Sexual Health

TOPLINE:

The use of menopausal hormone therapy (MHT) increases breast cancer risk in women with a strong family history of breast cancer. These women have a striking cumulative risk of developing breast cancer (age, 50-80 years) of 22.4%, according to a new modelling study of UK women.

METHODOLOGY:

This was a modeling study integrating two data-sets of UK women: the BOADICEA dataset of age-specific breast cancer risk with family history and the Collaborative Group on Hormonal Factors in Breast Cancer, which covers relative risk for breast cancer with different types and durations of MHT.

Four different breast cancer family history profiles were:

• “Average” family history of breast cancer has unknown affected family members;
• “Modest” family history comprises a single first-degree relative with breast cancer at the age of 60 years.
• “Intermediate” family history comprises a single first-degree relative who developed breast cancer at the age of 40 years.
• “Strong” family history comprises two first-degree relatives who developed breast cancer at the age of 50 years.

TAKEAWAY:

• The lowest risk category: “Average” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 9.8% and a risk of dying from breast cancer of 1.7%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 11.0% and 1.8%, respectively.
• The highest risk category: “Strong” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 19.6% and a risk of dying from breast cancer of 3.2%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 22.4% and 3.5%, respectively.

IN PRACTICE:

The authors concluded that, “These integrated data will enable more accurate estimates of absolute and attributable risk associated with MHT exposure for women with a family history of breast cancer, informing shared decision-making.”

SOURCE:

The lead author is Catherine Huntley of the Institute of Cancer Research, London, England. The study appeared in the British Journal of General Practice.

LIMITATIONS:

Limitations included modeling study that did not directly measure individuals with combined risks.

DISCLOSURES:

The study was funded by several sources including Cancer Research UK. The authors reported no conflicts of interest.

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

TOPLINE:

The use of menopausal hormone therapy (MHT) increases breast cancer risk in women with a strong family history of breast cancer. These women have a striking cumulative risk of developing breast cancer (age, 50-80 years) of 22.4%, according to a new modelling study of UK women.

METHODOLOGY:

This was a modeling study integrating two data-sets of UK women: the BOADICEA dataset of age-specific breast cancer risk with family history and the Collaborative Group on Hormonal Factors in Breast Cancer, which covers relative risk for breast cancer with different types and durations of MHT.

Four different breast cancer family history profiles were:

• “Average” family history of breast cancer has unknown affected family members;
• “Modest” family history comprises a single first-degree relative with breast cancer at the age of 60 years.
• “Intermediate” family history comprises a single first-degree relative who developed breast cancer at the age of 40 years.
• “Strong” family history comprises two first-degree relatives who developed breast cancer at the age of 50 years.

TAKEAWAY:

• The lowest risk category: “Average” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 9.8% and a risk of dying from breast cancer of 1.7%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 11.0% and 1.8%, respectively.
• The highest risk category: “Strong” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 19.6% and a risk of dying from breast cancer of 3.2%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 22.4% and 3.5%, respectively.

IN PRACTICE:

The authors concluded that, “These integrated data will enable more accurate estimates of absolute and attributable risk associated with MHT exposure for women with a family history of breast cancer, informing shared decision-making.”

SOURCE:

The lead author is Catherine Huntley of the Institute of Cancer Research, London, England. The study appeared in the British Journal of General Practice.

LIMITATIONS:

Limitations included modeling study that did not directly measure individuals with combined risks.

DISCLOSURES:

The study was funded by several sources including Cancer Research UK. The authors reported no conflicts of interest.

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

TOPLINE:

The use of menopausal hormone therapy (MHT) increases breast cancer risk in women with a strong family history of breast cancer. These women have a striking cumulative risk of developing breast cancer (age, 50-80 years) of 22.4%, according to a new modelling study of UK women.

METHODOLOGY:

This was a modeling study integrating two data-sets of UK women: the BOADICEA dataset of age-specific breast cancer risk with family history and the Collaborative Group on Hormonal Factors in Breast Cancer, which covers relative risk for breast cancer with different types and durations of MHT.

Four different breast cancer family history profiles were:

• “Average” family history of breast cancer has unknown affected family members;
• “Modest” family history comprises a single first-degree relative with breast cancer at the age of 60 years.
• “Intermediate” family history comprises a single first-degree relative who developed breast cancer at the age of 40 years.
• “Strong” family history comprises two first-degree relatives who developed breast cancer at the age of 50 years.

TAKEAWAY:

• The lowest risk category: “Average” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 9.8% and a risk of dying from breast cancer of 1.7%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 11.0% and 1.8%, respectively.
• The highest risk category: “Strong” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 19.6% and a risk of dying from breast cancer of 3.2%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 22.4% and 3.5%, respectively.

IN PRACTICE:

The authors concluded that, “These integrated data will enable more accurate estimates of absolute and attributable risk associated with MHT exposure for women with a family history of breast cancer, informing shared decision-making.”

SOURCE:

The lead author is Catherine Huntley of the Institute of Cancer Research, London, England. The study appeared in the British Journal of General Practice.

LIMITATIONS:

Limitations included modeling study that did not directly measure individuals with combined risks.

DISCLOSURES:

The study was funded by several sources including Cancer Research UK. The authors reported no conflicts of interest.

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

Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.

This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.

Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.

Sexual dysfunction is a common and significant late effect among CCS. The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
 

Characteristics and Mechanisms

Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.

As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.

Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.

Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects. 
 

Sexual Function in CCS

A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.

The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.

Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.

In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.

The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
 

Factors Influencing Sexual Function

The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.

Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.

Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.

Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.

The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.

Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.

Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.

Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
 

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.

This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.

Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.

Sexual dysfunction is a common and significant late effect among CCS. The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
 

Characteristics and Mechanisms

Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.

As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.

Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.

Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects. 
 

Sexual Function in CCS

A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.

The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.

Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.

In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.

The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
 

Factors Influencing Sexual Function

The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.

Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.

Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.

Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.

The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.

Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.

Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.

Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
 

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.

This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.

Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.

Sexual dysfunction is a common and significant late effect among CCS. The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
 

Characteristics and Mechanisms

Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.

As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.

Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.

Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects. 
 

Sexual Function in CCS

A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.

The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.

Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.

In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.

The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
 

Factors Influencing Sexual Function

The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.

Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.

Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.

Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.

The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.

Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.

Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.

Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
 

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Preexposure prophylaxis prescription reversals and abandonments were lower for patients seen by primary care clinicians than by other non–infectious disease clinicians, based on data from approximately 37,000 individuals.

Although preexposure prophylaxis (PrEP) has been associated with a reduced risk of HIV (human immunodeficiency virus) infection when used as prescribed, the association between PrEP prescription pickup and specialty of the prescribing clinician has not been examined, wrote Lorraine T. Dean, ScD, an epidemiologist at Johns Hopkins University, Baltimore, Maryland, and colleagues.

“HIV PrEP is highly effective at preventing new HIV cases, and while use is on the rise, is still used much less than it should be by people who are at risk of HIV,” Dr. Dean said in an interview. “This study is helpful in pinpointing who is at risk for not picking up PrEP and in helping us think through how to reach them so that they can be better positioned to get PrEP,” she said.

In a study published in JAMA Internal Medicine, the researchers reviewed data for PrEP care. The study population included 37,003 patients aged 18 years and older who received new insurer-approved PrEP prescriptions between 2015 and 2019. Most of the patients (77%) ranged in age from 25 to 64 years; 88% were male.

Pharmacy claims data were matched with clinician data from the US National Plan and Provider Enumeration System.

Clinicians were divided into three groups: primary care providers (PCPs), infectious disease specialists (IDs), and other specialists (defined as any clinician prescribing PrEP but not classified as a PCP or an ID specialist). The main binary outcomes were prescription reversal (defined as when a patient failed to retrieve a prescription) and abandonment (defined as when a patient neglected to pick up a prescription for 1 year).

Overall, of 24,604 patients 67% received prescriptions from PCPs, 3,571 (10%) received prescriptions from ID specialists, and 8828 (24%) received prescriptions from other specialty clinicians.

The prevalence of reversals for patients seen by PCPs, ID specialists, and other specialty clinicians was 18%, 18%, and 25%, respectively. The prevalence of abandonments by clinician group was 12%, 12%, and 20%, respectively.

In a regression analysis, patients prescribed PrEP by ID specialists had 10% lower odds of reversals and 12% lower odds of abandonments compared to those seen by PCPs (odds ratio 0.90 and 0.88, respectively). However, patients seen by other clinicians (not primary care or ID) were 33% and 54% more likely to have reversals and abandonments, respectively, compared with those seen by PCPs.

Many patients at risk for HIV first see a PCP and then are referred to a specialist, such as an ID physician, Dr. Dean said. “The patients who take the time to then follow up with a specialist may be most motivated and able to follow through with the specialist’s request, in this case, accessing their PrEP prescription,” she said. In the current study, the researchers were most surprised by how many other specialty providers are involved in PrEP care, which is very positive given the effectiveness of the medication, she noted.

“Our results suggest that a wide range of prescribers, regardless of specialty, should be equipped to prescribe PrEP as well as offer PrEP counseling,” Dr. Dean said. A key takeaway for clinicians is that PrEP should have no cost for the majority of patients in the United States, she emphasized. The absence of cost expands the population who should be interested and able to access PrEP, she said. Therefore, providers should be prepared to recommend PrEP to eligible patients, and seek training or continuing medical education for themselves so they feel equipped to prescribe and counsel patients on PrEP, she said.

“One limitation of this work is that, while it can point to what is happening, it cannot tell us why the reversals are happening; what is the reason patients prescribed by certain providers are more or less likely to get their PrEP,” Dr. Dean explained. “We have tried to do interviews with patients to understand why this might be happening, but it’s hard to find people who aren’t showing up to do something, compared to finding people who are showing up to do something,” she said. Alternatively, researchers could interview providers to understand their perspective on why differences in prescription pickups occur across specialties, she said.

Looking ahead, “a national PrEP program that includes elements of required clinician training could be beneficial, and research on how a national PrEP program could be implemented and impact HIV rates would be helpful in considering this strategy of prevention,” said Dr. Dean. 
 

Support All Prescribers to Increase PrEP Adherence

Differences in uptake of PrEP prescriptions may be explained by the different populations seen by various specialties, Meredith Green, MD, of Indiana University School of Medicine, Indianapolis, and Lona Mody, MD, of the University of Michigan, Ann Arbor, wrote in an accompanying editorial. However, the key question is how to support all prescribers and promote initiation and adherence to PrEP, they said.

Considerations include whether people at risk for HIV prefer to discuss PrEP with a clinician they already know, vs. a new specialist, but many PCPs are not familiar with the latest PrEP guidelines, they said.

“Interventions that support PrEP provision by PCPs, especially since they prescribed the largest proportion of PrEP prescriptions, can accelerate the uptake of PrEP,” the editorialists wrote.

“Supporting a diverse clinician workforce reflective of communities most impacted by HIV will remain critical, as will acknowledging and addressing HIV stigma,” they said. Educational interventions, including online programs and specialist access for complex cases, would help as well, they said. The approval of additional PrEP agents since the current study was conducted make it even more important to support PrEP prescribers and promote treatment adherence for those at risk for HIV, Dr. Green and Dr. Mody emphasized.

The study was funded by the National Institutes of Health. Dr. Dean had no financial conflicts to disclose. Dr. Green disclosed grants from Gilead and royalties from Wolters Kluwer unrelated to the current study; she also disclosed serving on the Centers for Disease Control and Prevention/Health Resources and Services Administration advisory committee on HIV, viral hepatitis, and sexually transmitted infection prevention and treatment. Dr. Mody disclosed grants from the US National Institute on Aging, Veterans Affairs, Centers for Disease Control and Prevention, NanoVibronix, and UpToDate unrelated to the current study.

Preexposure prophylaxis prescription reversals and abandonments were lower for patients seen by primary care clinicians than by other non–infectious disease clinicians, based on data from approximately 37,000 individuals.

Although preexposure prophylaxis (PrEP) has been associated with a reduced risk of HIV (human immunodeficiency virus) infection when used as prescribed, the association between PrEP prescription pickup and specialty of the prescribing clinician has not been examined, wrote Lorraine T. Dean, ScD, an epidemiologist at Johns Hopkins University, Baltimore, Maryland, and colleagues.

“HIV PrEP is highly effective at preventing new HIV cases, and while use is on the rise, is still used much less than it should be by people who are at risk of HIV,” Dr. Dean said in an interview. “This study is helpful in pinpointing who is at risk for not picking up PrEP and in helping us think through how to reach them so that they can be better positioned to get PrEP,” she said.

In a study published in JAMA Internal Medicine, the researchers reviewed data for PrEP care. The study population included 37,003 patients aged 18 years and older who received new insurer-approved PrEP prescriptions between 2015 and 2019. Most of the patients (77%) ranged in age from 25 to 64 years; 88% were male.

Pharmacy claims data were matched with clinician data from the US National Plan and Provider Enumeration System.

Clinicians were divided into three groups: primary care providers (PCPs), infectious disease specialists (IDs), and other specialists (defined as any clinician prescribing PrEP but not classified as a PCP or an ID specialist). The main binary outcomes were prescription reversal (defined as when a patient failed to retrieve a prescription) and abandonment (defined as when a patient neglected to pick up a prescription for 1 year).

Overall, of 24,604 patients 67% received prescriptions from PCPs, 3,571 (10%) received prescriptions from ID specialists, and 8828 (24%) received prescriptions from other specialty clinicians.

The prevalence of reversals for patients seen by PCPs, ID specialists, and other specialty clinicians was 18%, 18%, and 25%, respectively. The prevalence of abandonments by clinician group was 12%, 12%, and 20%, respectively.

In a regression analysis, patients prescribed PrEP by ID specialists had 10% lower odds of reversals and 12% lower odds of abandonments compared to those seen by PCPs (odds ratio 0.90 and 0.88, respectively). However, patients seen by other clinicians (not primary care or ID) were 33% and 54% more likely to have reversals and abandonments, respectively, compared with those seen by PCPs.

Many patients at risk for HIV first see a PCP and then are referred to a specialist, such as an ID physician, Dr. Dean said. “The patients who take the time to then follow up with a specialist may be most motivated and able to follow through with the specialist’s request, in this case, accessing their PrEP prescription,” she said. In the current study, the researchers were most surprised by how many other specialty providers are involved in PrEP care, which is very positive given the effectiveness of the medication, she noted.

“Our results suggest that a wide range of prescribers, regardless of specialty, should be equipped to prescribe PrEP as well as offer PrEP counseling,” Dr. Dean said. A key takeaway for clinicians is that PrEP should have no cost for the majority of patients in the United States, she emphasized. The absence of cost expands the population who should be interested and able to access PrEP, she said. Therefore, providers should be prepared to recommend PrEP to eligible patients, and seek training or continuing medical education for themselves so they feel equipped to prescribe and counsel patients on PrEP, she said.

“One limitation of this work is that, while it can point to what is happening, it cannot tell us why the reversals are happening; what is the reason patients prescribed by certain providers are more or less likely to get their PrEP,” Dr. Dean explained. “We have tried to do interviews with patients to understand why this might be happening, but it’s hard to find people who aren’t showing up to do something, compared to finding people who are showing up to do something,” she said. Alternatively, researchers could interview providers to understand their perspective on why differences in prescription pickups occur across specialties, she said.

Looking ahead, “a national PrEP program that includes elements of required clinician training could be beneficial, and research on how a national PrEP program could be implemented and impact HIV rates would be helpful in considering this strategy of prevention,” said Dr. Dean. 
 

Support All Prescribers to Increase PrEP Adherence

Differences in uptake of PrEP prescriptions may be explained by the different populations seen by various specialties, Meredith Green, MD, of Indiana University School of Medicine, Indianapolis, and Lona Mody, MD, of the University of Michigan, Ann Arbor, wrote in an accompanying editorial. However, the key question is how to support all prescribers and promote initiation and adherence to PrEP, they said.

