FDA Approves HIV Prevention Drug
Created: 2012-07-17 11:03 EST
Truvada is approved as the first pill to prevent HIV(Justin Sullivan/Getty Images)
The US Food and Drug Administration (FDA) yesterday (July 16) approved Truvada as the first pill to prevent HIV.
The drug, produced by Gilead Sciences Inc., has been shown in clinical trials to reduce the risk of HIV infection by up to 75 percent.
Dr. Debra Birnkrant, director of the Division of Antiviral Products at FDA, stressed in a statement that the drug, to be administered once a day, should be used in combination with safer sex practices.
The statement said: “Birnkrant stresses that Truvada is meant to be used as part of a comprehensive HIV prevention plan that includes consistent and correct condom use, risk reduction counseling, regular HIV testing, and treatment of any other sexually-transmitted infections. Truvada is not a substitute for safer sex practices.”
A clinical trial sponsored by the National Institute of Health found that Truvada reduced the risk of contracting HIV by 42 percent in gay and bisexual men and transgendered women.
A study by the University of Washington found a 75 percent risk reduction in heterosexual couples where one partner was HIV positive and the other was not.
Truvada is a combination of two antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate, and is designed for people who are HIV negative.
When it is used as a treatment for HIV rather than a preventative, the patient also takes a third drug, which may vary according to the needs of the patient.
People with a history of bone or kidney ailments need to be monitored when taking Truvada, as some adverse reversible symptoms were presented during clinical trials.
1.2 million Americans have HIV, according to the FDA.