FHI to stop study of Gilead's Truvada as HIV drug found not effective in prevention

A clinical trial by the not-for-profit organization Family Health International (FHI) designed to test whether Truvada (emtricitabine and tenofovir disoproxil fumarate) made by US drugmaker Gilead Sciences (Nasdaq: GILD) could prevent HIV infection in women at high risk of exposure to the virus was halted early after investigators determined it would probably not be effective.

Following a scheduled interim review of the study, known as FEM-PrEP, the Independent Data Monitoring Committee (IDMC) advised that the study will be highly unlikely to be able to demonstrate the effectiveness of Truvada in preventing HIV infection in the study population, even if it continued to its originally planned conclusion. The FHI 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. At this time, it cannot be determined whether or not Truvada works to prevent HIV infection in women.

The FEM-PrEP clinical trial - implemented by FHI in partnership with research centers in Africa - is designed to study whether HIV-negative women who are at higher risk of being exposed to HIV can safely use a daily dose of a pill called Truvada to prevent infection. This study was funded by the US Agency for International Development (USAID), with early funding from the Bill & Melinda Gates Foundation.