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Pharmacist-run PrEP clinic proves effective, profitable
SEATTLE – A pharmacist-run HIV pre-exposure prophylaxis (PrEP) clinic had a retention rate of 75% and achieved a financial return within the first year of operation.
The Seattle-area project allowed individuals to leave their first appointment with medication in hand, and it drew in many men who had no primary care provider.
The approach is a departure from typical PrEP assignment, in which a patient must navigate a provider, lab testing, a pharmacist, and the need for prior authorization, explained Elyse Tung-Wisner, PharmD, director of clinical services at Kelley-Ross Pharmacy, Seattle. That process can take a few days to a few weeks.
“For years, pharmacists have done glucose testing. A finger stick for an HIV test is a similar model. We applied the same protocol to PrEP,” said Dr. Tung-Wisner, who presented an analysis of the program in a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
In the program, patients can come in, receive counseling, undergo all tests, and the pharmacist can work through all the prior authorizations and patient-assistance programs. “Oftentimes, a patient can leave with medication in hand within an hour,” said Dr. Tung-Wisner.
“As far as we know, we’re the first in the country to have a pharmacist-run HIV PrEP clinic in a community pharmacy setting,” she added.
She and her colleagues presented data on the effectiveness and financial viability of what they term One-Step PrEP. In the program, pharmacists take a medical and sexual history of each patient, perform a risk assessment and laboratory testing, provide education, and prescribe and dispense PrEP if appropriate. The pharmacist also performs all guideline-recommended follow-up care.
From March 2015 through March 2016, 373 patients inquired about PrEP services. A total of 251 patients were evaluated in person and 245 (98%) went on to begin PrEP. Among those who started PrEP, 88% identified as men who have sex with men (mean age, 34 years; range, 18-64).
The program had a 75% retention rate over the first year, with one HIV seroconversion.
The initial start-up costs were recouped at 9 months, suggesting that the program quickly became financially sustainable.
It also reached a highly vulnerable, underserved population. The average men who have sex with men index score was 20, which indicates that the patients were high risk, Dr. Tung-Wisner noted.
And just 23% of the patients who were evaluated in person had a primary care provider. “That suggests we were accessing a patient population that has not already established care anywhere else,” she explained.
The program was run by Kelley-Ross Pharmacye. Dr. Tung-Wisner is an employee of the pharmacy.
SEATTLE – A pharmacist-run HIV pre-exposure prophylaxis (PrEP) clinic had a retention rate of 75% and achieved a financial return within the first year of operation.
The Seattle-area project allowed individuals to leave their first appointment with medication in hand, and it drew in many men who had no primary care provider.
The approach is a departure from typical PrEP assignment, in which a patient must navigate a provider, lab testing, a pharmacist, and the need for prior authorization, explained Elyse Tung-Wisner, PharmD, director of clinical services at Kelley-Ross Pharmacy, Seattle. That process can take a few days to a few weeks.
“For years, pharmacists have done glucose testing. A finger stick for an HIV test is a similar model. We applied the same protocol to PrEP,” said Dr. Tung-Wisner, who presented an analysis of the program in a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
In the program, patients can come in, receive counseling, undergo all tests, and the pharmacist can work through all the prior authorizations and patient-assistance programs. “Oftentimes, a patient can leave with medication in hand within an hour,” said Dr. Tung-Wisner.
“As far as we know, we’re the first in the country to have a pharmacist-run HIV PrEP clinic in a community pharmacy setting,” she added.
She and her colleagues presented data on the effectiveness and financial viability of what they term One-Step PrEP. In the program, pharmacists take a medical and sexual history of each patient, perform a risk assessment and laboratory testing, provide education, and prescribe and dispense PrEP if appropriate. The pharmacist also performs all guideline-recommended follow-up care.
From March 2015 through March 2016, 373 patients inquired about PrEP services. A total of 251 patients were evaluated in person and 245 (98%) went on to begin PrEP. Among those who started PrEP, 88% identified as men who have sex with men (mean age, 34 years; range, 18-64).
The program had a 75% retention rate over the first year, with one HIV seroconversion.
The initial start-up costs were recouped at 9 months, suggesting that the program quickly became financially sustainable.
It also reached a highly vulnerable, underserved population. The average men who have sex with men index score was 20, which indicates that the patients were high risk, Dr. Tung-Wisner noted.
And just 23% of the patients who were evaluated in person had a primary care provider. “That suggests we were accessing a patient population that has not already established care anywhere else,” she explained.
The program was run by Kelley-Ross Pharmacye. Dr. Tung-Wisner is an employee of the pharmacy.
SEATTLE – A pharmacist-run HIV pre-exposure prophylaxis (PrEP) clinic had a retention rate of 75% and achieved a financial return within the first year of operation.
The Seattle-area project allowed individuals to leave their first appointment with medication in hand, and it drew in many men who had no primary care provider.
The approach is a departure from typical PrEP assignment, in which a patient must navigate a provider, lab testing, a pharmacist, and the need for prior authorization, explained Elyse Tung-Wisner, PharmD, director of clinical services at Kelley-Ross Pharmacy, Seattle. That process can take a few days to a few weeks.
“For years, pharmacists have done glucose testing. A finger stick for an HIV test is a similar model. We applied the same protocol to PrEP,” said Dr. Tung-Wisner, who presented an analysis of the program in a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
In the program, patients can come in, receive counseling, undergo all tests, and the pharmacist can work through all the prior authorizations and patient-assistance programs. “Oftentimes, a patient can leave with medication in hand within an hour,” said Dr. Tung-Wisner.
“As far as we know, we’re the first in the country to have a pharmacist-run HIV PrEP clinic in a community pharmacy setting,” she added.
She and her colleagues presented data on the effectiveness and financial viability of what they term One-Step PrEP. In the program, pharmacists take a medical and sexual history of each patient, perform a risk assessment and laboratory testing, provide education, and prescribe and dispense PrEP if appropriate. The pharmacist also performs all guideline-recommended follow-up care.
From March 2015 through March 2016, 373 patients inquired about PrEP services. A total of 251 patients were evaluated in person and 245 (98%) went on to begin PrEP. Among those who started PrEP, 88% identified as men who have sex with men (mean age, 34 years; range, 18-64).
The program had a 75% retention rate over the first year, with one HIV seroconversion.
The initial start-up costs were recouped at 9 months, suggesting that the program quickly became financially sustainable.
It also reached a highly vulnerable, underserved population. The average men who have sex with men index score was 20, which indicates that the patients were high risk, Dr. Tung-Wisner noted.
And just 23% of the patients who were evaluated in person had a primary care provider. “That suggests we were accessing a patient population that has not already established care anywhere else,” she explained.
The program was run by Kelley-Ross Pharmacye. Dr. Tung-Wisner is an employee of the pharmacy.
Key clinical point: A pharmacist-run HIV pre-exposure prophylaxis (PrEP) clinic had a retention rate of 75% and achieved a financial return within the first year of operation.
Major finding: The retention rate was 75%, and only 23% of patients had a primary care physician.
Data source: A retrospective analysis of a program that served 251 patients.
Disclosures: The program was run by Kelley-Ross Pharmacy in Seattle. Dr. Tung-Wisner is an employee of the pharmacy.
Bundled maternal HIV, well-baby visits boost ART adherence
SEATTLE – When new moms can get their well-baby visits and HIV care together in the same office, they have better antiretroviral adherence, better viral suppression, and breast-feed longer, according to a randomized trial of 472 new moms with HIV in Cape Town, South Africa.
“It’s a simple and highly effective strategy for promoting maternal postpartum engagement” in HIV care, said lead investigator Landon Myer, MD, professor and head of epidemiology and biostatistics at the University of Cape Town.
Antiretroviral treatment management is often a routine part of prenatal care, but care splits after birth, with moms generally sent to an adult HIV clinic and babies in follow-up care at the pediatrician’s office. It’s a logistics problem for many, and women tend to prioritize the care of their infants over their own HIV.
“There’s a big push [globally] to identify interventions that can enhance women’s antiretroviral therapy (ART) adherence post partum,” Dr. Myer said.
The investigators had a hunch that bundling care would help. They randomized 234 women to centers with combined HIV and pediatric care within a week of birth and 238 to the usual split care approach. In the latter group, the mothers were referred to adult HIV services soon after delivery.
At 12 months, 77% of the women in the integrated-care group had viral loads below 50 copies/mL, versus 56% of women in the split care group. Women in the integrated group breastfed for about 9 months, versus 3 months in the control group. The findings were statistically significant.
“We were surprised by how big the differences were,” Dr. Myer said at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
Mother-to-child transmission was low, at about 0.55%, and did not differ by arm. Vaccination rates, vitamin use, and other infant outcomes were also similar in both groups. Just a few women in each arm dropped out before the 12-month, postpartum visit.
The mothers were a median of 28 years old, and all had started ART during pregnancy at a median of 21 weeks gestation, with a median pre-ART T-cell count of 354 cells/microL. Three-quarters had viral suppression below 50 copies/mL at randomization. About a quarter were giving birth for the first time. Mothers in the bundled-care group were referred back to adult HIV services at the end of breastfeeding.
Dr. Myer had no disclosures. The work was funded by the National Institutes of Health.
SEATTLE – When new moms can get their well-baby visits and HIV care together in the same office, they have better antiretroviral adherence, better viral suppression, and breast-feed longer, according to a randomized trial of 472 new moms with HIV in Cape Town, South Africa.
“It’s a simple and highly effective strategy for promoting maternal postpartum engagement” in HIV care, said lead investigator Landon Myer, MD, professor and head of epidemiology and biostatistics at the University of Cape Town.
