FDA staff: Gilead's Truvada may help reduce HIV risk

Published: May 8, 2012

WASHINGTON (Reuters) – Gilead Sciences Inc’s Truvada tablets appear safe and effective for reducing the risk of HIV infection, U.S. regulators said on Tuesday. But they recommended a cautious approach for using the drug in efforts to prevent the virus that causes AIDS.

Food and Drug Administration staff said Truvada, which is already being used by patients with the human immunodeficiency virus, is well tolerated overall by uninfected people and may prevent infection in high-risk individuals when used in combination with other strategies.

FDA staff also acknowledged a strong correlation between the drug’s efficacy at reducing HIV infection and the willingness of those taking it to adhere to the treatment.

Their 47-page review document said preventive use of the drug — a combination of Gilead’s HIV drugs Emtriva, also known as emtricitabine, and Viread, or tenofovir — should be weighed carefully against an individual’s risk for infection, readiness to adhere to the treatment and potential for kidney problems.

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