Oral PrEP Protects Women From HIV

Truvada PrEP demonstrated high efficacy in clinical trials for HIV prevention among women with high adherence

Oral pre-exposure prophylaxis, or PrEP, for HIV prevention has a similar efficacy in women with “abnormal” vs. “normal” vaginal microbiota, according to recent findings.

“PrEP works in women when it is taken, including in those with abnormal vaginal microbiota, and our results provide reassurance that oral PrEP delivery to women does not need to be accompanied by testing for [bacterial vaginosis],” said Renee Heffron, PhD, MPH, assistant professor of global health and epidemiology at the University of Washington.

Dr. Heffron and colleagues used data from the Partners PrEP study to evaluate the efficacy of daily oral Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences; FTC/TDF) among women with bacterial vaginosis (BV).

“In that study, women with abnormal vaginal microbiota did not have any protection from the tenofovir gel, whereas women with normal microbiota did have protection,” Dr. Heffron said.

“This is important because BV is common, affecting more than 25% — even up to 50% — of African women at risk for HIV,” said Dr. Heffron.

The Partners PrEP study was a placebo-controlled trial of daily oral FTC/TDF conducted in Kenya and Uganda that had high adherence and efficacy rates among women. Heffron and colleagues conducted a substudy of 1,470 participants who were defined by BV status. Nugent scores were used to indicate “normal” and “intermediate” vaginal microbiota and BV.

According to Heffron and colleagues, found that PrEP efficacy also was not different among women with detected vs. undetected Gardnerella/Bacteroides (69% vs. 77%) and Lactobacillus (74% vs. 70%).

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“PrEP is a new approach to HIV prevention that requires continuing collaboration between patients and providers, as effectiveness requires adherence to daily medication and regular medical visits for monitoring, counseling and testing,” said Dawn K. Smith, M.D., M.P.H., the epidemiologist in CDC’s Division of HIV/AIDS Prevention.

PrEP is a way for people who do not have HIV, but who are at substantial risk of getting it, to prevent HIV infection by taking a pill every day. These medicines work to keep the HIV virus from establishing a permanent infection.

The PrEP medication (Truvada) contains two medicines (tenofovir and emtricitabine) that are used in combination with other medicines to treat HIV.

The Gilead Advancing Access® co-pay coupon card may help eligible patients save on their TRUVADA for PrEP co-pay. It is not available for patients who are enrolled in any state- or federally-funded prescription drug program, such as Medicare Part D and Medicaid.

Previously, the ASPIRE study evaluated the effectiveness of a vaginal ring impregnated with the anti-HIV drug dapivirine. This study’s results were disappointing, producing an overall reduction in infections of 27%. Stratified by age, the vaginal ring had zero effectiveness for women aged 18-21, reduced infections by 56% in women aged 22-26, and reduced infections by 51% in women aged 27 and over.

Conflict disclosures: Dr. Heffron reports no relevant financial disclosures. Other members of this research team reported being a consultant for Cepheid, Merck and Symbiomix.