Considerations include whether people at risk for HIV prefer to discuss PrEP with a clinician they already know, vs. a new specialist, but many PCPs are not familiar with the latest PrEP guidelines, they said.

“Interventions that support PrEP provision by PCPs, especially since they prescribed the largest proportion of PrEP prescriptions, can accelerate the uptake of PrEP,” the editorialists wrote.

“Supporting a diverse clinician workforce reflective of communities most impacted by HIV will remain critical, as will acknowledging and addressing HIV stigma,” they said. Educational interventions, including online programs and specialist access for complex cases, would help as well, they said. The approval of additional PrEP agents since the current study was conducted make it even more important to support PrEP prescribers and promote treatment adherence for those at risk for HIV, Dr. Green and Dr. Mody emphasized.

The study was funded by the National Institutes of Health. Dr. Dean had no financial conflicts to disclose. Dr. Green disclosed grants from Gilead and royalties from Wolters Kluwer unrelated to the current study; she also disclosed serving on the Centers for Disease Control and Prevention/Health Resources and Services Administration advisory committee on HIV, viral hepatitis, and sexually transmitted infection prevention and treatment. Dr. Mody disclosed grants from the US National Institute on Aging, Veterans Affairs, Centers for Disease Control and Prevention, NanoVibronix, and UpToDate unrelated to the current study.

Preexposure prophylaxis prescription reversals and abandonments were lower for patients seen by primary care clinicians than by other non–infectious disease clinicians, based on data from approximately 37,000 individuals.

Although preexposure prophylaxis (PrEP) has been associated with a reduced risk of HIV (human immunodeficiency virus) infection when used as prescribed, the association between PrEP prescription pickup and specialty of the prescribing clinician has not been examined, wrote Lorraine T. Dean, ScD, an epidemiologist at Johns Hopkins University, Baltimore, Maryland, and colleagues.

“HIV PrEP is highly effective at preventing new HIV cases, and while use is on the rise, is still used much less than it should be by people who are at risk of HIV,” Dr. Dean said in an interview. “This study is helpful in pinpointing who is at risk for not picking up PrEP and in helping us think through how to reach them so that they can be better positioned to get PrEP,” she said.

In a study published in JAMA Internal Medicine, the researchers reviewed data for PrEP care. The study population included 37,003 patients aged 18 years and older who received new insurer-approved PrEP prescriptions between 2015 and 2019. Most of the patients (77%) ranged in age from 25 to 64 years; 88% were male.

Pharmacy claims data were matched with clinician data from the US National Plan and Provider Enumeration System.

Clinicians were divided into three groups: primary care providers (PCPs), infectious disease specialists (IDs), and other specialists (defined as any clinician prescribing PrEP but not classified as a PCP or an ID specialist). The main binary outcomes were prescription reversal (defined as when a patient failed to retrieve a prescription) and abandonment (defined as when a patient neglected to pick up a prescription for 1 year).

Overall, of 24,604 patients 67% received prescriptions from PCPs, 3,571 (10%) received prescriptions from ID specialists, and 8828 (24%) received prescriptions from other specialty clinicians.

The prevalence of reversals for patients seen by PCPs, ID specialists, and other specialty clinicians was 18%, 18%, and 25%, respectively. The prevalence of abandonments by clinician group was 12%, 12%, and 20%, respectively.

In a regression analysis, patients prescribed PrEP by ID specialists had 10% lower odds of reversals and 12% lower odds of abandonments compared to those seen by PCPs (odds ratio 0.90 and 0.88, respectively). However, patients seen by other clinicians (not primary care or ID) were 33% and 54% more likely to have reversals and abandonments, respectively, compared with those seen by PCPs.

Many patients at risk for HIV first see a PCP and then are referred to a specialist, such as an ID physician, Dr. Dean said. “The patients who take the time to then follow up with a specialist may be most motivated and able to follow through with the specialist’s request, in this case, accessing their PrEP prescription,” she said. In the current study, the researchers were most surprised by how many other specialty providers are involved in PrEP care, which is very positive given the effectiveness of the medication, she noted.

“Our results suggest that a wide range of prescribers, regardless of specialty, should be equipped to prescribe PrEP as well as offer PrEP counseling,” Dr. Dean said. A key takeaway for clinicians is that PrEP should have no cost for the majority of patients in the United States, she emphasized. The absence of cost expands the population who should be interested and able to access PrEP, she said. Therefore, providers should be prepared to recommend PrEP to eligible patients, and seek training or continuing medical education for themselves so they feel equipped to prescribe and counsel patients on PrEP, she said.

“One limitation of this work is that, while it can point to what is happening, it cannot tell us why the reversals are happening; what is the reason patients prescribed by certain providers are more or less likely to get their PrEP,” Dr. Dean explained. “We have tried to do interviews with patients to understand why this might be happening, but it’s hard to find people who aren’t showing up to do something, compared to finding people who are showing up to do something,” she said. Alternatively, researchers could interview providers to understand their perspective on why differences in prescription pickups occur across specialties, she said.

Looking ahead, “a national PrEP program that includes elements of required clinician training could be beneficial, and research on how a national PrEP program could be implemented and impact HIV rates would be helpful in considering this strategy of prevention,” said Dr. Dean. 
 

Support All Prescribers to Increase PrEP Adherence

Differences in uptake of PrEP prescriptions may be explained by the different populations seen by various specialties, Meredith Green, MD, of Indiana University School of Medicine, Indianapolis, and Lona Mody, MD, of the University of Michigan, Ann Arbor, wrote in an accompanying editorial. However, the key question is how to support all prescribers and promote initiation and adherence to PrEP, they said.

Considerations include whether people at risk for HIV prefer to discuss PrEP with a clinician they already know, vs. a new specialist, but many PCPs are not familiar with the latest PrEP guidelines, they said.

“Interventions that support PrEP provision by PCPs, especially since they prescribed the largest proportion of PrEP prescriptions, can accelerate the uptake of PrEP,” the editorialists wrote.

“Supporting a diverse clinician workforce reflective of communities most impacted by HIV will remain critical, as will acknowledging and addressing HIV stigma,” they said. Educational interventions, including online programs and specialist access for complex cases, would help as well, they said. The approval of additional PrEP agents since the current study was conducted make it even more important to support PrEP prescribers and promote treatment adherence for those at risk for HIV, Dr. Green and Dr. Mody emphasized.

The study was funded by the National Institutes of Health. Dr. Dean had no financial conflicts to disclose. Dr. Green disclosed grants from Gilead and royalties from Wolters Kluwer unrelated to the current study; she also disclosed serving on the Centers for Disease Control and Prevention/Health Resources and Services Administration advisory committee on HIV, viral hepatitis, and sexually transmitted infection prevention and treatment. Dr. Mody disclosed grants from the US National Institute on Aging, Veterans Affairs, Centers for Disease Control and Prevention, NanoVibronix, and UpToDate unrelated to the current study.

This transcript has been edited for clarity.

I would like to briefly discuss what I consider to be a very discouraging report and one that I believe we as an oncology society and, quite frankly, as a medical community need to deal with. 

The manuscript I’m referring to is from the United States Department of Health and Human Services, titled, “Human Papillomavirus Vaccination Coverage in Children Ages 9-17 Years: United States, 2022.” This particular analysis looked at the coverage of both men and women — young boys and young girls, I would say — receiving at least one dose of the recommended human papillomavirus (HPV) vaccination. 

Since 2006, girls have been recommended to receive HPV vaccination; for boys, it’s been since 2011. Certainly, the time period that we’re considering falls within the recommendations based on overwhelmingly positive data. Now, today, still, the recommendation is for more than one vaccine. Obviously, there may be evidence in the future that a single vaccination may be acceptable or appropriate. But today, it’s more than one. 

In this particular analysis, they were looking at just a single vaccination. The vaccines have targeted young individuals, both male and female children aged 11-12 years, but it’s certainly acceptable to look starting at age 9. 

What is the bottom line? At least one dose of the HPV vaccination was given to 38.6% of children aged 9-17 years in 2022. We are talking about a cancer-preventive vaccine, which on the basis of population-based data in the United States, but also in other countries, is incredibly effective in preventing HPV-associated cancers. This not only includes cervical cancer, but also a large percentage of head and neck cancers.

For this vaccine, which is incredibly safe and incredibly effective, in this country, only 38.6% have received even a single dose. It is noted that the individuals with private insurance had a higher rate, at 41.5%, than individuals with no insurance, at only 20.7%. 

In my opinion, this is clearly a failure of our public health establishment at all levels. My own focus has been in gynecologic cancers. I’ve seen young women with advanced cervical cancer, and this is a disease we can prevent. Yet, this is where we are. 

For those of you who are interested in cancer prevention or public health, I think this is a very sobering statistic. It’s my plea and my hope that we can, as a society, somehow do something about it. 

I thank you for listening. I would encourage you to think about this question if you’re in this area.
 

Dr. Markman, professor, Department of Medical Oncology and Therapeutics Research, City of Hope, Duarte, California, and president of Medicine & Science, City of Hope Atlanta, Chicago, and Phoenix, disclosed ties with GlaxoSmithKline and AstraZeneca.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

I would like to briefly discuss what I consider to be a very discouraging report and one that I believe we as an oncology society and, quite frankly, as a medical community need to deal with. 

The manuscript I’m referring to is from the United States Department of Health and Human Services, titled, “Human Papillomavirus Vaccination Coverage in Children Ages 9-17 Years: United States, 2022.” This particular analysis looked at the coverage of both men and women — young boys and young girls, I would say — receiving at least one dose of the recommended human papillomavirus (HPV) vaccination. 

Since 2006, girls have been recommended to receive HPV vaccination; for boys, it’s been since 2011. Certainly, the time period that we’re considering falls within the recommendations based on overwhelmingly positive data. Now, today, still, the recommendation is for more than one vaccine. Obviously, there may be evidence in the future that a single vaccination may be acceptable or appropriate. But today, it’s more than one. 

In this particular analysis, they were looking at just a single vaccination. The vaccines have targeted young individuals, both male and female children aged 11-12 years, but it’s certainly acceptable to look starting at age 9. 

What is the bottom line? At least one dose of the HPV vaccination was given to 38.6% of children aged 9-17 years in 2022. We are talking about a cancer-preventive vaccine, which on the basis of population-based data in the United States, but also in other countries, is incredibly effective in preventing HPV-associated cancers. This not only includes cervical cancer, but also a large percentage of head and neck cancers.

For this vaccine, which is incredibly safe and incredibly effective, in this country, only 38.6% have received even a single dose. It is noted that the individuals with private insurance had a higher rate, at 41.5%, than individuals with no insurance, at only 20.7%. 

In my opinion, this is clearly a failure of our public health establishment at all levels. My own focus has been in gynecologic cancers. I’ve seen young women with advanced cervical cancer, and this is a disease we can prevent. Yet, this is where we are. 

For those of you who are interested in cancer prevention or public health, I think this is a very sobering statistic. It’s my plea and my hope that we can, as a society, somehow do something about it. 

I thank you for listening. I would encourage you to think about this question if you’re in this area.
 

Dr. Markman, professor, Department of Medical Oncology and Therapeutics Research, City of Hope, Duarte, California, and president of Medicine & Science, City of Hope Atlanta, Chicago, and Phoenix, disclosed ties with GlaxoSmithKline and AstraZeneca.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

I would like to briefly discuss what I consider to be a very discouraging report and one that I believe we as an oncology society and, quite frankly, as a medical community need to deal with. 

The manuscript I’m referring to is from the United States Department of Health and Human Services, titled, “Human Papillomavirus Vaccination Coverage in Children Ages 9-17 Years: United States, 2022.” This particular analysis looked at the coverage of both men and women — young boys and young girls, I would say — receiving at least one dose of the recommended human papillomavirus (HPV) vaccination. 

Since 2006, girls have been recommended to receive HPV vaccination; for boys, it’s been since 2011. Certainly, the time period that we’re considering falls within the recommendations based on overwhelmingly positive data. Now, today, still, the recommendation is for more than one vaccine. Obviously, there may be evidence in the future that a single vaccination may be acceptable or appropriate. But today, it’s more than one. 

In this particular analysis, they were looking at just a single vaccination. The vaccines have targeted young individuals, both male and female children aged 11-12 years, but it’s certainly acceptable to look starting at age 9. 

What is the bottom line? At least one dose of the HPV vaccination was given to 38.6% of children aged 9-17 years in 2022. We are talking about a cancer-preventive vaccine, which on the basis of population-based data in the United States, but also in other countries, is incredibly effective in preventing HPV-associated cancers. This not only includes cervical cancer, but also a large percentage of head and neck cancers.

For this vaccine, which is incredibly safe and incredibly effective, in this country, only 38.6% have received even a single dose. It is noted that the individuals with private insurance had a higher rate, at 41.5%, than individuals with no insurance, at only 20.7%. 

In my opinion, this is clearly a failure of our public health establishment at all levels. My own focus has been in gynecologic cancers. I’ve seen young women with advanced cervical cancer, and this is a disease we can prevent. Yet, this is where we are. 

For those of you who are interested in cancer prevention or public health, I think this is a very sobering statistic. It’s my plea and my hope that we can, as a society, somehow do something about it. 

I thank you for listening. I would encourage you to think about this question if you’re in this area.
 

Dr. Markman, professor, Department of Medical Oncology and Therapeutics Research, City of Hope, Duarte, California, and president of Medicine & Science, City of Hope Atlanta, Chicago, and Phoenix, disclosed ties with GlaxoSmithKline and AstraZeneca.

A version of this article appeared on Medscape.com.

Women in the perimenopausal period who live in rural areas have a higher prevalence of symptoms typical of this period and a poorer health-related quality of life than women living in urban areas, according to a cross-sectional study that was conducted in Spain.

Cristina Llaneza Suárez, a specialist in family and community medicine and the lead author of the study, told this news organization that women living in rural areas face greater difficulties with access to healthcare services, employment, and transportation and a heavier burden of caregiving. She mentioned that these barriers “can represent an added challenge during the perimenopausal stage, when significant life changes generally occur for all women.” The challenges may lead to “poorer health-related quality of life during perimenopause, compared with women living in urban areas.”

The research group led by Dr. Llaneza aimed to test the hypothesis that sociodemographic characteristics influence symptoms and quality of life in women in perimenopause. They enrolled 270 women aged 45-55 years from eight autonomous communities in Spain who had variability in their menstrual cycles (lasting more than 7 days or amenorrhea greater than 60 days but less than a year).

This cross-sectional study was conducted from December 2019 to April 2023, using the short version of the Cervantes scale to assess health-related quality of life and the Beck Depression Inventory to evaluate associated depressive symptoms.

Among the main findings of the study was that sociocultural factors can influence the perception of perimenopausal symptoms. Living in rural areas has a negative effect on health-related quality of life scales, and this finding is consistent with those of previous studies conducted on women in India, Turkey, Poland, and Peru.

In addition, the selected sample of women experiencing changes in their menstrual cycles and residing in rural areas showed a high prevalence of hot flashes (70% overall and 80% in rural areas) and a poorer quality of life in women with obesity.

“It is striking that, although there is a worse perception of quality of life during perimenopause in women living in rural areas, the proportion of women experiencing some degree of depressive symptoms, according to the Beck inventory, was similar to that of women residing in urban areas,” said Dr. Llaneza. She noted that “no worse scores were observed in sexuality or in the couple relationship.”
 

Rural Physicians’ Role

Women in the perimenopausal period face significant challenges resulting from inadequate access to healthcare services and limited awareness about menopause. In many countries, this topic is still taboo, both in the family environment and in workplaces and health centers.

