston, who presented the new findings at the 2022 annual meeting of the American Urological Association.

For decades, semen analysis has been based on motility, morphology, and concentration. But these measures, while useful, are limited. Semen can still have low capacity for producing a pregnancy even when all three parameters are normal, Dr. Lipshultz told this news organization.

The test, called Path SpermQT (Inherent Biosciences) detects unstable gene promotors, which are the epigenetic markers for gene expression. In previous work with more than 1,300 gene samples, expression of the specific genes regulated by these promoters were linked to a wide variety of functions relevant to fertilization, such as spermatogenesis.

The test does not attempt to look for expression of specific unstable promoters but rather quantifies them to characterize sperm quality as excellent (≤ 10 unstable promoters), average (11-42), or poor (≥ 43).

In the studies that led to development of the SpermQT test, the number of unstable promoters correlated with pregnancy success. Pregnancy was achieved even among those in the group with poor sperm quality – but at very low rates.

Of the 172 semen samples collected so far in the ongoing analysis, sperm quality was characterized as excellent in 31%, average in 59%, and poor in 10%.

The stratifications for sperm quality were not significantly correlated with common measures of sperm viability, such as concentration, Dr. Lipshultz reported.

Certain patient characteristics were associated with greater sperm quality. These included use of antioxidant supplementation and low estrogen levels, as seen in men who had taken aromatase inhibitors.

So far, only one natural conception has occurred in the group with poor sperm versus eight in those with average or excellent quality.

The prognostic role of the test is only part of the picture.

“The exciting thing about this area of research is that epigenetics can be changed,” Dr. Lipshultz said in an interview. Based on the data so far, he said he is already starting to consider antioxidant supplementation and hormone modifications when sperm quality is poor.

The value of the Path SpermQT test for identifying treatment targets might eventually revolutionize the management of male infertility, Dr. Lipshultz said, but it has more immediate potential in helping couples decide whether to proceed with in vitro fertilization (IVF).

“We often see patients at an impasse when they are trying to decide to move to IVF,” he said. “A test like this could provide some direction. If sperm quality is good, the advice might be to keep trying. If poor, then a couple might want to move to IVF more quickly.”

A test of sperm quality on the basis of epigenetics “could change how we look at couples attempting to conceive,” agreed Peter N. Schlegel, MD, professor of urology and reproductive medicine, Weill Cornell Medicine, New York.

Dr. Schlegel praised several characteristics of the epigenetics test, including that 70%-80% of men with poor quality with SpermQT have normal results on standard assessments of semen. This finding suggests the tool is providing unique information about patients. He also noted that the studies so far indicate that sperm of poor quality for natural conception is still viable for IVF fertilization – which could be useful for couples weighing their options.

However, while the test is already available, Dr. Schlegel cautioned that much of the promise has yet to be documented.

“The results to date, despite being statistically significant, have only been gleaned from a small group of patients,” he said. “Much larger studies are needed before a change in practice is warranted.”

The value of SpermQT for identifying modifiable risks might be even further away.

“It is well recognized that environmental and lifestyle changes can affect methylation, but it is not known if the abnormalities seen so far could be influenced by lifestyle changes,” Dr. Schlegel said. Among the numerous steps needed to answer this question, he suggested that it might first be important “to evaluate why such changes in methylation occur.”

Dr. Lipshultz has financial relationships with several pharmaceutical companies, including Inherent Biosciences, which is marketing the SpermQT test. Dr. Schlegel has financial relationships with Theralogix, Posterity Health, and Roman Health.

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

A new study suggests that, at least for certain male patients, the answer to infertility might lie with epigenetics.

According to the study, a commercially available test of epigenetic anomalies – factors that affect how genes express themselves – can grade the likelihood that sperm are viable for conception.

“The uniqueness of epigenetics is that some of the abnormalities detected have the potential to be modified with lifestyle,” said Larry I. Lipshultz, MD, head of the Division of Male Reproductive Medicine and Surgery at Baylor College of Medicine, Houston, who presented the new findings at the 2022 annual meeting of the American Urological Association.

For decades, semen analysis has been based on motility, morphology, and concentration. But these measures, while useful, are limited. Semen can still have low capacity for producing a pregnancy even when all three parameters are normal, Dr. Lipshultz told this news organization.

The test, called Path SpermQT (Inherent Biosciences) detects unstable gene promotors, which are the epigenetic markers for gene expression. In previous work with more than 1,300 gene samples, expression of the specific genes regulated by these promoters were linked to a wide variety of functions relevant to fertilization, such as spermatogenesis.

The test does not attempt to look for expression of specific unstable promoters but rather quantifies them to characterize sperm quality as excellent (≤ 10 unstable promoters), average (11-42), or poor (≥ 43).

In the studies that led to development of the SpermQT test, the number of unstable promoters correlated with pregnancy success. Pregnancy was achieved even among those in the group with poor sperm quality – but at very low rates.

Of the 172 semen samples collected so far in the ongoing analysis, sperm quality was characterized as excellent in 31%, average in 59%, and poor in 10%.

The stratifications for sperm quality were not significantly correlated with common measures of sperm viability, such as concentration, Dr. Lipshultz reported.

Certain patient characteristics were associated with greater sperm quality. These included use of antioxidant supplementation and low estrogen levels, as seen in men who had taken aromatase inhibitors.

So far, only one natural conception has occurred in the group with poor sperm versus eight in those with average or excellent quality.

The prognostic role of the test is only part of the picture.

“The exciting thing about this area of research is that epigenetics can be changed,” Dr. Lipshultz said in an interview. Based on the data so far, he said he is already starting to consider antioxidant supplementation and hormone modifications when sperm quality is poor.

The value of the Path SpermQT test for identifying treatment targets might eventually revolutionize the management of male infertility, Dr. Lipshultz said, but it has more immediate potential in helping couples decide whether to proceed with in vitro fertilization (IVF).

“We often see patients at an impasse when they are trying to decide to move to IVF,” he said. “A test like this could provide some direction. If sperm quality is good, the advice might be to keep trying. If poor, then a couple might want to move to IVF more quickly.”

A test of sperm quality on the basis of epigenetics “could change how we look at couples attempting to conceive,” agreed Peter N. Schlegel, MD, professor of urology and reproductive medicine, Weill Cornell Medicine, New York.

Dr. Schlegel praised several characteristics of the epigenetics test, including that 70%-80% of men with poor quality with SpermQT have normal results on standard assessments of semen. This finding suggests the tool is providing unique information about patients. He also noted that the studies so far indicate that sperm of poor quality for natural conception is still viable for IVF fertilization – which could be useful for couples weighing their options.

However, while the test is already available, Dr. Schlegel cautioned that much of the promise has yet to be documented.

“The results to date, despite being statistically significant, have only been gleaned from a small group of patients,” he said. “Much larger studies are needed before a change in practice is warranted.”

The value of SpermQT for identifying modifiable risks might be even further away.

“It is well recognized that environmental and lifestyle changes can affect methylation, but it is not known if the abnormalities seen so far could be influenced by lifestyle changes,” Dr. Schlegel said. Among the numerous steps needed to answer this question, he suggested that it might first be important “to evaluate why such changes in methylation occur.”

Dr. Lipshultz has financial relationships with several pharmaceutical companies, including Inherent Biosciences, which is marketing the SpermQT test. Dr. Schlegel has financial relationships with Theralogix, Posterity Health, and Roman Health.

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

A new study suggests that, at least for certain male patients, the answer to infertility might lie with epigenetics.

According to the study, a commercially available test of epigenetic anomalies – factors that affect how genes express themselves – can grade the likelihood that sperm are viable for conception.

“The uniqueness of epigenetics is that some of the abnormalities detected have the potential to be modified with lifestyle,” said Larry I. Lipshultz, MD, head of the Division of Male Reproductive Medicine and Surgery at Baylor College of Medicine, Houston, who presented the new findings at the 2022 annual meeting of the American Urological Association.

For decades, semen analysis has been based on motility, morphology, and concentration. But these measures, while useful, are limited. Semen can still have low capacity for producing a pregnancy even when all three parameters are normal, Dr. Lipshultz told this news organization.

The test, called Path SpermQT (Inherent Biosciences) detects unstable gene promotors, which are the epigenetic markers for gene expression. In previous work with more than 1,300 gene samples, expression of the specific genes regulated by these promoters were linked to a wide variety of functions relevant to fertilization, such as spermatogenesis.

The test does not attempt to look for expression of specific unstable promoters but rather quantifies them to characterize sperm quality as excellent (≤ 10 unstable promoters), average (11-42), or poor (≥ 43).

In the studies that led to development of the SpermQT test, the number of unstable promoters correlated with pregnancy success. Pregnancy was achieved even among those in the group with poor sperm quality – but at very low rates.

Of the 172 semen samples collected so far in the ongoing analysis, sperm quality was characterized as excellent in 31%, average in 59%, and poor in 10%.

The stratifications for sperm quality were not significantly correlated with common measures of sperm viability, such as concentration, Dr. Lipshultz reported.

Certain patient characteristics were associated with greater sperm quality. These included use of antioxidant supplementation and low estrogen levels, as seen in men who had taken aromatase inhibitors.

So far, only one natural conception has occurred in the group with poor sperm versus eight in those with average or excellent quality.

The prognostic role of the test is only part of the picture.

“The exciting thing about this area of research is that epigenetics can be changed,” Dr. Lipshultz said in an interview. Based on the data so far, he said he is already starting to consider antioxidant supplementation and hormone modifications when sperm quality is poor.

The value of the Path SpermQT test for identifying treatment targets might eventually revolutionize the management of male infertility, Dr. Lipshultz said, but it has more immediate potential in helping couples decide whether to proceed with in vitro fertilization (IVF).

“We often see patients at an impasse when they are trying to decide to move to IVF,” he said. “A test like this could provide some direction. If sperm quality is good, the advice might be to keep trying. If poor, then a couple might want to move to IVF more quickly.”

