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News From the Food and Drug Administration
March 15, 2016

Combination Treatment for HCV

JAMA. 2016;315(11):1101. doi:10.1001/jama.2016.2070

A new fixed-dose combination medication for adults with chronic hepatitis C virus (HCV) genotype 1 or 4 infections has gained FDA approval. Of the estimated 3 million people with HCV infection in the United States, genotype 1 is the most common and genotype 4 is among the least common (http://1.usa.gov/1ZXciW4).

Elbasvir and grazoprevir, marketed as Zepatier, is taken orally once daily with or without ribavirin. The drug’s safety and efficacy with or without ribavirin were evaluated in 6 clinical studies that included 1373 patients who had chronic HCV genotype 1 or 4 infections with or without cirrhosis. The studies were designed to determine whether patients still had detectable virus levels in their blood 12 weeks after completing treatment.

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