Last reviewed · How we verify
Elbasvir/Grazoprevir Fixed Dose Combination
Elbasvir and grazoprevir are hepatitis C virus (HCV) NS5A inhibitor and NS3/4A protease inhibitor, respectively, that work together to block viral replication.
Elbasvir and grazoprevir are hepatitis C virus (HCV) NS5A inhibitor and NS3/4A protease inhibitor, respectively, that work together to block viral replication. Used for Chronic hepatitis C virus infection (genotype 1, 4, 5, 6).
At a glance
| Generic name | Elbasvir/Grazoprevir Fixed Dose Combination |
|---|---|
| Sponsor | University Hospital, Clermont-Ferrand |
| Drug class | HCV direct-acting antiviral combination (NS5A inhibitor + NS3/4A protease inhibitor) |
| Target | HCV NS5A protein and HCV NS3/4A serine protease |
| Modality | Small molecule |
| Therapeutic area | Virology / Hepatology |
| Phase | Phase 3 |
Mechanism of action
Elbasvir inhibits the HCV NS5A protein, which is essential for viral RNA replication and virion assembly. Grazoprevir inhibits the HCV NS3/4A serine protease, which is required for processing of the HCV polyprotein. Together, this dual mechanism prevents HCV replication and allows viral clearance.
Approved indications
- Chronic hepatitis C virus infection (genotype 1, 4, 5, 6)
Common side effects
- Headache
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- Zepatier in Patients with Substance Use
- Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naïve, HCV-Infected Patients (PHASE3)
- Real World Experience of Chronic Hepatitis C (CHC) Treatment in Israel
- Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) With or Without Ribavirin for Participants With Hepatitis C Genotype 1, 4, or 6 Infections Who Have Failed Prior Treatment With Pegylated Interferon + Ribavirin (MK-5172-068) (PHASE3)
- An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus:C-EDGE CO-INFXN (MK-5172-061) (PHASE3)
- Eight Weeks of Elbasvir/Grazoprevir in the Treatment of HCV Genotype 4 (PHASE3)
- Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, With Non-severe Fibrosis (PHASE3)
- Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant (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: