FDA Approves New Drug to Treat HIV-1Last Updated: August 13, 2013. Tivicay (dolutegravir) has been approved by the U.S. Food and Drug Administration to treat infection with HIV-1, a strain of the virus that causes AIDS.
TUESDAY, Aug. 13 (HealthDay News) -- Tivicay (dolutegravir) has been approved by the U.S. Food and Drug Administration to treat infection with HIV-1, a strain of the virus that causes AIDS.
The drug, among a class called integrase strand transfer inhibitors, interferes with an enzyme that HIV needs to multiply. It's been approved in combination with other antiretroviral drugs and for people aged 12 and older who weigh at least 40 kilograms (approximately 88 pounds), the FDA said in a news release.
Some 50,000 Americans acquire HIV infection each year, and about 15,500 people died from the disease in 2010, the agency said, citing the U.S. Centers for Disease Control and Prevention.
The drug's safety and effectiveness were evaluated in clinical studies involving more than 2,500 adults and children, the FDA said. The most common side effects included difficulty sleeping and headache as well as more serious problems, including allergic-like reactions and abnormal liver function in people who had hepatitis B or C.
Tivicay is produced by GlaxoSmithKline, based in Research Triangle Park, N.C.
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