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Merck's HIV drug gets US FDA approval

The U.S. FDA approved Merck & Co. Inc.'s Isentress HD for treating HIV-1 infection in adult and pediatric patients in combination with other anti-retroviral agents.

Isentress HD is a new 1,200-milligram, once-daily dose of the company’s integrase inhibitor, Isentress, for patients weighing at least 40 kilograms who have not received prior treatment or whose virus has been suppressed on an initial regimen of Isentress 400 milligrams given twice daily.

The approval of Isentress HD was supported by the results of a pivotal phase 3 study that showed that 89% of treatment-naive patients who received the drug achieved viral suppression of HIV-1 RNA, or viral load, of less than 40 copies per milliliter, compared to 88% of patients receiving Isentress 400 milligrams twice a day, each in combination therapy with emtricitabine + tenofovir disoproxil fumarate.

Merck expects the drug to be available in pharmacies in about four weeks.