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FDA Approves Zepatier for Treatment of Chronic HCV

Genotypes 1 and 4 infections targeted

The US Food and Drug Administration (FDA) approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.

Indications: Zepatier is a fixed-dose combination production 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 and 4 infection in adults.

Dosage/Administration: Recommended dosage is 1 tablet taken orally once daily with our without food for either 12 or 16 weeks. Tablets are 50 mg elbasvir and 100 mg grazoprevir. Testing prior to initiation:

• Genotype 1a includes: testing for the presence of virus with NS5A resistance-associated polymorphisms is recommended.

• Obtain hepatic laboratory testing.

Adverse reactions: In subjects receiving Zepatier for 12 weeks, the most commonly reported adverse reactions of all intensity (≥5% in placebo-controlled trials) were fatigue, headache, and nausea. In subjects receiving Zepatier for 16 weeks, the most commonly reported adverse reactions of moderate to severe intensity were anemia and headache.

Citation: US Food and Drug Administration. FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4. FDA Web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm483828.htm. Accessed February 1, 2016.

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FDA Approves Zepatier for Treatment of Chronic HCV, Genotypes 1 and 4 infections targeted