Merck announced that FDA has approved Zepatier (elbasvir and grazoprevir) following priority review by the FDA. Zepatier (pronounced ZEP-ah-teer) is a once-daily, fixed-dose combination tablet containing the NS5A inhibitor elbasvir (50 mg) and the NS3/4A protease inhibitor grazoprevir (100 mg). Across multiple clinical studies, Zepatier achieved high rates of sustained virologic response ranging from 94 to 97 percent in GT1-infected patients, and 97 to 100 percent in GT4-infected patients. Sustained virologic response is defined as HCV RNA levels measuring less than the lower limit of quantification at 12 weeks after the cessation of treatment (SVR12), indicating that a patient’s HCV infection has been cured.

Indication: Zepatier is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated with or without ribavirin for treatment of chronic HCV genotypes 1 or 4 infection in adults.

Adverse Reactions: In subjects receiving Zepatier for 12 weeks, the most commonly reported adverse reactions of all intensity were fatigue, headache, and nausea. In subjects receiving Zepatier with ribavirin for 16 weeks, the most commonly reported adverse reactions of moderate or severe intensity were anemia and headache.

Citation: Merck receives FDA approval of Zepatier (elbasvir and grazoprevir) for the treatment of chronic hepatitis C virus genotype 1 or 4 infection in adults following priority review. [news release]. Kenilworth, NJ: Merck; January 28, 2016. http://www.mercknewsroom.com/news-release/prescription-medicine-news/merck-receives-fda-approval-zepatier-elbasvir-and-grazoprevi. Accessed February 1, 2016.