Final results from trial of Truvada (Gilead Sciences) for HIV Prevention

Final results from the FEM-PrEP HIV-prevention trial of Truvada (emtricitabine/tenofovir disoproxil fumarate), from Gilead Sciences, reinforce the key role of adherence in HIV Prevention studies and the need to determine better approaches to support adherence in future pre-exposure prophylaxis (PrEP) programs. Despite targeted counseling and support, adherence to the drug regimen was low, suggesting that women in the clinical trial population may have had difficulty adhering to a daily pill regimen. Because of low adherence, FEM-PrEP was unable to determine whether the study drug could reduce the risk of HIV infection.

The trial included 2,120 women and thirty-three HIV infections occurred in the Truvada arm and 35 in the placebo arm. "Results from FEM-PrEP are important since they demonstrate clearly that achieving good adherence will be a key factor in successful PrEP strategies," said Dr. Lut Van Damme, FEM-PrEP principal investigator. Results are published in the NEJM. Based on other PrEP study results, an advisory committee recently recommended that the FDA approve HIV prevention as an indication for the use of Truvada for men who have sex with men, serodiscordant couples and other high-risk populations. A decision by the FDA is expected by mid-September 2012. See: "Preexposure Prophylaxis for HIV Infection among African Women" Lut Van Damme et al. NEJM 11 July 2012 (DOI:10.1056/NEJMoa1202614).