HealthDay News — The FDA has approved dolutegravir (Tivicay, GlaxoSmithKline) to treat HIV-1 infection in combination with other antiretroviral drugs.

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

Some 50,000 Americans acquire HIV infection each year, and about 15,500 people died from the disease in 2010, CDC data indicate. 

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Dolutegravir belongs to a class of medications called integrase strand transfer inhibitors, which interfere with an enzyme that HIV needs to multiply. It is specifically indicated in treatment-naïve and in treatment-experienced adults, including those who have been treated with other integrase strand transfer inhibitors. Dolutegravir is also approved in children >12 years weighing >40kg who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors.

Dolutegravir’s approval was based on safety and effectiveness data from clinical studies involving 2,539 adults and children. Study results showed that dolutegravir-containing regimens were effective in viral load reduction.

A fifth trial established the pharmacokinetics, safety and activity of the drug as part of treatment regimens in children >12 years old weighing >40kg who have not previously taken integrase strand transfer inhibitors.

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 with hepatitis B or C.

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