April 18, 2011

Dear Advocates,

Today the FEM-PrEP trial team announced that its effectiveness trial of oral pre-exposure prophylaxis (PrEP) in women will close. This update contains links and resources, including AVAC’s statement and information on a global teleconference to help advocates understand this development.

To discuss these results with trial investigators and other key resource people, advocates are invited to join a global teleconference on Tuesday, April 19, 10-11am ET (see www.timeanddate.com for the time in your area).

Call-in Details
Please use this link to register prior to the call.

For the complete list of toll-free numbers click here.

At a scheduled, interim data review, the Independent Data Monitoring Committee (IDMC) for the FEM-PrEP study of oral PrEP using 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 has, therefore, recommended that the study be discontinued.

This is a setback for ARV-based prevention research, which has generated exciting results in the recent past, notably with the iPrEx trial of oral TDF/FTC and the CAPRISA 004 trial of 1% tenofovir gel. However, the findings from a single trial do not predict those from other ongoing trials. AVAC believes there is still a strong rationale for continuing other trials, including those in women, in hopes of obtaining a better result in the future.

Two other ongoing trials in sub-Saharan Africa are evaluating oral TDF/FTC and/or TDF alone among heterosexuals. The VOICE trial is evaluating oral TDF and TDF/FTC as well as 1% tenofovir gel in 5,000 women in sub-Saharan Africa. Partners PrEP is evaluating oral TDF and TDF/FTC in the HIV-negative member of couples in which one partner is HIV-infected.

Additional resources can be found at www.avac.org/prep.

Best,
AVAC