Dr. Llaneza mentioned that when she began her training as a primary care physician in a rural population, she witnessed firsthand some of the barriers that women in this age group face, such as limited access to healthcare due to a lack of public transportation. She added that, coupled with this challenge, “there are no regular public transport services that allow independent access for patients, and many [women] lack a driver’s license, making them dependent on others to receive healthcare.” Another important point that she identified was the lack of health education in rural populations, which leads to a minimization of perimenopausal symptoms and causes delays in prevention and early detection.

According to the World Health Organization, healthcare professionals often lack the necessary training to recognize and treat the symptoms of perimenopause and postmenopause. This situation, coupled with the limited attention given to the sexual well-being of menopausal women, contributes to gynecological problems and risks for sexually transmitted infections in this population. The absence of specific health policies and funding for menopause exacerbates the situation, particularly in regions where other health needs compete for limited resources.

Dr. Llaneza noted that primary care physicians in rural areas are responsible for leading primary prevention actions through community interventions that contribute to improving health. Community physicians in rural areas have a lower patient load than urban physicians do. Therefore, “this allows for a more thorough management and closer monitoring of these conditions, which highlights the importance of prevention of perimenopausal symptoms and community education,” she said.

An important goal in improving the quality of life of women in the perimenopausal period is reducing symptoms. Hormone replacement therapy is the cornerstone of treatment, along with nonhormonal therapies such as the use of isoflavones. However, the aforementioned barriers lead to a delay in initiating effective treatment.

Dr. Llaneza added that the main limitation that she encountered during her clinical practice in rural areas regarding the initiation of hormonal therapy was “the reluctance of certain professionals to start it, as they consider that these drugs should be prescribed by menopause specialists because of potential side effects and the increased risk for developing breast cancer.”
 

Call for Training

Dr. Llaneza and her research team emphasized the need for further research on new drugs for controlling vasomotor symptoms, expressing their interest in conducting additional studies. “We would like to conduct a study on the use of these therapies in perimenopausal and postmenopausal women residing in rural areas.

“We believe that our data may be of interest to healthcare authorities seeking to combat population exodus in rural areas,” they wrote. In addition, they recommended additional training for rural primary care physicians on perimenopause and menopause topics regarding prevention, management, and access, as well as further awareness about preventing depressive symptoms in this population.

Dr. Llaneza declared that she has no relevant financial relationships.
 

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Women in the perimenopausal period who live in rural areas have a higher prevalence of symptoms typical of this period and a poorer health-related quality of life than women living in urban areas, according to a cross-sectional study that was conducted in Spain.

Cristina Llaneza Suárez, a specialist in family and community medicine and the lead author of the study, told this news organization that women living in rural areas face greater difficulties with access to healthcare services, employment, and transportation and a heavier burden of caregiving. She mentioned that these barriers “can represent an added challenge during the perimenopausal stage, when significant life changes generally occur for all women.” The challenges may lead to “poorer health-related quality of life during perimenopause, compared with women living in urban areas.”

The research group led by Dr. Llaneza aimed to test the hypothesis that sociodemographic characteristics influence symptoms and quality of life in women in perimenopause. They enrolled 270 women aged 45-55 years from eight autonomous communities in Spain who had variability in their menstrual cycles (lasting more than 7 days or amenorrhea greater than 60 days but less than a year).

This cross-sectional study was conducted from December 2019 to April 2023, using the short version of the Cervantes scale to assess health-related quality of life and the Beck Depression Inventory to evaluate associated depressive symptoms.

Among the main findings of the study was that sociocultural factors can influence the perception of perimenopausal symptoms. Living in rural areas has a negative effect on health-related quality of life scales, and this finding is consistent with those of previous studies conducted on women in India, Turkey, Poland, and Peru.

In addition, the selected sample of women experiencing changes in their menstrual cycles and residing in rural areas showed a high prevalence of hot flashes (70% overall and 80% in rural areas) and a poorer quality of life in women with obesity.

“It is striking that, although there is a worse perception of quality of life during perimenopause in women living in rural areas, the proportion of women experiencing some degree of depressive symptoms, according to the Beck inventory, was similar to that of women residing in urban areas,” said Dr. Llaneza. She noted that “no worse scores were observed in sexuality or in the couple relationship.”
 

Rural Physicians’ Role

Women in the perimenopausal period face significant challenges resulting from inadequate access to healthcare services and limited awareness about menopause. In many countries, this topic is still taboo, both in the family environment and in workplaces and health centers.

Dr. Llaneza mentioned that when she began her training as a primary care physician in a rural population, she witnessed firsthand some of the barriers that women in this age group face, such as limited access to healthcare due to a lack of public transportation. She added that, coupled with this challenge, “there are no regular public transport services that allow independent access for patients, and many [women] lack a driver’s license, making them dependent on others to receive healthcare.” Another important point that she identified was the lack of health education in rural populations, which leads to a minimization of perimenopausal symptoms and causes delays in prevention and early detection.

According to the World Health Organization, healthcare professionals often lack the necessary training to recognize and treat the symptoms of perimenopause and postmenopause. This situation, coupled with the limited attention given to the sexual well-being of menopausal women, contributes to gynecological problems and risks for sexually transmitted infections in this population. The absence of specific health policies and funding for menopause exacerbates the situation, particularly in regions where other health needs compete for limited resources.

Dr. Llaneza noted that primary care physicians in rural areas are responsible for leading primary prevention actions through community interventions that contribute to improving health. Community physicians in rural areas have a lower patient load than urban physicians do. Therefore, “this allows for a more thorough management and closer monitoring of these conditions, which highlights the importance of prevention of perimenopausal symptoms and community education,” she said.

An important goal in improving the quality of life of women in the perimenopausal period is reducing symptoms. Hormone replacement therapy is the cornerstone of treatment, along with nonhormonal therapies such as the use of isoflavones. However, the aforementioned barriers lead to a delay in initiating effective treatment.

Dr. Llaneza added that the main limitation that she encountered during her clinical practice in rural areas regarding the initiation of hormonal therapy was “the reluctance of certain professionals to start it, as they consider that these drugs should be prescribed by menopause specialists because of potential side effects and the increased risk for developing breast cancer.”
 

Call for Training

Dr. Llaneza and her research team emphasized the need for further research on new drugs for controlling vasomotor symptoms, expressing their interest in conducting additional studies. “We would like to conduct a study on the use of these therapies in perimenopausal and postmenopausal women residing in rural areas.

“We believe that our data may be of interest to healthcare authorities seeking to combat population exodus in rural areas,” they wrote. In addition, they recommended additional training for rural primary care physicians on perimenopause and menopause topics regarding prevention, management, and access, as well as further awareness about preventing depressive symptoms in this population.

Dr. Llaneza declared that she has no relevant financial relationships.
 

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Women in the perimenopausal period who live in rural areas have a higher prevalence of symptoms typical of this period and a poorer health-related quality of life than women living in urban areas, according to a cross-sectional study that was conducted in Spain.

Cristina Llaneza Suárez, a specialist in family and community medicine and the lead author of the study, told this news organization that women living in rural areas face greater difficulties with access to healthcare services, employment, and transportation and a heavier burden of caregiving. She mentioned that these barriers “can represent an added challenge during the perimenopausal stage, when significant life changes generally occur for all women.” The challenges may lead to “poorer health-related quality of life during perimenopause, compared with women living in urban areas.”

The research group led by Dr. Llaneza aimed to test the hypothesis that sociodemographic characteristics influence symptoms and quality of life in women in perimenopause. They enrolled 270 women aged 45-55 years from eight autonomous communities in Spain who had variability in their menstrual cycles (lasting more than 7 days or amenorrhea greater than 60 days but less than a year).

This cross-sectional study was conducted from December 2019 to April 2023, using the short version of the Cervantes scale to assess health-related quality of life and the Beck Depression Inventory to evaluate associated depressive symptoms.

Among the main findings of the study was that sociocultural factors can influence the perception of perimenopausal symptoms. Living in rural areas has a negative effect on health-related quality of life scales, and this finding is consistent with those of previous studies conducted on women in India, Turkey, Poland, and Peru.

In addition, the selected sample of women experiencing changes in their menstrual cycles and residing in rural areas showed a high prevalence of hot flashes (70% overall and 80% in rural areas) and a poorer quality of life in women with obesity.

“It is striking that, although there is a worse perception of quality of life during perimenopause in women living in rural areas, the proportion of women experiencing some degree of depressive symptoms, according to the Beck inventory, was similar to that of women residing in urban areas,” said Dr. Llaneza. She noted that “no worse scores were observed in sexuality or in the couple relationship.”
 

Rural Physicians’ Role

Women in the perimenopausal period face significant challenges resulting from inadequate access to healthcare services and limited awareness about menopause. In many countries, this topic is still taboo, both in the family environment and in workplaces and health centers.

Dr. Llaneza mentioned that when she began her training as a primary care physician in a rural population, she witnessed firsthand some of the barriers that women in this age group face, such as limited access to healthcare due to a lack of public transportation. She added that, coupled with this challenge, “there are no regular public transport services that allow independent access for patients, and many [women] lack a driver’s license, making them dependent on others to receive healthcare.” Another important point that she identified was the lack of health education in rural populations, which leads to a minimization of perimenopausal symptoms and causes delays in prevention and early detection.

According to the World Health Organization, healthcare professionals often lack the necessary training to recognize and treat the symptoms of perimenopause and postmenopause. This situation, coupled with the limited attention given to the sexual well-being of menopausal women, contributes to gynecological problems and risks for sexually transmitted infections in this population. The absence of specific health policies and funding for menopause exacerbates the situation, particularly in regions where other health needs compete for limited resources.

Dr. Llaneza noted that primary care physicians in rural areas are responsible for leading primary prevention actions through community interventions that contribute to improving health. Community physicians in rural areas have a lower patient load than urban physicians do. Therefore, “this allows for a more thorough management and closer monitoring of these conditions, which highlights the importance of prevention of perimenopausal symptoms and community education,” she said.

An important goal in improving the quality of life of women in the perimenopausal period is reducing symptoms. Hormone replacement therapy is the cornerstone of treatment, along with nonhormonal therapies such as the use of isoflavones. However, the aforementioned barriers lead to a delay in initiating effective treatment.

Dr. Llaneza added that the main limitation that she encountered during her clinical practice in rural areas regarding the initiation of hormonal therapy was “the reluctance of certain professionals to start it, as they consider that these drugs should be prescribed by menopause specialists because of potential side effects and the increased risk for developing breast cancer.”
 

Call for Training

Dr. Llaneza and her research team emphasized the need for further research on new drugs for controlling vasomotor symptoms, expressing their interest in conducting additional studies. “We would like to conduct a study on the use of these therapies in perimenopausal and postmenopausal women residing in rural areas.

“We believe that our data may be of interest to healthcare authorities seeking to combat population exodus in rural areas,” they wrote. In addition, they recommended additional training for rural primary care physicians on perimenopause and menopause topics regarding prevention, management, and access, as well as further awareness about preventing depressive symptoms in this population.

Dr. Llaneza declared that she has no relevant financial relationships.
 

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Twice-yearly injections are 100% effective in preventing new infections, according to the final results from the PURPOSE 1 trial of lenacapavir.

For weeks, the HIV community has been talking about this highly anticipated clinical trial and whether the strong — and to many, surprising — interim results would hold at final presentation at the International AIDS Conference 2024 in Munich, Germany.

Presenting the results, Linda-Gail Bekker, MD, director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, reported zero new infections in those who got the shots in the study of about 5000 young women. In the group given daily oral preexposure prophylaxis (PrEP), roughly 2% contracted HIV from infected partners.

“A twice-yearly PrEP choice could overcome some of the adherence and persistence challenges and contribute critically to our quest to reduce HIV infection in women around the world,” Dr. Bekker said about the results, which were published simultaneously in The New England Journal of Medicine.

PURPOSE 1 confirmed that lenacapavir is a “breakthrough” for HIV prevention, said International AIDS Society president Sharon Lewin, PhD, MBBS. It has “huge public health potential,” said Dr. Lewin, the AIDS 2024 conference cochair and director of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne in Australia.

Lenacapavir is a novel, first-in-class multistage HIV-1 capsid inhibitor with a long half-life, which enables the twice-yearly dosing.

PURPOSE 1 enrolled women aged 15-25 years who were at risk for HIV in South Africa and Uganda, with a primary endpoint of HIV infection. Because of the previously announced interim results, which showed the injection was preventing infections, study sponsor Gilead Sciences discontinued the randomized phase of the trial and shifted to an open-label design for lenacapavir.

“One hundred percent efficacy is more that we could ever have hoped for a potential prevention efficacy,” said Christoph Spinner, MD, MBA, an infectious disease specialist at the University Hospital of the Technical University of Munich and AIDS 2024 conference cochair.

Dr. Spinner added that while this is the first study of lenacapavir for PrEP, it’s also the first to explore outcomes of emtricitabine-tenofovir in cisgender women.
 

Strong Adherence Rates

The twice-yearly injection demonstrated adherence rates above 90% in the trial for both the 6- and 12-month injection intervals.

“Adherence was 91.5% at week 26 and 92.8% at week 52,” Dr. Bekker reported. 

The trial compared three PrEP options including the lenacapavir injection to once-daily oral emtricitabine 200 mg and tenofovir-alafenamide 25 mg (F/TAF) and once-daily emtricitabine 200 mg and tenofovir–disoproxil fumarate 300 mg (F/TDF).

“Most participants in both the F/TAF and F/TDF groups had low adherence, and this declined over time,” Dr. Bekker reported. At 52 weeks, the vast majority of patients on both oral therapies had low adherence with dosing, defined at less than two doses a week.

Dr. Bekker called the adherence to the oral agents in this trial “disappointing.”

Findings from the trial underscore the challenges of adherence to a daily oral medication, Rochelle Walensky, MD, and Lindsey Baden, MD, from the Harvard Kennedy School of Government and Harvard Business School in Cambridge, Massachusetts, wrote in an editorial accompanying the published results.

With almost 92% attendance for the twice-yearly lenacapavir injections, the “well-done,” large, randomized, controlled trial “exemplifies not only that women can dependably adhere to this administration schedule, but also that levels of an HIV-1 capsid inhibitor can remain high enough over a period of 6 months to reliably prevent infection,” they added. 

Another key focus of the presentation was adverse events. The rate of adverse events grade 3 or more in the lenacapavir arm was 4.1%, Bekker said, which is slightly lower than the rates in the oral arms. The rates of serious adverse events were 2.8% for lenacapavir, 4% for F/TAF and 3.3% for F/TDF. 
 

Injection Site Reactions

Injection site reactions occurred in 68% of the lenacapavir group, including 63% with subcutaneous nodules.

The injection can form “a drug depot which may be palpable as a nodule,” Dr. Bekker said. In the placebo group, 34% of patients had injection-site reactions and 16% had nodules. Nearly all injection-site reactions were grade 1 or 2, she said. “Higher grade injection-site reactions were rare and not serious and occurred in a similar percentage in lenacapavir and placebo,” she said.

Overall, more than 25,000 injections of lenacapavir have been given, Dr. Bekker said, and four patients discontinued treatment because of injection-site reactions. “Reporting of injection-site reactions, including nodules, decreased with subsequent doses,” she said.

Contraception was not a requirement for enrollment in the study, Dr. Bekker pointed out, and pregnancy outcomes across the treatment arms were similar to the general population.
 

First in a Series of Trials

This is the first in a series of PURPOSE trials, Bekker reported. The phase 3 PURPOSE 2 trial, enrolling 3000 gay men, transgender women, transgender men and gender nonbinary people who have sex with male partners, is the second pivotal trial now underway.

Three other smaller trials are in the clinic in the United States and Europe.

