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Elbasvir and Grazoprevir
ZEPATIER combines elbasvir and grazoprevir to directly act against hepatitis C virus.
At a glance
| Generic name | Elbasvir and Grazoprevir |
|---|---|
| Sponsor | University Hospital, Toulouse |
| Drug class | Hepatitis C Virus NS5A Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
Mechanism of action
ZEPATIER is a combination of two drugs, elbasvir and grazoprevir, which work together to inhibit the hepatitis C virus. These drugs are classified as direct-acting antiviral agents, meaning they target specific components of the virus to prevent it from replicating and spreading within the body.
Approved indications
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/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions (5.1) ]. WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV See full prescribing information for complete boxed warning. Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.1 )
Common side effects
- Fatigue
- Headache
- Fatigue
- Headache
- Nausea
- Insomnia
- Diarrhea
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.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Elbasvir and Grazoprevir CI brief — competitive landscape report
- Elbasvir and Grazoprevir updates RSS · CI watch RSS
- University Hospital, Toulouse portfolio CI