Last reviewed 2026-04-20 · How we verify

Zepatier

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with ZEPATIER. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HB

Common side effects

• Fatigue
• Headache
• Nausea
• Insomnia
• Diarrhea
• Anemia

Serious adverse events

• Serious adverse reactions (ZEPATIER with ribavirin for 16 weeks)

Key clinical trials

• Pembrolizumab (MK-3475) in Hepatocellular Carcinoma (PHASE2)
• Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients. (PHASE3)
• Zepatier in Patients with Substance Use
• HCV Treatment Immune Response With Grazoprevir/Elbasvir Before or After Renal Transplant (PHASE4)
• Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients (PHASE1, PHASE2)
• Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079) (PHASE2)
• Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication (PHASE4)
• ATTIC - Access To Treat in the Community (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Zepatier CI brief — competitive landscape report
• Zepatier updates RSS · CI watch RSS
• Mater Misericordiae University Hospital portfolio CI