First HIV Prevention Drug Approved by FDA

Jul 17, 2012 | Lauren Edmundson | Outbreak News

The FDA announced yesterday that it has approved Truvada, the first pill that prevents infection with HIV after sexual exposure. The drug is to be used in combination with other prevention methods, such as condoms and counseling. Experts estimate the drug will cost about $450/year in the United States.

Truvada is a pre-exposure prophylaxis method, meaning it reduces the likelihood that exposure to HIV will result in infection with the virus. It is recommended for adults who are at high risk of infection, such as individuals whose partners have HIV. The FDA strongly warned against the use of this drug in patients who are already infected with HIV or whose status is unknown.

Truvada, manufactured by Gilead Sciences, Inc., is already in use as a treatment for HIV as part of antiretroviral therapy. Its new use has been tested in two large clinical trials. The first study found that Truvada reduced risk of infection by forty-two percent among men who have sex with men. In the second study involving heterosexual couples, Truvada reduced the risk of infection by seventy-five percent.

FDA Commissioner Dr. Marget A. Hamburg called the administration’s announcement a “milestone in our fight against HIV.”

HIV, or human immunodeficiency virus, is a virus that attacks the body’s immune system and can lead to AIDS, or acquired immune deficiency syndrome. While HIV prevention strategies exist, there is no cure for HIV or AIDS. The virus is spread through contact with infected blood, semen, vaginal fluid, and breast milk. Experts believe that over one million people are currently infected with HIV in the US.

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