FHI to Initiate Orderly Closure of FEM-PrEP

Following a scheduled interim review of data from the FEM-PrEP study of oral pre-exposure prophylaxis (PrEP) using daily TDF/FTC (brand-name Truvada), the Independent Data Monitoring Committee (IDMC) advised that the FEM-PrEP study will be highly unlikely to be able to demonstrate the effectiveness of Truvada [emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF)] in preventing HIV infection in the study population, even if it continued to its originally planned conclusion. Family Health International (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 full statement is available below.

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