Antiretroviral treatment management is often a routine part of prenatal care, but care splits after birth, with moms generally sent to an adult HIV clinic and babies in follow-up care at the pediatrician’s office. It’s a logistics problem for many, and women tend to prioritize the care of their infants over their own HIV.
“There’s a big push [globally] to identify interventions that can enhance women’s antiretroviral therapy (ART) adherence post partum,” Dr. Myer said.
The investigators had a hunch that bundling care would help. They randomized 234 women to centers with combined HIV and pediatric care within a week of birth and 238 to the usual split care approach. In the latter group, the mothers were referred to adult HIV services soon after delivery.
At 12 months, 77% of the women in the integrated-care group had viral loads below 50 copies/mL, versus 56% of women in the split care group. Women in the integrated group breastfed for about 9 months, versus 3 months in the control group. The findings were statistically significant.
“We were surprised by how big the differences were,” Dr. Myer said at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
Mother-to-child transmission was low, at about 0.55%, and did not differ by arm. Vaccination rates, vitamin use, and other infant outcomes were also similar in both groups. Just a few women in each arm dropped out before the 12-month, postpartum visit.
The mothers were a median of 28 years old, and all had started ART during pregnancy at a median of 21 weeks gestation, with a median pre-ART T-cell count of 354 cells/microL. Three-quarters had viral suppression below 50 copies/mL at randomization. About a quarter were giving birth for the first time. Mothers in the bundled-care group were referred back to adult HIV services at the end of breastfeeding.
Dr. Myer had no disclosures. The work was funded by the National Institutes of Health.
SEATTLE – When new moms can get their well-baby visits and HIV care together in the same office, they have better antiretroviral adherence, better viral suppression, and breast-feed longer, according to a randomized trial of 472 new moms with HIV in Cape Town, South Africa.
“It’s a simple and highly effective strategy for promoting maternal postpartum engagement” in HIV care, said lead investigator Landon Myer, MD, professor and head of epidemiology and biostatistics at the University of Cape Town.
Antiretroviral treatment management is often a routine part of prenatal care, but care splits after birth, with moms generally sent to an adult HIV clinic and babies in follow-up care at the pediatrician’s office. It’s a logistics problem for many, and women tend to prioritize the care of their infants over their own HIV.
“There’s a big push [globally] to identify interventions that can enhance women’s antiretroviral therapy (ART) adherence post partum,” Dr. Myer said.
The investigators had a hunch that bundling care would help. They randomized 234 women to centers with combined HIV and pediatric care within a week of birth and 238 to the usual split care approach. In the latter group, the mothers were referred to adult HIV services soon after delivery.
At 12 months, 77% of the women in the integrated-care group had viral loads below 50 copies/mL, versus 56% of women in the split care group. Women in the integrated group breastfed for about 9 months, versus 3 months in the control group. The findings were statistically significant.
“We were surprised by how big the differences were,” Dr. Myer said at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
Mother-to-child transmission was low, at about 0.55%, and did not differ by arm. Vaccination rates, vitamin use, and other infant outcomes were also similar in both groups. Just a few women in each arm dropped out before the 12-month, postpartum visit.
The mothers were a median of 28 years old, and all had started ART during pregnancy at a median of 21 weeks gestation, with a median pre-ART T-cell count of 354 cells/microL. Three-quarters had viral suppression below 50 copies/mL at randomization. About a quarter were giving birth for the first time. Mothers in the bundled-care group were referred back to adult HIV services at the end of breastfeeding.
Dr. Myer had no disclosures. The work was funded by the National Institutes of Health.
AT CROI
Key clinical point:
Major finding: At 12 months, 77% of the women in the integrated-care group had viral loads below 50 copies/mL, versus 56% of women in the control arm. Women in the integrated group breastfed for about 9 months, versus 3 months in the split-care group.
Data source: A randomized trial of 472 new moms with HIV and their babies in Cape Town, South Africa.
Disclosures: Dr. Myer had no disclosures. The work was funded by the National Institutes of Health.
Choice of protease inhibitor may impact CVD risk in HIV+ patients
SEATTLE – A study of newer generation protease inhibitors (PIs) suggests that ritonavir-boosted atazanavir (ATV/r) has a better cardiovascular safety profile than ritonavir-boosted darunavir (DRV/r). After adjustment for age and other factors, patients taking DRV/r had a higher incidence rate ratio of cardiovascular disease during a 5-year follow-up compared to pre-exposure, while no such increase was seen in patients taking ATV/r.
Older protease inhibitors had been shown to be associated with increased CVD risk, but the newer generation of drugs had not been similarly examined. A previous analysis of the D:A:D (Data collection on Adverse events of Anti-HIV Drugs) study had shown no effect of ATV/r with cardiovascular risk, but the follow-up time was short.
The data suggest that ATV/r may be the best choice for patients at heightened risk of cardiovascular disease. “This is just the results from the first five years, and we need to reassess at some point, but according to what we know now, it does really look like a quite real effect,” Dr Ryom added.
The researchers examined longer-term results from 35,711 (47.8% white, 73.6% men, median age 44) participants in the D:A:D study, who were followed beginning January 1, 2009 through the earliest CVD diagnosis, last visit plus 6 months, or February 1, 2016.
After adjustment for baseline variables potentially on the causal pathway between PI use and cardiovascular disease, the researchers found that, compared to baseline pre-exposure levels, patients taking ATV/r had a 5-year incidence rate ratio (IRR) of CVD of 1.03 (95% confidence interval 0.90-1.18), while those taking DRV/r had an IRR 1.59 (95% CI, 1.33-1.91).
Time-updated adjustment analyses for factors potentially on the causal pathway made no meaningful difference in the calculation of incidence risk ratios. “This suggests that the association we say for boosted darunavir is not moderated by dyslipidemia, which is interesting and in contrast to what we saw in first-generation protease inhibitors,” Dr Ryom said during her talk.
Adjusting for bilirubin levels had no impact on the associations.
There was no data on drug dose, and due to the observational nature of the study, the researchers could not prove a causal association between CVD risk and use of either drug, but the results were convincing enough for Dr Ryom to consider a drug that appears friendlier to the cardiovascular system, particularly in high risk patients, though she also noted that there is evidence that ATV/r could lead to kidney stones and chronic kidney disease. “So it’s very difficult to balance the different risks. You really need to tailor your choice according to the patient that is in front of you,” Dr Ryom said.
The study was funded by The Oversight Committee for the Evaluation of Metabolic Complications of HAART, which included both academic and industry sources, and the Danish National Research Foundation. Dr Ryom reported having no financial disclosures.
SEATTLE – A study of newer generation protease inhibitors (PIs) suggests that ritonavir-boosted atazanavir (ATV/r) has a better cardiovascular safety profile than ritonavir-boosted darunavir (DRV/r). After adjustment for age and other factors, patients taking DRV/r had a higher incidence rate ratio of cardiovascular disease during a 5-year follow-up compared to pre-exposure, while no such increase was seen in patients taking ATV/r.
Older protease inhibitors had been shown to be associated with increased CVD risk, but the newer generation of drugs had not been similarly examined. A previous analysis of the D:A:D (Data collection on Adverse events of Anti-HIV Drugs) study had shown no effect of ATV/r with cardiovascular risk, but the follow-up time was short.
The data suggest that ATV/r may be the best choice for patients at heightened risk of cardiovascular disease. “This is just the results from the first five years, and we need to reassess at some point, but according to what we know now, it does really look like a quite real effect,” Dr Ryom added.
The researchers examined longer-term results from 35,711 (47.8% white, 73.6% men, median age 44) participants in the D:A:D study, who were followed beginning January 1, 2009 through the earliest CVD diagnosis, last visit plus 6 months, or February 1, 2016.
After adjustment for baseline variables potentially on the causal pathway between PI use and cardiovascular disease, the researchers found that, compared to baseline pre-exposure levels, patients taking ATV/r had a 5-year incidence rate ratio (IRR) of CVD of 1.03 (95% confidence interval 0.90-1.18), while those taking DRV/r had an IRR 1.59 (95% CI, 1.33-1.91).
Time-updated adjustment analyses for factors potentially on the causal pathway made no meaningful difference in the calculation of incidence risk ratios. “This suggests that the association we say for boosted darunavir is not moderated by dyslipidemia, which is interesting and in contrast to what we saw in first-generation protease inhibitors,” Dr Ryom said during her talk.
Adjusting for bilirubin levels had no impact on the associations.
There was no data on drug dose, and due to the observational nature of the study, the researchers could not prove a causal association between CVD risk and use of either drug, but the results were convincing enough for Dr Ryom to consider a drug that appears friendlier to the cardiovascular system, particularly in high risk patients, though she also noted that there is evidence that ATV/r could lead to kidney stones and chronic kidney disease. “So it’s very difficult to balance the different risks. You really need to tailor your choice according to the patient that is in front of you,” Dr Ryom said.
The study was funded by The Oversight Committee for the Evaluation of Metabolic Complications of HAART, which included both academic and industry sources, and the Danish National Research Foundation. Dr Ryom reported having no financial disclosures.
SEATTLE – A study of newer generation protease inhibitors (PIs) suggests that ritonavir-boosted atazanavir (ATV/r) has a better cardiovascular safety profile than ritonavir-boosted darunavir (DRV/r). After adjustment for age and other factors, patients taking DRV/r had a higher incidence rate ratio of cardiovascular disease during a 5-year follow-up compared to pre-exposure, while no such increase was seen in patients taking ATV/r.
Older protease inhibitors had been shown to be associated with increased CVD risk, but the newer generation of drugs had not been similarly examined. A previous analysis of the D:A:D (Data collection on Adverse events of Anti-HIV Drugs) study had shown no effect of ATV/r with cardiovascular risk, but the follow-up time was short.
