via Business Wire News Releases, by AIDS Healthcare Foundation

AIDS Healthcare Foundation (AHF) unveiled a new print ad today that lays out data on the use of Gilead’s blockbuster HIV treatment drug Truvada as a pre-exposure prophylaxis (PrEP) or HIV prevention pill raising questions about the wisdom of pursuing approval by the U.S. Food & Drug Administration (FDA) for this new use of the drug. The information detailed in the “Gilead’s Truvada as Prevention – Just the Facts” ad illuminates the reasons why it is premature for the U.S. Food & Drug Administration to consider approval of Truvada as PrEP. In the ad, AHF also calls on Gilead “to make certain that their drug when used for prevention does no harm to the individual or the overall public health.”

The ad is scheduled to begin running this week in eight publications aimed at an LGBT (Lesbian, Gay, Bisexual and Transgender) audience: Bay Area Reporter in San Francisco, California; GA Voice in Atlanta, Georgia: Gay City News in New York, New York; South Florida Gay News in Miami/Ft. Lauderdale, Florida; Washington Blade in Washington, D.C.; and Windy City Times in Chicago, Illinois. It will begin running next week in the following publications: Frontiers Magazine in Los Angeles, California and Out Front in Denver, Colorado.

The push for FDA approval of PrEP has increased since November 2010 when the results of the iPrEx study were released. The study of 2,499 high-risk men who have sex with men (MSM) found that the once-daily pill could decrease the likelihood of HIV infection by 42%. Since then many have raised concerns about the consequences of widespread use of PrEP and its possible affect on behavior. Letters signed by 618 doctors and advocates have been sent to the FDA and to drug-maker Gilead Sciences urging a halt to pursuit of FDA approval for use of Gilead’s blockbuster AIDS treatment drug Truvada as PrEP. In the letter sent by doctors–spearheaded by AHF–the doctors expressed concern that widespread use of PrEP, based on the available data, will unwittingly lead to more risky behavior, and more HIV infections. Lack of real-world data has also been cited as a concern.

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