A test of sperm quality on the basis of epigenetics “could change how we look at couples attempting to conceive,” agreed Peter N. Schlegel, MD, professor of urology and reproductive medicine, Weill Cornell Medicine, New York.

Dr. Schlegel praised several characteristics of the epigenetics test, including that 70%-80% of men with poor quality with SpermQT have normal results on standard assessments of semen. This finding suggests the tool is providing unique information about patients. He also noted that the studies so far indicate that sperm of poor quality for natural conception is still viable for IVF fertilization – which could be useful for couples weighing their options.

However, while the test is already available, Dr. Schlegel cautioned that much of the promise has yet to be documented.

“The results to date, despite being statistically significant, have only been gleaned from a small group of patients,” he said. “Much larger studies are needed before a change in practice is warranted.”

The value of SpermQT for identifying modifiable risks might be even further away.

“It is well recognized that environmental and lifestyle changes can affect methylation, but it is not known if the abnormalities seen so far could be influenced by lifestyle changes,” Dr. Schlegel said. Among the numerous steps needed to answer this question, he suggested that it might first be important “to evaluate why such changes in methylation occur.”

Dr. Lipshultz has financial relationships with several pharmaceutical companies, including Inherent Biosciences, which is marketing the SpermQT test. Dr. Schlegel has financial relationships with Theralogix, Posterity Health, and Roman Health.

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

A wearable patch that delivers electrical stimulation to the perineum may postpone premature ejaculation, according to research presented at the annual meeting of the American Urological Association. The disposable device appears to work by helping men contract the muscles in the pelvic floor, allowing them to postpone climax.

Among 34 men with a lifelong history of premature ejaculation, average intravaginal ejaculatory latency time – the time from vaginal penetration to ejaculation – increased from about 67 seconds at baseline to 123 seconds when they used the device.

Another 17 participants received a sham treatment – stimulation they could feel but that did not activate muscles. In this group, time to ejaculation increased from 63 seconds to 81 seconds.

The longer duration with active treatment was statistically significant (P < .0001), whereas the increase in the control group was not (P = .1653), said Ege Can Serefoglu, MD, a researcher at Biruni University, Istanbul, and editor-in-chief of the International Journal of Impotence Research.

Dr. Serefoglu is a member of the scientific advisory board for Virility Medical, a company in Hod Hasharon, Israel, that is developing the stimulator. Marketed as vPatch, the device is expected to be available in 2023, Dr. Serefoglu said. It was cleared by the Food and Drug Administration in November and has CE-mark approval in Europe, according to the company.
 

Common problem, limited options

Research shows that 20%-30% of men are not happy with their time to ejaculation, Dr. Serefoglu said.

The International Society for Sexual Medicine defines premature ejaculation as ejaculation which always or almost always occurs within about 1 minute of penetration, the patient is unable to delay this occurrence, and the condition causes personal distress.

“Unfortunately, in spite of its high prevalence we do not really have any satisfying treatment options,” Dr. Serefoglu said.

Topical anesthetics may be used to decrease the sensitivity of the glans penis, and selective serotonin reuptake inhibitors may help delay ejaculation. But these options have limited efficacy and low adherence, he said.

Preclinical studies have shown that injection of botulinum toxin into the bulbospongiosus muscles is associated with a dose-dependent increase in ejaculation latency in rats.

Data on ClinicalTrials.gov show that this approach also may increase ejaculation latency in men, Dr. Serefoglu said. Although investigators found no safety concerns, drugmaker Allergan made a strategic business decision to stop developing this treatment approach, according to the registration entry for the study.

The idea for vPatch came from researchers wondering if instead of paralyzing the muscles with botulinum toxin, they used electrical stimulation to cause contraction of those muscles, Dr. Serefoglu said. A smaller proof-of-concept study demonstrated the feasibility and safety of this technique.

To further assess the safety and efficacy of a transcutaneous perineal electrical stimulator for the treatment of premature ejaculation, investigators conducted the randomized, double-blind, sham-controlled trial at Rambam Medical Centre, Haifa, Israel, and Villa Donatello Clinic, Florence, Italy.

The trial included males with premature ejaculation aged 18-60 years. Their female partners measured IELT using a stopwatch during four sexual intercourse sessions before treatment, and four times on treatment, at home.

In addition to the increased time to ejaculation, perceived control over ejaculation, satisfaction with sexual intercourse, personal distress related to ejaculation, and interpersonal difficulty related to ejaculation all significantly improved with vPatch, the researchers found.

Of participants who received active treatment, 73.5% reported a subjective sense of improvement versus 41.2% of the control group.
 

Potential reactions

No serious adverse events were observed, Dr. Serefoglu reported. Potential adverse reactions include redness, discomfort, and localized pain, according to the company’s website.

Men should not use vPatch if they have been diagnosed with pelvic cancer, or if they have an implanted electronic device, diabetes with peripheral neuropathy, or perineal dermatologic diseases, irritations, or lesions. Other precautions include avoiding use of the vPatch in water or humid environments. The device has not been tested on use with a pregnant partner.

The disposable patches are meant for one-time use. “The miniaturized perineal stimulation device may become an on-demand, drug-free therapeutic option,” Dr. Serefoglu said.

Combining electrical stimulation with other treatment approaches may provide additional benefit, said Bradley Schwartz, DO, professor and chairman of urology at Southern Illinois University, Springfield, who moderated the session at the AUA meeting at which the results of the study were presented.

“You go from 1 to 2 minutes just with this device,” Dr. Schwartz said. “If you went from 2 to 3 minutes, you would essentially be tripling their pleasure or their time, which might make a significant difference.”

Serefoglu agreed that combining the stimulator with other treatment approaches such as topical anesthetics could increase patient satisfaction.

Comoderator Kelly Healy, MD, assistant professor of urology at Columbia University Medical Center, New York, highlighted a direction for future research: examining outcomes according to different types of relationships, as well as partner satisfaction.

“That is a perfect question that should also be considered in the future trials,” Dr. Serefoglu said. “This was mainly focused on the man’s satisfaction. But men are trying to delay their ejaculation to satisfy their partner.”

Dr. Serefoglu is on the scientific advisory board for Virility Medical, which sponsored the study. Dr. Healy had no disclosures. Dr. Schwartz disclosed ties to Cook Medical.

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

A wearable patch that delivers electrical stimulation to the perineum may postpone premature ejaculation, according to research presented at the annual meeting of the American Urological Association. The disposable device appears to work by helping men contract the muscles in the pelvic floor, allowing them to postpone climax.

Among 34 men with a lifelong history of premature ejaculation, average intravaginal ejaculatory latency time – the time from vaginal penetration to ejaculation – increased from about 67 seconds at baseline to 123 seconds when they used the device.

Another 17 participants received a sham treatment – stimulation they could feel but that did not activate muscles. In this group, time to ejaculation increased from 63 seconds to 81 seconds.

The longer duration with active treatment was statistically significant (P < .0001), whereas the increase in the control group was not (P = .1653), said Ege Can Serefoglu, MD, a researcher at Biruni University, Istanbul, and editor-in-chief of the International Journal of Impotence Research.

Dr. Serefoglu is a member of the scientific advisory board for Virility Medical, a company in Hod Hasharon, Israel, that is developing the stimulator. Marketed as vPatch, the device is expected to be available in 2023, Dr. Serefoglu said. It was cleared by the Food and Drug Administration in November and has CE-mark approval in Europe, according to the company.
 

Common problem, limited options

Research shows that 20%-30% of men are not happy with their time to ejaculation, Dr. Serefoglu said.

The International Society for Sexual Medicine defines premature ejaculation as ejaculation which always or almost always occurs within about 1 minute of penetration, the patient is unable to delay this occurrence, and the condition causes personal distress.

“Unfortunately, in spite of its high prevalence we do not really have any satisfying treatment options,” Dr. Serefoglu said.

Topical anesthetics may be used to decrease the sensitivity of the glans penis, and selective serotonin reuptake inhibitors may help delay ejaculation. But these options have limited efficacy and low adherence, he said.

Preclinical studies have shown that injection of botulinum toxin into the bulbospongiosus muscles is associated with a dose-dependent increase in ejaculation latency in rats.

Data on ClinicalTrials.gov show that this approach also may increase ejaculation latency in men, Dr. Serefoglu said. Although investigators found no safety concerns, drugmaker Allergan made a strategic business decision to stop developing this treatment approach, according to the registration entry for the study.

The idea for vPatch came from researchers wondering if instead of paralyzing the muscles with botulinum toxin, they used electrical stimulation to cause contraction of those muscles, Dr. Serefoglu said. A smaller proof-of-concept study demonstrated the feasibility and safety of this technique.

To further assess the safety and efficacy of a transcutaneous perineal electrical stimulator for the treatment of premature ejaculation, investigators conducted the randomized, double-blind, sham-controlled trial at Rambam Medical Centre, Haifa, Israel, and Villa Donatello Clinic, Florence, Italy.

The trial included males with premature ejaculation aged 18-60 years. Their female partners measured IELT using a stopwatch during four sexual intercourse sessions before treatment, and four times on treatment, at home.

In addition to the increased time to ejaculation, perceived control over ejaculation, satisfaction with sexual intercourse, personal distress related to ejaculation, and interpersonal difficulty related to ejaculation all significantly improved with vPatch, the researchers found.

Of participants who received active treatment, 73.5% reported a subjective sense of improvement versus 41.2% of the control group.
 

Potential reactions

No serious adverse events were observed, Dr. Serefoglu reported. Potential adverse reactions include redness, discomfort, and localized pain, according to the company’s website.

Men should not use vPatch if they have been diagnosed with pelvic cancer, or if they have an implanted electronic device, diabetes with peripheral neuropathy, or perineal dermatologic diseases, irritations, or lesions. Other precautions include avoiding use of the vPatch in water or humid environments. The device has not been tested on use with a pregnant partner.

The disposable patches are meant for one-time use. “The miniaturized perineal stimulation device may become an on-demand, drug-free therapeutic option,” Dr. Serefoglu said.