The data suggest that ATV/r may be the best choice for patients at heightened risk of cardiovascular disease. “This is just the results from the first five years, and we need to reassess at some point, but according to what we know now, it does really look like a quite real effect,” Dr Ryom added.
The researchers examined longer-term results from 35,711 (47.8% white, 73.6% men, median age 44) participants in the D:A:D study, who were followed beginning January 1, 2009 through the earliest CVD diagnosis, last visit plus 6 months, or February 1, 2016.
After adjustment for baseline variables potentially on the causal pathway between PI use and cardiovascular disease, the researchers found that, compared to baseline pre-exposure levels, patients taking ATV/r had a 5-year incidence rate ratio (IRR) of CVD of 1.03 (95% confidence interval 0.90-1.18), while those taking DRV/r had an IRR 1.59 (95% CI, 1.33-1.91).
Time-updated adjustment analyses for factors potentially on the causal pathway made no meaningful difference in the calculation of incidence risk ratios. “This suggests that the association we say for boosted darunavir is not moderated by dyslipidemia, which is interesting and in contrast to what we saw in first-generation protease inhibitors,” Dr Ryom said during her talk.
Adjusting for bilirubin levels had no impact on the associations.
There was no data on drug dose, and due to the observational nature of the study, the researchers could not prove a causal association between CVD risk and use of either drug, but the results were convincing enough for Dr Ryom to consider a drug that appears friendlier to the cardiovascular system, particularly in high risk patients, though she also noted that there is evidence that ATV/r could lead to kidney stones and chronic kidney disease. “So it’s very difficult to balance the different risks. You really need to tailor your choice according to the patient that is in front of you,” Dr Ryom said.
The study was funded by The Oversight Committee for the Evaluation of Metabolic Complications of HAART, which included both academic and industry sources, and the Danish National Research Foundation. Dr Ryom reported having no financial disclosures.
AT CROI 2017
Key clinical point: Atazanavir may be safer for HIV-positive patients at high CVD risk.
Major finding: Patients taking darunavir had a 59% higher incidence of cardiovascular disease than those taking atazanavir.
Data source: Retrospective analysis of 35,711 patients.
Disclosures: The study was funded by The Oversight Committee for the Evaluation of Metabolic Complications of HAART, which included both academic and industry sources, and the Danish National Research Foundation. Dr Ryom reported having no financial disclosures.
Statins may protect against HIV rebound
SEATTLE – Statins appeared to reduce the risk of viral rebound in HIV patients on antiretroviral therapy, suggesting modest antiviral activity, according to a review of 19,324 HIV-positive veterans who started combination ART from 1995-2011.
It’s been shown before that statins are active against HIV in vitro; the new study is likely the first to show an effect in actual patients, and it was only found in those who used statins consistently, perhaps because of the drugs’ short half-life. “In addition to their cardiovascular benefits, statins could increase the durability of successful antiretroviral therapy. Whether this effect is direct or mediated by [statins’] anti-inflammatory properties merits further evaluation,” concluded investigators led by Henning Drechsler, MD, an infectious disease specialist at the Dallas Veterans Affairs Medical Center.
After adjusting for a range of confounders, including demographics, substance use, and ART adherence assessed by pharmacy fill records, the team found that statins use within 7 days of testing was associated with almost a 20% drop in the risk of decreased risk of VF (adjusted HR 0.81, 95% 0.75-0.88), with a similar benefit for use within 3 months. There was no protective effect for blood pressure drugs, and a slight increase for patients on cardioprotective aspirin.
About a third of the patients – almost all men, around 48 years old – had at least tried statins, generally after their viral loads were suppressed and most often pravastatin or simvastatin. Statins’ protection against VF was present over the whole study period and among all types of ART and levels, but became less pronounced after 2005 in patients with optimal ART adherence, and in those taking newer options. The median observation time was 5.9 years.
“I am very confident that this is not a data fluke,” Dr. Drechsler said at the 2017 Conference on Retroviruses and Opportunistic Infections. He noted that there may even be role for statin use in HIV patients without dyslipidemia, but with the current study, “it’s hard to say. You really do need a prospect study.”
He plans to keep looking into the issue. Meanwhile, a large trial of statin use in HIV is underway.
Dr. Drechsler said he had no disclosures.
SEATTLE – Statins appeared to reduce the risk of viral rebound in HIV patients on antiretroviral therapy, suggesting modest antiviral activity, according to a review of 19,324 HIV-positive veterans who started combination ART from 1995-2011.
It’s been shown before that statins are active against HIV in vitro; the new study is likely the first to show an effect in actual patients, and it was only found in those who used statins consistently, perhaps because of the drugs’ short half-life. “In addition to their cardiovascular benefits, statins could increase the durability of successful antiretroviral therapy. Whether this effect is direct or mediated by [statins’] anti-inflammatory properties merits further evaluation,” concluded investigators led by Henning Drechsler, MD, an infectious disease specialist at the Dallas Veterans Affairs Medical Center.
After adjusting for a range of confounders, including demographics, substance use, and ART adherence assessed by pharmacy fill records, the team found that statins use within 7 days of testing was associated with almost a 20% drop in the risk of decreased risk of VF (adjusted HR 0.81, 95% 0.75-0.88), with a similar benefit for use within 3 months. There was no protective effect for blood pressure drugs, and a slight increase for patients on cardioprotective aspirin.
About a third of the patients – almost all men, around 48 years old – had at least tried statins, generally after their viral loads were suppressed and most often pravastatin or simvastatin. Statins’ protection against VF was present over the whole study period and among all types of ART and levels, but became less pronounced after 2005 in patients with optimal ART adherence, and in those taking newer options. The median observation time was 5.9 years.
“I am very confident that this is not a data fluke,” Dr. Drechsler said at the 2017 Conference on Retroviruses and Opportunistic Infections. He noted that there may even be role for statin use in HIV patients without dyslipidemia, but with the current study, “it’s hard to say. You really do need a prospect study.”
He plans to keep looking into the issue. Meanwhile, a large trial of statin use in HIV is underway.
Dr. Drechsler said he had no disclosures.
SEATTLE – Statins appeared to reduce the risk of viral rebound in HIV patients on antiretroviral therapy, suggesting modest antiviral activity, according to a review of 19,324 HIV-positive veterans who started combination ART from 1995-2011.
It’s been shown before that statins are active against HIV in vitro; the new study is likely the first to show an effect in actual patients, and it was only found in those who used statins consistently, perhaps because of the drugs’ short half-life. “In addition to their cardiovascular benefits, statins could increase the durability of successful antiretroviral therapy. Whether this effect is direct or mediated by [statins’] anti-inflammatory properties merits further evaluation,” concluded investigators led by Henning Drechsler, MD, an infectious disease specialist at the Dallas Veterans Affairs Medical Center.
After adjusting for a range of confounders, including demographics, substance use, and ART adherence assessed by pharmacy fill records, the team found that statins use within 7 days of testing was associated with almost a 20% drop in the risk of decreased risk of VF (adjusted HR 0.81, 95% 0.75-0.88), with a similar benefit for use within 3 months. There was no protective effect for blood pressure drugs, and a slight increase for patients on cardioprotective aspirin.
About a third of the patients – almost all men, around 48 years old – had at least tried statins, generally after their viral loads were suppressed and most often pravastatin or simvastatin. Statins’ protection against VF was present over the whole study period and among all types of ART and levels, but became less pronounced after 2005 in patients with optimal ART adherence, and in those taking newer options. The median observation time was 5.9 years.
“I am very confident that this is not a data fluke,” Dr. Drechsler said at the 2017 Conference on Retroviruses and Opportunistic Infections. He noted that there may even be role for statin use in HIV patients without dyslipidemia, but with the current study, “it’s hard to say. You really do need a prospect study.”
He plans to keep looking into the issue. Meanwhile, a large trial of statin use in HIV is underway.
Dr. Drechsler said he had no disclosures.
AT CROI 2017
Post-exposure doxycycline halves STIs among MSM
SEATTLE – When men who have sex with men were given doxycycline and told to take it after unprotected sex, the incidence of sexually transmitted infections dropped 47% over about 9 months in France.
“We were quite surprised to see” such a strong effect, especially since it was achieved with “a very low use of doxycycline, less than two pills per week” among the 232 men in the study, said lead investigator Jean-Michel Molina, MD, of St. Louis Hospital, Paris.
Sexually transmitted infections (STIs) are especially high among men who have sex with men (MSM), and several of the physicians in Dr. Molina’s audience were glad to hear of an intervention that puts a dent in a difficult problem. Even so, he stressed repeatedly that prophylactic antibiotics for STIs aren’t ready for general practice; the concern is inducing resistance by a too-liberal use. He and his team are analyzing samples they collected for emerging resistance.
“We need to be careful,” Dr. Molina said “these are results from a limited number of people” with short follow-up. “We need more research,” he added.
However, with such low antibiotic pressure, less than two pills a week, resistance might be unlikely. Syphilis and chlamydia might also be less likely to build resistance than gonorrhea, he noted.
All the subjects were in a post-exposure HIV prophylaxis trial. Given the risk of STIs in that setting, it “was a great opportunity to” study the intervention, Dr. Molina said.
His team randomized 116 men to take two 100 mg pills of doxycycline within 72 hours of condomless sexual intercourse, without exceeding six pills per week. They were given enough pills to cover their exposures from unprotected sex, so they didn’t have to make frequent visits to the study clinic. The other 116 men were randomized to observation.
Men in both groups came in every 8 weeks for HIV and syphilis serology tests, and PCR tests of urine and anal and oral swabs for chlamydia and gonorrhea. The median follow-up was 8.7 months.
