FDA delays decision on HIV drug for prevention of AIDS virus

fda logo FDA delays decision on HIV drug for prevention of AIDS virusThe Food and Drug Administration (FDA) will take more time to decide whether to allow a treatment for HIV to be prescribed to prevent the disease for individuals at risk for becoming infected.

Last month, an FDA advisory panel recommended approving Truvada for people at risk for contracting HIV, such as gay and bisexual men. The FDA is not required to follow the recommendations of its expert panels, but it often does.

Gilead Sciences, the drug’s manufacturer, submitted updated information on the planned safety materials for Truvada that would be distributed to doctors and patients. The FDA usually postpones its review of medications when additional information is submitted. The FDA is now expected to rule on the new indication for Truvada by September 14.

Truvada was approved in 2004 for the treatment of people who are infected with HIV, the virus that causes AIDS. The drug is made up of two older HIV drugs, Emtriva and Viread.

In 2010, data from a three-year study showed that daily doses of Truvada cut the risk of HIV infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling. In 2011, another study found that the drug reduced the infection risk by 75 percent in heterosexual couples in which one partner was infected with HIV and the other was not.

Despite the promising results with Truvada, some critics argue that the drug will give users a false sense of security and discourage condom use, which is the most consistently reliable prevention against HIV.

Source: PharmPro