WASHINGTON – A US Food and Drug Administration (FDA) panel of outside experts has recommended Gilead Sciences Inc’s Truvada as a treatment for preventing HIV infection among people at risk of contracting Aids, including homosexual and bisexual men.
In a move that could lead to a new milestone in the fight against 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.
The panel also approved Truvada’s use for the domestic partners of HIV-infected people and others at risk of sexual transmission, but several members said there should be more data on the drug’s efficacy to justify its 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 US.
The drug combines Gilead’s HIV drug 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.
Nearly 1.2 million Americans are infected with HIV. But clinical research, which shows Truvada to be effective at preventing the spread of HIV among people who take the pill daily, has raised hopes that the United States could stem the growth of a national HIV epidemic that has stubbornly generated 50,000 new infection cases a year over the past two decades.
Studies showed Truvada to be more than 90 per cent effective at preventing HIV infection among test subjects who took the drug as prescribed, but only 44 per cent effective among test populations that used it intermittently.
– (Reuters)