AIDS United Lauds Food and Drug Administration for Supporting Expansion of HIV Prevention Toolbox
WASHINGTON, D.C. -- May 11, 2012 -- AIDS United applauds the potential of expansion of available options for HIV prevention marked by the Food and Drug Administration (FDA)'s recommendation of approval of the use of the drug tenofovir/emtricitabine (marketed as Truvada, manufactured by Gilead Sciences) for use as part of a comprehensive HIV prevention strategy called pre-exposure prophylaxis, or PrEP. In written comments submitted to the FDA, AIDS United expressed its support of the FDA’s approval of Truvada as PrEP for uninfected adults.
In its comments, AIDS United urged that the labeling of Truvada as PrEP stress the importance of two critical points -- the adherence to the prescribed regimen, and the use of PrEP in combination with other HIV prevention measures, notably the consistent use of condoms. AIDS United also expressed concerns about the cost and availability of the drug for those who need it most and the need for ongoing clinical research, especially for women.
The FDA Antiviral Drug Advisory Committee voted yesterday to recommend approval of Truvada to be indicated for use as pre-exposure prophylaxis (PrEP) for HIV prevention by uninfected men who have sex with men, the uninfected partner in a serodiscordant relationship, and other uninfected adults at risk of becoming infected through sexual activity. The recommendation goes to the FDA for final approval; FDA action is expected in June. If approved, Truvada will be the first antiretroviral drug approved for HIV prevention among uninfected adults.
“Yesterday’s meeting and committee vote is an important step forward in expanding the available options for HIV prevention and a further step in meeting the goal of reducing the number of new HIV infections, especially among gay, bisexual men, and other men who have sex with men,” said Victor Barnes, AIDS United Interim President and CEO. “AIDS United urges the FDA to give final approval to Truvada as PrEP and will continue to advocate for our concerns about the implementation of PrEP and further research on PrEP.”