FDA Approves ZEPATIER for the Treatment of Chronic Hepatitis C Infection

On January 28, 2016, the United States Food and Drug Administration (FDA) approved Zepatier (elbasvir and grazoprevir) for the treatment of chronic genotype 1 or 4 hepatitis C virus (HCV) infection in adults. 

FDA says that the approved recommended dosage of Zepatier is one tablet taken orally once daily with or without food for 12 weeks. In genotype 1a patients with certain baseline NS5A polymorphisms or genotype 4 patients who have failed prior treatment with peginterferon alpha (PegIFN) and ribavirin (RBV), Zepatier should be administered for 16 weeks in combination with RBV. In genotype 1 patients who have failed treatment with PegIFN, RBV, and an HCV NS3/4A protease inhibitor (boceprevir, simeprevir or telaprevir), Zepatier should be administered for 12 weeks in combination with RBV. Each Zepatier tablet contains 50 mg of elbasvir and 100 mg of grazoprevir.