PURPOSE 1 participants will continue to access lenacapavir until the product is available in South Africa and Uganda, Dr. Bekker said. Trial sponsor Gilead Sciences is also developing a direct licensing program to expedite generic access to the drug in high-incidence, resource-limited countries, she said.

Dr. Walensky and Dr. Baden report that lenacapavir currently costs about $43,000 annually in the United States. “But the results of the PURPOSE 1 trial have now created a moral imperative to make lenacapavir broadly accessible and affordable as PrEP” to people who were enrolled, as well as all those who are similarly eligible and could benefit.

So now we have a PrEP product with high efficacy, they added. “That is great news for science but not (yet) great for women.” 

Given the high pregnancy rate among participants in the PURPOSE 1 trial, Dr. Walensky and Dr. Baden point out the assessment of lenacapavir safety is a priority. They are also interested in learning more about drug resistance with this new option. 

“I f approved and delivered — rapidly, affordably, and equitably — to those who need or want it, this long-acting tool could help accelerate global progress in HIV prevention,” Dr. Lewin said.

Now, she added, “we eagerly await results from PURPOSE 2.”
 

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

Twice-yearly injections are 100% effective in preventing new infections, according to the final results from the PURPOSE 1 trial of lenacapavir.

For weeks, the HIV community has been talking about this highly anticipated clinical trial and whether the strong — and to many, surprising — interim results would hold at final presentation at the International AIDS Conference 2024 in Munich, Germany.

Presenting the results, Linda-Gail Bekker, MD, director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, reported zero new infections in those who got the shots in the study of about 5000 young women. In the group given daily oral preexposure prophylaxis (PrEP), roughly 2% contracted HIV from infected partners.

“A twice-yearly PrEP choice could overcome some of the adherence and persistence challenges and contribute critically to our quest to reduce HIV infection in women around the world,” Dr. Bekker said about the results, which were published simultaneously in The New England Journal of Medicine.

PURPOSE 1 confirmed that lenacapavir is a “breakthrough” for HIV prevention, said International AIDS Society president Sharon Lewin, PhD, MBBS. It has “huge public health potential,” said Dr. Lewin, the AIDS 2024 conference cochair and director of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne in Australia.

Lenacapavir is a novel, first-in-class multistage HIV-1 capsid inhibitor with a long half-life, which enables the twice-yearly dosing.

PURPOSE 1 enrolled women aged 15-25 years who were at risk for HIV in South Africa and Uganda, with a primary endpoint of HIV infection. Because of the previously announced interim results, which showed the injection was preventing infections, study sponsor Gilead Sciences discontinued the randomized phase of the trial and shifted to an open-label design for lenacapavir.

“One hundred percent efficacy is more that we could ever have hoped for a potential prevention efficacy,” said Christoph Spinner, MD, MBA, an infectious disease specialist at the University Hospital of the Technical University of Munich and AIDS 2024 conference cochair.

Dr. Spinner added that while this is the first study of lenacapavir for PrEP, it’s also the first to explore outcomes of emtricitabine-tenofovir in cisgender women.
 

Strong Adherence Rates

The twice-yearly injection demonstrated adherence rates above 90% in the trial for both the 6- and 12-month injection intervals.

“Adherence was 91.5% at week 26 and 92.8% at week 52,” Dr. Bekker reported. 

The trial compared three PrEP options including the lenacapavir injection to once-daily oral emtricitabine 200 mg and tenofovir-alafenamide 25 mg (F/TAF) and once-daily emtricitabine 200 mg and tenofovir–disoproxil fumarate 300 mg (F/TDF).

“Most participants in both the F/TAF and F/TDF groups had low adherence, and this declined over time,” Dr. Bekker reported. At 52 weeks, the vast majority of patients on both oral therapies had low adherence with dosing, defined at less than two doses a week.

Dr. Bekker called the adherence to the oral agents in this trial “disappointing.”

Findings from the trial underscore the challenges of adherence to a daily oral medication, Rochelle Walensky, MD, and Lindsey Baden, MD, from the Harvard Kennedy School of Government and Harvard Business School in Cambridge, Massachusetts, wrote in an editorial accompanying the published results.

With almost 92% attendance for the twice-yearly lenacapavir injections, the “well-done,” large, randomized, controlled trial “exemplifies not only that women can dependably adhere to this administration schedule, but also that levels of an HIV-1 capsid inhibitor can remain high enough over a period of 6 months to reliably prevent infection,” they added. 

Another key focus of the presentation was adverse events. The rate of adverse events grade 3 or more in the lenacapavir arm was 4.1%, Bekker said, which is slightly lower than the rates in the oral arms. The rates of serious adverse events were 2.8% for lenacapavir, 4% for F/TAF and 3.3% for F/TDF. 
 

Injection Site Reactions

Injection site reactions occurred in 68% of the lenacapavir group, including 63% with subcutaneous nodules.

The injection can form “a drug depot which may be palpable as a nodule,” Dr. Bekker said. In the placebo group, 34% of patients had injection-site reactions and 16% had nodules. Nearly all injection-site reactions were grade 1 or 2, she said. “Higher grade injection-site reactions were rare and not serious and occurred in a similar percentage in lenacapavir and placebo,” she said.

Overall, more than 25,000 injections of lenacapavir have been given, Dr. Bekker said, and four patients discontinued treatment because of injection-site reactions. “Reporting of injection-site reactions, including nodules, decreased with subsequent doses,” she said.

Contraception was not a requirement for enrollment in the study, Dr. Bekker pointed out, and pregnancy outcomes across the treatment arms were similar to the general population.
 

First in a Series of Trials

This is the first in a series of PURPOSE trials, Bekker reported. The phase 3 PURPOSE 2 trial, enrolling 3000 gay men, transgender women, transgender men and gender nonbinary people who have sex with male partners, is the second pivotal trial now underway.

Three other smaller trials are in the clinic in the United States and Europe.

PURPOSE 1 participants will continue to access lenacapavir until the product is available in South Africa and Uganda, Dr. Bekker said. Trial sponsor Gilead Sciences is also developing a direct licensing program to expedite generic access to the drug in high-incidence, resource-limited countries, she said.

Dr. Walensky and Dr. Baden report that lenacapavir currently costs about $43,000 annually in the United States. “But the results of the PURPOSE 1 trial have now created a moral imperative to make lenacapavir broadly accessible and affordable as PrEP” to people who were enrolled, as well as all those who are similarly eligible and could benefit.

So now we have a PrEP product with high efficacy, they added. “That is great news for science but not (yet) great for women.” 

Given the high pregnancy rate among participants in the PURPOSE 1 trial, Dr. Walensky and Dr. Baden point out the assessment of lenacapavir safety is a priority. They are also interested in learning more about drug resistance with this new option. 

“I f approved and delivered — rapidly, affordably, and equitably — to those who need or want it, this long-acting tool could help accelerate global progress in HIV prevention,” Dr. Lewin said.

Now, she added, “we eagerly await results from PURPOSE 2.”
 

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

Twice-yearly injections are 100% effective in preventing new infections, according to the final results from the PURPOSE 1 trial of lenacapavir.

For weeks, the HIV community has been talking about this highly anticipated clinical trial and whether the strong — and to many, surprising — interim results would hold at final presentation at the International AIDS Conference 2024 in Munich, Germany.

Presenting the results, Linda-Gail Bekker, MD, director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, reported zero new infections in those who got the shots in the study of about 5000 young women. In the group given daily oral preexposure prophylaxis (PrEP), roughly 2% contracted HIV from infected partners.

“A twice-yearly PrEP choice could overcome some of the adherence and persistence challenges and contribute critically to our quest to reduce HIV infection in women around the world,” Dr. Bekker said about the results, which were published simultaneously in The New England Journal of Medicine.

PURPOSE 1 confirmed that lenacapavir is a “breakthrough” for HIV prevention, said International AIDS Society president Sharon Lewin, PhD, MBBS. It has “huge public health potential,” said Dr. Lewin, the AIDS 2024 conference cochair and director of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne in Australia.

Lenacapavir is a novel, first-in-class multistage HIV-1 capsid inhibitor with a long half-life, which enables the twice-yearly dosing.

PURPOSE 1 enrolled women aged 15-25 years who were at risk for HIV in South Africa and Uganda, with a primary endpoint of HIV infection. Because of the previously announced interim results, which showed the injection was preventing infections, study sponsor Gilead Sciences discontinued the randomized phase of the trial and shifted to an open-label design for lenacapavir.

“One hundred percent efficacy is more that we could ever have hoped for a potential prevention efficacy,” said Christoph Spinner, MD, MBA, an infectious disease specialist at the University Hospital of the Technical University of Munich and AIDS 2024 conference cochair.

Dr. Spinner added that while this is the first study of lenacapavir for PrEP, it’s also the first to explore outcomes of emtricitabine-tenofovir in cisgender women.
 

Strong Adherence Rates

The twice-yearly injection demonstrated adherence rates above 90% in the trial for both the 6- and 12-month injection intervals.

“Adherence was 91.5% at week 26 and 92.8% at week 52,” Dr. Bekker reported. 

The trial compared three PrEP options including the lenacapavir injection to once-daily oral emtricitabine 200 mg and tenofovir-alafenamide 25 mg (F/TAF) and once-daily emtricitabine 200 mg and tenofovir–disoproxil fumarate 300 mg (F/TDF).

“Most participants in both the F/TAF and F/TDF groups had low adherence, and this declined over time,” Dr. Bekker reported. At 52 weeks, the vast majority of patients on both oral therapies had low adherence with dosing, defined at less than two doses a week.

Dr. Bekker called the adherence to the oral agents in this trial “disappointing.”

Findings from the trial underscore the challenges of adherence to a daily oral medication, Rochelle Walensky, MD, and Lindsey Baden, MD, from the Harvard Kennedy School of Government and Harvard Business School in Cambridge, Massachusetts, wrote in an editorial accompanying the published results.

With almost 92% attendance for the twice-yearly lenacapavir injections, the “well-done,” large, randomized, controlled trial “exemplifies not only that women can dependably adhere to this administration schedule, but also that levels of an HIV-1 capsid inhibitor can remain high enough over a period of 6 months to reliably prevent infection,” they added. 

Another key focus of the presentation was adverse events. The rate of adverse events grade 3 or more in the lenacapavir arm was 4.1%, Bekker said, which is slightly lower than the rates in the oral arms. The rates of serious adverse events were 2.8% for lenacapavir, 4% for F/TAF and 3.3% for F/TDF. 
 

Injection Site Reactions

Injection site reactions occurred in 68% of the lenacapavir group, including 63% with subcutaneous nodules.

The injection can form “a drug depot which may be palpable as a nodule,” Dr. Bekker said. In the placebo group, 34% of patients had injection-site reactions and 16% had nodules. Nearly all injection-site reactions were grade 1 or 2, she said. “Higher grade injection-site reactions were rare and not serious and occurred in a similar percentage in lenacapavir and placebo,” she said.

Overall, more than 25,000 injections of lenacapavir have been given, Dr. Bekker said, and four patients discontinued treatment because of injection-site reactions. “Reporting of injection-site reactions, including nodules, decreased with subsequent doses,” she said.

Contraception was not a requirement for enrollment in the study, Dr. Bekker pointed out, and pregnancy outcomes across the treatment arms were similar to the general population.
 

First in a Series of Trials

This is the first in a series of PURPOSE trials, Bekker reported. The phase 3 PURPOSE 2 trial, enrolling 3000 gay men, transgender women, transgender men and gender nonbinary people who have sex with male partners, is the second pivotal trial now underway.

Three other smaller trials are in the clinic in the United States and Europe.

PURPOSE 1 participants will continue to access lenacapavir until the product is available in South Africa and Uganda, Dr. Bekker said. Trial sponsor Gilead Sciences is also developing a direct licensing program to expedite generic access to the drug in high-incidence, resource-limited countries, she said.

Dr. Walensky and Dr. Baden report that lenacapavir currently costs about $43,000 annually in the United States. “But the results of the PURPOSE 1 trial have now created a moral imperative to make lenacapavir broadly accessible and affordable as PrEP” to people who were enrolled, as well as all those who are similarly eligible and could benefit.

So now we have a PrEP product with high efficacy, they added. “That is great news for science but not (yet) great for women.” 

Given the high pregnancy rate among participants in the PURPOSE 1 trial, Dr. Walensky and Dr. Baden point out the assessment of lenacapavir safety is a priority. They are also interested in learning more about drug resistance with this new option. 

“I f approved and delivered — rapidly, affordably, and equitably — to those who need or want it, this long-acting tool could help accelerate global progress in HIV prevention,” Dr. Lewin said.

Now, she added, “we eagerly await results from PURPOSE 2.”
 

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

This transcript has been edited for clarity. 

Rachel S. Rubin, MD: I have an interesting topic for you — kind of shocking, actually. Some of you may have read a story earlier this year in The New York Times about the alarming rise among young people of choking or strangulation during sex. I spoke recently with Dr. Debby Herbenick about this concerning and violent trend. Dr. Herbenick is a well-known sexuality researcher and professor at the Indiana University School of Public Health. Welcome, Dr. Herbenick. Can you tell us about your research into this new trend?

Debby Herbenick, PhD: This is some of the most important research that I’ve done. I’ve been studying sexual behaviors and trends for about 14 years in terms of nationally representative studies that we do. Over time, we noticed a trend of increasing prevalence of rough sex practices. 

Now, there’s always been a lot of sexual diversity in the world throughout history. But the main trend that we have focused on in recent years that is important for everyone in medicine to know about is this rapid increase — actually, a really big increase — in what people call “sexual choking,” even though it’s a form of strangulation. The increase is mostly seen in teenagers and young adults. 

We’ve done US nationally representative surveys as well as college campus representative surveys. We find that consistently across four campus representative surveys that 64% of women report having ever been choked during sex, and around 1 in 3 women (aged 18-24 years) throughout the whole country report having been choked during their most recent sexual activity with another person. They call it choking, but because it involves usually one hand — sometimes two hands or a forearm or an object, like a belt or a cord to tie around the neck — it is technically strangulation, because it’s external pressure to the neck to reduce or stop airflow or blood flow. 

Dr. Rubin: These numbers are staggering, right? Everyone listening now is taking care of someone who has been strangled as a form of sexual pleasure. What does this mean from a safety perspective? And as doctors who are working these patients up for migraines and other health problems, what is the research showing? 

Dr. Herbenick: We certainly are seeing people report recurrent headaches and ringing in the ears. There are things we’ve just barely scratched the surface on. Those of us working in this space believe that for anybody coming in for an unexplained stroke (for example, under age 50), you might consider some imaging to see if they have a dissection. We are hearing about people who, when you really probe to find out whether they’ve had pressure on the neck, they report that indeed that they have. So, we have to be thinking about neurologic symptoms. We know that they’re experiencing these at a pretty high rate. 

For people who are engaging in these practices, they should know about the health risks, but we find that most don’t. They may have heard that if it’s really intense high pressure, that in rare cases people can die, but most have never heard of anything in between. So, they’re not necessarily connecting their voice hoarseness, or the recurrent headaches or the sensitivity to light they are having, to an experience of being choked. We need to be paying attention to neurologic symptoms. 

Most physicians I speak with at conferences say that where they feel like they can step into this conversation is through anticipatory guidance and letting their patients know that they may have heard about this trend, and a lot of people are talking about the health consequences, and I want to share some information with you — not coming at it from a place of shame or judgment, but providing some information so that [patients] actually get some medical facts about this that could be lifesaving. 

Dr. Rubin: I see such a big gap in my medical training. I was taught to say, “Hey, do you smoke, do you drink, do you do drugs? Do you have sex? Men, women, or both?”And that’s it. And then maybe use birth control, and don’t get an STD, thinking about herpes, syphilis, gonorrhea, and chlamydia. We weren’t really trained to talk to patients about what kind of sex they are having, or how to talk to patients in a way that is open-minded but also safety-conscious and how the concept of safe sex is more than wear a condom and use birth control.

