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HIV & AIDS Health Center

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New HIV Drug Approved by FDA

WebMD News from HealthDay

A new drug to treat HIV infection was approved by the U.S. Food and Drug Administration on Monday.

Marketed as Tivicay, the medication interferes with an enzyme that is essential to the ability of the HIV virus to multiply and spread within the human body, the agency said in a news release. It is a pill that is to be taken once a day with other HIV drugs, according to the FDA.

"HIV-infected individuals require treatment regimens personalized to fit their condition and their needs," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in the release. "The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA."

Approved for use in both people who have been diagnosed with HIV but have never taken medications to treat the virus and in those who have taken other HIV drugs, Tivicay (dolutegravir) is also approved for certain children under the age of 12.

The approval was based on the results of five clinical trials involving more than 2,500 patients. Insomnia and headaches were common side effects of the medication, along with hypersensitivity and abnormal liver function in HIV patients who have also been diagnosed with hepatitis B and/or C, the agency said in the release.

Almost 50,000 Americans are infected with HIV every year, according to the U.S. Centers for Disease Control and Prevention, and more than 15,000 died of the disease in 2010.

Tivicay is made by GlaxoSmithKline, based in Research Triangle Park, N.C., according to the FDA.

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