Twenty-eight patients in the doxycycline group caught a new STI (24%, 37.7 events per 100 patient years) versus 45 in the observation arm (38.8%, 69.7 events per 100 patient years). Doxycycline prophylaxis almost halved the risk (HR 0.53, 95% CI 0.33-0.85, P = .008). More than two-thirds of the infections in both groups were asymptomatic.
The doxycycline group took a median of seven pills/month; eight patients (7%) stopped using the drug due to gastrointestinal side effects.
There was no significant change in sexual behavior in the study arms. Both groups reported a median of about 5-10 sexual partners at each 2 month follow-up visit, and most reported anal sex without a condom. The men were an average of about 40 years old.
Dr. Molina is a consultant for Merck and Viiv, and a speaker and researcher for Gilead, which was one of several funders of the work.
[email protected]
On Twitter @IDPractitioner
SEATTLE – When men who have sex with men were given doxycycline and told to take it after unprotected sex, the incidence of sexually transmitted infections dropped 47% over about 9 months in France.
“We were quite surprised to see” such a strong effect, especially since it was achieved with “a very low use of doxycycline, less than two pills per week” among the 232 men in the study, said lead investigator Jean-Michel Molina, MD, of St. Louis Hospital, Paris.
Sexually transmitted infections (STIs) are especially high among men who have sex with men (MSM), and several of the physicians in Dr. Molina’s audience were glad to hear of an intervention that puts a dent in a difficult problem. Even so, he stressed repeatedly that prophylactic antibiotics for STIs aren’t ready for general practice; the concern is inducing resistance by a too-liberal use. He and his team are analyzing samples they collected for emerging resistance.
“We need to be careful,” Dr. Molina said “these are results from a limited number of people” with short follow-up. “We need more research,” he added.
However, with such low antibiotic pressure, less than two pills a week, resistance might be unlikely. Syphilis and chlamydia might also be less likely to build resistance than gonorrhea, he noted.
All the subjects were in a post-exposure HIV prophylaxis trial. Given the risk of STIs in that setting, it “was a great opportunity to” study the intervention, Dr. Molina said.
His team randomized 116 men to take two 100 mg pills of doxycycline within 72 hours of condomless sexual intercourse, without exceeding six pills per week. They were given enough pills to cover their exposures from unprotected sex, so they didn’t have to make frequent visits to the study clinic. The other 116 men were randomized to observation.
Men in both groups came in every 8 weeks for HIV and syphilis serology tests, and PCR tests of urine and anal and oral swabs for chlamydia and gonorrhea. The median follow-up was 8.7 months.
Twenty-eight patients in the doxycycline group caught a new STI (24%, 37.7 events per 100 patient years) versus 45 in the observation arm (38.8%, 69.7 events per 100 patient years). Doxycycline prophylaxis almost halved the risk (HR 0.53, 95% CI 0.33-0.85, P = .008). More than two-thirds of the infections in both groups were asymptomatic.
The doxycycline group took a median of seven pills/month; eight patients (7%) stopped using the drug due to gastrointestinal side effects.
There was no significant change in sexual behavior in the study arms. Both groups reported a median of about 5-10 sexual partners at each 2 month follow-up visit, and most reported anal sex without a condom. The men were an average of about 40 years old.
Dr. Molina is a consultant for Merck and Viiv, and a speaker and researcher for Gilead, which was one of several funders of the work.
[email protected]
On Twitter @IDPractitioner
SEATTLE – When men who have sex with men were given doxycycline and told to take it after unprotected sex, the incidence of sexually transmitted infections dropped 47% over about 9 months in France.
“We were quite surprised to see” such a strong effect, especially since it was achieved with “a very low use of doxycycline, less than two pills per week” among the 232 men in the study, said lead investigator Jean-Michel Molina, MD, of St. Louis Hospital, Paris.
Sexually transmitted infections (STIs) are especially high among men who have sex with men (MSM), and several of the physicians in Dr. Molina’s audience were glad to hear of an intervention that puts a dent in a difficult problem. Even so, he stressed repeatedly that prophylactic antibiotics for STIs aren’t ready for general practice; the concern is inducing resistance by a too-liberal use. He and his team are analyzing samples they collected for emerging resistance.
“We need to be careful,” Dr. Molina said “these are results from a limited number of people” with short follow-up. “We need more research,” he added.
However, with such low antibiotic pressure, less than two pills a week, resistance might be unlikely. Syphilis and chlamydia might also be less likely to build resistance than gonorrhea, he noted.
All the subjects were in a post-exposure HIV prophylaxis trial. Given the risk of STIs in that setting, it “was a great opportunity to” study the intervention, Dr. Molina said.
His team randomized 116 men to take two 100 mg pills of doxycycline within 72 hours of condomless sexual intercourse, without exceeding six pills per week. They were given enough pills to cover their exposures from unprotected sex, so they didn’t have to make frequent visits to the study clinic. The other 116 men were randomized to observation.
Men in both groups came in every 8 weeks for HIV and syphilis serology tests, and PCR tests of urine and anal and oral swabs for chlamydia and gonorrhea. The median follow-up was 8.7 months.
Twenty-eight patients in the doxycycline group caught a new STI (24%, 37.7 events per 100 patient years) versus 45 in the observation arm (38.8%, 69.7 events per 100 patient years). Doxycycline prophylaxis almost halved the risk (HR 0.53, 95% CI 0.33-0.85, P = .008). More than two-thirds of the infections in both groups were asymptomatic.
The doxycycline group took a median of seven pills/month; eight patients (7%) stopped using the drug due to gastrointestinal side effects.
There was no significant change in sexual behavior in the study arms. Both groups reported a median of about 5-10 sexual partners at each 2 month follow-up visit, and most reported anal sex without a condom. The men were an average of about 40 years old.
Dr. Molina is a consultant for Merck and Viiv, and a speaker and researcher for Gilead, which was one of several funders of the work.
[email protected]
On Twitter @IDPractitioner
AT CROI 2017
Key clinical point:
Major finding: Twenty-eight patients in the doxycycline group caught a new STI (24%, 37.7 events per 100 patient years) versus 45 in the observation arm (38.8%, 69.7 events per 100 patient years).
Data source: Randomized, open-label trial of 232 MSM.
Disclosures: The lead investigator is a consultant for Merck and Viiv, and a speaker and researcher for Gilead, which was one of several funders of the work.
Oral PrEP works despite bacterial vaginosis
SEATTLE – Bacterial vaginosis does not decrease the effectiveness of oral pre-exposure prophylaxis (PrEP) for HIV prevention, according to an investigation of 1,470 women in Africa.
Daily oral PrEP with tenofovir pills was 77% effective in protecting women with bacterial vaginosis from HIV, and 73% effective in women who did not have BV over the 3-year study. The difference was not statistically significant.
Bacterial vaginosis in PrEP has been a concern ever since it was reported in the summer of 2016 that vaginal tenofovir gel didn’t prevent HIV in women with the condition. “Our results provide reassurance ... We [saw] no evidence that oral PrEP effectiveness was reduced in East African women with Gram stain evidence of BV or vaginal dysbiosis. Oral PrEP delivery to women does not need to be accompanied by testing for BV,” Dr. Heffron said.
It’s likely that Gardnerella vaginalis degrades topical tenofovir when applied vaginally; oral administration bypasses the effect.
The findings come from a subanalysis of the Partners PrEP Study, a phase III trial of daily oral PrEP in Kenya and Uganda. The investigators broke out PrEP results according to BV status, with BV defined as a Nugent score of 7-10, assessed annually. Adherence was high in the 985 women randomized to PrEP, at about 80%.
There were 0.9 cases of newly acquired HIV per 100 person-years among women in the BV PrEP group, versus 3.5 per 100 person-years among BV women not on prep. PrEP was about 63% effective in women with intermediate Nugent scores of 4-6. The differences in HIV protection according to Nugent score were not statistically significant (P = .9).
It didn’t matter if women had Gardnerella, Bacteroides, or Lactobacillus morphotypes. All three are markers of abnormal vaginal microbiota, but PrEP still worked.
The median age in the study was 33 years, and 24% of the women had BV at baseline.
Dr. Heffron did not report any disclosures. The Gates Foundation and other sources funded the work.
SEATTLE – Bacterial vaginosis does not decrease the effectiveness of oral pre-exposure prophylaxis (PrEP) for HIV prevention, according to an investigation of 1,470 women in Africa.
Daily oral PrEP with tenofovir pills was 77% effective in protecting women with bacterial vaginosis from HIV, and 73% effective in women who did not have BV over the 3-year study. The difference was not statistically significant.
Bacterial vaginosis in PrEP has been a concern ever since it was reported in the summer of 2016 that vaginal tenofovir gel didn’t prevent HIV in women with the condition. “Our results provide reassurance ... We [saw] no evidence that oral PrEP effectiveness was reduced in East African women with Gram stain evidence of BV or vaginal dysbiosis. Oral PrEP delivery to women does not need to be accompanied by testing for BV,” Dr. Heffron said.
It’s likely that Gardnerella vaginalis degrades topical tenofovir when applied vaginally; oral administration bypasses the effect.
The findings come from a subanalysis of the Partners PrEP Study, a phase III trial of daily oral PrEP in Kenya and Uganda. The investigators broke out PrEP results according to BV status, with BV defined as a Nugent score of 7-10, assessed annually. Adherence was high in the 985 women randomized to PrEP, at about 80%.
There were 0.9 cases of newly acquired HIV per 100 person-years among women in the BV PrEP group, versus 3.5 per 100 person-years among BV women not on prep. PrEP was about 63% effective in women with intermediate Nugent scores of 4-6. The differences in HIV protection according to Nugent score were not statistically significant (P = .9).
It didn’t matter if women had Gardnerella, Bacteroides, or Lactobacillus morphotypes. All three are markers of abnormal vaginal microbiota, but PrEP still worked.