Combining electrical stimulation with other treatment approaches may provide additional benefit, said Bradley Schwartz, DO, professor and chairman of urology at Southern Illinois University, Springfield, who moderated the session at the AUA meeting at which the results of the study were presented.

“You go from 1 to 2 minutes just with this device,” Dr. Schwartz said. “If you went from 2 to 3 minutes, you would essentially be tripling their pleasure or their time, which might make a significant difference.”

Serefoglu agreed that combining the stimulator with other treatment approaches such as topical anesthetics could increase patient satisfaction.

Comoderator Kelly Healy, MD, assistant professor of urology at Columbia University Medical Center, New York, highlighted a direction for future research: examining outcomes according to different types of relationships, as well as partner satisfaction.

“That is a perfect question that should also be considered in the future trials,” Dr. Serefoglu said. “This was mainly focused on the man’s satisfaction. But men are trying to delay their ejaculation to satisfy their partner.”

Dr. Serefoglu is on the scientific advisory board for Virility Medical, which sponsored the study. Dr. Healy had no disclosures. Dr. Schwartz disclosed ties to Cook Medical.

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

A wearable patch that delivers electrical stimulation to the perineum may postpone premature ejaculation, according to research presented at the annual meeting of the American Urological Association. The disposable device appears to work by helping men contract the muscles in the pelvic floor, allowing them to postpone climax.

Among 34 men with a lifelong history of premature ejaculation, average intravaginal ejaculatory latency time – the time from vaginal penetration to ejaculation – increased from about 67 seconds at baseline to 123 seconds when they used the device.

Another 17 participants received a sham treatment – stimulation they could feel but that did not activate muscles. In this group, time to ejaculation increased from 63 seconds to 81 seconds.

The longer duration with active treatment was statistically significant (P < .0001), whereas the increase in the control group was not (P = .1653), said Ege Can Serefoglu, MD, a researcher at Biruni University, Istanbul, and editor-in-chief of the International Journal of Impotence Research.

Dr. Serefoglu is a member of the scientific advisory board for Virility Medical, a company in Hod Hasharon, Israel, that is developing the stimulator. Marketed as vPatch, the device is expected to be available in 2023, Dr. Serefoglu said. It was cleared by the Food and Drug Administration in November and has CE-mark approval in Europe, according to the company.
 

Common problem, limited options

Research shows that 20%-30% of men are not happy with their time to ejaculation, Dr. Serefoglu said.

The International Society for Sexual Medicine defines premature ejaculation as ejaculation which always or almost always occurs within about 1 minute of penetration, the patient is unable to delay this occurrence, and the condition causes personal distress.

“Unfortunately, in spite of its high prevalence we do not really have any satisfying treatment options,” Dr. Serefoglu said.

Topical anesthetics may be used to decrease the sensitivity of the glans penis, and selective serotonin reuptake inhibitors may help delay ejaculation. But these options have limited efficacy and low adherence, he said.

Preclinical studies have shown that injection of botulinum toxin into the bulbospongiosus muscles is associated with a dose-dependent increase in ejaculation latency in rats.

Data on ClinicalTrials.gov show that this approach also may increase ejaculation latency in men, Dr. Serefoglu said. Although investigators found no safety concerns, drugmaker Allergan made a strategic business decision to stop developing this treatment approach, according to the registration entry for the study.

The idea for vPatch came from researchers wondering if instead of paralyzing the muscles with botulinum toxin, they used electrical stimulation to cause contraction of those muscles, Dr. Serefoglu said. A smaller proof-of-concept study demonstrated the feasibility and safety of this technique.

To further assess the safety and efficacy of a transcutaneous perineal electrical stimulator for the treatment of premature ejaculation, investigators conducted the randomized, double-blind, sham-controlled trial at Rambam Medical Centre, Haifa, Israel, and Villa Donatello Clinic, Florence, Italy.

The trial included males with premature ejaculation aged 18-60 years. Their female partners measured IELT using a stopwatch during four sexual intercourse sessions before treatment, and four times on treatment, at home.

In addition to the increased time to ejaculation, perceived control over ejaculation, satisfaction with sexual intercourse, personal distress related to ejaculation, and interpersonal difficulty related to ejaculation all significantly improved with vPatch, the researchers found.

Of participants who received active treatment, 73.5% reported a subjective sense of improvement versus 41.2% of the control group.
 

Potential reactions

No serious adverse events were observed, Dr. Serefoglu reported. Potential adverse reactions include redness, discomfort, and localized pain, according to the company’s website.

Men should not use vPatch if they have been diagnosed with pelvic cancer, or if they have an implanted electronic device, diabetes with peripheral neuropathy, or perineal dermatologic diseases, irritations, or lesions. Other precautions include avoiding use of the vPatch in water or humid environments. The device has not been tested on use with a pregnant partner.

The disposable patches are meant for one-time use. “The miniaturized perineal stimulation device may become an on-demand, drug-free therapeutic option,” Dr. Serefoglu said.

Combining electrical stimulation with other treatment approaches may provide additional benefit, said Bradley Schwartz, DO, professor and chairman of urology at Southern Illinois University, Springfield, who moderated the session at the AUA meeting at which the results of the study were presented.

“You go from 1 to 2 minutes just with this device,” Dr. Schwartz said. “If you went from 2 to 3 minutes, you would essentially be tripling their pleasure or their time, which might make a significant difference.”

Serefoglu agreed that combining the stimulator with other treatment approaches such as topical anesthetics could increase patient satisfaction.

Comoderator Kelly Healy, MD, assistant professor of urology at Columbia University Medical Center, New York, highlighted a direction for future research: examining outcomes according to different types of relationships, as well as partner satisfaction.

“That is a perfect question that should also be considered in the future trials,” Dr. Serefoglu said. “This was mainly focused on the man’s satisfaction. But men are trying to delay their ejaculation to satisfy their partner.”

Dr. Serefoglu is on the scientific advisory board for Virility Medical, which sponsored the study. Dr. Healy had no disclosures. Dr. Schwartz disclosed ties to Cook Medical.

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

NEW YORK (Reuters) – A one-week course of doxycycline was superior to a single dose of azithromycin in women with concurrent vaginal and anorectal chlamydia infection in an unblinded randomized controlled trial, mirroring previous results in men.

Researchers suggest that doxycycline should be the first-line therapy for chlamydia infection in women.

“It is clear we must consider that any woman with a urogenital infection must have an effective treatment for the anal infection, since nearly 80% of women have an anal infection concomitant with the vaginal infection,” Dr. Bertille de Barbeyrac of the University of Bordeaux, France, told Reuters Health by email.

However, she noted that “even [though] the study shows that doxycycline is more effective than azithromycin on anal infection, other studies are needed to prove that residual anal infection after treatment with azithromycin can be a source of vaginal contamination and therefore justify changing practices and eliminating azithromycin as a treatment for lower urogenital chlamydial infection in women.”

“There are other reasons [to make] this change,” she added, “such as the acquisition of macrolide resistance by M. genitalium following heavy use of azithromycin.”

As reported in The Lancet Infectious Diseases, Dr. Barbeyrac and colleagues randomly assigned 460 women (median age, 21) to either doxycycline or azithromycin in a multicenter, open-label superiority trial.

Participants received either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days – that is, 100 mg of doxycycline twice daily).

The primary outcome was that the microbiological anorectal cure rate, defined as a C. trachomatis-negative nucleic acid amplification test (NAAT), resulted in anorectal specimens six weeks after treatment initiation among women who had a baseline positive result (about half the women in each treatment group).

Ninety-four percent of the doxycycline group versus 85% of the azithromycin group had an anorectal cure (adjusted odds ratio with imputation of missing values, 0.43).

Adverse events possibly related to treatment occurred in 11% of the doxycycline group versus 13% of the azithromycin group. Gastrointestinal disorders were most frequent, occurring in 8% of the doxycycline and 11% of the azithromycin groups.

Summing up, the authors write, “The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women.”

Dr. Meleen Chuang, medical director of women’s health at the Family Health Centers at NYU Langone, Brooklyn, commented in an email to Reuters Health that after reviewing this study “as well as CDC and WHO recommendations updated as of 2022, health care providers should be treating C. trachomatis infections with doxycycline 100 mg twice a day for seven days as first-line therapy rather than azithromycin, [given] concerns of increasing macrolide drug resistance against Mycoplasma genitalium and Neisseria gonorrhea.”

“Our clinicians also see the growing uptick of syphilis, gonorrhea, and chlamydia infections in our population, similarly to the rest of the United States since 2020,” she noted. “With the increase in STD infection ... treatment with doxycycline therapy with an important caveat to the patient to complete the one-week treatment regimen is extremely important.”

Dr. Latasha Murphy of the Gynecologic Care Institute at Mercy, Baltimore, also commented in an email to Reuters Health. She noted, “this study does not mirror my clinical experience. More patients have side effects from doxycycline than azithromycin in my experience. Also, anorectal screening is not routine in STD screening.”

“If any major changes to clinical care are made,” she said, “it may be for more consistent screening for anorectal disease. This may ultimately lead to doxycycline being the first line-treatment. More research is needed before making any definitive changes.”
 

Reuters Health Information © 2022

NEW YORK (Reuters) – A one-week course of doxycycline was superior to a single dose of azithromycin in women with concurrent vaginal and anorectal chlamydia infection in an unblinded randomized controlled trial, mirroring previous results in men.

Researchers suggest that doxycycline should be the first-line therapy for chlamydia infection in women.

“It is clear we must consider that any woman with a urogenital infection must have an effective treatment for the anal infection, since nearly 80% of women have an anal infection concomitant with the vaginal infection,” Dr. Bertille de Barbeyrac of the University of Bordeaux, France, told Reuters Health by email.

However, she noted that “even [though] the study shows that doxycycline is more effective than azithromycin on anal infection, other studies are needed to prove that residual anal infection after treatment with azithromycin can be a source of vaginal contamination and therefore justify changing practices and eliminating azithromycin as a treatment for lower urogenital chlamydial infection in women.”

