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Gilead's hepatitis C drug gets US FDA approval for patients co-infected with HIV

The U.S. Food and Drug Administration approved updated labeling for Gilead Sciences Inc.'s Epclusa, a drug for adults with chronic hepatitis C virus infection, to include use in patients co-infected with HIV.

The supplemental new drug application was supported by data from a phase 3 study, which evaluated patients with genotype 1 to 4 hepatitis C virus infection who were co-infected with HIV and on stable antiretroviral therapy.

In the study, 95% of patients achieved the primary goal of an undetectable viral load 12 weeks after completing therapy.