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.