This idea of rough sex practices and how to talk to teenagers — maybe our pediatricians should be talking about this. Where do we start in terms of how to bring up these conversations and with what level of detail? 

Dr. Herbenick: We find that some young people are already being asked about some of the effects that might be showing on their bodies. It might be that their provider notices some bruising, or marks on their bodies from other types of rough sex practices like hitting and spanking. So that could be an entry point there. Choking is far more prevalent than slapping, so if you’re seeing some marks on the body, then it’s also a good time to ask about other practices they might be engaging in, especially higher risk ones like choking or strangulation. It’s offering some information and even saying, “Look, I’m not here to shame or judge you. I just want you to have some information about this” and giving them an opportunity to ask questions, too. 

We have found that almost nobody talks with their nurse or doctor, even if they have symptoms after being choked or strangled during sex. Just 1% of women with choking-related symptoms, 7% of men, and far fewer trans and nonbinary young people report talking with a nurse or doctor, mostly because they say it doesn’t seem like a big deal. The symptoms got better quickly. Sometimes they’re afraid of being shamed for their sexual behavior, and that’s why they say they don’t talk with somebody. 

They need some type of open-door anticipatory guidance as a way forward. Not everyone is comfortable directly asking whether a patient is engaging in this, but at least letting people know that you’ve heard of this behavior and providing some medical facts can give us a step forward with creating these conversations. 

Dr. Rubin: Can you tell us where is this research going in terms of next steps? Other things that you’re looking at? And what are you excited about? 

Dr. Herbenick: I’m excited about some work I did with a collaborator and colleague of mine, Dr. Keisuke Kawata, that he led a couple of years ago. He’s a neuroscientist. We were looking at potential cumulative effects on the brain. Now we’re taking some of that research into its next steps. We’re also doing more focused studies on other health consequences and hopefully finding out how we can test different educational messages and get people to learn more fact-based information about this, and then see if that is effective in prevention. 

Dr. Rubin: It sounds like a public health campaign is really needed about how to get the word out there about the health consequences of these activities. We’re asking people often enough. In my clinic, I try to keep it open-ended — tell me what sex looks like. What does it look like, and what do you want it to look like? Because I see a lot of people with problems, but if they don’t bring it to me, I don’t necessarily bring it up to them. Until I heard your lecture, and I thought, oh my gosh, I’m not even asking the right questions. Are you hopeful that there will be more public health messaging out there? 

Dr. Herbenick: I am. Years ago, when the child and adolescent choking game became a thing, the Centers for Disease Control and Prevention (CDC) issued reports about it and warnings to parents. And this is a far, far higher prevalence than that ever was. So, I would love to see organizations like the CDC and medical groups getting involved and educating their members and making statements. This is really impacting a huge generation of girls and women, because when it happens during sex between women and men, the choking is mostly happening to the girls and women. It’s also prevalent among sexual minority individuals. But we are talking about this whole generation of young women and what’s happening to their bodies and their brain health. We really need to step into this conversation. 

Dr. Rubin: Very few of us are sexual medicine–trained physicians, and very few of us feel confident and comfortable talking about sexual health issues. But people are getting hurt. People are having real consequences of these behaviors because of our lack of education, knowledge, and even discussion around it. So thank you for doing this research, because had you not done this research, we wouldn’t have found out that 64% of people are engaging in these types of activities. That is not rare.

Dr. Rubin is an assistant clinical professor, Department of Urology, at Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.

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

This transcript has been edited for clarity. 

Rachel S. Rubin, MD: I have an interesting topic for you — kind of shocking, actually. Some of you may have read a story earlier this year in The New York Times about the alarming rise among young people of choking or strangulation during sex. I spoke recently with Dr. Debby Herbenick about this concerning and violent trend. Dr. Herbenick is a well-known sexuality researcher and professor at the Indiana University School of Public Health. Welcome, Dr. Herbenick. Can you tell us about your research into this new trend?

Debby Herbenick, PhD: This is some of the most important research that I’ve done. I’ve been studying sexual behaviors and trends for about 14 years in terms of nationally representative studies that we do. Over time, we noticed a trend of increasing prevalence of rough sex practices. 

Now, there’s always been a lot of sexual diversity in the world throughout history. But the main trend that we have focused on in recent years that is important for everyone in medicine to know about is this rapid increase — actually, a really big increase — in what people call “sexual choking,” even though it’s a form of strangulation. The increase is mostly seen in teenagers and young adults. 

We’ve done US nationally representative surveys as well as college campus representative surveys. We find that consistently across four campus representative surveys that 64% of women report having ever been choked during sex, and around 1 in 3 women (aged 18-24 years) throughout the whole country report having been choked during their most recent sexual activity with another person. They call it choking, but because it involves usually one hand — sometimes two hands or a forearm or an object, like a belt or a cord to tie around the neck — it is technically strangulation, because it’s external pressure to the neck to reduce or stop airflow or blood flow. 

Dr. Rubin: These numbers are staggering, right? Everyone listening now is taking care of someone who has been strangled as a form of sexual pleasure. What does this mean from a safety perspective? And as doctors who are working these patients up for migraines and other health problems, what is the research showing? 

Dr. Herbenick: We certainly are seeing people report recurrent headaches and ringing in the ears. There are things we’ve just barely scratched the surface on. Those of us working in this space believe that for anybody coming in for an unexplained stroke (for example, under age 50), you might consider some imaging to see if they have a dissection. We are hearing about people who, when you really probe to find out whether they’ve had pressure on the neck, they report that indeed that they have. So, we have to be thinking about neurologic symptoms. We know that they’re experiencing these at a pretty high rate. 

For people who are engaging in these practices, they should know about the health risks, but we find that most don’t. They may have heard that if it’s really intense high pressure, that in rare cases people can die, but most have never heard of anything in between. So, they’re not necessarily connecting their voice hoarseness, or the recurrent headaches or the sensitivity to light they are having, to an experience of being choked. We need to be paying attention to neurologic symptoms. 

Most physicians I speak with at conferences say that where they feel like they can step into this conversation is through anticipatory guidance and letting their patients know that they may have heard about this trend, and a lot of people are talking about the health consequences, and I want to share some information with you — not coming at it from a place of shame or judgment, but providing some information so that [patients] actually get some medical facts about this that could be lifesaving. 

Dr. Rubin: I see such a big gap in my medical training. I was taught to say, “Hey, do you smoke, do you drink, do you do drugs? Do you have sex? Men, women, or both?”And that’s it. And then maybe use birth control, and don’t get an STD, thinking about herpes, syphilis, gonorrhea, and chlamydia. We weren’t really trained to talk to patients about what kind of sex they are having, or how to talk to patients in a way that is open-minded but also safety-conscious and how the concept of safe sex is more than wear a condom and use birth control.

This idea of rough sex practices and how to talk to teenagers — maybe our pediatricians should be talking about this. Where do we start in terms of how to bring up these conversations and with what level of detail? 

Dr. Herbenick: We find that some young people are already being asked about some of the effects that might be showing on their bodies. It might be that their provider notices some bruising, or marks on their bodies from other types of rough sex practices like hitting and spanking. So that could be an entry point there. Choking is far more prevalent than slapping, so if you’re seeing some marks on the body, then it’s also a good time to ask about other practices they might be engaging in, especially higher risk ones like choking or strangulation. It’s offering some information and even saying, “Look, I’m not here to shame or judge you. I just want you to have some information about this” and giving them an opportunity to ask questions, too. 

We have found that almost nobody talks with their nurse or doctor, even if they have symptoms after being choked or strangled during sex. Just 1% of women with choking-related symptoms, 7% of men, and far fewer trans and nonbinary young people report talking with a nurse or doctor, mostly because they say it doesn’t seem like a big deal. The symptoms got better quickly. Sometimes they’re afraid of being shamed for their sexual behavior, and that’s why they say they don’t talk with somebody. 

They need some type of open-door anticipatory guidance as a way forward. Not everyone is comfortable directly asking whether a patient is engaging in this, but at least letting people know that you’ve heard of this behavior and providing some medical facts can give us a step forward with creating these conversations. 

Dr. Rubin: Can you tell us where is this research going in terms of next steps? Other things that you’re looking at? And what are you excited about? 

Dr. Herbenick: I’m excited about some work I did with a collaborator and colleague of mine, Dr. Keisuke Kawata, that he led a couple of years ago. He’s a neuroscientist. We were looking at potential cumulative effects on the brain. Now we’re taking some of that research into its next steps. We’re also doing more focused studies on other health consequences and hopefully finding out how we can test different educational messages and get people to learn more fact-based information about this, and then see if that is effective in prevention. 

Dr. Rubin: It sounds like a public health campaign is really needed about how to get the word out there about the health consequences of these activities. We’re asking people often enough. In my clinic, I try to keep it open-ended — tell me what sex looks like. What does it look like, and what do you want it to look like? Because I see a lot of people with problems, but if they don’t bring it to me, I don’t necessarily bring it up to them. Until I heard your lecture, and I thought, oh my gosh, I’m not even asking the right questions. Are you hopeful that there will be more public health messaging out there? 

Dr. Herbenick: I am. Years ago, when the child and adolescent choking game became a thing, the Centers for Disease Control and Prevention (CDC) issued reports about it and warnings to parents. And this is a far, far higher prevalence than that ever was. So, I would love to see organizations like the CDC and medical groups getting involved and educating their members and making statements. This is really impacting a huge generation of girls and women, because when it happens during sex between women and men, the choking is mostly happening to the girls and women. It’s also prevalent among sexual minority individuals. But we are talking about this whole generation of young women and what’s happening to their bodies and their brain health. We really need to step into this conversation. 

Dr. Rubin: Very few of us are sexual medicine–trained physicians, and very few of us feel confident and comfortable talking about sexual health issues. But people are getting hurt. People are having real consequences of these behaviors because of our lack of education, knowledge, and even discussion around it. So thank you for doing this research, because had you not done this research, we wouldn’t have found out that 64% of people are engaging in these types of activities. That is not rare.

Dr. Rubin is an assistant clinical professor, Department of Urology, at Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.

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

This transcript has been edited for clarity. 

Rachel S. Rubin, MD: I have an interesting topic for you — kind of shocking, actually. Some of you may have read a story earlier this year in The New York Times about the alarming rise among young people of choking or strangulation during sex. I spoke recently with Dr. Debby Herbenick about this concerning and violent trend. Dr. Herbenick is a well-known sexuality researcher and professor at the Indiana University School of Public Health. Welcome, Dr. Herbenick. Can you tell us about your research into this new trend?

Debby Herbenick, PhD: This is some of the most important research that I’ve done. I’ve been studying sexual behaviors and trends for about 14 years in terms of nationally representative studies that we do. Over time, we noticed a trend of increasing prevalence of rough sex practices. 

Now, there’s always been a lot of sexual diversity in the world throughout history. But the main trend that we have focused on in recent years that is important for everyone in medicine to know about is this rapid increase — actually, a really big increase — in what people call “sexual choking,” even though it’s a form of strangulation. The increase is mostly seen in teenagers and young adults. 

We’ve done US nationally representative surveys as well as college campus representative surveys. We find that consistently across four campus representative surveys that 64% of women report having ever been choked during sex, and around 1 in 3 women (aged 18-24 years) throughout the whole country report having been choked during their most recent sexual activity with another person. They call it choking, but because it involves usually one hand — sometimes two hands or a forearm or an object, like a belt or a cord to tie around the neck — it is technically strangulation, because it’s external pressure to the neck to reduce or stop airflow or blood flow. 

Dr. Rubin: These numbers are staggering, right? Everyone listening now is taking care of someone who has been strangled as a form of sexual pleasure. What does this mean from a safety perspective? And as doctors who are working these patients up for migraines and other health problems, what is the research showing? 

Dr. Herbenick: We certainly are seeing people report recurrent headaches and ringing in the ears. There are things we’ve just barely scratched the surface on. Those of us working in this space believe that for anybody coming in for an unexplained stroke (for example, under age 50), you might consider some imaging to see if they have a dissection. We are hearing about people who, when you really probe to find out whether they’ve had pressure on the neck, they report that indeed that they have. So, we have to be thinking about neurologic symptoms. We know that they’re experiencing these at a pretty high rate. 

For people who are engaging in these practices, they should know about the health risks, but we find that most don’t. They may have heard that if it’s really intense high pressure, that in rare cases people can die, but most have never heard of anything in between. So, they’re not necessarily connecting their voice hoarseness, or the recurrent headaches or the sensitivity to light they are having, to an experience of being choked. We need to be paying attention to neurologic symptoms. 

Most physicians I speak with at conferences say that where they feel like they can step into this conversation is through anticipatory guidance and letting their patients know that they may have heard about this trend, and a lot of people are talking about the health consequences, and I want to share some information with you — not coming at it from a place of shame or judgment, but providing some information so that [patients] actually get some medical facts about this that could be lifesaving. 

Dr. Rubin: I see such a big gap in my medical training. I was taught to say, “Hey, do you smoke, do you drink, do you do drugs? Do you have sex? Men, women, or both?”And that’s it. And then maybe use birth control, and don’t get an STD, thinking about herpes, syphilis, gonorrhea, and chlamydia. We weren’t really trained to talk to patients about what kind of sex they are having, or how to talk to patients in a way that is open-minded but also safety-conscious and how the concept of safe sex is more than wear a condom and use birth control.

This idea of rough sex practices and how to talk to teenagers — maybe our pediatricians should be talking about this. Where do we start in terms of how to bring up these conversations and with what level of detail? 

Dr. Herbenick: We find that some young people are already being asked about some of the effects that might be showing on their bodies. It might be that their provider notices some bruising, or marks on their bodies from other types of rough sex practices like hitting and spanking. So that could be an entry point there. Choking is far more prevalent than slapping, so if you’re seeing some marks on the body, then it’s also a good time to ask about other practices they might be engaging in, especially higher risk ones like choking or strangulation. It’s offering some information and even saying, “Look, I’m not here to shame or judge you. I just want you to have some information about this” and giving them an opportunity to ask questions, too. 

We have found that almost nobody talks with their nurse or doctor, even if they have symptoms after being choked or strangled during sex. Just 1% of women with choking-related symptoms, 7% of men, and far fewer trans and nonbinary young people report talking with a nurse or doctor, mostly because they say it doesn’t seem like a big deal. The symptoms got better quickly. Sometimes they’re afraid of being shamed for their sexual behavior, and that’s why they say they don’t talk with somebody. 

They need some type of open-door anticipatory guidance as a way forward. Not everyone is comfortable directly asking whether a patient is engaging in this, but at least letting people know that you’ve heard of this behavior and providing some medical facts can give us a step forward with creating these conversations. 

Dr. Rubin: Can you tell us where is this research going in terms of next steps? Other things that you’re looking at? And what are you excited about? 

Dr. Herbenick: I’m excited about some work I did with a collaborator and colleague of mine, Dr. Keisuke Kawata, that he led a couple of years ago. He’s a neuroscientist. We were looking at potential cumulative effects on the brain. Now we’re taking some of that research into its next steps. We’re also doing more focused studies on other health consequences and hopefully finding out how we can test different educational messages and get people to learn more fact-based information about this, and then see if that is effective in prevention. 

Dr. Rubin: It sounds like a public health campaign is really needed about how to get the word out there about the health consequences of these activities. We’re asking people often enough. In my clinic, I try to keep it open-ended — tell me what sex looks like. What does it look like, and what do you want it to look like? Because I see a lot of people with problems, but if they don’t bring it to me, I don’t necessarily bring it up to them. Until I heard your lecture, and I thought, oh my gosh, I’m not even asking the right questions. Are you hopeful that there will be more public health messaging out there? 

Dr. Herbenick: I am. Years ago, when the child and adolescent choking game became a thing, the Centers for Disease Control and Prevention (CDC) issued reports about it and warnings to parents. And this is a far, far higher prevalence than that ever was. So, I would love to see organizations like the CDC and medical groups getting involved and educating their members and making statements. This is really impacting a huge generation of girls and women, because when it happens during sex between women and men, the choking is mostly happening to the girls and women. It’s also prevalent among sexual minority individuals. But we are talking about this whole generation of young women and what’s happening to their bodies and their brain health. We really need to step into this conversation. 

Dr. Rubin: Very few of us are sexual medicine–trained physicians, and very few of us feel confident and comfortable talking about sexual health issues. But people are getting hurt. People are having real consequences of these behaviors because of our lack of education, knowledge, and even discussion around it. So thank you for doing this research, because had you not done this research, we wouldn’t have found out that 64% of people are engaging in these types of activities. That is not rare.

Dr. Rubin is an assistant clinical professor, Department of Urology, at Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.

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

Lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, has shown 100% efficacy in preventing HIV in women at a high risk for infection, according to an interim analysis of the phase 3 PURPOSE 1 trial.

The results were so promising that the independent data monitoring committee recommended that Gilead Sciences stop the blinded phase of the trial and offer open-label lenacapavir to all participants.

The results were both unexpected and exciting. “I’ve been in the HIV field for a really long time, and there’s no other phase 3 PrEP trial that found zero infections,” said Moupali Das, MD, PhD, executive director of clinical development at Gilead Sciences, Foster City, California.

PURPOSE 1 is evaluating the safety and efficacy of two regimens — twice-yearly subcutaneous lenacapavir for pre-exposure prophylaxis and once-daily oral Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) — in women and girls aged 16-25 years. The two drugs are being compared with the standard once-daily oral Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg).

There were no cases of HIV infection among the more than 2000 women in the lenacapavir group; in contrast, the incidence of HIV in the Descovy group was 2.02 per 100 person-years and in the Truvada group was 1.69 per 100 person-years.

The background incidence of HIV, one of the primary endpoints of the trial, was 2.41 per 100 person-years with lenacapavir. All the drugs were shown to be safe and well tolerated, and the full interim data from the trial will be released at an upcoming conference, according to Dr. Das.
 

No New Cases

The medical community is “thrilled” with the results so far, said Monica Gandhi, MD, director of the UCSF-Gladstone Center for AIDS Research. “We have to wait for the full data, but so far, it has been 100% effective and far superior to other treatments.”

Dr. Gandhi said she is waiting to see more details on side effects and tolerability, as well as discontinuation rates in the trial and the reasons people dropped out. For example, lenacapavir tends to cause nodules to form under the skin, which are the depots from which the drug is released over the course of 6 months. Gandhi said she is interested in whether any participants found them bothersome enough to discontinue the treatment.

The global HIV epidemic is still ongoing, with 1.3 million new infections in 2022, and existing oral PrEP options, and even the long-acting injectable cabotegravir, have so far failed to make as much of a dent in infection rates as hoped, said Dr. Gandhi. “We’ve been waiting for another option.”

The twice-yearly lenacapavir shot is easy and convenient to administer, compared with oral PrEP. Many people — especially younger individuals such as those enrolled in PURPOSE 1 — find it difficult to remember to take the pills every day.
 

A Discreet Option

Many participants in the trial said that they were uncomfortable with the stigma that can be attached to HIV PrEP. They did not want people to see the pill bottle in their house or hear it rattling in their purse. So an injection given just twice a year in a doctor’s office is attractive.

“This is a discrete option. People were very excited about the privacy and not having to take daily pills,” said Dr. Das. “PrEP only works if you take it.”

Better adherence to the treatment regimen is likely one reason that lenacapavir outperformed oral PrEP. But lenacapavir also has a unique mechanism of action as a multistage viral capsid inhibitor, Dr. Das said. It targets the capsid both before and after the virus integrates into the nucleus, which could be another reason for its potency.

Although the results are encouraging, there is still some concern about how accessible the drug will be, especially in low- and middle-income countries where the burden of HIV is the highest. “No one has any clue on how Gilead plans to make this accessible,” said Dr. Gandhi.
 

Access Issues

The company has not signed up for the Medicines Patent Pool (MPP) to allow companies to manufacture generic formulations of lenacapavir, which Dr. Gandhi said is the traditional route to provide cheaper alternatives in poorer countries. The “disastrous” rollout of injectable cabotegravir, which is still not widely available in lower-income countries, is a worrying precedent.

Gilead Sciences confirmed that all 5300 participants in the PURPOSE 1 study will have the option to continue receiving lenacapavir until the drug is generally available in their country. The company has committed to ensuring a dedicated Gilead Sciences supply in the countries where the need is the greatest until voluntary licensing partners are able to supply high-quality, low-cost versions of lenacapavir.

And rather than going through the third-party MPP, Gilead Sciences is negotiating a voluntary licensing program directly with other partners to supply generic versions of the drug in poorer countries.

Lenacapavir is already approved for the treatment of multidrug-resistant HIV but is not yet approved for HIV prevention. A sister trial, PURPOSE 2, is ongoing and is testing lenacapavir in men who have sex with men and in transgender men, transgender women, and nonbinary individuals who have sex with partners assigned male at birth. Should those results, expected by the end of 2024 or early 2025, be positive, the company will move forward with regulatory filings for lenacapavir PrEP.

Three other trials are also ongoing. PURPOSE 3 and PURPOSE 4 are smaller US-based studies of women and people who inject drugs, and PURPOSE 5 is enrolling people at a high risk for HIV in France and the United Kingdom to provide European data for European regulators.

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

Lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, has shown 100% efficacy in preventing HIV in women at a high risk for infection, according to an interim analysis of the phase 3 PURPOSE 1 trial.

The results were so promising that the independent data monitoring committee recommended that Gilead Sciences stop the blinded phase of the trial and offer open-label lenacapavir to all participants.

The results were both unexpected and exciting. “I’ve been in the HIV field for a really long time, and there’s no other phase 3 PrEP trial that found zero infections,” said Moupali Das, MD, PhD, executive director of clinical development at Gilead Sciences, Foster City, California.

PURPOSE 1 is evaluating the safety and efficacy of two regimens — twice-yearly subcutaneous lenacapavir for pre-exposure prophylaxis and once-daily oral Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) — in women and girls aged 16-25 years. The two drugs are being compared with the standard once-daily oral Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg).

There were no cases of HIV infection among the more than 2000 women in the lenacapavir group; in contrast, the incidence of HIV in the Descovy group was 2.02 per 100 person-years and in the Truvada group was 1.69 per 100 person-years.

The background incidence of HIV, one of the primary endpoints of the trial, was 2.41 per 100 person-years with lenacapavir. All the drugs were shown to be safe and well tolerated, and the full interim data from the trial will be released at an upcoming conference, according to Dr. Das.
 

No New Cases

The medical community is “thrilled” with the results so far, said Monica Gandhi, MD, director of the UCSF-Gladstone Center for AIDS Research. “We have to wait for the full data, but so far, it has been 100% effective and far superior to other treatments.”

Dr. Gandhi said she is waiting to see more details on side effects and tolerability, as well as discontinuation rates in the trial and the reasons people dropped out. For example, lenacapavir tends to cause nodules to form under the skin, which are the depots from which the drug is released over the course of 6 months. Gandhi said she is interested in whether any participants found them bothersome enough to discontinue the treatment.

The global HIV epidemic is still ongoing, with 1.3 million new infections in 2022, and existing oral PrEP options, and even the long-acting injectable cabotegravir, have so far failed to make as much of a dent in infection rates as hoped, said Dr. Gandhi. “We’ve been waiting for another option.”

The twice-yearly lenacapavir shot is easy and convenient to administer, compared with oral PrEP. Many people — especially younger individuals such as those enrolled in PURPOSE 1 — find it difficult to remember to take the pills every day.
 

A Discreet Option

Many participants in the trial said that they were uncomfortable with the stigma that can be attached to HIV PrEP. They did not want people to see the pill bottle in their house or hear it rattling in their purse. So an injection given just twice a year in a doctor’s office is attractive.

“This is a discrete option. People were very excited about the privacy and not having to take daily pills,” said Dr. Das. “PrEP only works if you take it.”

Better adherence to the treatment regimen is likely one reason that lenacapavir outperformed oral PrEP. But lenacapavir also has a unique mechanism of action as a multistage viral capsid inhibitor, Dr. Das said. It targets the capsid both before and after the virus integrates into the nucleus, which could be another reason for its potency.

Although the results are encouraging, there is still some concern about how accessible the drug will be, especially in low- and middle-income countries where the burden of HIV is the highest. “No one has any clue on how Gilead plans to make this accessible,” said Dr. Gandhi.
 

Access Issues

The company has not signed up for the Medicines Patent Pool (MPP) to allow companies to manufacture generic formulations of lenacapavir, which Dr. Gandhi said is the traditional route to provide cheaper alternatives in poorer countries. The “disastrous” rollout of injectable cabotegravir, which is still not widely available in lower-income countries, is a worrying precedent.

Gilead Sciences confirmed that all 5300 participants in the PURPOSE 1 study will have the option to continue receiving lenacapavir until the drug is generally available in their country. The company has committed to ensuring a dedicated Gilead Sciences supply in the countries where the need is the greatest until voluntary licensing partners are able to supply high-quality, low-cost versions of lenacapavir.

And rather than going through the third-party MPP, Gilead Sciences is negotiating a voluntary licensing program directly with other partners to supply generic versions of the drug in poorer countries.

Lenacapavir is already approved for the treatment of multidrug-resistant HIV but is not yet approved for HIV prevention. A sister trial, PURPOSE 2, is ongoing and is testing lenacapavir in men who have sex with men and in transgender men, transgender women, and nonbinary individuals who have sex with partners assigned male at birth. Should those results, expected by the end of 2024 or early 2025, be positive, the company will move forward with regulatory filings for lenacapavir PrEP.

Three other trials are also ongoing. PURPOSE 3 and PURPOSE 4 are smaller US-based studies of women and people who inject drugs, and PURPOSE 5 is enrolling people at a high risk for HIV in France and the United Kingdom to provide European data for European regulators.

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

Lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, has shown 100% efficacy in preventing HIV in women at a high risk for infection, according to an interim analysis of the phase 3 PURPOSE 1 trial.

The results were so promising that the independent data monitoring committee recommended that Gilead Sciences stop the blinded phase of the trial and offer open-label lenacapavir to all participants.

The results were both unexpected and exciting. “I’ve been in the HIV field for a really long time, and there’s no other phase 3 PrEP trial that found zero infections,” said Moupali Das, MD, PhD, executive director of clinical development at Gilead Sciences, Foster City, California.

PURPOSE 1 is evaluating the safety and efficacy of two regimens — twice-yearly subcutaneous lenacapavir for pre-exposure prophylaxis and once-daily oral Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) — in women and girls aged 16-25 years. The two drugs are being compared with the standard once-daily oral Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg).

There were no cases of HIV infection among the more than 2000 women in the lenacapavir group; in contrast, the incidence of HIV in the Descovy group was 2.02 per 100 person-years and in the Truvada group was 1.69 per 100 person-years.

The background incidence of HIV, one of the primary endpoints of the trial, was 2.41 per 100 person-years with lenacapavir. All the drugs were shown to be safe and well tolerated, and the full interim data from the trial will be released at an upcoming conference, according to Dr. Das.
 

No New Cases

The medical community is “thrilled” with the results so far, said Monica Gandhi, MD, director of the UCSF-Gladstone Center for AIDS Research. “We have to wait for the full data, but so far, it has been 100% effective and far superior to other treatments.”

Dr. Gandhi said she is waiting to see more details on side effects and tolerability, as well as discontinuation rates in the trial and the reasons people dropped out. For example, lenacapavir tends to cause nodules to form under the skin, which are the depots from which the drug is released over the course of 6 months. Gandhi said she is interested in whether any participants found them bothersome enough to discontinue the treatment.

The global HIV epidemic is still ongoing, with 1.3 million new infections in 2022, and existing oral PrEP options, and even the long-acting injectable cabotegravir, have so far failed to make as much of a dent in infection rates as hoped, said Dr. Gandhi. “We’ve been waiting for another option.”

The twice-yearly lenacapavir shot is easy and convenient to administer, compared with oral PrEP. Many people — especially younger individuals such as those enrolled in PURPOSE 1 — find it difficult to remember to take the pills every day.
 

A Discreet Option

Many participants in the trial said that they were uncomfortable with the stigma that can be attached to HIV PrEP. They did not want people to see the pill bottle in their house or hear it rattling in their purse. So an injection given just twice a year in a doctor’s office is attractive.

“This is a discrete option. People were very excited about the privacy and not having to take daily pills,” said Dr. Das. “PrEP only works if you take it.”

Better adherence to the treatment regimen is likely one reason that lenacapavir outperformed oral PrEP. But lenacapavir also has a unique mechanism of action as a multistage viral capsid inhibitor, Dr. Das said. It targets the capsid both before and after the virus integrates into the nucleus, which could be another reason for its potency.

Although the results are encouraging, there is still some concern about how accessible the drug will be, especially in low- and middle-income countries where the burden of HIV is the highest. “No one has any clue on how Gilead plans to make this accessible,” said Dr. Gandhi.
 

Access Issues

The company has not signed up for the Medicines Patent Pool (MPP) to allow companies to manufacture generic formulations of lenacapavir, which Dr. Gandhi said is the traditional route to provide cheaper alternatives in poorer countries. The “disastrous” rollout of injectable cabotegravir, which is still not widely available in lower-income countries, is a worrying precedent.

Gilead Sciences confirmed that all 5300 participants in the PURPOSE 1 study will have the option to continue receiving lenacapavir until the drug is generally available in their country. The company has committed to ensuring a dedicated Gilead Sciences supply in the countries where the need is the greatest until voluntary licensing partners are able to supply high-quality, low-cost versions of lenacapavir.

And rather than going through the third-party MPP, Gilead Sciences is negotiating a voluntary licensing program directly with other partners to supply generic versions of the drug in poorer countries.

Lenacapavir is already approved for the treatment of multidrug-resistant HIV but is not yet approved for HIV prevention. A sister trial, PURPOSE 2, is ongoing and is testing lenacapavir in men who have sex with men and in transgender men, transgender women, and nonbinary individuals who have sex with partners assigned male at birth. Should those results, expected by the end of 2024 or early 2025, be positive, the company will move forward with regulatory filings for lenacapavir PrEP.

Three other trials are also ongoing. PURPOSE 3 and PURPOSE 4 are smaller US-based studies of women and people who inject drugs, and PURPOSE 5 is enrolling people at a high risk for HIV in France and the United Kingdom to provide European data for European regulators.

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

From adolescence onward, the need for sexual health is particularly important. Yet, information and healthcare services are limited, which often leaves patients in distress and subject to misconceptions. What are the specific issues related to sexuality in adolescence, middle age, and beyond? This news organization interviewed Carol Burté, MD, a specialist in sexual medicine from Monaco.

Question: Regarding young individuals, what about sex education in schools?

Dr. Burté: The French law of 2018 specifies that at least three annual sessions must be devoted to sex education in elementary school, middle school, and high school.

In practice, this is not always the case, and interventions are very focused on prevention and rules. Sexuality is almost always absent from the program. Sexuality means: What does it mean to have desire? How does pleasure work? At what age do we have sex? etc. Young people receive prevention advice, but the link with sexuality is not made.

Sexuality remains taboo. You know, like in books: “They got married and had many children ...” End of the story, we don’t know more [laughs].

