-- Scott Roberts
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,
headache and more serious problems including allergic-like
reactions and abnormal liver function in people who had hepatitis B
Tivicay is produced by GlaxoSmithKline, based in Research
Triangle Park, N.C.
The U.S. Department of Health and Human Services's
has more about HIV/AIDS.
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