July 13, 2011

CONRAD Statement on Pre-Exposure Prophylaxis Trials: First Studies to Prove ARVs Effective in Preventing HIV in Heterosexuals


Our colleagues at the University of Washington and the U.S. Center for Disease Control and Prevention announced today that trials of daily oral use of tenofovir (TDF) and tenofovir combined with emtricitabine (FTC/TDF) demonstrated effectiveness in preventing HIV infection in heterosexual men and women.  The Partners PrEP trial of 4,758 discordant couples in Kenya and Uganda, led by the University of Washington’s International Clinical Research Center, had a total of 78 HIV infections with 18 in the TDF group (62% fewer infections), 13 in the FTC/TDF group (73% fewer infections) and 47 in those assigned to placebo.  The CDC trial tested FTC/TDF in a study of uninfected heterosexual men and women in Botswana and demonstrated 63% fewer HIV infections compared to placebo; however, a separate analysis that excluded any HIV infections that occurred more than 30 days after a participants last reported drug dose indicated that FTC/TDF reduced the risk of HIV infection by 78%.

Today’s announcement gives us great cause for celebration - these outstanding results are the first studies to show that daily oral use of antiretrovirals are effective in preventing HIV infections in heterosexual men and women.  As with all HIV prevention trials, these results open the door to numerous questions.  Going forward, we anticipate many discussions in the field with researchers, donors and advocates regarding ongoing trials and continued use of placebos, adherence, gender differences, funding, treatment as prevention, and comparisons to other methods of HIV prevention.

We at CONRAD believe that women around the world need a variety of options for HIV prevention, to include daily pills, vaginal gels and rings and prevention methods that include contraceptives.  We hope ongoing trials will provide confirmatory results for tenofovir gel, thus adding an important tool to the field that has finally expanded in terms of options.  Congratulations to our friends at the University of Washington, the CDC and Gilead, and our thanks to the men and women in Kenya, Uganda and Botswana for participating in a serious milestone in the HIV prevention world.