Question: And outside the school setting, do doctors sufficiently address sexual health issues with adolescents?

Dr. Burté: Rarely. I understand that a general practitioner has little time, but they can still ask the young person if they have any questions. They can refer them to someone or provide reading recommendations. Regarding sex education on the Internet, there are many well-made websites, such as the one by the national education system.

Also, it is important to give young people lifestyle advice to combat overweight, sedentary behavior, etc., by explaining to them that these factors can lead to sexual disorders later as well as infertility.

Another very important point: There is an inequality between boys and girls, but this time, to the disadvantage of boys. We have a sexual health consultation dedicated to young girls for the pill, but no one examines the boys. However, testicular cancer or undescended testicles can occur. I think we really need to change things and establish a clinical examination for boys in adolescence.

Question: More and more young people identify as asexual. What do you think of this?

Dr. Burté: People who identify as asexual represent about 1% of the population. These are individuals who are not attracted to having sexual relationships with someone. This does not prevent them from having a boyfriend, a girlfriend, masturbating, etc. It is sexual intercourse that does not interest them. These young people often say they have done it all. They have seen a lot of images, viewed sexuality as gymnastics with all the positions, tricks. They are jaded. Also, when you are faced with an image that provides a very strong and rapid stimulation, human relationships seem much more difficult because, obviously, you will never reproduce that sensation when you are with your partner with whom you must connect. The relationship is no longer emotional and shared. Yet, sexuality is emotional, relational, intellectual.

I think people go through phases. At a certain point, they feel asexual, but they can change their minds and think differently if they have real encounters, encounters that are increasingly difficult. Today, we are witnessing a loss of confidence. Young people, but also others, want to protect themselves from everything, especially from falling in love, not get back into a relationship because it is constraining. 

Question: Data show that young people are exposed to pornography at an increasingly early age. Is this a problem for their future sexuality?

Dr. Burté: The exposure to pornography at an early age, around 11 years old, has only been a reality for the past decade. It is too early to say how it will impact their sexuality. When examining the literature on this subject, some publications indicate that the consequences can be dramatic for children. Others show that children can distinguish between reality and fantasy.

Whenever I see young people in consultation, I ask them whether they feel pornography has helped or hindered them, whether it is the cause of the issue they are facing. I would say that, other than those who have viewed pornography under duress, which is of the order of violence, pornography does not seem to pose a problem. It can even provide certain knowledge. 

Question: What about sexual violence in children? What are the consequences?

Dr. Burté: In sexual medicine, this is one of the questions we ask systematically because it is very common. It is important to keep in mind that this not only affects girls; boys are also sexually abused. The consequences are dramatic in terms of psychosexual development. Each case is different. 

Question: At the other end of life, is it “normal” to have sexual disorders at a certain age? Should we resign ourselves?

Dr. Burté: When it comes to sexuality, people have many misconceptions and beliefs that are conveyed through media and the Internet. One of them is to believe that because we are aging, we cannot have a proper sexuality. Sexuality slows down with age, as all sensitivities decrease, but desire is something present throughout life. Yet, seniors are rarely questioned about their sexual health by the media.

Note that older people in institutions face an additional obstacle: lack of privacy. Is this normal? Sexuality releases endorphins, oxytocin, it is well-being that costs nothing. It is something that should be prescribed!

Question: Chronic diseases, disabilities with incidence increases with age — are they not inevitable obstacles to a fulfilling sexuality?

Dr. Burté: It is possible to have a sexual life regardless of the disease one has, cancer, diabetes, rheumatic disease — regardless of the disability. 

A collaboration with the National Cancer Institute on the preservation of sexual health after cancer in which I participated shows that people are extremely demanding of care and that this care is still very insufficient, unfortunately, even in the case of prostate cancer, for example, when it should be obvious.

Question: But aging itself brings challenges in terms of sexuality. 

Dr. Burté: Yes, in men, the consequences of low testosterone levels are well known. Therefore, we must stop thinking that men do not have their “menopause.” Men often have a testosterone deficiency after a certain age. This is very annoying because they have many symptoms that are truly unpleasant and yet can be corrected by completely reliable treatments.

Men are very misinformed on this subject. We talk about gender inequality, but in this area, a young woman who has her first period knows very well that one day she will go through menopause, but a boy has no idea that one day he will have hormone problems.

Question: Therefore, is it important to question men past the age of 50 years?

Dr. Burté: Yes. Faced with sexual symptoms or simply fatigue, or among those who are a bit depressed, investigating a testosterone deficiency should be part of the reflexes.

Also, if you ask a man in general, “How is it going from a sexual point of view,” and he answers that everything is going well, this means he has good arteries, good veins, a good nervous system, sufficient hormones, and psychologically, everything is going rather well. Conversely, erectile dysfunction can be one of the first symptoms of cardiovascular pathologies.

After a certain age, there is no test that provides as much information about people’s health as this question about sexual health.

Question: On their side, are women better cared for at menopause?

Dr. Burté: Yes, but women still lack explanations. I work in sexual medicine, and in my consultation, I see women who come simply to get information about menopause.

Women must know that menopause is a turning point in life because they will spend 30%-40% of their lives without hormones.

It is important to explain that indeed, after menopause, without treatment, it is not the same. There are genital and urinary, psychological, sexual, and skin consequences. It is important to provide true data on the influence of hormonal treatments. Today, hormone fear is not over. I think we need to rehabilitate treatments, care for women.

Question: So we must not forget men or women. 

Dr. Burté: Yes. It is also very important to adopt a perspective not only for the individual but also for the couple. If you treat a man with testosterone, after 3 months, he will be in great shape. However, if the couple has long been accustomed to having a limited sexual life, if the woman is not supported on her side, the couple will be unbalanced. The couple is concerned with managing the hormonal changes of both.

Question: Sexual medicine is essential, yet it seems inaccessible. 

Dr. Burté: There are very few specialists in sexual medicine because there is no legal provision for it. These consultations are lengthy but not valued. Who wants to work for that?

If there was reimbursement for sexual medicine consultations at age 15 years, at menopause, and for men around the age of 50 years, it would change mentalities. Sexual medicine must be integrated into medicine. It should also be noted that not all sexologists are physicians.

Some people are very well trained through universities, and others are not. Ideally, someone with a sexual disorder should first have a sexual medicine consultation to understand the situation. Then, the physician can refer the patient to a competent sexologist because we work in a network.

Dr. Burté has no conflicts of interest related to the subject. 

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. 

A version of this article appeared on Medscape.com.

From adolescence onward, the need for sexual health is particularly important. Yet, information and healthcare services are limited, which often leaves patients in distress and subject to misconceptions. What are the specific issues related to sexuality in adolescence, middle age, and beyond? This news organization interviewed Carol Burté, MD, a specialist in sexual medicine from Monaco.

Question: Regarding young individuals, what about sex education in schools?

Dr. Burté: The French law of 2018 specifies that at least three annual sessions must be devoted to sex education in elementary school, middle school, and high school.

In practice, this is not always the case, and interventions are very focused on prevention and rules. Sexuality is almost always absent from the program. Sexuality means: What does it mean to have desire? How does pleasure work? At what age do we have sex? etc. Young people receive prevention advice, but the link with sexuality is not made.

Sexuality remains taboo. You know, like in books: “They got married and had many children ...” End of the story, we don’t know more [laughs].

Question: And outside the school setting, do doctors sufficiently address sexual health issues with adolescents?

Dr. Burté: Rarely. I understand that a general practitioner has little time, but they can still ask the young person if they have any questions. They can refer them to someone or provide reading recommendations. Regarding sex education on the Internet, there are many well-made websites, such as the one by the national education system.

Also, it is important to give young people lifestyle advice to combat overweight, sedentary behavior, etc., by explaining to them that these factors can lead to sexual disorders later as well as infertility.

Another very important point: There is an inequality between boys and girls, but this time, to the disadvantage of boys. We have a sexual health consultation dedicated to young girls for the pill, but no one examines the boys. However, testicular cancer or undescended testicles can occur. I think we really need to change things and establish a clinical examination for boys in adolescence.

Question: More and more young people identify as asexual. What do you think of this?

Dr. Burté: People who identify as asexual represent about 1% of the population. These are individuals who are not attracted to having sexual relationships with someone. This does not prevent them from having a boyfriend, a girlfriend, masturbating, etc. It is sexual intercourse that does not interest them. These young people often say they have done it all. They have seen a lot of images, viewed sexuality as gymnastics with all the positions, tricks. They are jaded. Also, when you are faced with an image that provides a very strong and rapid stimulation, human relationships seem much more difficult because, obviously, you will never reproduce that sensation when you are with your partner with whom you must connect. The relationship is no longer emotional and shared. Yet, sexuality is emotional, relational, intellectual.

I think people go through phases. At a certain point, they feel asexual, but they can change their minds and think differently if they have real encounters, encounters that are increasingly difficult. Today, we are witnessing a loss of confidence. Young people, but also others, want to protect themselves from everything, especially from falling in love, not get back into a relationship because it is constraining. 

Question: Data show that young people are exposed to pornography at an increasingly early age. Is this a problem for their future sexuality?

Dr. Burté: The exposure to pornography at an early age, around 11 years old, has only been a reality for the past decade. It is too early to say how it will impact their sexuality. When examining the literature on this subject, some publications indicate that the consequences can be dramatic for children. Others show that children can distinguish between reality and fantasy.

Whenever I see young people in consultation, I ask them whether they feel pornography has helped or hindered them, whether it is the cause of the issue they are facing. I would say that, other than those who have viewed pornography under duress, which is of the order of violence, pornography does not seem to pose a problem. It can even provide certain knowledge. 

Question: What about sexual violence in children? What are the consequences?

Dr. Burté: In sexual medicine, this is one of the questions we ask systematically because it is very common. It is important to keep in mind that this not only affects girls; boys are also sexually abused. The consequences are dramatic in terms of psychosexual development. Each case is different. 

Question: At the other end of life, is it “normal” to have sexual disorders at a certain age? Should we resign ourselves?

Dr. Burté: When it comes to sexuality, people have many misconceptions and beliefs that are conveyed through media and the Internet. One of them is to believe that because we are aging, we cannot have a proper sexuality. Sexuality slows down with age, as all sensitivities decrease, but desire is something present throughout life. Yet, seniors are rarely questioned about their sexual health by the media.

Note that older people in institutions face an additional obstacle: lack of privacy. Is this normal? Sexuality releases endorphins, oxytocin, it is well-being that costs nothing. It is something that should be prescribed!

Question: Chronic diseases, disabilities with incidence increases with age — are they not inevitable obstacles to a fulfilling sexuality?

Dr. Burté: It is possible to have a sexual life regardless of the disease one has, cancer, diabetes, rheumatic disease — regardless of the disability. 

A collaboration with the National Cancer Institute on the preservation of sexual health after cancer in which I participated shows that people are extremely demanding of care and that this care is still very insufficient, unfortunately, even in the case of prostate cancer, for example, when it should be obvious.

Question: But aging itself brings challenges in terms of sexuality. 

Dr. Burté: Yes, in men, the consequences of low testosterone levels are well known. Therefore, we must stop thinking that men do not have their “menopause.” Men often have a testosterone deficiency after a certain age. This is very annoying because they have many symptoms that are truly unpleasant and yet can be corrected by completely reliable treatments.

Men are very misinformed on this subject. We talk about gender inequality, but in this area, a young woman who has her first period knows very well that one day she will go through menopause, but a boy has no idea that one day he will have hormone problems.

Question: Therefore, is it important to question men past the age of 50 years?

Dr. Burté: Yes. Faced with sexual symptoms or simply fatigue, or among those who are a bit depressed, investigating a testosterone deficiency should be part of the reflexes.

Also, if you ask a man in general, “How is it going from a sexual point of view,” and he answers that everything is going well, this means he has good arteries, good veins, a good nervous system, sufficient hormones, and psychologically, everything is going rather well. Conversely, erectile dysfunction can be one of the first symptoms of cardiovascular pathologies.

After a certain age, there is no test that provides as much information about people’s health as this question about sexual health.

Question: On their side, are women better cared for at menopause?

Dr. Burté: Yes, but women still lack explanations. I work in sexual medicine, and in my consultation, I see women who come simply to get information about menopause.

Women must know that menopause is a turning point in life because they will spend 30%-40% of their lives without hormones.

It is important to explain that indeed, after menopause, without treatment, it is not the same. There are genital and urinary, psychological, sexual, and skin consequences. It is important to provide true data on the influence of hormonal treatments. Today, hormone fear is not over. I think we need to rehabilitate treatments, care for women.

Question: So we must not forget men or women. 

Dr. Burté: Yes. It is also very important to adopt a perspective not only for the individual but also for the couple. If you treat a man with testosterone, after 3 months, he will be in great shape. However, if the couple has long been accustomed to having a limited sexual life, if the woman is not supported on her side, the couple will be unbalanced. The couple is concerned with managing the hormonal changes of both.

Question: Sexual medicine is essential, yet it seems inaccessible. 

Dr. Burté: There are very few specialists in sexual medicine because there is no legal provision for it. These consultations are lengthy but not valued. Who wants to work for that?

If there was reimbursement for sexual medicine consultations at age 15 years, at menopause, and for men around the age of 50 years, it would change mentalities. Sexual medicine must be integrated into medicine. It should also be noted that not all sexologists are physicians.

Some people are very well trained through universities, and others are not. Ideally, someone with a sexual disorder should first have a sexual medicine consultation to understand the situation. Then, the physician can refer the patient to a competent sexologist because we work in a network.

Dr. Burté has no conflicts of interest related to the subject. 

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. 

A version of this article appeared on Medscape.com.

From adolescence onward, the need for sexual health is particularly important. Yet, information and healthcare services are limited, which often leaves patients in distress and subject to misconceptions. What are the specific issues related to sexuality in adolescence, middle age, and beyond? This news organization interviewed Carol Burté, MD, a specialist in sexual medicine from Monaco.

Question: Regarding young individuals, what about sex education in schools?

Dr. Burté: The French law of 2018 specifies that at least three annual sessions must be devoted to sex education in elementary school, middle school, and high school.

In practice, this is not always the case, and interventions are very focused on prevention and rules. Sexuality is almost always absent from the program. Sexuality means: What does it mean to have desire? How does pleasure work? At what age do we have sex? etc. Young people receive prevention advice, but the link with sexuality is not made.

Sexuality remains taboo. You know, like in books: “They got married and had many children ...” End of the story, we don’t know more [laughs].

Question: And outside the school setting, do doctors sufficiently address sexual health issues with adolescents?

Dr. Burté: Rarely. I understand that a general practitioner has little time, but they can still ask the young person if they have any questions. They can refer them to someone or provide reading recommendations. Regarding sex education on the Internet, there are many well-made websites, such as the one by the national education system.

Also, it is important to give young people lifestyle advice to combat overweight, sedentary behavior, etc., by explaining to them that these factors can lead to sexual disorders later as well as infertility.

Another very important point: There is an inequality between boys and girls, but this time, to the disadvantage of boys. We have a sexual health consultation dedicated to young girls for the pill, but no one examines the boys. However, testicular cancer or undescended testicles can occur. I think we really need to change things and establish a clinical examination for boys in adolescence.

Question: More and more young people identify as asexual. What do you think of this?

Dr. Burté: People who identify as asexual represent about 1% of the population. These are individuals who are not attracted to having sexual relationships with someone. This does not prevent them from having a boyfriend, a girlfriend, masturbating, etc. It is sexual intercourse that does not interest them. These young people often say they have done it all. They have seen a lot of images, viewed sexuality as gymnastics with all the positions, tricks. They are jaded. Also, when you are faced with an image that provides a very strong and rapid stimulation, human relationships seem much more difficult because, obviously, you will never reproduce that sensation when you are with your partner with whom you must connect. The relationship is no longer emotional and shared. Yet, sexuality is emotional, relational, intellectual.