“There are other reasons [to make] this change,” she added, “such as the acquisition of macrolide resistance by M. genitalium following heavy use of azithromycin.”

As reported in The Lancet Infectious Diseases, Dr. Barbeyrac and colleagues randomly assigned 460 women (median age, 21) to either doxycycline or azithromycin in a multicenter, open-label superiority trial.

Participants received either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days – that is, 100 mg of doxycycline twice daily).

The primary outcome was that the microbiological anorectal cure rate, defined as a C. trachomatis-negative nucleic acid amplification test (NAAT), resulted in anorectal specimens six weeks after treatment initiation among women who had a baseline positive result (about half the women in each treatment group).

Ninety-four percent of the doxycycline group versus 85% of the azithromycin group had an anorectal cure (adjusted odds ratio with imputation of missing values, 0.43).

Adverse events possibly related to treatment occurred in 11% of the doxycycline group versus 13% of the azithromycin group. Gastrointestinal disorders were most frequent, occurring in 8% of the doxycycline and 11% of the azithromycin groups.

Summing up, the authors write, “The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women.”

Dr. Meleen Chuang, medical director of women’s health at the Family Health Centers at NYU Langone, Brooklyn, commented in an email to Reuters Health that after reviewing this study “as well as CDC and WHO recommendations updated as of 2022, health care providers should be treating C. trachomatis infections with doxycycline 100 mg twice a day for seven days as first-line therapy rather than azithromycin, [given] concerns of increasing macrolide drug resistance against Mycoplasma genitalium and Neisseria gonorrhea.”

“Our clinicians also see the growing uptick of syphilis, gonorrhea, and chlamydia infections in our population, similarly to the rest of the United States since 2020,” she noted. “With the increase in STD infection ... treatment with doxycycline therapy with an important caveat to the patient to complete the one-week treatment regimen is extremely important.”

Dr. Latasha Murphy of the Gynecologic Care Institute at Mercy, Baltimore, also commented in an email to Reuters Health. She noted, “this study does not mirror my clinical experience. More patients have side effects from doxycycline than azithromycin in my experience. Also, anorectal screening is not routine in STD screening.”

“If any major changes to clinical care are made,” she said, “it may be for more consistent screening for anorectal disease. This may ultimately lead to doxycycline being the first line-treatment. More research is needed before making any definitive changes.”
 

Reuters Health Information © 2022

NEW YORK (Reuters) – A one-week course of doxycycline was superior to a single dose of azithromycin in women with concurrent vaginal and anorectal chlamydia infection in an unblinded randomized controlled trial, mirroring previous results in men.

Researchers suggest that doxycycline should be the first-line therapy for chlamydia infection in women.

“It is clear we must consider that any woman with a urogenital infection must have an effective treatment for the anal infection, since nearly 80% of women have an anal infection concomitant with the vaginal infection,” Dr. Bertille de Barbeyrac of the University of Bordeaux, France, told Reuters Health by email.

However, she noted that “even [though] the study shows that doxycycline is more effective than azithromycin on anal infection, other studies are needed to prove that residual anal infection after treatment with azithromycin can be a source of vaginal contamination and therefore justify changing practices and eliminating azithromycin as a treatment for lower urogenital chlamydial infection in women.”

“There are other reasons [to make] this change,” she added, “such as the acquisition of macrolide resistance by M. genitalium following heavy use of azithromycin.”

As reported in The Lancet Infectious Diseases, Dr. Barbeyrac and colleagues randomly assigned 460 women (median age, 21) to either doxycycline or azithromycin in a multicenter, open-label superiority trial.

Participants received either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days – that is, 100 mg of doxycycline twice daily).

The primary outcome was that the microbiological anorectal cure rate, defined as a C. trachomatis-negative nucleic acid amplification test (NAAT), resulted in anorectal specimens six weeks after treatment initiation among women who had a baseline positive result (about half the women in each treatment group).

Ninety-four percent of the doxycycline group versus 85% of the azithromycin group had an anorectal cure (adjusted odds ratio with imputation of missing values, 0.43).

Adverse events possibly related to treatment occurred in 11% of the doxycycline group versus 13% of the azithromycin group. Gastrointestinal disorders were most frequent, occurring in 8% of the doxycycline and 11% of the azithromycin groups.

Summing up, the authors write, “The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women.”

Dr. Meleen Chuang, medical director of women’s health at the Family Health Centers at NYU Langone, Brooklyn, commented in an email to Reuters Health that after reviewing this study “as well as CDC and WHO recommendations updated as of 2022, health care providers should be treating C. trachomatis infections with doxycycline 100 mg twice a day for seven days as first-line therapy rather than azithromycin, [given] concerns of increasing macrolide drug resistance against Mycoplasma genitalium and Neisseria gonorrhea.”

“Our clinicians also see the growing uptick of syphilis, gonorrhea, and chlamydia infections in our population, similarly to the rest of the United States since 2020,” she noted. “With the increase in STD infection ... treatment with doxycycline therapy with an important caveat to the patient to complete the one-week treatment regimen is extremely important.”

Dr. Latasha Murphy of the Gynecologic Care Institute at Mercy, Baltimore, also commented in an email to Reuters Health. She noted, “this study does not mirror my clinical experience. More patients have side effects from doxycycline than azithromycin in my experience. Also, anorectal screening is not routine in STD screening.”

“If any major changes to clinical care are made,” she said, “it may be for more consistent screening for anorectal disease. This may ultimately lead to doxycycline being the first line-treatment. More research is needed before making any definitive changes.”
 

Reuters Health Information © 2022

Over-the-counter medications, food supplements, and other drugs may interact with antiretroviral therapy (ART) in people living with HIV and be harmful, an industry-sponsored clinical survey from Denmark reports.

“Our study confirms that polypharmacy and being on a protease inhibitor–based regimen increase the risk of potential drug-drug interactions [PDDIs] considerably and highlights the importance of questioning people living with HIV [PLWH] about dietary supplement intake,” the authors, led by Michaela Tinggaard, MD, Copenhagen University Hospital, wrote in HIV Medicine.

“Potential drug-drug interactions were common among our study population. Although the clinical significance of the majority of the identified PDDIs may be low, most of them were avoidable through a change or discontinuation of the comedication, a change in ART or by spacing drugs,” they added.

Senior author Thomas Benfield, MD, DTMH, DMSc, a professor of infectious diseases at the University of Copenhagen, and colleagues collected information on prescription medication, over-the-counter medication, and dietary supplements from adults living with HIV who received ART from two outpatient clinics.

The researchers estimated the prevalence of non-HIV comedications, and they used the University of Liverpool HIV Drug Interactions database to identify potential drug-drug interactions. They evaluated PDDIs and used logistic regression models to investigate links between PDDIs and relevant variables.

The study included 337 people living with HIV receiving ART. The median age was 53 years, 77% of them were male, and 96% were virally suppressed, with HIV-RNA viral load less than 50 copies/mL.

Overall, 26% of participants received five or more comedications, and 56% took dietary supplements.

In the medication lists of 52% of patients, the authors identified coadministration of drugs that required dose adjustment or monitoring; 4.5% of patients were taking drugs that should not be coadministered.

The researchers detected several factors that independently predicted PDDIs:

• Male sex (odds ratio, 1.9; 95% confidence interval, 1.0-3.4)
• Being on a protease inhibitor (OR, 4.3; 95% CI, 1.9-9.7)
• Receiving five or more comedications (OR, 3.3; 95% CI, 1.5-7.2)
• Taking over-the-counter medications (OR, 1.9; 95% CI, 1.1-3.3)
• Taking dietary supplements (OR, 2.0; 95% CI, 1.2-3.3)

Comorbidities and OTC medications increase in aging people with HIV

Indira Brar, MD, an infectious diseases senior staff physician and the medical director of HIV services at Henry Ford Health in Detroit, called the study and important resource for educating providers and patients about over-the-counter drugs.

“The main strength of the study is that it includes a decent number of aging patients living with HIV, the age group in which we worry about drug interactions,” she said in an interview.

“As patients get older, they have increased comorbidities. As comorbidities increase, the number of medications increases. As the number of medications increases, the drug interactions increase,” said Dr. Brar, who was not involved in the study. “Also, as patients get older, they tend to take more over-the-counter drugs.”

Dr. Brar explained how drug-drug interactions can harm patients.

“Drugs added to a patient who is already on ART could decrease the level of the ART and cause the patient to develop a drug-resistant HIV infection,” she said. “Or the ART the patient is on can increase the levels of the new drugs that have been added, and that could have potential toxicity and side effects.

“Food supplements, including multivitamins, calcium, and magnesium, are often overlooked because we think they’re benign. But these drugs can bind our new antiretrovirals, the integrase inhibitors. They can decrease their levels in the patient and cause drug-resistant HIV infection.

“In our clinic, we always tell our patients to please call us before they take any medication, so we can make sure there is no drug interaction,” Dr. Brar said.

Nan Wang, PharmD, a clinical pharmacy specialist at University Hospitals Cleveland Medical Center, noted in an email that drug-drug interactions with ARTs are common.

“Understanding the prevalence of antiretroviral drug interactions in a patient population can help identify certain medications that require enhanced vigilance and can guide our clinical interventions,” said Dr. Wang, who was not associated with the research.

Joseph Alvarnas, MD, a hematologist and oncologist at City of Hope Comprehensive Cancer Center in Duarte, Calif., said that this is “a methodologically sound and well-designed study that’s a timely, important reminder that providers need to think carefully and comprehensively when caring for their patients living with HIV.”

Dr. Alvarnas, who was not involved in the study, said that, with the widespread availability of ART, HIV has become a chronic, manageable condition in an aging population.

“ART agents, particularly the ritonavir-boosted protease inhibitors, increase the likelihood of patients having a potentially significant drug-drug interaction with one of their chronic care medications,” he added. “Even seemingly low-risk supplements such as multivitamins may result in a negative impact upon effective ART treatment of PLWH.”

