Truvada approved by FDA as first HIV-prevention pill
(CBS News) Truvada has been approved by the Food and Drug Administration as the first pill to prevent HIV.
Gilead Sciences' Truvada has been taken by people over 12 with human immunodeficiency virus in conjunction with other antiretroviral drugs since it was first approved by the FDA in 2004. The new approval applies in combination with safer sex practices for preventative use in healthy individuals who are at a high risk for HIV or who may have sex with HIV-positive partners.
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"Today's approval marks an important milestone in our fight against HIV," FDA Commissioner Dr. Margaret A. Hamburg said in a press release. "Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."
In the announcement, the FDA strongly recommended against Truvada's use to prevent disease transmission in individuals who may already have HIV.
The most common side effects reported with Truvada were diarrhea, nausea, abdominal pain, headache and weight loss. Serious side effects were uncommon.
In May, a panel of expert advisers who make recommendations to the FDA voted to back Truvada's use for HIV prevention in healthy, high-risk individuals but the FDA was not bound to accept the panel's recommendation. The experts at the time questioned the drug's effectiveness for females, who have shown much lower rates of protection in the research.
Research showing Truvada may prevent HIV transmission first arose in 2010, when a government study found it cut infection risk in healthy gay and bisexual men by 42 percent, when accompanied by condoms and STD counseling. Another study found the pill may reduce HIV risk by 75 percent among heterosexual couples in which one partner is infected with the virus. Some doctors had already been prescribing Truvada off-label for HIV prevention.
Following the FDA advisory panel's initial recommendation in May, some HIV advocateshailed the announcementas "nearing a watershed moment in our fight against HIV."