I think people go through phases. At a certain point, they feel asexual, but they can change their minds and think differently if they have real encounters, encounters that are increasingly difficult. Today, we are witnessing a loss of confidence. Young people, but also others, want to protect themselves from everything, especially from falling in love, not get back into a relationship because it is constraining. 

Question: Data show that young people are exposed to pornography at an increasingly early age. Is this a problem for their future sexuality?

Dr. Burté: The exposure to pornography at an early age, around 11 years old, has only been a reality for the past decade. It is too early to say how it will impact their sexuality. When examining the literature on this subject, some publications indicate that the consequences can be dramatic for children. Others show that children can distinguish between reality and fantasy.

Whenever I see young people in consultation, I ask them whether they feel pornography has helped or hindered them, whether it is the cause of the issue they are facing. I would say that, other than those who have viewed pornography under duress, which is of the order of violence, pornography does not seem to pose a problem. It can even provide certain knowledge. 

Question: What about sexual violence in children? What are the consequences?

Dr. Burté: In sexual medicine, this is one of the questions we ask systematically because it is very common. It is important to keep in mind that this not only affects girls; boys are also sexually abused. The consequences are dramatic in terms of psychosexual development. Each case is different. 

Question: At the other end of life, is it “normal” to have sexual disorders at a certain age? Should we resign ourselves?

Dr. Burté: When it comes to sexuality, people have many misconceptions and beliefs that are conveyed through media and the Internet. One of them is to believe that because we are aging, we cannot have a proper sexuality. Sexuality slows down with age, as all sensitivities decrease, but desire is something present throughout life. Yet, seniors are rarely questioned about their sexual health by the media.

Note that older people in institutions face an additional obstacle: lack of privacy. Is this normal? Sexuality releases endorphins, oxytocin, it is well-being that costs nothing. It is something that should be prescribed!

Question: Chronic diseases, disabilities with incidence increases with age — are they not inevitable obstacles to a fulfilling sexuality?

Dr. Burté: It is possible to have a sexual life regardless of the disease one has, cancer, diabetes, rheumatic disease — regardless of the disability. 

A collaboration with the National Cancer Institute on the preservation of sexual health after cancer in which I participated shows that people are extremely demanding of care and that this care is still very insufficient, unfortunately, even in the case of prostate cancer, for example, when it should be obvious.

Question: But aging itself brings challenges in terms of sexuality. 

Dr. Burté: Yes, in men, the consequences of low testosterone levels are well known. Therefore, we must stop thinking that men do not have their “menopause.” Men often have a testosterone deficiency after a certain age. This is very annoying because they have many symptoms that are truly unpleasant and yet can be corrected by completely reliable treatments.

Men are very misinformed on this subject. We talk about gender inequality, but in this area, a young woman who has her first period knows very well that one day she will go through menopause, but a boy has no idea that one day he will have hormone problems.

Question: Therefore, is it important to question men past the age of 50 years?

Dr. Burté: Yes. Faced with sexual symptoms or simply fatigue, or among those who are a bit depressed, investigating a testosterone deficiency should be part of the reflexes.

Also, if you ask a man in general, “How is it going from a sexual point of view,” and he answers that everything is going well, this means he has good arteries, good veins, a good nervous system, sufficient hormones, and psychologically, everything is going rather well. Conversely, erectile dysfunction can be one of the first symptoms of cardiovascular pathologies.

After a certain age, there is no test that provides as much information about people’s health as this question about sexual health.

Question: On their side, are women better cared for at menopause?

Dr. Burté: Yes, but women still lack explanations. I work in sexual medicine, and in my consultation, I see women who come simply to get information about menopause.

Women must know that menopause is a turning point in life because they will spend 30%-40% of their lives without hormones.

It is important to explain that indeed, after menopause, without treatment, it is not the same. There are genital and urinary, psychological, sexual, and skin consequences. It is important to provide true data on the influence of hormonal treatments. Today, hormone fear is not over. I think we need to rehabilitate treatments, care for women.

Question: So we must not forget men or women. 

Dr. Burté: Yes. It is also very important to adopt a perspective not only for the individual but also for the couple. If you treat a man with testosterone, after 3 months, he will be in great shape. However, if the couple has long been accustomed to having a limited sexual life, if the woman is not supported on her side, the couple will be unbalanced. The couple is concerned with managing the hormonal changes of both.

Question: Sexual medicine is essential, yet it seems inaccessible. 

Dr. Burté: There are very few specialists in sexual medicine because there is no legal provision for it. These consultations are lengthy but not valued. Who wants to work for that?

If there was reimbursement for sexual medicine consultations at age 15 years, at menopause, and for men around the age of 50 years, it would change mentalities. Sexual medicine must be integrated into medicine. It should also be noted that not all sexologists are physicians.

Some people are very well trained through universities, and others are not. Ideally, someone with a sexual disorder should first have a sexual medicine consultation to understand the situation. Then, the physician can refer the patient to a competent sexologist because we work in a network.

Dr. Burté has no conflicts of interest related to the subject. 

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. 

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

There has been a large amount of news lately about dating online and dating apps. Probably the most common way younger people find potential partners is to go online and see who’s there that they might want to meet. 

Online dating is also notorious for being full of scammers. There are all kinds of people out there that you have to be careful of, who are trying to rip you off by saying, “Send me money, I’m in trouble,” or “Now that we have a relationship, will you support my particular entrepreneurial idea?” Certainly, dangers are there. 

Another danger we don’t talk much about is meeting people who have sexually transmitted diseases. That’s been a problem before websites and before dating apps. I think the opportunity of meeting more people — strangers, people you don’t really know — who may not tell you the truth about their health, and particularly their sexual health, is really out there. 

It’s always good medical advice to tell people to practice safe sex, and that often involves a man wearing a condom. It certainly is the case that we want to attend not just to the prevention of unwanted pregnancy but also to the transmission of diseases. I think it’s very important to tell women of reproductive age to get their HPV shot to try to reduce cancers in their reproductive systems, or sometimes in men — anal cancers, or even being a transmitter of disease. 

Even then, certainly one wants to recommend that, in an age where some people are going to meet many partners that they don’t know well or don’t have much background with, it’s wise to try to prevent diseases using the vaccines we’ve got, using the contraceptive methods that will prevent disease transmission, and reminding people to ask about sex life. 

I did come across a website that just startled me. It’s called HeHealth, and basically it says to men, if you are conscientious about your sex life, take a picture of your penis, send it to us, and we have doctors — I presume they’re US doctors but I don’t know — who will diagnose venereal diseases based on that picture. I presume women could also say, “Before we have sex, or now that we’re approaching that possibility, I want you to send a picture to this company on this website.” 

Now, a couple of reminders. I think we all know this, but just because you’re not manifesting symptoms on your reproductive organs doesn’t mean you don’t have a sexual disease. It’s not a reliable measure. Yes, maybe you could have somebody say: “Oh, that looks nasty. I’m not sure you ought to have sex right now, and maybe you should go get some treatment.” This is going to miss many cases and is not a reliable indicator that your partner is safe in terms of not transmitting diseases to you. 

It also isn’t clear what they do with these images. Do they keep them? Who can see them? Could they resell them? What sort of privacy protection have you got if you decide to use this? 

There’s another issue here, which is, if they misdiagnose someone and you do catch a sexual disease, who’s liable? Can you go after them for using doctors who weren’t competent or transmitting images that weren’t really adequate because you didn’t know how to take that picture properly when you sent that off to them? There are many unknowns. 

The bottom line is that we’re in a different world, I think, of romance. We’re in a world where some people are going to meet more partners. Some people are going to meet more strangers. One approach is to have us take pictures of ourselves, send them off to who knows where, and ask for a green light to go ahead and have sexual relations. I don’t think we’re anywhere close to being able to rely on that as a way to avoid the risks of unprotected sexual behavior. 

We do know what to do in dealing with patients who are sexually active. First, we have to ask them. Then we’ve got to recommend available vaccinations to prevent the transmission of some cancers, the HPV vaccine. Then they need that reminder about safe sexual practices not only to protect against unwanted pregnancy, but still, in this day and age, to protect against syphilis, which is on the rise, plus HIV, gonorrhea, chlamydia, and other sexually transmissible diseases. 

I’m not going to rely on the penis picture to make the world safe for sex. I think we have to still use the old-fashioned techniques of education and prevention to do the best we can.

Dr. Caplan is director of the Division of Medical Ethics at New York University Langone Medical Center, New York City. He reported conflicts of interest with Johnson & Johnson’s Panel for Compassionate Drug Use and Medscape.

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

This transcript has been edited for clarity. 

There has been a large amount of news lately about dating online and dating apps. Probably the most common way younger people find potential partners is to go online and see who’s there that they might want to meet. 

Online dating is also notorious for being full of scammers. There are all kinds of people out there that you have to be careful of, who are trying to rip you off by saying, “Send me money, I’m in trouble,” or “Now that we have a relationship, will you support my particular entrepreneurial idea?” Certainly, dangers are there. 

Another danger we don’t talk much about is meeting people who have sexually transmitted diseases. That’s been a problem before websites and before dating apps. I think the opportunity of meeting more people — strangers, people you don’t really know — who may not tell you the truth about their health, and particularly their sexual health, is really out there. 

It’s always good medical advice to tell people to practice safe sex, and that often involves a man wearing a condom. It certainly is the case that we want to attend not just to the prevention of unwanted pregnancy but also to the transmission of diseases. I think it’s very important to tell women of reproductive age to get their HPV shot to try to reduce cancers in their reproductive systems, or sometimes in men — anal cancers, or even being a transmitter of disease. 

Even then, certainly one wants to recommend that, in an age where some people are going to meet many partners that they don’t know well or don’t have much background with, it’s wise to try to prevent diseases using the vaccines we’ve got, using the contraceptive methods that will prevent disease transmission, and reminding people to ask about sex life. 

I did come across a website that just startled me. It’s called HeHealth, and basically it says to men, if you are conscientious about your sex life, take a picture of your penis, send it to us, and we have doctors — I presume they’re US doctors but I don’t know — who will diagnose venereal diseases based on that picture. I presume women could also say, “Before we have sex, or now that we’re approaching that possibility, I want you to send a picture to this company on this website.” 

Now, a couple of reminders. I think we all know this, but just because you’re not manifesting symptoms on your reproductive organs doesn’t mean you don’t have a sexual disease. It’s not a reliable measure. Yes, maybe you could have somebody say: “Oh, that looks nasty. I’m not sure you ought to have sex right now, and maybe you should go get some treatment.” This is going to miss many cases and is not a reliable indicator that your partner is safe in terms of not transmitting diseases to you. 

It also isn’t clear what they do with these images. Do they keep them? Who can see them? Could they resell them? What sort of privacy protection have you got if you decide to use this? 

There’s another issue here, which is, if they misdiagnose someone and you do catch a sexual disease, who’s liable? Can you go after them for using doctors who weren’t competent or transmitting images that weren’t really adequate because you didn’t know how to take that picture properly when you sent that off to them? There are many unknowns. 

The bottom line is that we’re in a different world, I think, of romance. We’re in a world where some people are going to meet more partners. Some people are going to meet more strangers. One approach is to have us take pictures of ourselves, send them off to who knows where, and ask for a green light to go ahead and have sexual relations. I don’t think we’re anywhere close to being able to rely on that as a way to avoid the risks of unprotected sexual behavior. 

We do know what to do in dealing with patients who are sexually active. First, we have to ask them. Then we’ve got to recommend available vaccinations to prevent the transmission of some cancers, the HPV vaccine. Then they need that reminder about safe sexual practices not only to protect against unwanted pregnancy, but still, in this day and age, to protect against syphilis, which is on the rise, plus HIV, gonorrhea, chlamydia, and other sexually transmissible diseases. 

I’m not going to rely on the penis picture to make the world safe for sex. I think we have to still use the old-fashioned techniques of education and prevention to do the best we can.

Dr. Caplan is director of the Division of Medical Ethics at New York University Langone Medical Center, New York City. He reported conflicts of interest with Johnson & Johnson’s Panel for Compassionate Drug Use and Medscape.

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

This transcript has been edited for clarity. 

There has been a large amount of news lately about dating online and dating apps. Probably the most common way younger people find potential partners is to go online and see who’s there that they might want to meet. 

Online dating is also notorious for being full of scammers. There are all kinds of people out there that you have to be careful of, who are trying to rip you off by saying, “Send me money, I’m in trouble,” or “Now that we have a relationship, will you support my particular entrepreneurial idea?” Certainly, dangers are there. 

Another danger we don’t talk much about is meeting people who have sexually transmitted diseases. That’s been a problem before websites and before dating apps. I think the opportunity of meeting more people — strangers, people you don’t really know — who may not tell you the truth about their health, and particularly their sexual health, is really out there. 

It’s always good medical advice to tell people to practice safe sex, and that often involves a man wearing a condom. It certainly is the case that we want to attend not just to the prevention of unwanted pregnancy but also to the transmission of diseases. I think it’s very important to tell women of reproductive age to get their HPV shot to try to reduce cancers in their reproductive systems, or sometimes in men — anal cancers, or even being a transmitter of disease. 

Even then, certainly one wants to recommend that, in an age where some people are going to meet many partners that they don’t know well or don’t have much background with, it’s wise to try to prevent diseases using the vaccines we’ve got, using the contraceptive methods that will prevent disease transmission, and reminding people to ask about sex life. 

I did come across a website that just startled me. It’s called HeHealth, and basically it says to men, if you are conscientious about your sex life, take a picture of your penis, send it to us, and we have doctors — I presume they’re US doctors but I don’t know — who will diagnose venereal diseases based on that picture. I presume women could also say, “Before we have sex, or now that we’re approaching that possibility, I want you to send a picture to this company on this website.” 

Now, a couple of reminders. I think we all know this, but just because you’re not manifesting symptoms on your reproductive organs doesn’t mean you don’t have a sexual disease. It’s not a reliable measure. Yes, maybe you could have somebody say: “Oh, that looks nasty. I’m not sure you ought to have sex right now, and maybe you should go get some treatment.” This is going to miss many cases and is not a reliable indicator that your partner is safe in terms of not transmitting diseases to you. 

It also isn’t clear what they do with these images. Do they keep them? Who can see them? Could they resell them? What sort of privacy protection have you got if you decide to use this? 

There’s another issue here, which is, if they misdiagnose someone and you do catch a sexual disease, who’s liable? Can you go after them for using doctors who weren’t competent or transmitting images that weren’t really adequate because you didn’t know how to take that picture properly when you sent that off to them? There are many unknowns. 

The bottom line is that we’re in a different world, I think, of romance. We’re in a world where some people are going to meet more partners. Some people are going to meet more strangers. One approach is to have us take pictures of ourselves, send them off to who knows where, and ask for a green light to go ahead and have sexual relations. I don’t think we’re anywhere close to being able to rely on that as a way to avoid the risks of unprotected sexual behavior. 

We do know what to do in dealing with patients who are sexually active. First, we have to ask them. Then we’ve got to recommend available vaccinations to prevent the transmission of some cancers, the HPV vaccine. Then they need that reminder about safe sexual practices not only to protect against unwanted pregnancy, but still, in this day and age, to protect against syphilis, which is on the rise, plus HIV, gonorrhea, chlamydia, and other sexually transmissible diseases. 

I’m not going to rely on the penis picture to make the world safe for sex. I think we have to still use the old-fashioned techniques of education and prevention to do the best we can.

Dr. Caplan is director of the Division of Medical Ethics at New York University Langone Medical Center, New York City. He reported conflicts of interest with Johnson & Johnson’s Panel for Compassionate Drug Use and Medscape.

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