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Zepatier (ELBASVIR)
Zepatier works by blocking the NS5A protein of the hepatitis C virus, preventing it from replicating.
Zepatier (elbasvir) is a small molecule Hepatitis C Virus NS5A Inhibitor developed by Merck Sharp Dohme. It was approved by the FDA in 2016 for the treatment of chronic hepatitis C. Zepatier works by inhibiting the NS5A protein of the hepatitis C virus, preventing the virus from replicating. The commercial status of Zepatier is patented, and it is not yet off-patent. Key safety considerations include potential interactions with other medications and monitoring for liver function.
At a glance
| Generic name | ELBASVIR |
|---|---|
| Sponsor | Merck & Co. |
| Drug class | Hepatitis C Virus NS5A Inhibitor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2016 |
Mechanism of action
ZEPATIER is fixed-dose combination of elbasvir and grazoprevir which are direct-acting antiviral agents against the hepatitis virus [see Microbiology (12.4)].
Approved indications
- Chronic hepatitis C
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
- Nausea
- Insomnia
- Diarrhea
- Anemia
- Dyspnea
- Rash or Pruritus
- Irritability
- Abdominal pain
- Depression
- Arthralgia
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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
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
- Merck & Co. portfolio CI