FDA Advisory Panel Backs Preventive Use of HIV Drug

On Thursday, advisors to the Food and Drug Administration recommended the agency approve the use of Truvada in healthy people who are at high risk for HIV infection.

FDA's advisory panel, composed of 22 outside medical experts, evaluated studies of once-a-day Truvada and heard scientific presentations. Several speakers told the panel better prevention methods besides condoms and counseling are needed to make a dent in the estimated 50,000 new infections that occur in the United States each year. Truvada is not meant to replace these safe-sex measures but to be used with them to enhance protection. The drug is already approved for treating HIV infection.

Many newly infected Americans are men whose sexual partners are unaware of their infection; young black men who have sex with men are at highest risk. Truvada would be prescribed for high-risk groups like MSM with multiple sex partners, people in serodiscordant relationships, and sex workers.

However, the advisors struggled with how to ensure healthy people taking Truvada do so safely and effectively. While the medicine would come with specific instructions, including the need for HIV screening before starting the regimen and other lab tests, FDA officials said Thursday there is no practical way to enforce a testing requirement. Further, such a requirement could pose a barrier to use. Some panelists voted "no" or abstained due to a lack of data for Truvada's efficacy in women and African-Americans.

FDA typically follows the guidance of its advisory panels. Agency approval may make it more likely that health insurers would cover the cost of the drug's preventive use.

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