AHF: FDA ‘Reckless’ in Approving Gilead’s Controversial HIV ‘Prevention’ Pill

No HIV testing requirement baffles AIDS advocates

Press Teleconference: 3pm Eastern TODAY

<0> AHF: FDA ‘Reckless’ in Approving Gilead’s Controversial HIV ‘Prevention’ Pill </0>

<0> AIDS Healthcare FoundationCommunications DirectorWork: (323) 308-1833 Cell: (323) 791-5526orAIDS Healthcare FoundationGeneral Counsel & Chief of Public AffairsWork: (323) 860-5259 </0>

, the nation’s largest HIV/AIDS nonprofit medical provider, blasted the for its decision earlier today to approve an application by for the use of its blockbuster AIDS treatment Truvada as a form of an HIV prevention pill. In February 2012, the FDA granted an expedited review of Gilead’s application for approval by the FDA to market once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV in uninfected adults.

“The FDA’s approval of Gilead’s Truvada as a form of HIV prevention today without any requirement for HIV testing is completely reckless and a move that will ultimately set back years of HIV prevention efforts,” said , AHF’s President. “From the beginning we believe there was a rush to judgment by government officials and others in favor of such approval despite decidedly mixed studies offered in support. And while FDA recommends a negative HIV test prior to use of Truvada as PrEP and states that use by people with an is it in no way actually requires HIV testing in any manner—just strengthening of the ‘Boxed Warning’ on Gilead’s packaging. The FDA’s move today is negligence bordering the equivalence of malpractice which will sadly result in new infections, drug resistance and serious side effects among many, many people.”

Gilead first filed a supplemental new drug application (sNDA) for use of Truvada as prevention in December; in February 2012, the FDA granted an expedited review of Gilead’s application for approval by the FDA to market once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV in uninfected adults. On May 10, the FDA held an Advisory Committee hearing on the issue during which public comment opposing such use of the drug was heard from by more than 25 members of the audience. At the conclusion of the meeting, the Advisory Committee voted to advise the FDA to grant approval of Gilead’s application. Under statutory regulations, it was expected that a ruling by the FDA would be issued by Friday, June 15.

(AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 176,000 individuals in 26 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: , find us on Facebook: and follow us on Twitter: @aidshealthcare

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