The Food and Drug Adminstration today announced the approval of the first drug for use in people who are not infected with the human immunodeficiency virus (HIV), to prevent its transmission, which some are calling a landmark in the fight against AIDS.
The drug, Truvada, is actually a combination of two medicines and is manufactured by Gilead Sciences, Inc. of Foster City, Calif. While Truvada has been approved since 2004 as a treatment for those already infected with the HIV virus, this is the first time any drug has been approved for pre-exposure prophylaxis, or PrEP.
The study that led to the drug's approval found the risk of transmission among men who have sex with men decreased more than 40 percent. Furthermore, it showed a decrease of more than 70 percent in risk of transmission among heterosexual couples in which one partner was infected with HIV but the other was not.
"Truvada should not be used alone for preventing infections," cautioned Dr. Debra Birnkrant, director of the Division of Antiviral Products at the FDA's Center for Drug Evaluation and Research. "However, when used in combination with other prevention methods, such as safer sex practices, counseling, and regular testing to determine infection status, Truvada is effective in reducing the risk of transmission."
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