Family Health International (FHI) Statement on the FEM-PrEP HIV Prevention Study
Following a scheduled interim review of the FEM-PrEP study, a Family Health International pre exposure prophylaxsis (PrEP) study held in partnership with centers in Africa, the Independent Data Monitoring Committee (IDMC) has advised the study be closed.
Following a scheduled interim review of the FEM-PrEP study, a Family Health International pre exposure prophylaxsis (PrEP) study held in partnership with centers in Africa, the Independent Data Monitoring Committee (IDMC) has advised the study be closed. The FEM-PrEP clinical trial was designed to study whether HIV-negative women who are at higher risk of being exposed to HIV can safely use a daily dose of Truvada [emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF)]to prevent infection. Their findings showed that the study is highly unlikely to demonstrate the effectiveness of Truvada in preventing HIV infection in the study population, even if it continued to its originally planned conclusion. FHI has subsequently concurred and has therefore decided to initiate an orderly closure of the study over the next few months. The final analyses have not yet been conducted therefore it cannot yet be determined whether or not Truvada works to prevent HIV infection in women.
The FEM-PrEP outcome is surprising and disappointing, given a number of earlier studies suggesting the promise of pre-exposure prophylaxis (PrEP) using antiretrovirals. Most recently, the iPrEX study showed that use of Truvada can prevent infection in men who have sex with men at risk of HIV.
There are a number of possible reasons for the study findings, including low adherence to study regimen, a true lack of effect of the product among women (versus men who have sex with men), or other factors still to be determined. FHI will be conducting further analyses and will share additional findings in the coming months. The IDMC commended the trial team on a study conducted to a high standard with good follow-up and careful attention to good clinical practice and ethical standards.
