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FDA Approves Truvada for HIV Prevention

Update Date: Jul 16, 2012 02:27 PM EDT

There is a new breakthrough in the fight against HIV/AIDS. The Food and Drug Administration (FDA) has approved the new use of Truvada to reduce the risk of sexually contracting HIV. The once-a-day medication is designed to help adults who do not have HIV but are at high risk of becoming infected.

Truvada is a combination of two antiretroviral medications used to treat HIV-tenofovir disoproxil fumarate and emtricitabine. Truvada was approved by FDA in 2004 for HIV-infected adults and children over 12 years old.

Researchers say persons who want to take the new medication should be HIV negative and tested for hepatitis B. Researchers said once the medication is administered, patients must be on the alert for flu-like symptoms - even if the previous HIV test comes back negative. Flu-like symptoms could mean that there is a HIV infection present in the body. HIV could take up to three months to show up in the bloodstream.

"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."

Researchers say that Truvada is not a substitute for safe sex and people using the medication should consistently and correctly use condoms, test regular of HIV, continue to treat other sexually-transmitted infections and get counseling on risk reduction.

Researchers tested a daily dose of Truvada in two large clinical trials and the results showed significant reduction to the risk of HIV infection

In one study, the risk of HIV was lowered by 42 percent in about 2,500 HIV-negative gay and bisexual men and transgender women. In the second study, the risk of HIV was lowered by 75 percent in about 4,800 heterosexual couples in which one partner was HIV positive and the other was not.

The studies were sponsored National Institutes of Health and the University of Washington.

Researchers said the side effects of Truvada were "mild and reversible with discontinuation of the medication." The most common side effects reported with Truvada included diarrhea, nausea, abdominal pain, headache, and weight loss. However, people taking the medication with a history of bone or kidney ailments should be regularly monitored to ensure their continued health.

About 1.2 million Americans have HIV. The body's immune system is devastated by AIDS, leaving those who have it vulnerable to deadly infections. Each year, about 50,000 adults and adolescents in the U.S. are newly diagnosed with HIV. The overall rate of HIV infection has remained stable at least since 2004.

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