FDA Approves Truvada -- First Pill To Prevent HIV Infection

By Amir Khan on July 17, 2012 12:11 PM EDT

HIV
Electron microscope scan of HIV (Photo: Creative Commons)

The Food and Drug Administration approved a new drug on Tuesday that some are calling a landmark in the battle against HIV and AIDS. The drug, Truvada, is intended to prevent HIV infection, the first time a drug has been approved to prevent, not treat, the virus.

HIV causes a failure of the immune system. Some people develop flulike symptoms within a few weeks of being infected, but most infected people show no symptoms, according to the Centers for Disease Control and Prevention. More than 1 million Americans live with HIV, and about 25 percent of seropositive people are unaware of their HIV status, according to the CDC.

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The drug is actually a combination of two medicines and has been approved to treat HIV since 2004, but the FDA on Tuesday approved it for HIV prevention -- a first.

"Truvada should not be used alone for preventing infections," Dr. Debra Birnkrant, director of the Division of Antiviral Products at the FDA's Center for Drug Evaluation and Research, said, according to ABC News. "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."

No cure for HIV is known, but treatments include drug cocktails that inhibit formation of new HIV particles. If treatment begins early, life expectancy is 32 years, according to a 2006 study published in Med Care. Life expectancy shrinks as treatment is delayed.

Risk factors for HIV include having sex with multiple partners, having sex without a condom, and having sex with men who have sex with men, according to the National Institute of Allergy and Infection Diseases

The study that led to the drugs approval found that the HIV risk among men who have sex with men decreased by more than 40 percent when they were on Truvada. In addition, among heterosexual couples in which only one partner is infected, the risk of transmission decreased 70 percent.

"The approval of Truvada to prevent HIV infection in uninfected individuals who are at high risk of sexually acquired HIV infection is a significant development, providing an important addition to our toolkit of HIV prevention interventions," Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Disease, told ABC News. "However, it is critical to stress that Truvada as 'pre-exposure prophylaxis' should not be considered a stand-alone method, but should be used in conjunction with other proven HIV prevention strategies."

And while some worry that Truvada will lead to more risky behavior, Birnkrant found the opposite to be true.

"What we found was that condom use increased over time and sexually transmitted infections either remained at baseline levels or decreased," she told the Associated Press. "So in essence, we don't have any strong evidence that condoms were not used or there was a decrease in condom use."

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