Preventing HIV-1 Infection in Women using Oral Pre-Exposure Prophylaxis: A Meta-analysis of Current Evidence

Abstract

The World Health Organization has issued an early release revision to its antiretroviral guidelines in which PrEP (Pre-exposure prophylaxis in the form of daily oral, fixed dose combination tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)) is recommended as a prevention option to all people at substantial risk of acquiring HIV. However, lack of effectiveness in two major women-only PrEP trials, VOICE and FEM PrEP, continue to be a cause for concern about achieving effectiveness for women in Southern Africa. We conducted a series of meta-analyses of oral TDF/FTC effectiveness in women including all five randomized placebo-controlled trials that included women. An adherence-based meta-analysis model showed that with high levels of adherence (75%), oral PrEP is estimated to be effective (RR=0.39, 95% CI 0.25 to 0.60). Provided that these results apply to women in Southern Africa, future prevention trial designs in that region should account for potentially reduced HIV incidence when PrEP is available.