FDA Approves Zepatier for Treatment of Hep C

The U.S. Food and Drug Administration has approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic Hepatitis C genotypes 1 and 4 infections in adult patients.

The safety and efficacy of Zepatier with or without ribavirin was evaluated in clinical trials of 1,373 participants with chronic HCV genotype 1 or 4 infections with and without cirrhosis. The participants received Zepatier with or without ribavirin once daily for 12 or 16 weeks.

The overall SVR (cure) rates ranged from 94-97 percent in genotype 1-infected subjects and from 97-100 percent in genotype 4-infected subjects across trials for the approved treatment regimens.

The cost of Zepatier has been announced at $54,600  for a 12-week regimen.

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