“The essential next step is that these findings are integrated carefully into decision-support systems, electronic health record prescribing systems, and pharmacy safety-check systems to ensure that we reduce the risk of patient harm,” Dr. Alvarnas advised.

Dr. Benfield and several study coauthors reported financial relationships with GlaxoSmithKline and other pharmaceutical companies. Other coauthors, as well as Dr. Alvarnas, Dr. Brar, and Dr. Wang, reported no relevant financial relationships. The study was supported by GlaxoSmithKline.

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

Over-the-counter medications, food supplements, and other drugs may interact with antiretroviral therapy (ART) in people living with HIV and be harmful, an industry-sponsored clinical survey from Denmark reports.

“Our study confirms that polypharmacy and being on a protease inhibitor–based regimen increase the risk of potential drug-drug interactions [PDDIs] considerably and highlights the importance of questioning people living with HIV [PLWH] about dietary supplement intake,” the authors, led by Michaela Tinggaard, MD, Copenhagen University Hospital, wrote in HIV Medicine.

“Potential drug-drug interactions were common among our study population. Although the clinical significance of the majority of the identified PDDIs may be low, most of them were avoidable through a change or discontinuation of the comedication, a change in ART or by spacing drugs,” they added.

Senior author Thomas Benfield, MD, DTMH, DMSc, a professor of infectious diseases at the University of Copenhagen, and colleagues collected information on prescription medication, over-the-counter medication, and dietary supplements from adults living with HIV who received ART from two outpatient clinics.

The researchers estimated the prevalence of non-HIV comedications, and they used the University of Liverpool HIV Drug Interactions database to identify potential drug-drug interactions. They evaluated PDDIs and used logistic regression models to investigate links between PDDIs and relevant variables.

The study included 337 people living with HIV receiving ART. The median age was 53 years, 77% of them were male, and 96% were virally suppressed, with HIV-RNA viral load less than 50 copies/mL.

Overall, 26% of participants received five or more comedications, and 56% took dietary supplements.

In the medication lists of 52% of patients, the authors identified coadministration of drugs that required dose adjustment or monitoring; 4.5% of patients were taking drugs that should not be coadministered.

The researchers detected several factors that independently predicted PDDIs:

• Male sex (odds ratio, 1.9; 95% confidence interval, 1.0-3.4)
• Being on a protease inhibitor (OR, 4.3; 95% CI, 1.9-9.7)
• Receiving five or more comedications (OR, 3.3; 95% CI, 1.5-7.2)
• Taking over-the-counter medications (OR, 1.9; 95% CI, 1.1-3.3)
• Taking dietary supplements (OR, 2.0; 95% CI, 1.2-3.3)

Comorbidities and OTC medications increase in aging people with HIV

Indira Brar, MD, an infectious diseases senior staff physician and the medical director of HIV services at Henry Ford Health in Detroit, called the study and important resource for educating providers and patients about over-the-counter drugs.

“The main strength of the study is that it includes a decent number of aging patients living with HIV, the age group in which we worry about drug interactions,” she said in an interview.

“As patients get older, they have increased comorbidities. As comorbidities increase, the number of medications increases. As the number of medications increases, the drug interactions increase,” said Dr. Brar, who was not involved in the study. “Also, as patients get older, they tend to take more over-the-counter drugs.”

Dr. Brar explained how drug-drug interactions can harm patients.

“Drugs added to a patient who is already on ART could decrease the level of the ART and cause the patient to develop a drug-resistant HIV infection,” she said. “Or the ART the patient is on can increase the levels of the new drugs that have been added, and that could have potential toxicity and side effects.

“Food supplements, including multivitamins, calcium, and magnesium, are often overlooked because we think they’re benign. But these drugs can bind our new antiretrovirals, the integrase inhibitors. They can decrease their levels in the patient and cause drug-resistant HIV infection.

“In our clinic, we always tell our patients to please call us before they take any medication, so we can make sure there is no drug interaction,” Dr. Brar said.

Nan Wang, PharmD, a clinical pharmacy specialist at University Hospitals Cleveland Medical Center, noted in an email that drug-drug interactions with ARTs are common.

“Understanding the prevalence of antiretroviral drug interactions in a patient population can help identify certain medications that require enhanced vigilance and can guide our clinical interventions,” said Dr. Wang, who was not associated with the research.

Joseph Alvarnas, MD, a hematologist and oncologist at City of Hope Comprehensive Cancer Center in Duarte, Calif., said that this is “a methodologically sound and well-designed study that’s a timely, important reminder that providers need to think carefully and comprehensively when caring for their patients living with HIV.”

Dr. Alvarnas, who was not involved in the study, said that, with the widespread availability of ART, HIV has become a chronic, manageable condition in an aging population.

“ART agents, particularly the ritonavir-boosted protease inhibitors, increase the likelihood of patients having a potentially significant drug-drug interaction with one of their chronic care medications,” he added. “Even seemingly low-risk supplements such as multivitamins may result in a negative impact upon effective ART treatment of PLWH.”

“The essential next step is that these findings are integrated carefully into decision-support systems, electronic health record prescribing systems, and pharmacy safety-check systems to ensure that we reduce the risk of patient harm,” Dr. Alvarnas advised.

Dr. Benfield and several study coauthors reported financial relationships with GlaxoSmithKline and other pharmaceutical companies. Other coauthors, as well as Dr. Alvarnas, Dr. Brar, and Dr. Wang, reported no relevant financial relationships. The study was supported by GlaxoSmithKline.

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

Over-the-counter medications, food supplements, and other drugs may interact with antiretroviral therapy (ART) in people living with HIV and be harmful, an industry-sponsored clinical survey from Denmark reports.

“Our study confirms that polypharmacy and being on a protease inhibitor–based regimen increase the risk of potential drug-drug interactions [PDDIs] considerably and highlights the importance of questioning people living with HIV [PLWH] about dietary supplement intake,” the authors, led by Michaela Tinggaard, MD, Copenhagen University Hospital, wrote in HIV Medicine.

“Potential drug-drug interactions were common among our study population. Although the clinical significance of the majority of the identified PDDIs may be low, most of them were avoidable through a change or discontinuation of the comedication, a change in ART or by spacing drugs,” they added.

Senior author Thomas Benfield, MD, DTMH, DMSc, a professor of infectious diseases at the University of Copenhagen, and colleagues collected information on prescription medication, over-the-counter medication, and dietary supplements from adults living with HIV who received ART from two outpatient clinics.

The researchers estimated the prevalence of non-HIV comedications, and they used the University of Liverpool HIV Drug Interactions database to identify potential drug-drug interactions. They evaluated PDDIs and used logistic regression models to investigate links between PDDIs and relevant variables.

The study included 337 people living with HIV receiving ART. The median age was 53 years, 77% of them were male, and 96% were virally suppressed, with HIV-RNA viral load less than 50 copies/mL.

Overall, 26% of participants received five or more comedications, and 56% took dietary supplements.

In the medication lists of 52% of patients, the authors identified coadministration of drugs that required dose adjustment or monitoring; 4.5% of patients were taking drugs that should not be coadministered.

The researchers detected several factors that independently predicted PDDIs:

• Male sex (odds ratio, 1.9; 95% confidence interval, 1.0-3.4)
• Being on a protease inhibitor (OR, 4.3; 95% CI, 1.9-9.7)
• Receiving five or more comedications (OR, 3.3; 95% CI, 1.5-7.2)
• Taking over-the-counter medications (OR, 1.9; 95% CI, 1.1-3.3)
• Taking dietary supplements (OR, 2.0; 95% CI, 1.2-3.3)

Comorbidities and OTC medications increase in aging people with HIV

Indira Brar, MD, an infectious diseases senior staff physician and the medical director of HIV services at Henry Ford Health in Detroit, called the study and important resource for educating providers and patients about over-the-counter drugs.

“The main strength of the study is that it includes a decent number of aging patients living with HIV, the age group in which we worry about drug interactions,” she said in an interview.

“As patients get older, they have increased comorbidities. As comorbidities increase, the number of medications increases. As the number of medications increases, the drug interactions increase,” said Dr. Brar, who was not involved in the study. “Also, as patients get older, they tend to take more over-the-counter drugs.”

Dr. Brar explained how drug-drug interactions can harm patients.

“Drugs added to a patient who is already on ART could decrease the level of the ART and cause the patient to develop a drug-resistant HIV infection,” she said. “Or the ART the patient is on can increase the levels of the new drugs that have been added, and that could have potential toxicity and side effects.

“Food supplements, including multivitamins, calcium, and magnesium, are often overlooked because we think they’re benign. But these drugs can bind our new antiretrovirals, the integrase inhibitors. They can decrease their levels in the patient and cause drug-resistant HIV infection.

“In our clinic, we always tell our patients to please call us before they take any medication, so we can make sure there is no drug interaction,” Dr. Brar said.

Nan Wang, PharmD, a clinical pharmacy specialist at University Hospitals Cleveland Medical Center, noted in an email that drug-drug interactions with ARTs are common.

“Understanding the prevalence of antiretroviral drug interactions in a patient population can help identify certain medications that require enhanced vigilance and can guide our clinical interventions,” said Dr. Wang, who was not associated with the research.

Joseph Alvarnas, MD, a hematologist and oncologist at City of Hope Comprehensive Cancer Center in Duarte, Calif., said that this is “a methodologically sound and well-designed study that’s a timely, important reminder that providers need to think carefully and comprehensively when caring for their patients living with HIV.”

Dr. Alvarnas, who was not involved in the study, said that, with the widespread availability of ART, HIV has become a chronic, manageable condition in an aging population.

“ART agents, particularly the ritonavir-boosted protease inhibitors, increase the likelihood of patients having a potentially significant drug-drug interaction with one of their chronic care medications,” he added. “Even seemingly low-risk supplements such as multivitamins may result in a negative impact upon effective ART treatment of PLWH.”

“The essential next step is that these findings are integrated carefully into decision-support systems, electronic health record prescribing systems, and pharmacy safety-check systems to ensure that we reduce the risk of patient harm,” Dr. Alvarnas advised.

