This update includes links to several new resources designed to help advocates understand and communicate about developments in HIV prevention research, particularly the FEM-PrEP trial of oral TDF/FTC as pre-exposure prophylaxis (PrEP) for HIV prevention in HIV-negative women. The resources include:
By way of background—at a scheduled interim data review on April 18, the Independent Data Monitoring Committee (IDMC) for the FEM-PrEP study of oral PrEP using once-daily TDF/FTC (brand-name Truvada) determined that the trial would not be able to answer the question of whether the study drug decreased risk of HIV infection among HIV-negative women at risk via sexual transmission. The IDMC therefore recommended that the study be discontinued, and the study sponsor, FHI, has decided to begin an orderly closure of the study ahead of its anticipated end date. Click here to listen to a recording of a global civil society teleconference on the FEM-PrEP announcement.
It’s important for advocates to note that on May 9, the Data and Safety Monitoring Board for the VOICE trial met for a scheduled review and recommended that the trial continue without alteration. VOICE is a five-arm trial evaluating the safety and effectiveness of evaluating once-daily oral TDF, once-daily oral TDF/FTC and once-daily 1% tenofovir gel for HIV prevention in HIV-negative women. VOICE is one of two ongoing trials (the other is the Partners PrEP trial in serodiscordant couples) that will provide more information on oral PrEP using TDF/FTC in women.
Another resource for advocates is a call this Thursday hosted by the Global Campaign for Microbicides, which will provide a platform to further discuss the FEM-PrEP trial and what it means for HIV prevention research and advocacy in Africa. Click here for more details and to register.
To learn more about ongoing trials and to add your questions or concerns to our list, please contact us at email@example.com.