WASHINGTON (Reuters) – A US Food and Drug Administration panel of outside experts recommended Gilead Sciences Inc’s Truvada as a treatment for preventing HIV infection among people at risk for contracting AIDS, including homosexual and bisexual men.
In a move that could lead to a new milestone for treatment in the evolution of the worldwide AIDS epidemic, the FDA advisory committee voted 19-3 to endorse the drug’s use for controlling HIV infection among the highest risk group — men who have sex with men.
By narrower margins, the panel also approved Truvada’s use for the domestic partners of HIV infected people and others at risk for sexual transmission, with some members saying there was not enough data on the drug’s efficacy to justify use in the wider population.
The recommendation will be forwarded to FDA regulators, who must decide whether to give Truvada final approval as the first drug for use as a preventive treatment for HIV in the United States.
Shares in Gilead Sciences closed 1.2 percent higher at $51.25 before the panel voted.
The drug combines Gilead’s HIV drugs Emtriva, also known as emtricitabine, with Viread, or tenofovir. It already has FDA approval to treat people infected with the human immunodeficiency virus that causes AIDS.