HIV-prevention pill OK’d by FDA

WASHINGTON – The Food and Drug Administration on Monday approved the first drug shown to reduce the risk of HIV infection, the latest milestone in the 30-year battle against the virus that causes AIDS.

The agency approved Gilead Sciences’ pill Truvada as a preventive measure for healthy people who are at high risk of acquiring HIV through sexual activity, such as those who have HIV-infected partners. The decision comes less than two weeks after the agency approved another landmark product: the first over-the-counter HIV test that Americans can use in the privacy of their homes.

The two developments are seen as the biggest steps in years toward curbing the spread of HIV in the U.S., which has held steady at about 50,000 new infections per year for the last 15 years. An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated. It’s estimated that one-fifth, or about 240,000 people, are unaware they are infected.

“I think the combination of self-testing and a medicine that you can take at home to prevent infection could mean a whole new approach to HIV prevention that is a bit more realistic,” said Dr. Demetre Daskalakis of New York University’s Langone Medical Center, who served on the FDA panel that recommended approving Truvada. While a positive step forward, Daskalakis added that Truvada would likely be unavailable for many people without health insurance, who often face the greatest risk of acquiring HIV.

Researchers had long sought to create a pill that could help stem the epidemic. Public health advocates said Monday that Truvada represents a major breakthrough, both as a medical therapy and as a means of expanding other preventive measures. Patients who get a prescription for Truvada will be expected to take part in a comprehensive HIV prevention plan, which experts say will enhance the drug’s impact.

But HIV experts have raised concerns that patients might not use the drug correctly. Dr. Tom Giordano of Baylor College of Medicine said Monday the drug must be taken every day to be effective, and would be most effective for a relatively small group.

“It’s been most effective in people who are at very high risk and are able to take the drug on a regular basis,” said Giordano, who served on the FDA panel that recommended approving the drug.

The drug’s label carries a warning that people should be tested to make sure they don’t have HIV before starting Truvada. Patients who already have the virus could develop resistance to the drug. The label also warns of kidney and liver problems.

Because Truvada is on the market to manage HIV, some doctors already prescribe it as a preventive measure. FDA approval allows marketing for that use, which could dramatically increase prescriptions.