The median age in the study was 33 years, and 24% of the women had BV at baseline.
Dr. Heffron did not report any disclosures. The Gates Foundation and other sources funded the work.
SEATTLE – Bacterial vaginosis does not decrease the effectiveness of oral pre-exposure prophylaxis (PrEP) for HIV prevention, according to an investigation of 1,470 women in Africa.
Daily oral PrEP with tenofovir pills was 77% effective in protecting women with bacterial vaginosis from HIV, and 73% effective in women who did not have BV over the 3-year study. The difference was not statistically significant.
Bacterial vaginosis in PrEP has been a concern ever since it was reported in the summer of 2016 that vaginal tenofovir gel didn’t prevent HIV in women with the condition. “Our results provide reassurance ... We [saw] no evidence that oral PrEP effectiveness was reduced in East African women with Gram stain evidence of BV or vaginal dysbiosis. Oral PrEP delivery to women does not need to be accompanied by testing for BV,” Dr. Heffron said.
It’s likely that Gardnerella vaginalis degrades topical tenofovir when applied vaginally; oral administration bypasses the effect.
The findings come from a subanalysis of the Partners PrEP Study, a phase III trial of daily oral PrEP in Kenya and Uganda. The investigators broke out PrEP results according to BV status, with BV defined as a Nugent score of 7-10, assessed annually. Adherence was high in the 985 women randomized to PrEP, at about 80%.
There were 0.9 cases of newly acquired HIV per 100 person-years among women in the BV PrEP group, versus 3.5 per 100 person-years among BV women not on prep. PrEP was about 63% effective in women with intermediate Nugent scores of 4-6. The differences in HIV protection according to Nugent score were not statistically significant (P = .9).
It didn’t matter if women had Gardnerella, Bacteroides, or Lactobacillus morphotypes. All three are markers of abnormal vaginal microbiota, but PrEP still worked.
The median age in the study was 33 years, and 24% of the women had BV at baseline.
Dr. Heffron did not report any disclosures. The Gates Foundation and other sources funded the work.
AT CROI
Key clinical point:
Major finding: Daily oral PrEP with tenofovir pills was 77% effective in protecting women with bacterial vaginosis from HIV, and 73% effective in women who did not have BV over the 3-year study.
Data source: Randomized trial of 1,470 women in Kenya and Uganda
Disclosures: The lead investigator did not report any disclosures. The Gates Foundation and other sources funded the work.
Tap patients with suspected HIV neurosyphilis regardless of symptoms
SEATTLE – Neurologic symptoms are an unreliable indicator of neurosyphilis in patients with HIV, according to University of Washington, Seattle, investigators.
After tapping 385 HIV patients with untreated syphilis and possible central nervous system involvement, “the bottom line was that [symptom] sensitivity was so low that not having [symptoms] really shouldn’t reassure you. If you are concerned that your patient could have neurosyphilis because of other factors” – such as an especially high rapid plasma reagin titer or low CD4 count – “you still need to tap them,” said lead investigator Arielle P. Davis, MD, who is in the department of neurology at the university.
In the prospective study, symptoms were simply not sensitive enough to rule anything out. Moderate or greater photophobia had a sensitivity of 6.3% for a reactive cerebrospinal fluid Venereal Disease Research Laboratory (CSF-VDRL) syphilis test; moderate or greater vision loss was 38.1% sensitive for reactive CSF-VDRL, moderate or greater hearing loss was 13.2% sensitive, and moderate or greater gait incoordination was 1.5% sensitive.
Specificity was markedly better for each of those symptoms, and more than 95% for moderate or greater photophobia, hearing loss, and gait incoordination. “In general, as the severity of photophobia, vision loss, hearing loss, and gait incoordination increased, the specificity increased, but at the expense of sensitivity,” the investigators wrote in their poster, which Dr. Davis presented at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
CSF-VDRL was reactive in 68 subjects (18%). The odds of a reactive CSF-VDRL were significantly higher in patients with vision loss (odds ratio, 2.2; 95% confidence interval, 1.2-4.0; P = .01) and trended toward significance in those with moderate or greater hearing loss (OR, 2.5; 95% CI, 1.0-6.6; P = .06).
Overall, “patients with mild or greater photophobia, vision loss, gait incoordination, and moderate or greater hearing loss were significantly more likely to have a reactive CSF-VDRL, and the presence of any of these four symptoms should [remain] a criterion for pursuing a lumbar puncture.” However, “lack of neurologic symptoms in HIV-infected patients with syphilis should not reassure clinicians that their patients do not have neurosyphilis,” Dr. Davis and her team concluded.
The participants were almost entirely men and mostly white. The average age was about 40 years, and the median rapid plasma reagin titer was 1:64. About 48% of the subjects reported at least mild vision loss, 40% reported mild or worse headache, and 17% reported some degree of hearing loss. Overall, 15.5%-17.2% reported at least mild photophobia, stiff neck, or gait incoordination.
The work was funded by the National Institutes of Health. Dr. Davis did not have any relevant disclosures.
SEATTLE – Neurologic symptoms are an unreliable indicator of neurosyphilis in patients with HIV, according to University of Washington, Seattle, investigators.
After tapping 385 HIV patients with untreated syphilis and possible central nervous system involvement, “the bottom line was that [symptom] sensitivity was so low that not having [symptoms] really shouldn’t reassure you. If you are concerned that your patient could have neurosyphilis because of other factors” – such as an especially high rapid plasma reagin titer or low CD4 count – “you still need to tap them,” said lead investigator Arielle P. Davis, MD, who is in the department of neurology at the university.
In the prospective study, symptoms were simply not sensitive enough to rule anything out. Moderate or greater photophobia had a sensitivity of 6.3% for a reactive cerebrospinal fluid Venereal Disease Research Laboratory (CSF-VDRL) syphilis test; moderate or greater vision loss was 38.1% sensitive for reactive CSF-VDRL, moderate or greater hearing loss was 13.2% sensitive, and moderate or greater gait incoordination was 1.5% sensitive.
Specificity was markedly better for each of those symptoms, and more than 95% for moderate or greater photophobia, hearing loss, and gait incoordination. “In general, as the severity of photophobia, vision loss, hearing loss, and gait incoordination increased, the specificity increased, but at the expense of sensitivity,” the investigators wrote in their poster, which Dr. Davis presented at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
CSF-VDRL was reactive in 68 subjects (18%). The odds of a reactive CSF-VDRL were significantly higher in patients with vision loss (odds ratio, 2.2; 95% confidence interval, 1.2-4.0; P = .01) and trended toward significance in those with moderate or greater hearing loss (OR, 2.5; 95% CI, 1.0-6.6; P = .06).
Overall, “patients with mild or greater photophobia, vision loss, gait incoordination, and moderate or greater hearing loss were significantly more likely to have a reactive CSF-VDRL, and the presence of any of these four symptoms should [remain] a criterion for pursuing a lumbar puncture.” However, “lack of neurologic symptoms in HIV-infected patients with syphilis should not reassure clinicians that their patients do not have neurosyphilis,” Dr. Davis and her team concluded.
The participants were almost entirely men and mostly white. The average age was about 40 years, and the median rapid plasma reagin titer was 1:64. About 48% of the subjects reported at least mild vision loss, 40% reported mild or worse headache, and 17% reported some degree of hearing loss. Overall, 15.5%-17.2% reported at least mild photophobia, stiff neck, or gait incoordination.
The work was funded by the National Institutes of Health. Dr. Davis did not have any relevant disclosures.
SEATTLE – Neurologic symptoms are an unreliable indicator of neurosyphilis in patients with HIV, according to University of Washington, Seattle, investigators.
After tapping 385 HIV patients with untreated syphilis and possible central nervous system involvement, “the bottom line was that [symptom] sensitivity was so low that not having [symptoms] really shouldn’t reassure you. If you are concerned that your patient could have neurosyphilis because of other factors” – such as an especially high rapid plasma reagin titer or low CD4 count – “you still need to tap them,” said lead investigator Arielle P. Davis, MD, who is in the department of neurology at the university.
In the prospective study, symptoms were simply not sensitive enough to rule anything out. Moderate or greater photophobia had a sensitivity of 6.3% for a reactive cerebrospinal fluid Venereal Disease Research Laboratory (CSF-VDRL) syphilis test; moderate or greater vision loss was 38.1% sensitive for reactive CSF-VDRL, moderate or greater hearing loss was 13.2% sensitive, and moderate or greater gait incoordination was 1.5% sensitive.
Specificity was markedly better for each of those symptoms, and more than 95% for moderate or greater photophobia, hearing loss, and gait incoordination. “In general, as the severity of photophobia, vision loss, hearing loss, and gait incoordination increased, the specificity increased, but at the expense of sensitivity,” the investigators wrote in their poster, which Dr. Davis presented at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
CSF-VDRL was reactive in 68 subjects (18%). The odds of a reactive CSF-VDRL were significantly higher in patients with vision loss (odds ratio, 2.2; 95% confidence interval, 1.2-4.0; P = .01) and trended toward significance in those with moderate or greater hearing loss (OR, 2.5; 95% CI, 1.0-6.6; P = .06).
Overall, “patients with mild or greater photophobia, vision loss, gait incoordination, and moderate or greater hearing loss were significantly more likely to have a reactive CSF-VDRL, and the presence of any of these four symptoms should [remain] a criterion for pursuing a lumbar puncture.” However, “lack of neurologic symptoms in HIV-infected patients with syphilis should not reassure clinicians that their patients do not have neurosyphilis,” Dr. Davis and her team concluded.
The participants were almost entirely men and mostly white. The average age was about 40 years, and the median rapid plasma reagin titer was 1:64. About 48% of the subjects reported at least mild vision loss, 40% reported mild or worse headache, and 17% reported some degree of hearing loss. Overall, 15.5%-17.2% reported at least mild photophobia, stiff neck, or gait incoordination.
