Drug shows promise of preventing HIV; FDA considers prescriptions for high-risk patients

WASHINGTON The Associated Press Published Tuesday, May. 08, 2012 1:10PM EDT Last updated Tuesday, May. 08, 2012 1:17PM EDT

Federal drug regulators on Tuesday affirmed landmark study results showing that a popular HIV-fighting pill can also help healthy people avoid contracting the virus that causes AIDS in the first place. While the pill appears safe and effective for prevention, scientists stressed that it only works when taken on a daily basis.

The Food and Drug Administration will hold a meeting Thursday to discuss whether Truvada should be approved for people who are at risk of contracting HIV through sexual intercourse. The agency's positive review posted Tuesday suggests the daily pill will become the first drug approved to prevent HIV infection in high-risk patients.

FDA reviewers conclude that taking Truvada pre-emptively could spare patients infection with a serious and life-threatening illness that requires lifelong treatment.

Despite the positive results, reviewers said that patients must be diligent about taking the pill every day. Adherence to the medication was less than perfect in clinical trials, and reviewers said that patients in the real world may forget to take their medication even more than those in clinical studies.

First announced in 2010, Truvada's preventive ability was hailed as a breakthrough in the 30-year campaign against the AIDS epidemic. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 44 per cent, when accompanied by condoms and counselling. Another study found that Truvada reduced infection by 75 per cent in heterosexual couples in which one partner was HIV infected and the other was not.

The FDA's panel of advisers will take separate votes on whether Truvada should be approved for:

gay and bisexual men

men or women in relationships with HIV-positive partners

other people at risk of acquiring HIV through sexual activity

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Drug shows promise of preventing HIV; FDA considers prescriptions for high-risk patients