Dr. Benfield and several study coauthors reported financial relationships with GlaxoSmithKline and other pharmaceutical companies. Other coauthors, as well as Dr. Alvarnas, Dr. Brar, and Dr. Wang, reported no relevant financial relationships. The study was supported by GlaxoSmithKline.

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

Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.

The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.

“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.

The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.

The study was published online in The Lancet.

The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
 

First head-to-head trial

For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.

The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.

Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.

The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.

Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.

“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.

Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.

They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.

“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.

The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.

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

Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.

The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.

“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.

The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.

The study was published online in The Lancet.

The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
 

First head-to-head trial

For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.

The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.

Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.

The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.

Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.

“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.

Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.

They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.

“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.

The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.

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

Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.

The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.

“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.

The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.

The study was published online in The Lancet.

The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
 

First head-to-head trial

For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.

The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.

Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.

The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.

Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.

“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.

Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.

They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.

“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.

The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.

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

Twelve years after the human papillomavirus (HPV) vaccination program was introduced in the United States, the overall prevalence of cancer-causing HPV strains covered by the vaccine dropped by 85% among females – 90% among vaccinated females and 74% among unvaccinated females – a strong sign of herd immunity, a new analysis of a nationally representative database is showing.

“HPV vaccination is working well,” Hannah Rosenblum, MD, Centers for Disease Control and Prevention, Atlanta, told this news organization in an email.

“Twelve years after introduction of HPV vaccination in the United States, national data demonstrate increasing impact among females and strong herd effects among unvaccinated females,” she added. “[Although] vaccination coverage and completion of the recommended dose in the United States is lower than coverage with other adolescent vaccinations, HPV vaccination is the best way to prevent HPV infections that can lead to several cancers in both females and males.”

The study was published online in Annals of Internal Medicine.
 

NHANES survey

The authors used data from the National Health and Nutrition Examination Survey (NHANES) to examine the four HPV types in the quadrivalent vaccine before 2003 and 2006 (the pre-vaccine era) and then again between 2007-2010, 2011-2014, and 2015-2018 (the vaccine era). For females, they analyzed demographic and HPV prevalence data across each 4-year era.

“Analyses were limited to sexually experienced participants, to ensure that all those included had an opportunity for HPV exposure, and to participants aged 14-24 years with adequate self-collected cervicovaginal specimens,” the authors explain.

This resulted in a sample size of 3,197 females. Demographic and HPV prevalence data were also collected from males but only during the 2013-2016 era, because those are the only years for which male HPV typing data are available in NHANES. Again, analyses were limited to sexually experienced males aged 14-24 years with adequate self-collected penile specimens, which resulted in a sample size of 661 males.

Over the 12 years of follow-up for females, there was a steady increase in females reporting having received at least one dose of the HPV vaccine – from slightly over 25% during 2007-12 to 59% during 2015-2018. The percentage of males who reported having at least one HPV dose also increased, from 29.5% in 2016 to 34.5% in 2018.

During the earliest vaccine era (2007-2010), the prevalence of the four HPV strains covered by the vaccine was 7.3% among vaccinated females, compared with 20.4% among unvaccinated females. “By 2015 to 2018, the prevalence was 2.8% (prevalence ratio, 0.16; 95% confidence interval, 0.07-0.39). The prevalence of the four vaccine-covered types was only 1.9% in vaccinated females, compared with 4.8% in unvaccinated females (PR, 0.40; 95% CI, 0.11-1.41).

In contrast, the prevalence of HPV types that were not covered by the vaccine showed little change – from 51.1% in the pre-vaccine era to 47.6% during 2015-2018 (PR, 0.93; 95% CI, 0.80-1.08). The authors considered this a good sign because it indicates that vaccine-type HPV infections are not being replaced with other oncogenic HPV infections. Between 2013 and 2016, the difference in the prevalence of the four HPV vaccine types was smaller at 1.8% among vaccinated males and 3.5% among unvaccinated males (PR, 0.49; 95% CI, 0.11-2.20).

Again, the prevalence of non-HPV vaccine types was not significantly different between vaccinated and unvaccinated males: 30.7% versus 34.3%.

During the vaccine era, effectiveness for females ranged from 60% to 84%. For males, vaccine effectiveness could only be evaluated for the single 4-year period from 2013 to 2016, and it was estimated at 51%. Dr. Rosenblum noted that vaccine efficacy estimates were lower on this national survey than the almost 100% efficacy rates observed in clinical trials in both males and females.

“This might be due in part to many participants receiving the vaccine at an older age than is recommended when they could have been infected [with HPV] at the time of vaccination,” Dr. Rosenblum said. She also noted that because males were incorporated into the HPV vaccination program years after females, they likely also experienced strong herd effects from the vaccine, making it challenging to estimate vaccine effectiveness.

Dr. Rosenblum also noted that there have already been documented declines in cervical precancers and high-grade vulvar and vaginal precancers, as well as genital warts and juvenile-onset recurrent respiratory papillomatosis. At the same time, the incidence of cervical precancers has recently declined among U.S. females in their late teens and early 20s – “likely reflecting the impact of vaccination,” she said.

“This study is good news for the United States HPV vaccination program, and all efforts are needed to ensure that children and adolescents receive routinely recommended vaccinations [including vaccination against HPV],” Dr. Rosenblum added.
 

Editorial comment

Commenting on the findings, Rebecca Perkins, MD, Boston University School of Medicine, and colleagues point out that the COVID-19 pandemic has led to disruptions in HPV vaccination programs and has reversed much of the progress made in recent years. “During the pandemic, providers and health systems have deprioritized adolescent vaccination and particularly HPV vaccination, which in turn has led to more severe drops for HPV vaccination than for other adolescent vaccinations, and for adolescent vaccination, compared with early childhood and adult vaccinations,” Dr. Perkins and colleagues write in an accompanying editorial.

Thus, the need to compensate for the cumulative deficit of missed vaccinations over the past 2 years has created a “serious and urgent threat” to cancer prevention efforts – “a shortfall from which it may take a decade to recover,” the editorialists predict. To try and reverse this trend, several practices have been shown to improve HPV vaccination rates.

The first is a strong provider recommendation such as, “Your child is due for an HPV vaccine today.” The second is to give standing orders to allow nurses and medical assistants to administer vaccinations without requiring intervention by a physician. Lastly, programs to remind patients when vaccines are due and to recall them for appointments also work well.

“Using evidence-based methods and redoubling our efforts to prioritize HPV vaccination will be crucial to ensuring that we do not lose a generation to preventable HPV-associated cancer,” write Dr. Perkins and colleagues.

The study authors and editorialists have disclosed no relevant financial relationships.

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

Twelve years after the human papillomavirus (HPV) vaccination program was introduced in the United States, the overall prevalence of cancer-causing HPV strains covered by the vaccine dropped by 85% among females – 90% among vaccinated females and 74% among unvaccinated females – a strong sign of herd immunity, a new analysis of a nationally representative database is showing.

“HPV vaccination is working well,” Hannah Rosenblum, MD, Centers for Disease Control and Prevention, Atlanta, told this news organization in an email.

“Twelve years after introduction of HPV vaccination in the United States, national data demonstrate increasing impact among females and strong herd effects among unvaccinated females,” she added. “[Although] vaccination coverage and completion of the recommended dose in the United States is lower than coverage with other adolescent vaccinations, HPV vaccination is the best way to prevent HPV infections that can lead to several cancers in both females and males.”

The study was published online in Annals of Internal Medicine.
 

NHANES survey

The authors used data from the National Health and Nutrition Examination Survey (NHANES) to examine the four HPV types in the quadrivalent vaccine before 2003 and 2006 (the pre-vaccine era) and then again between 2007-2010, 2011-2014, and 2015-2018 (the vaccine era). For females, they analyzed demographic and HPV prevalence data across each 4-year era.

“Analyses were limited to sexually experienced participants, to ensure that all those included had an opportunity for HPV exposure, and to participants aged 14-24 years with adequate self-collected cervicovaginal specimens,” the authors explain.

This resulted in a sample size of 3,197 females. Demographic and HPV prevalence data were also collected from males but only during the 2013-2016 era, because those are the only years for which male HPV typing data are available in NHANES. Again, analyses were limited to sexually experienced males aged 14-24 years with adequate self-collected penile specimens, which resulted in a sample size of 661 males.

Over the 12 years of follow-up for females, there was a steady increase in females reporting having received at least one dose of the HPV vaccine – from slightly over 25% during 2007-12 to 59% during 2015-2018. The percentage of males who reported having at least one HPV dose also increased, from 29.5% in 2016 to 34.5% in 2018.

During the earliest vaccine era (2007-2010), the prevalence of the four HPV strains covered by the vaccine was 7.3% among vaccinated females, compared with 20.4% among unvaccinated females. “By 2015 to 2018, the prevalence was 2.8% (prevalence ratio, 0.16; 95% confidence interval, 0.07-0.39). The prevalence of the four vaccine-covered types was only 1.9% in vaccinated females, compared with 4.8% in unvaccinated females (PR, 0.40; 95% CI, 0.11-1.41).

In contrast, the prevalence of HPV types that were not covered by the vaccine showed little change – from 51.1% in the pre-vaccine era to 47.6% during 2015-2018 (PR, 0.93; 95% CI, 0.80-1.08). The authors considered this a good sign because it indicates that vaccine-type HPV infections are not being replaced with other oncogenic HPV infections. Between 2013 and 2016, the difference in the prevalence of the four HPV vaccine types was smaller at 1.8% among vaccinated males and 3.5% among unvaccinated males (PR, 0.49; 95% CI, 0.11-2.20).

Again, the prevalence of non-HPV vaccine types was not significantly different between vaccinated and unvaccinated males: 30.7% versus 34.3%.

During the vaccine era, effectiveness for females ranged from 60% to 84%. For males, vaccine effectiveness could only be evaluated for the single 4-year period from 2013 to 2016, and it was estimated at 51%. Dr. Rosenblum noted that vaccine efficacy estimates were lower on this national survey than the almost 100% efficacy rates observed in clinical trials in both males and females.