The work was funded by the National Institutes of Health. Dr. Davis did not have any relevant disclosures.
AT CROI
Key clinical point:
Major finding: Moderate or greater photophobia had a sensitivity of 6.3% for a reactive CSF-VDRL syphilis test; moderate or greater vision loss was 38.1% sensitive for reactive CSF-VDRL, moderate or greater hearing loss 13.2% sensitive, and moderate or greater gait incoordination 1.5% sensitive.
Data source: Lumbar punctures of 385 HIV patients with syphilis
Disclosures: The work was funded by the National Institutes of Health. The lead investigator didn’t have any relevant disclosures.
PrEP sexual health intervention improves adherence
SEATTLE – A behavioral intervention that takes a nontraditional approach to counseling for pre-exposure prophylaxis (PrEP) therapy boosted its adherence, according to a new study.
The New York City–based intervention program eschews the traditional approach that presents as a strategy to avoid risk. “We frame the choice of taking PrEP in terms of: Is PrEP something that’s going to help you have a safe and fulfilling sex life?” said Sarit A. Golub, PhD, MPH, a professor of psychology at Hunter College, N.Y., and the City University of New York, who presented a study examining its efficacy at a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
Typically, HIV clinics focus on identifying people at high risk as PrEP candidates and encourage them to adopt the regimen, but Dr. Golub thinks that approach can be counterproductive. “They say to a patient: ‘You have been identified as being at risk.’ As a psychologist, I see that [this] is rife for a self-fulfilling prophecy. ‘My doctor thinks I’m so high risk that I’m going to get HIV’ ” for sure, Dr. Golub said.
The sexual health intervention, designed to encourage adoption of PrEP, begins with a simple query: What is your ideal sex life? “People are like, ‘Excuse me?’ We’ve actually had guys cry and say, ‘Nobody has ever asked me that,’ ” Dr. Golub said.
The adherence intervention, provided to subjects who have decided to adopt PrEP, helps patients understand what happens if they stop taking the drugs and encourages them to link taking the pills to an activity that they engage in every day.
“The language and the frame in both is about patient empowerment and patient agency,” Dr. Golub said.
To test the efficacy of the two interventions, the researchers recruited 300 men who have sex with men and transgender women (aged 18-63 years; 49% white) who had chosen to start PrEP. They were randomized to one of four groups: sexual health intervention only; adherence intervention only; both interventions; or neither intervention.
The researchers assessed adherence by measuring drug concentrations in dried blood spot testing at 3-month and 6-month follow-up visits.
Across all participants, adherence was high at 3 months: 90.3% had drug concentrations at a level suggesting they were taking their medication at least four times a week. Among participants receiving at least one of the interventions, adherence was 96.6%, compared with 84% (P = .002) among those who received neither intervention.
At 6 months, those who received at least one intervention continued to outperform those who received neither intervention (92.1% vs. 85.7%), but the difference did not reach statistical significance.
The study impressed K. Rivet Amico, PhD, a research associate professor at the University of Michigan, Ann Arbor. “I think it’s incredibly important. It focuses on really prioritizing sexual health, as opposed to just the dispensation of drug and medication monitoring. It’s a very comprehensive kind of approach, and it engages people more,” she said.
Many cities are rolling out programs similar to the one described by Dr. Golub, but the approach remained unproven. The study “is building the evidence base. We have a lot of anecdotal evidence, but it’s very nice to be collecting data,” Dr. Amico added.
The study was funded by the National Institutes of Health and Gilead. Dr. Golub reported having no financial disclosures. Dr. Amico has received an educational grant from Gilead.
SEATTLE – A behavioral intervention that takes a nontraditional approach to counseling for pre-exposure prophylaxis (PrEP) therapy boosted its adherence, according to a new study.
The New York City–based intervention program eschews the traditional approach that presents as a strategy to avoid risk. “We frame the choice of taking PrEP in terms of: Is PrEP something that’s going to help you have a safe and fulfilling sex life?” said Sarit A. Golub, PhD, MPH, a professor of psychology at Hunter College, N.Y., and the City University of New York, who presented a study examining its efficacy at a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
Typically, HIV clinics focus on identifying people at high risk as PrEP candidates and encourage them to adopt the regimen, but Dr. Golub thinks that approach can be counterproductive. “They say to a patient: ‘You have been identified as being at risk.’ As a psychologist, I see that [this] is rife for a self-fulfilling prophecy. ‘My doctor thinks I’m so high risk that I’m going to get HIV’ ” for sure, Dr. Golub said.
The sexual health intervention, designed to encourage adoption of PrEP, begins with a simple query: What is your ideal sex life? “People are like, ‘Excuse me?’ We’ve actually had guys cry and say, ‘Nobody has ever asked me that,’ ” Dr. Golub said.
The adherence intervention, provided to subjects who have decided to adopt PrEP, helps patients understand what happens if they stop taking the drugs and encourages them to link taking the pills to an activity that they engage in every day.
“The language and the frame in both is about patient empowerment and patient agency,” Dr. Golub said.
To test the efficacy of the two interventions, the researchers recruited 300 men who have sex with men and transgender women (aged 18-63 years; 49% white) who had chosen to start PrEP. They were randomized to one of four groups: sexual health intervention only; adherence intervention only; both interventions; or neither intervention.
The researchers assessed adherence by measuring drug concentrations in dried blood spot testing at 3-month and 6-month follow-up visits.
Across all participants, adherence was high at 3 months: 90.3% had drug concentrations at a level suggesting they were taking their medication at least four times a week. Among participants receiving at least one of the interventions, adherence was 96.6%, compared with 84% (P = .002) among those who received neither intervention.
At 6 months, those who received at least one intervention continued to outperform those who received neither intervention (92.1% vs. 85.7%), but the difference did not reach statistical significance.
The study impressed K. Rivet Amico, PhD, a research associate professor at the University of Michigan, Ann Arbor. “I think it’s incredibly important. It focuses on really prioritizing sexual health, as opposed to just the dispensation of drug and medication monitoring. It’s a very comprehensive kind of approach, and it engages people more,” she said.
Many cities are rolling out programs similar to the one described by Dr. Golub, but the approach remained unproven. The study “is building the evidence base. We have a lot of anecdotal evidence, but it’s very nice to be collecting data,” Dr. Amico added.
The study was funded by the National Institutes of Health and Gilead. Dr. Golub reported having no financial disclosures. Dr. Amico has received an educational grant from Gilead.
SEATTLE – A behavioral intervention that takes a nontraditional approach to counseling for pre-exposure prophylaxis (PrEP) therapy boosted its adherence, according to a new study.
The New York City–based intervention program eschews the traditional approach that presents as a strategy to avoid risk. “We frame the choice of taking PrEP in terms of: Is PrEP something that’s going to help you have a safe and fulfilling sex life?” said Sarit A. Golub, PhD, MPH, a professor of psychology at Hunter College, N.Y., and the City University of New York, who presented a study examining its efficacy at a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
Typically, HIV clinics focus on identifying people at high risk as PrEP candidates and encourage them to adopt the regimen, but Dr. Golub thinks that approach can be counterproductive. “They say to a patient: ‘You have been identified as being at risk.’ As a psychologist, I see that [this] is rife for a self-fulfilling prophecy. ‘My doctor thinks I’m so high risk that I’m going to get HIV’ ” for sure, Dr. Golub said.
The sexual health intervention, designed to encourage adoption of PrEP, begins with a simple query: What is your ideal sex life? “People are like, ‘Excuse me?’ We’ve actually had guys cry and say, ‘Nobody has ever asked me that,’ ” Dr. Golub said.
The adherence intervention, provided to subjects who have decided to adopt PrEP, helps patients understand what happens if they stop taking the drugs and encourages them to link taking the pills to an activity that they engage in every day.
“The language and the frame in both is about patient empowerment and patient agency,” Dr. Golub said.
To test the efficacy of the two interventions, the researchers recruited 300 men who have sex with men and transgender women (aged 18-63 years; 49% white) who had chosen to start PrEP. They were randomized to one of four groups: sexual health intervention only; adherence intervention only; both interventions; or neither intervention.
The researchers assessed adherence by measuring drug concentrations in dried blood spot testing at 3-month and 6-month follow-up visits.
Across all participants, adherence was high at 3 months: 90.3% had drug concentrations at a level suggesting they were taking their medication at least four times a week. Among participants receiving at least one of the interventions, adherence was 96.6%, compared with 84% (P = .002) among those who received neither intervention.
At 6 months, those who received at least one intervention continued to outperform those who received neither intervention (92.1% vs. 85.7%), but the difference did not reach statistical significance.
The study impressed K. Rivet Amico, PhD, a research associate professor at the University of Michigan, Ann Arbor. “I think it’s incredibly important. It focuses on really prioritizing sexual health, as opposed to just the dispensation of drug and medication monitoring. It’s a very comprehensive kind of approach, and it engages people more,” she said.
Many cities are rolling out programs similar to the one described by Dr. Golub, but the approach remained unproven. The study “is building the evidence base. We have a lot of anecdotal evidence, but it’s very nice to be collecting data,” Dr. Amico added.
The study was funded by the National Institutes of Health and Gilead. Dr. Golub reported having no financial disclosures. Dr. Amico has received an educational grant from Gilead.
AT CROI
Key clinical point:
Major finding: Recipients had an adherence of 96.6% at 3 months, compared with 84% in controls.
Data source: Randomized, controlled trial of 300 PrEP users.
Disclosures: The study was funded by the National Institutes of Health and Gilead. Dr. Golub reported having no financial disclosures. Dr. Amico has received an educational grant from Gilead.
