The FDA has approved Zepatier (elbasvir and grazoprevir) for the treatment of patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adults. Zepatier can be used with or without ribavirin.

“[This] approval provides another oral treatment option for patients with genotypes 1 and 4 HCV infections without requiring use of interferon,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Zepatier’s safety and efficacy was evaluated in a series of clinical trials that included 1,373 participants with chronic HCV genotype 1 or 4 infections with and without cirrhosis. Participants were treated with Zepatier with or without ribavirin once daily for 12 or 16 weeks. The studies’ primary end point was a sustained virologic response 12 weeks after finishing treatment.

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Results indicated that 94% to 97% of patients with genotype 1 infections and 97% to 100% of patients with genotype 4 infections had sustained virologic responses.

The most common side effects experienced by patients taking Zepatier alone were fatigue, headache, and nausea. The most common side effects experienced by patients taking Zepatier with ribavirin were anemia and headache.

Healthcare providers should note that approximately 1% of participants in clinical trials experienced an increase of liver enzymes to greater than 5 times the upper limit of normal. Thus, liver-related blood tests should be performed prior to patients starting therapy and periodically during treatment. Patients with moderate or severe liver impairment should not be treated with Zepatier.