amfAR, The Foundation for AIDS Research

amfAR Applauds FDA Panel Recommendation on Pre-Exposure Prophylaxis (PrEP), Urges Swift Action on Approval

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   NEW YORK, May 11, 2012—amfAR, The Foundation for AIDS Research on Friday applauded the recommendation by an FDA advisory panel to approve the antiretroviral drug Truvada as an option for HIV prevention.    

In light of the panel’s recommendation, amfAR now calls on the FDA to issue an approval for Truvada as PrEP without delay. In testimony before the advisory panel yesterday, amfAR also emphasized the need for demonstration projects to determine how PrEP can be used for optimal public health impact, and for policy measures and education initiatives to ensure those who could most benefit from PrEP have access to it.    

Several clinical trials over the past few years have shown that Truvada, which is currently approved for HIV treatment, can also help prevent infection in sexually active adults.  Truvada, manufactured by Gilead Sciences Inc., was studied in several major trials that demonstrated that the once-daily pill, when taken consistently, significantly reduces the chances of acquiring HIV.     

“We need new tools as part of a comprehensive approach to reduce HIV infection rates in the United States and globally,” said amfAR CEO Kevin Robert Frost. “Truvada, when taken as directed, works. The FDA panel’s recommendation recognizes that this is the type of innovative science we need right now if we want to change the course of the epidemic.”     

“Our challenge now is to understand how to use PrEP effectively to tackle HIV incidence worldwide,” said Chris Collins, amfAR’s vice president and director of public policy. “PrEP is certainly not for everyone, but delivered in a targeted way and as part of a comprehensive approach that includes other evidence-based interventions like AIDS treatment, condoms, education, syringe exchange, and male circumcision, PrEP may play an important role in beginning to end the AIDS epidemic.”    

The FDA is expected to make its decision in June. In the meantime, many advocates have begun to focus on how use of Truvada as a prevention tool could be implemented in the U.S.    

About amfAR  

amfAR, The Foundation for AIDS Research, is one of the world’s leading nonprofit organizations dedicated to the support of AIDS research, HIV prevention, treatment education, and the advocacy of sound AIDS-related public policy. Since 1985, amfAR has invested more than $366 million in its programs and has awarded grants to more than 2,000 research teams worldwide.  

Click here for amfAR statement to the FDA.