Following infection, semen is Zika’s last refuge
SEATTLE – Zika virus RNA lingered longer in semen than in any other body fluid but was cleared by 95% of men after 3 months, according to investigators from the Centers for Disease Control and Prevention.
The findings support the agency’s recommendation that men abstain from sex or use a condom for 6 months after coming down with symptoms. There had been concern following case reports of two men with semen positive for Zika RNA beyond 180 days, but further study supported the recommendation.
Many wondered if 6 months was too short, creating “a lot of anxiety and some confusion. It was good to find that [6 months is fine],” said senior CDC epidemiologist and lead investigator Gabriela Paz-Bailey, MD. “Based on our findings, late detection seems rare,” and the longest any infectious virus has been found in semen is 69 days.
The investigation team collected body fluids for 6 months from 150 patients in Puerto Rico who had confirmed Zika infection. Samples included semen samples from 55 men and vaginal secretions from 95 women in the study. Most of the participants presented to a hospital with symptoms, but some were household contacts who didn’t remember symptoms until asked.
“We found that two out of every three people who have evidence of infection reported symptoms,” which was higher than what was expected for an infection thought to be asymptomatic in many who remembered symptoms only when drilled by persistent epidemiologists. “You have to ask the questions,” Dr. Paz-Bailey said at the annual Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
The samples were tested by reverse transcriptase polymerase chain reaction to see how long viral RNA stayed in various body fluids. Urine often is used to screen patients for Zika RNA, but the team found that virus evidence lasts longer in serum. While half of patients still had Zika RNA in their serum 2 weeks after symptom onset, and 5% were positive after about 2 months, urine was positive for Zika RNA in half of patients for only about a week. After 39 days, only 5% had RNA in their urine.
“It was thought that you could detect the virus more often in urine. We found the opposite. This is new. Serum may be a superior diagnostic specimen compared to urine,” Dr. Paz-Bailey said.
Additionally, RNA was found in semen longer than any other fluid, with about half of men positive after a month and 5% at about 3 months. The maximum for detection of Zika RNA in semen was 125 days. Meanwhile, RNA was largely undetectable in saliva and vaginal fluids after a week.
Until now, the 6-month window for men has been based on case reports and cross-sectional observations, mostly of travelers returning to the United States. The new findings bolster the 6-month abstinence or condom use recommendation but also support advice that women avoid pregnancy for 2 months following symptom onset, although the evidence for a 2-month window in women isn’t as strong.
The serum findings “suggest that the risk of intrauterine transmission ... is small” in women trying to conceive toward the end of the 2-month period, but “we will continue to monitor women of reproductive age to inform evaluations of these recommendations,” Dr. Paz-Bailey and her colleagues said in a report published after the presentation (N Engl J Med. 2017 Feb 14. doi: 10.1056/NEJMoa1613108).
It’s unclear if finding Zika RNA in body fluids means that there’s still active virus that can be transmitted. The team is plating out their specimens to see if they grow live virus.
The results are from an interim analysis. CDC plans to recruit at least 300 people into the study.
Dr. Paz-Bailey had no relevant financial disclosures. CDC funded the work.
SEATTLE – Zika virus RNA lingered longer in semen than in any other body fluid but was cleared by 95% of men after 3 months, according to investigators from the Centers for Disease Control and Prevention.
The findings support the agency’s recommendation that men abstain from sex or use a condom for 6 months after coming down with symptoms. There had been concern following case reports of two men with semen positive for Zika RNA beyond 180 days, but further study supported the recommendation.
Many wondered if 6 months was too short, creating “a lot of anxiety and some confusion. It was good to find that [6 months is fine],” said senior CDC epidemiologist and lead investigator Gabriela Paz-Bailey, MD. “Based on our findings, late detection seems rare,” and the longest any infectious virus has been found in semen is 69 days.
The investigation team collected body fluids for 6 months from 150 patients in Puerto Rico who had confirmed Zika infection. Samples included semen samples from 55 men and vaginal secretions from 95 women in the study. Most of the participants presented to a hospital with symptoms, but some were household contacts who didn’t remember symptoms until asked.
“We found that two out of every three people who have evidence of infection reported symptoms,” which was higher than what was expected for an infection thought to be asymptomatic in many who remembered symptoms only when drilled by persistent epidemiologists. “You have to ask the questions,” Dr. Paz-Bailey said at the annual Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
The samples were tested by reverse transcriptase polymerase chain reaction to see how long viral RNA stayed in various body fluids. Urine often is used to screen patients for Zika RNA, but the team found that virus evidence lasts longer in serum. While half of patients still had Zika RNA in their serum 2 weeks after symptom onset, and 5% were positive after about 2 months, urine was positive for Zika RNA in half of patients for only about a week. After 39 days, only 5% had RNA in their urine.
“It was thought that you could detect the virus more often in urine. We found the opposite. This is new. Serum may be a superior diagnostic specimen compared to urine,” Dr. Paz-Bailey said.
Additionally, RNA was found in semen longer than any other fluid, with about half of men positive after a month and 5% at about 3 months. The maximum for detection of Zika RNA in semen was 125 days. Meanwhile, RNA was largely undetectable in saliva and vaginal fluids after a week.
Until now, the 6-month window for men has been based on case reports and cross-sectional observations, mostly of travelers returning to the United States. The new findings bolster the 6-month abstinence or condom use recommendation but also support advice that women avoid pregnancy for 2 months following symptom onset, although the evidence for a 2-month window in women isn’t as strong.
The serum findings “suggest that the risk of intrauterine transmission ... is small” in women trying to conceive toward the end of the 2-month period, but “we will continue to monitor women of reproductive age to inform evaluations of these recommendations,” Dr. Paz-Bailey and her colleagues said in a report published after the presentation (N Engl J Med. 2017 Feb 14. doi: 10.1056/NEJMoa1613108).
It’s unclear if finding Zika RNA in body fluids means that there’s still active virus that can be transmitted. The team is plating out their specimens to see if they grow live virus.
The results are from an interim analysis. CDC plans to recruit at least 300 people into the study.
Dr. Paz-Bailey had no relevant financial disclosures. CDC funded the work.
SEATTLE – Zika virus RNA lingered longer in semen than in any other body fluid but was cleared by 95% of men after 3 months, according to investigators from the Centers for Disease Control and Prevention.
The findings support the agency’s recommendation that men abstain from sex or use a condom for 6 months after coming down with symptoms. There had been concern following case reports of two men with semen positive for Zika RNA beyond 180 days, but further study supported the recommendation.
Many wondered if 6 months was too short, creating “a lot of anxiety and some confusion. It was good to find that [6 months is fine],” said senior CDC epidemiologist and lead investigator Gabriela Paz-Bailey, MD. “Based on our findings, late detection seems rare,” and the longest any infectious virus has been found in semen is 69 days.
The investigation team collected body fluids for 6 months from 150 patients in Puerto Rico who had confirmed Zika infection. Samples included semen samples from 55 men and vaginal secretions from 95 women in the study. Most of the participants presented to a hospital with symptoms, but some were household contacts who didn’t remember symptoms until asked.
“We found that two out of every three people who have evidence of infection reported symptoms,” which was higher than what was expected for an infection thought to be asymptomatic in many who remembered symptoms only when drilled by persistent epidemiologists. “You have to ask the questions,” Dr. Paz-Bailey said at the annual Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
The samples were tested by reverse transcriptase polymerase chain reaction to see how long viral RNA stayed in various body fluids. Urine often is used to screen patients for Zika RNA, but the team found that virus evidence lasts longer in serum. While half of patients still had Zika RNA in their serum 2 weeks after symptom onset, and 5% were positive after about 2 months, urine was positive for Zika RNA in half of patients for only about a week. After 39 days, only 5% had RNA in their urine.
“It was thought that you could detect the virus more often in urine. We found the opposite. This is new. Serum may be a superior diagnostic specimen compared to urine,” Dr. Paz-Bailey said.
Additionally, RNA was found in semen longer than any other fluid, with about half of men positive after a month and 5% at about 3 months. The maximum for detection of Zika RNA in semen was 125 days. Meanwhile, RNA was largely undetectable in saliva and vaginal fluids after a week.
Until now, the 6-month window for men has been based on case reports and cross-sectional observations, mostly of travelers returning to the United States. The new findings bolster the 6-month abstinence or condom use recommendation but also support advice that women avoid pregnancy for 2 months following symptom onset, although the evidence for a 2-month window in women isn’t as strong.
The serum findings “suggest that the risk of intrauterine transmission ... is small” in women trying to conceive toward the end of the 2-month period, but “we will continue to monitor women of reproductive age to inform evaluations of these recommendations,” Dr. Paz-Bailey and her colleagues said in a report published after the presentation (N Engl J Med. 2017 Feb 14. doi: 10.1056/NEJMoa1613108).
It’s unclear if finding Zika RNA in body fluids means that there’s still active virus that can be transmitted. The team is plating out their specimens to see if they grow live virus.
The results are from an interim analysis. CDC plans to recruit at least 300 people into the study.
Dr. Paz-Bailey had no relevant financial disclosures. CDC funded the work.
AT CROI
Key clinical point:
Major finding: Semen still had detectable Zika RNA in about half of men after a month and 5% at about 3 months. The maximum for detection in semen was 125 days.
Data source: A study of 150 patients in Puerto Rica with confirmed Zika infection.
Disclosures: The lead investigator had no disclosures. CDC funded the work.
Unrestricted DAA access halved Dutch HCV incidence in HIV
SEATTLE – New hepatitis C infections among HIV-positive men who have sex with men (MSM) were halved in the Netherlands by unrestricted access to direct-acting antivirals (DAAs), primarily ledipasvir/sofosbuvir tablets (Harvoni), according to Dutch investigators.
