Thursday, May 10, 2012

The FDA Evalutes the Decision on PrEP for HIV Prevention

via The New York Times, Denis Grady

An advisory panel to the Food and Drug Administration is expected to vote Thursday on whether a drug already used to treat H.I.V. infection should also be approved to prevent it. Such a recommendation, if made, would mark the first time that government advisers have advocated giving antiviral medicine to healthy people who might be exposed through sexual activity to the virus that causes AIDS.

Studies have shown that people who take the medicine, Truvada, every day have a greatly reduced risk of infection.

The F.D.A. usually accepts the advice of its advisory panels, which are made up of outside experts, mostly from medical schools.

On Thursday morning, the panel evaluated studies of the once-a-day pill and heard scientific presentations about whether Truvada should be prescribed for people at high risk of infection, like gay men who have multiple sex partners, especially those who do not always use condoms, and people in relationships with someone who is H.I.V.-positive. Young black men who have sex with other men are at highest risk.

The drug is meant not to replace condoms and other safe-sex measures, but to be used with them for added protection.

Experts say better methods of prevention are needed because there are 50,000 new H.I.V. infections a year in the United States. Several speakers emphasized on Thursday that that number had not budged in 15 to 20 years. Counseling and condoms are not doing the job, they said, and many of the newly infected are men whose sexual partners do not realize they are H.I.V.-positive.

Read the Rest.


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