FDA approves new GSK drug to treat HIV infection

WASHINGTON — The U.S. Food and Drug Administration on Monday approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection that is manufactured by GlaxoSmithKline.

Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs.

Tivicay is approved for use in a broad population of HIV-infected patients. It can be used to treat HIV-infected adults who have never taken HIV therapy (treatment-naïve) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors. Tivicay is also approved for children ages 12 years and older weighing at least 40 kilograms who are treatment-naïve or treatment-experienced, but have not previously taken other integrase strand transfer inhibitors.

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

About 50,000 Americans become infected with HIV each year and about 15,500 died from the disease in 2010, according to the Centers for Disease Control and Prevention.

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