Since 2015, DAAs have been available to all newly acquired hepatitis C virus (HCV) patients without restriction. Due to the high cost of the drugs, payers in the United States and some other Western countries limit access to only patients with severe liver disease.*
The Dutch government, however, requires insurers to cover them, and has negotiated price discounts with makers. “The price that is paid is secret,” but it’s less than the standard cost of, for instance, €45,000 for a 3-month course of [ledipasvir/sofosbuvir] in the Netherlands, said senior investigator Bart Rijnders, MD, an infectious diseases assistant professor at Erasmus University Medical Center, Rotterdam. 
The study compared the incidence of acute HCV (aHCV) in HIV-positive MSM in 2014, before unrestricted access to DAAs, to the incidence of aHCV in 2016, after limits were lifted. The investigators used data from 18 HIV treatment centers spread across the Netherlands, capturing about 80% of Dutch MSM being treated for HIV.
In 2014, there were 93 aHCV infections diagnosed among the men, translating to an incidence of 11.2 cases per 1,000 person-years of follow-up (95% CI, 9.1-13.7 cases). In 2016, there were 49 aHCV cases, an incidence of 5.5 cases per 1,000 person-years (95% CI, 4.1–7.2, P less than .001). At the same time, there was a substantial increase in new syphilis cases, indicating that the 51% reduction in aHCV over 2 years was not due to changes in behavior.
Meanwhile, “within 14 months after these drugs became available to all, 75% of the HIV-positive MSM in the Netherlands were cured of their infection,” Dr. Rijnders said at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
Ledipasvir/sofosbuvir was the DAA used by about 90% of the men.
In short, unrestricted access to DAAs wiped out the infection so that men were no longer passing it to other men. The results are “an example of what is possible if you search for HCV and treat it as soon as you find it. You cure patients and prevent new infections. In the long run, you may save money,” he said, especially as more DAA options come on the market and prices fall.
Almost all the subjects were seen in their HIV clinic at least twice a year. An uptick in liver enzymes triggered HCV testing. The investigators checked positive results against patients’ own stored blood samples to distinguish new from chronic infections.
The study wasn’t funded, but Dr. Rijnders is a paid researcher for Merck’s DAA option, elbasvir/grazoprevir (Zepatier).
*This story was updated on February 24, 2017.
This is the first proof that early treatment of acute HCV could be a form of prevention. By removing the fibrosis requirement and restrictions forbidding treatment of people who are actively engaged in high-risk behaviors, they are reducing new infections.
We are far behind in the United States; 90% of states have restrictions that don’t allow uniform uptake of hepatitis C treatment and many forbid treatment for people who are actively using drugs. Having restrictions on people that don’t have enough liver disease is like telling a person with HIV they can’t be treated because their CD4 count isn’t below 200.
David Thomas, MD, is professor of medicine and director of the division of infectious diseases at Johns Hopkins University, Baltimore. He wasn’t involved with the work.
This is the first proof that early treatment of acute HCV could be a form of prevention. By removing the fibrosis requirement and restrictions forbidding treatment of people who are actively engaged in high-risk behaviors, they are reducing new infections.
We are far behind in the United States; 90% of states have restrictions that don’t allow uniform uptake of hepatitis C treatment and many forbid treatment for people who are actively using drugs. Having restrictions on people that don’t have enough liver disease is like telling a person with HIV they can’t be treated because their CD4 count isn’t below 200.
David Thomas, MD, is professor of medicine and director of the division of infectious diseases at Johns Hopkins University, Baltimore. He wasn’t involved with the work.
This is the first proof that early treatment of acute HCV could be a form of prevention. By removing the fibrosis requirement and restrictions forbidding treatment of people who are actively engaged in high-risk behaviors, they are reducing new infections.
We are far behind in the United States; 90% of states have restrictions that don’t allow uniform uptake of hepatitis C treatment and many forbid treatment for people who are actively using drugs. Having restrictions on people that don’t have enough liver disease is like telling a person with HIV they can’t be treated because their CD4 count isn’t below 200.
David Thomas, MD, is professor of medicine and director of the division of infectious diseases at Johns Hopkins University, Baltimore. He wasn’t involved with the work.
SEATTLE – New hepatitis C infections among HIV-positive men who have sex with men (MSM) were halved in the Netherlands by unrestricted access to direct-acting antivirals (DAAs), primarily ledipasvir/sofosbuvir tablets (Harvoni), according to Dutch investigators.
Since 2015, DAAs have been available to all newly acquired hepatitis C virus (HCV) patients without restriction. Due to the high cost of the drugs, payers in the United States and some other Western countries limit access to only patients with severe liver disease.*
The Dutch government, however, requires insurers to cover them, and has negotiated price discounts with makers. “The price that is paid is secret,” but it’s less than the standard cost of, for instance, €45,000 for a 3-month course of [ledipasvir/sofosbuvir] in the Netherlands, said senior investigator Bart Rijnders, MD, an infectious diseases assistant professor at Erasmus University Medical Center, Rotterdam.
The study compared the incidence of acute HCV (aHCV) in HIV-positive MSM in 2014, before unrestricted access to DAAs, to the incidence of aHCV in 2016, after limits were lifted. The investigators used data from 18 HIV treatment centers spread across the Netherlands, capturing about 80% of Dutch MSM being treated for HIV.
In 2014, there were 93 aHCV infections diagnosed among the men, translating to an incidence of 11.2 cases per 1,000 person-years of follow-up (95% CI, 9.1-13.7 cases). In 2016, there were 49 aHCV cases, an incidence of 5.5 cases per 1,000 person-years (95% CI, 4.1–7.2, P less than .001). At the same time, there was a substantial increase in new syphilis cases, indicating that the 51% reduction in aHCV over 2 years was not due to changes in behavior.
Meanwhile, “within 14 months after these drugs became available to all, 75% of the HIV-positive MSM in the Netherlands were cured of their infection,” Dr. Rijnders said at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
Ledipasvir/sofosbuvir was the DAA used by about 90% of the men.
In short, unrestricted access to DAAs wiped out the infection so that men were no longer passing it to other men. The results are “an example of what is possible if you search for HCV and treat it as soon as you find it. You cure patients and prevent new infections. In the long run, you may save money,” he said, especially as more DAA options come on the market and prices fall.
Almost all the subjects were seen in their HIV clinic at least twice a year. An uptick in liver enzymes triggered HCV testing. The investigators checked positive results against patients’ own stored blood samples to distinguish new from chronic infections.
The study wasn’t funded, but Dr. Rijnders is a paid researcher for Merck’s DAA option, elbasvir/grazoprevir (Zepatier).
*This story was updated on February 24, 2017.
SEATTLE – New hepatitis C infections among HIV-positive men who have sex with men (MSM) were halved in the Netherlands by unrestricted access to direct-acting antivirals (DAAs), primarily ledipasvir/sofosbuvir tablets (Harvoni), according to Dutch investigators.
Since 2015, DAAs have been available to all newly acquired hepatitis C virus (HCV) patients without restriction. Due to the high cost of the drugs, payers in the United States and some other Western countries limit access to only patients with severe liver disease.*
The Dutch government, however, requires insurers to cover them, and has negotiated price discounts with makers. “The price that is paid is secret,” but it’s less than the standard cost of, for instance, €45,000 for a 3-month course of [ledipasvir/sofosbuvir] in the Netherlands, said senior investigator Bart Rijnders, MD, an infectious diseases assistant professor at Erasmus University Medical Center, Rotterdam.
The study compared the incidence of acute HCV (aHCV) in HIV-positive MSM in 2014, before unrestricted access to DAAs, to the incidence of aHCV in 2016, after limits were lifted. The investigators used data from 18 HIV treatment centers spread across the Netherlands, capturing about 80% of Dutch MSM being treated for HIV.
In 2014, there were 93 aHCV infections diagnosed among the men, translating to an incidence of 11.2 cases per 1,000 person-years of follow-up (95% CI, 9.1-13.7 cases). In 2016, there were 49 aHCV cases, an incidence of 5.5 cases per 1,000 person-years (95% CI, 4.1–7.2, P less than .001). At the same time, there was a substantial increase in new syphilis cases, indicating that the 51% reduction in aHCV over 2 years was not due to changes in behavior.
Meanwhile, “within 14 months after these drugs became available to all, 75% of the HIV-positive MSM in the Netherlands were cured of their infection,” Dr. Rijnders said at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
Ledipasvir/sofosbuvir was the DAA used by about 90% of the men.
In short, unrestricted access to DAAs wiped out the infection so that men were no longer passing it to other men. The results are “an example of what is possible if you search for HCV and treat it as soon as you find it. You cure patients and prevent new infections. In the long run, you may save money,” he said, especially as more DAA options come on the market and prices fall.
Almost all the subjects were seen in their HIV clinic at least twice a year. An uptick in liver enzymes triggered HCV testing. The investigators checked positive results against patients’ own stored blood samples to distinguish new from chronic infections.
The study wasn’t funded, but Dr. Rijnders is a paid researcher for Merck’s DAA option, elbasvir/grazoprevir (Zepatier).
*This story was updated on February 24, 2017.
AT CROI
Key clinical point:
Major finding: In 2014, there were 93 acute HCV infections diagnosed among HIV-positive men who have sex with men, translating to an incidence of 11.2 cases per 1,000 person-years of follow-up (95% CI, 9.1-13.7 cases). In 2016, there were 49 cases, an incidence of 5.5 cases per 1,000 person years (95% CI, 4.1–7.2, P less than .001).
Data source: HIV treatment centers in the Netherlands
Disclosures: The study wasn’t funded, but the senior investigator is a paid researcher for Merck’s DAA option, elbasvir/grazoprevir (Zepatier).