“This might be due in part to many participants receiving the vaccine at an older age than is recommended when they could have been infected [with HPV] at the time of vaccination,” Dr. Rosenblum said. She also noted that because males were incorporated into the HPV vaccination program years after females, they likely also experienced strong herd effects from the vaccine, making it challenging to estimate vaccine effectiveness.

Dr. Rosenblum also noted that there have already been documented declines in cervical precancers and high-grade vulvar and vaginal precancers, as well as genital warts and juvenile-onset recurrent respiratory papillomatosis. At the same time, the incidence of cervical precancers has recently declined among U.S. females in their late teens and early 20s – “likely reflecting the impact of vaccination,” she said.

“This study is good news for the United States HPV vaccination program, and all efforts are needed to ensure that children and adolescents receive routinely recommended vaccinations [including vaccination against HPV],” Dr. Rosenblum added.
 

Editorial comment

Commenting on the findings, Rebecca Perkins, MD, Boston University School of Medicine, and colleagues point out that the COVID-19 pandemic has led to disruptions in HPV vaccination programs and has reversed much of the progress made in recent years. “During the pandemic, providers and health systems have deprioritized adolescent vaccination and particularly HPV vaccination, which in turn has led to more severe drops for HPV vaccination than for other adolescent vaccinations, and for adolescent vaccination, compared with early childhood and adult vaccinations,” Dr. Perkins and colleagues write in an accompanying editorial.

Thus, the need to compensate for the cumulative deficit of missed vaccinations over the past 2 years has created a “serious and urgent threat” to cancer prevention efforts – “a shortfall from which it may take a decade to recover,” the editorialists predict. To try and reverse this trend, several practices have been shown to improve HPV vaccination rates.

The first is a strong provider recommendation such as, “Your child is due for an HPV vaccine today.” The second is to give standing orders to allow nurses and medical assistants to administer vaccinations without requiring intervention by a physician. Lastly, programs to remind patients when vaccines are due and to recall them for appointments also work well.

“Using evidence-based methods and redoubling our efforts to prioritize HPV vaccination will be crucial to ensuring that we do not lose a generation to preventable HPV-associated cancer,” write Dr. Perkins and colleagues.

The study authors and editorialists have disclosed no relevant financial relationships.

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

Twelve years after the human papillomavirus (HPV) vaccination program was introduced in the United States, the overall prevalence of cancer-causing HPV strains covered by the vaccine dropped by 85% among females – 90% among vaccinated females and 74% among unvaccinated females – a strong sign of herd immunity, a new analysis of a nationally representative database is showing.

“HPV vaccination is working well,” Hannah Rosenblum, MD, Centers for Disease Control and Prevention, Atlanta, told this news organization in an email.

“Twelve years after introduction of HPV vaccination in the United States, national data demonstrate increasing impact among females and strong herd effects among unvaccinated females,” she added. “[Although] vaccination coverage and completion of the recommended dose in the United States is lower than coverage with other adolescent vaccinations, HPV vaccination is the best way to prevent HPV infections that can lead to several cancers in both females and males.”

The study was published online in Annals of Internal Medicine.
 

NHANES survey

The authors used data from the National Health and Nutrition Examination Survey (NHANES) to examine the four HPV types in the quadrivalent vaccine before 2003 and 2006 (the pre-vaccine era) and then again between 2007-2010, 2011-2014, and 2015-2018 (the vaccine era). For females, they analyzed demographic and HPV prevalence data across each 4-year era.

“Analyses were limited to sexually experienced participants, to ensure that all those included had an opportunity for HPV exposure, and to participants aged 14-24 years with adequate self-collected cervicovaginal specimens,” the authors explain.

This resulted in a sample size of 3,197 females. Demographic and HPV prevalence data were also collected from males but only during the 2013-2016 era, because those are the only years for which male HPV typing data are available in NHANES. Again, analyses were limited to sexually experienced males aged 14-24 years with adequate self-collected penile specimens, which resulted in a sample size of 661 males.

Over the 12 years of follow-up for females, there was a steady increase in females reporting having received at least one dose of the HPV vaccine – from slightly over 25% during 2007-12 to 59% during 2015-2018. The percentage of males who reported having at least one HPV dose also increased, from 29.5% in 2016 to 34.5% in 2018.

During the earliest vaccine era (2007-2010), the prevalence of the four HPV strains covered by the vaccine was 7.3% among vaccinated females, compared with 20.4% among unvaccinated females. “By 2015 to 2018, the prevalence was 2.8% (prevalence ratio, 0.16; 95% confidence interval, 0.07-0.39). The prevalence of the four vaccine-covered types was only 1.9% in vaccinated females, compared with 4.8% in unvaccinated females (PR, 0.40; 95% CI, 0.11-1.41).

In contrast, the prevalence of HPV types that were not covered by the vaccine showed little change – from 51.1% in the pre-vaccine era to 47.6% during 2015-2018 (PR, 0.93; 95% CI, 0.80-1.08). The authors considered this a good sign because it indicates that vaccine-type HPV infections are not being replaced with other oncogenic HPV infections. Between 2013 and 2016, the difference in the prevalence of the four HPV vaccine types was smaller at 1.8% among vaccinated males and 3.5% among unvaccinated males (PR, 0.49; 95% CI, 0.11-2.20).

Again, the prevalence of non-HPV vaccine types was not significantly different between vaccinated and unvaccinated males: 30.7% versus 34.3%.

During the vaccine era, effectiveness for females ranged from 60% to 84%. For males, vaccine effectiveness could only be evaluated for the single 4-year period from 2013 to 2016, and it was estimated at 51%. Dr. Rosenblum noted that vaccine efficacy estimates were lower on this national survey than the almost 100% efficacy rates observed in clinical trials in both males and females.

“This might be due in part to many participants receiving the vaccine at an older age than is recommended when they could have been infected [with HPV] at the time of vaccination,” Dr. Rosenblum said. She also noted that because males were incorporated into the HPV vaccination program years after females, they likely also experienced strong herd effects from the vaccine, making it challenging to estimate vaccine effectiveness.

Dr. Rosenblum also noted that there have already been documented declines in cervical precancers and high-grade vulvar and vaginal precancers, as well as genital warts and juvenile-onset recurrent respiratory papillomatosis. At the same time, the incidence of cervical precancers has recently declined among U.S. females in their late teens and early 20s – “likely reflecting the impact of vaccination,” she said.

“This study is good news for the United States HPV vaccination program, and all efforts are needed to ensure that children and adolescents receive routinely recommended vaccinations [including vaccination against HPV],” Dr. Rosenblum added.
 

Editorial comment

Commenting on the findings, Rebecca Perkins, MD, Boston University School of Medicine, and colleagues point out that the COVID-19 pandemic has led to disruptions in HPV vaccination programs and has reversed much of the progress made in recent years. “During the pandemic, providers and health systems have deprioritized adolescent vaccination and particularly HPV vaccination, which in turn has led to more severe drops for HPV vaccination than for other adolescent vaccinations, and for adolescent vaccination, compared with early childhood and adult vaccinations,” Dr. Perkins and colleagues write in an accompanying editorial.

Thus, the need to compensate for the cumulative deficit of missed vaccinations over the past 2 years has created a “serious and urgent threat” to cancer prevention efforts – “a shortfall from which it may take a decade to recover,” the editorialists predict. To try and reverse this trend, several practices have been shown to improve HPV vaccination rates.

The first is a strong provider recommendation such as, “Your child is due for an HPV vaccine today.” The second is to give standing orders to allow nurses and medical assistants to administer vaccinations without requiring intervention by a physician. Lastly, programs to remind patients when vaccines are due and to recall them for appointments also work well.

“Using evidence-based methods and redoubling our efforts to prioritize HPV vaccination will be crucial to ensuring that we do not lose a generation to preventable HPV-associated cancer,” write Dr. Perkins and colleagues.

The study authors and editorialists have disclosed no relevant financial relationships.

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

The Food and Drug Administration has authorized ultrathin panties that can be worn to reduce the risk of sexually transmitted diseases during oral sex.

The underwear, sold as Lorals for Protection, are single-use, vanilla-scented, natural latex panties that cover the genitals and anus and block the transfer of bodily fluids during oral sex, according to the company website. They sell in packages of four for $25.

The FDA didn’t run human clinical trials but granted authorization after the company gave it data about the product, The New York Times reported.

“The FDA’s authorization of this product gives people another option to protect against STIs during oral sex,” said Courtney Lias, PhD, director of the FDA office that led the review of the underwear.

Previously, the FDA authorized oral dams to prevent the spread of STIs during oral sex. Oral dams, sometimes called oral sex condoms, are thin latex barriers that go between one partner’s mouth and the other person’s genitals. The dams haven’t been widely used, partly because a person has to hold the dam in place during sex, unlike the panties.

“They’re extremely unpopular,” Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, told the Times. “I mean, honestly, could there be anything less sexy than a dental dam?”Melanie Cristol said she came up with the idea for the panties after discovering on her 2014 honeymoon that she had an infection that could be sexually transmitted.

“I wanted to feel sexy and confident and use something that was made with my body and actual sex in mind,” she told the Times.

The panties are made of material about as thin as a condom and form a seal on the thigh to keep fluids inside, she said.

Dr. Marrazzo said the panties are an advancement because there are few options for safe oral sex. She noted that some teenagers have their first sexual experience with oral sex and that the panties could reduce anxiety for people of all ages.

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

The Food and Drug Administration has authorized ultrathin panties that can be worn to reduce the risk of sexually transmitted diseases during oral sex.

The underwear, sold as Lorals for Protection, are single-use, vanilla-scented, natural latex panties that cover the genitals and anus and block the transfer of bodily fluids during oral sex, according to the company website. They sell in packages of four for $25.

The FDA didn’t run human clinical trials but granted authorization after the company gave it data about the product, The New York Times reported.

“The FDA’s authorization of this product gives people another option to protect against STIs during oral sex,” said Courtney Lias, PhD, director of the FDA office that led the review of the underwear.

