ZEPATIER is a fixed-dose combination of elbasvir and grazoprevir which are direct-acting antiviral agents against the hepatitis C virus

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 r bavirin for treatment of chronic HCV genotypes 1 or 4 infection in adults.

Testing prior to initiation:
• Genotype 1a: Testing for the presence of virus with NS5A resistance-associated polymorphisms is recommended.
• Obtain hepatic laboratory testing.
• Recommended dosage: One tablet taken orally once daily with or without food See package insert for complete information.

In subjects receiving ZEPATIER for 12 weeks, the most commonly reported adverse reactions of all intensity (greater than or equal to 5% in placebo-controlled trials) 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 (greater than or equal to 5%) were anemia and headache.

• Patients with moderate or severe hepatic impairment (Child-Pugh B or C).
• OATP1B1/3 inhibitors, strong CYP3A inducers, and efavirenz.
• If ZEPATIER is administered with ribavirin, the contraindications to r bavirin also apply.

• ALT elevations: Perform hepatic laboratory testing prior to therapy, at treatment week 8, and as clinically indicated. For patients receiving 16 weeks of therapy, perform additional hepatic laboratory testing at treatment week 12. For ALT elevations on ZEPATIER, follow recommendations in full prescribing information.
• Risk associated with r bavirin combination treatment: If ZEPATIER is administered with r bavirin, the warnings and precautions for ribavirin also apply.