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April 13, 2010

FDA Warns That Truvada Ads Overstate the HIV Drug’s Long-Term Success

The U.S. Food and Drug Administration (FDA) warned pharmaceutical company Gilead Sciences Inc. that the print advertising for its HIV medication Truvada claims the drug is more effective in the long term than it really is, the San Francisco Business Times reports.

The ad in question shows photographs of a woman at a graduation, in an office setting and as a married woman sitting on a sofa. The text below the images reads, “With once a day Truvada for my HIV, I can plan for long-term success.”

“The print ad is false or misleading because it overstates the efficacy of Truvada, makes unsubstantiated claims and minimizes the risks associated with the drug,” the FDA regulatory review officer Aline Moukhtara said in a letter to Gilead’s director of regulator affairs, Joyce Acbay.

The FDA adds that the “totality of these claims and presentations misleadingly suggests” that HIV-positive people using Truvada can manage their viral load and increased CD4 count over the long term. However, the FDA claims that this efficacy “has not been demonstrated by substantial evidence or substantial clinical experience.”

The agency does note that Gilead points out in the ad, in a smaller font, that the drug was evaluated “through three years of a clinical study” and “proven over the long term…in three years of a clinical study.”

“However, this contextual information does not mitigate the overwhelming impression created by the prominent images and claims in the print ad, which suggest that patients can expect long-term treatment success with Truvada as they achieve their hopes and dreams, such as graduation, a career and marriage,” the FDA said. “Any of these goals can easily take more than three years to accomplish.”



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