Previously, the FDA authorized oral dams to prevent the spread of STIs during oral sex. Oral dams, sometimes called oral sex condoms, are thin latex barriers that go between one partner’s mouth and the other person’s genitals. The dams haven’t been widely used, partly because a person has to hold the dam in place during sex, unlike the panties.

“They’re extremely unpopular,” Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, told the Times. “I mean, honestly, could there be anything less sexy than a dental dam?”Melanie Cristol said she came up with the idea for the panties after discovering on her 2014 honeymoon that she had an infection that could be sexually transmitted.

“I wanted to feel sexy and confident and use something that was made with my body and actual sex in mind,” she told the Times.

The panties are made of material about as thin as a condom and form a seal on the thigh to keep fluids inside, she said.

Dr. Marrazzo said the panties are an advancement because there are few options for safe oral sex. She noted that some teenagers have their first sexual experience with oral sex and that the panties could reduce anxiety for people of all ages.

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

The Food and Drug Administration has authorized ultrathin panties that can be worn to reduce the risk of sexually transmitted diseases during oral sex.

The underwear, sold as Lorals for Protection, are single-use, vanilla-scented, natural latex panties that cover the genitals and anus and block the transfer of bodily fluids during oral sex, according to the company website. They sell in packages of four for $25.

The FDA didn’t run human clinical trials but granted authorization after the company gave it data about the product, The New York Times reported.

“The FDA’s authorization of this product gives people another option to protect against STIs during oral sex,” said Courtney Lias, PhD, director of the FDA office that led the review of the underwear.

Previously, the FDA authorized oral dams to prevent the spread of STIs during oral sex. Oral dams, sometimes called oral sex condoms, are thin latex barriers that go between one partner’s mouth and the other person’s genitals. The dams haven’t been widely used, partly because a person has to hold the dam in place during sex, unlike the panties.

“They’re extremely unpopular,” Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, told the Times. “I mean, honestly, could there be anything less sexy than a dental dam?”Melanie Cristol said she came up with the idea for the panties after discovering on her 2014 honeymoon that she had an infection that could be sexually transmitted.

“I wanted to feel sexy and confident and use something that was made with my body and actual sex in mind,” she told the Times.

The panties are made of material about as thin as a condom and form a seal on the thigh to keep fluids inside, she said.

Dr. Marrazzo said the panties are an advancement because there are few options for safe oral sex. She noted that some teenagers have their first sexual experience with oral sex and that the panties could reduce anxiety for people of all ages.

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

California researchers are seeking women willing to use sex toys for science.

A group at Cedars-Sinai Medical Center in Los Angeles has launched a study to see whether the current generation of vibrators – powerful, technologically advanced, even Bluetooth-enabled – can improve sexual health, pelvic floor function, and overall well-being.

“We have not had good-quality studies with the use of modern vibrators,” Alexandra Dubinskaya, MD, an obstetrician who is leading the study, said in an interview.

Vibrators of various kinds have been used by women for centuries if not millennia. More than half of women in the United States have at least some experience with the devices.

Victorian-era physicians are said to have routinely prescribed multiple types of vibrators to treat “female hysteria,” although the frequency with which vibrators were recommended for therapeutic purposes has been questioned.

Still, Dr. Dubinskaya said vibrators have a long history of use as therapy – with some evidence of success.

She and her colleagues reviewed the medical literature and found that studies generally supported the use of vibrators for increased blood flow in pelvic tissues, improved sexual function, including orgasms, and possibly urinary incontinence by helping to strengthen the pelvic floor. They also appear to boost desire, arousal, and genital sensation.

For the new study, Dr. Dubinskaya and her colleagues hope to eventually include 100 women between the ages of 18 and 99 years. Each will receive a commercially available genital vibrator and instructions to use the device to reach orgasm three times per week for 3 to 4 months. The researchers will track any changes in sexual function, pelvic prolapse, urinary continence, and other measures of pelvic and sexual health.

The goal of the study, Dr. Dubinskaya said, is to provide prospective data for clinicians who might consider recommending vibrators to their patients – a list that includes urologists, gynecologists, and experts in sexual medicine.

These clinicians “are frequently the first to encounter questions on women’s sexual function, pelvic floor problems, and vulvar health,” Dr. Dubinskaya said. She noted that such questions are common.

Asking women to consider using vibrators might seem too sensitive a subject in a clinical setting, but Dr. Dubinskaya said data indicate that women are receptive to the suggestion.

Debra Lynne Herbenick, PhD, director of the Center for Sexual Health Promotion and a professor of public health at Indiana University, Indianapolis, who has studied vibrator use in the United States, said the research could make a valuable contribution to sexual health.

“This study is an important next step because it is a prospective study and will be able to assess changes in sexual and pelvic floor function over time in relation to vibrator use,” Dr. Herbenick said. Owing to the limited quality of the currently available evidence, these data have the potential “to support clinicians’ recommendations and also their communication with patients.”

Dr. Dubinskaya and Dr. Herbenick reported no relevant financial relationships.

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

California researchers are seeking women willing to use sex toys for science.

A group at Cedars-Sinai Medical Center in Los Angeles has launched a study to see whether the current generation of vibrators – powerful, technologically advanced, even Bluetooth-enabled – can improve sexual health, pelvic floor function, and overall well-being.

“We have not had good-quality studies with the use of modern vibrators,” Alexandra Dubinskaya, MD, an obstetrician who is leading the study, said in an interview.

Vibrators of various kinds have been used by women for centuries if not millennia. More than half of women in the United States have at least some experience with the devices.

Victorian-era physicians are said to have routinely prescribed multiple types of vibrators to treat “female hysteria,” although the frequency with which vibrators were recommended for therapeutic purposes has been questioned.

Still, Dr. Dubinskaya said vibrators have a long history of use as therapy – with some evidence of success.

She and her colleagues reviewed the medical literature and found that studies generally supported the use of vibrators for increased blood flow in pelvic tissues, improved sexual function, including orgasms, and possibly urinary incontinence by helping to strengthen the pelvic floor. They also appear to boost desire, arousal, and genital sensation.

For the new study, Dr. Dubinskaya and her colleagues hope to eventually include 100 women between the ages of 18 and 99 years. Each will receive a commercially available genital vibrator and instructions to use the device to reach orgasm three times per week for 3 to 4 months. The researchers will track any changes in sexual function, pelvic prolapse, urinary continence, and other measures of pelvic and sexual health.

The goal of the study, Dr. Dubinskaya said, is to provide prospective data for clinicians who might consider recommending vibrators to their patients – a list that includes urologists, gynecologists, and experts in sexual medicine.

These clinicians “are frequently the first to encounter questions on women’s sexual function, pelvic floor problems, and vulvar health,” Dr. Dubinskaya said. She noted that such questions are common.

Asking women to consider using vibrators might seem too sensitive a subject in a clinical setting, but Dr. Dubinskaya said data indicate that women are receptive to the suggestion.

Debra Lynne Herbenick, PhD, director of the Center for Sexual Health Promotion and a professor of public health at Indiana University, Indianapolis, who has studied vibrator use in the United States, said the research could make a valuable contribution to sexual health.

“This study is an important next step because it is a prospective study and will be able to assess changes in sexual and pelvic floor function over time in relation to vibrator use,” Dr. Herbenick said. Owing to the limited quality of the currently available evidence, these data have the potential “to support clinicians’ recommendations and also their communication with patients.”

Dr. Dubinskaya and Dr. Herbenick reported no relevant financial relationships.

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

California researchers are seeking women willing to use sex toys for science.

A group at Cedars-Sinai Medical Center in Los Angeles has launched a study to see whether the current generation of vibrators – powerful, technologically advanced, even Bluetooth-enabled – can improve sexual health, pelvic floor function, and overall well-being.

“We have not had good-quality studies with the use of modern vibrators,” Alexandra Dubinskaya, MD, an obstetrician who is leading the study, said in an interview.

Vibrators of various kinds have been used by women for centuries if not millennia. More than half of women in the United States have at least some experience with the devices.

Victorian-era physicians are said to have routinely prescribed multiple types of vibrators to treat “female hysteria,” although the frequency with which vibrators were recommended for therapeutic purposes has been questioned.

Still, Dr. Dubinskaya said vibrators have a long history of use as therapy – with some evidence of success.

She and her colleagues reviewed the medical literature and found that studies generally supported the use of vibrators for increased blood flow in pelvic tissues, improved sexual function, including orgasms, and possibly urinary incontinence by helping to strengthen the pelvic floor. They also appear to boost desire, arousal, and genital sensation.

For the new study, Dr. Dubinskaya and her colleagues hope to eventually include 100 women between the ages of 18 and 99 years. Each will receive a commercially available genital vibrator and instructions to use the device to reach orgasm three times per week for 3 to 4 months. The researchers will track any changes in sexual function, pelvic prolapse, urinary continence, and other measures of pelvic and sexual health.

The goal of the study, Dr. Dubinskaya said, is to provide prospective data for clinicians who might consider recommending vibrators to their patients – a list that includes urologists, gynecologists, and experts in sexual medicine.

These clinicians “are frequently the first to encounter questions on women’s sexual function, pelvic floor problems, and vulvar health,” Dr. Dubinskaya said. She noted that such questions are common.

Asking women to consider using vibrators might seem too sensitive a subject in a clinical setting, but Dr. Dubinskaya said data indicate that women are receptive to the suggestion.

Debra Lynne Herbenick, PhD, director of the Center for Sexual Health Promotion and a professor of public health at Indiana University, Indianapolis, who has studied vibrator use in the United States, said the research could make a valuable contribution to sexual health.

“This study is an important next step because it is a prospective study and will be able to assess changes in sexual and pelvic floor function over time in relation to vibrator use,” Dr. Herbenick said. Owing to the limited quality of the currently available evidence, these data have the potential “to support clinicians’ recommendations and also their communication with patients.”

Dr. Dubinskaya and Dr. Herbenick reported no relevant financial relationships.

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