Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; elbasvir/grazoprevir: 50 mg/100 mg) |
| Drug Class | Hepatitis C virus (HCV) NS5A inhibitors and hepatitis C virus (HCV) NS3/4A protease inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for treatment of chronic HCV genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg
- Indicated for use with ribavirin in certain patient populations.
Latest News
Summary
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- End-of-Treatment Response (ETR): Grazoprevir plus elbasvir (Zepatier) significantly improved ETR compared to placebo (relative risk (RR) 174.99, 95% confidence interval (CI) 11.03 to 2775.78; low certainty), while standard interferon likely improves ETR over placebo or control (RR 8.62, 95% CI 3.03 to 24.55; moderate certainty), and PEG interferon may improve ETR compared to standard interferon (RR 1.53, 95% CI 1.09 to 2.15; low certainty).
- Sustained Virological Response (SVR): In HIV/HCV co-infected patients, grazoprevir-elbasvir +/- ribavirin achieved an SVR rate of 95.6% (95% CrI, 91.7-98.1%). PEG (pegylated) interferon plus ribavirin may improve SVR compared to PEG interferon alone (RR 1.80, 95% CI 1.46 to 2.21; low certainty).
- Relapse Rates: PEG interferon plus ribavirin may reduce relapse rates compared to PEG interferon alone (RR 0.33, 95% CI 0.23 to 0.48; low certainty).
- Adverse Events (AEs): Among 1743 participants treated with grazoprevir plus elbasvir (Zepatier) for 12 weeks, 61.3% experienced at least one AE, with drug-related AEs in 28.2% of cases. Common AEs included headache (10.6%), fatigue (8.7%), nasopharyngitis (5.8%), nausea (5.1%), and diarrhea (5.0%). Serious AEs occurred in 2.1% of participants, and 0.7% discontinued due to AEs.
- Comparison in Specific Populations: Adverse event profiles were similar in participants with comorbidities, such as CKD stage 4/5, inherited blood disorders, and those on opioid agonist therapy, as well as among HIV/HCV co-infected patients, showing no significant safety differences compared to those receiving placebo.
- Safety and effectiveness outcomes for grazoprevir plus elbasvir (Zepatier) were consistent across populations with chronic kidney disease (CKD) stage 4/5, inherited blood disorders (IBLD), those on opioid agonist therapy (OAT), and HIV/HCV co-infected patients, showing similar safety profiles compared to placebo and an SVR rate of 95.6% (95% credible interval (CrI), 91.7-98.1%) in HIV/HCV co-infected individuals.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Zepatier (elbasvir and grazoprevir) Prescribing Information. | 2016 | Merck Sharp & Dohme LLC Rahway, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Interventions for dialysis patients with hepatitis C virus (HCV) infection | 2023 | The Cochrane Database of Systematic Reviews, |
| Safety and tolerability of elbasvir/grazoprevir in chronic hepatitis C virus therapy: Integrated analysis from clinical trials | 2020 | Journal of Viral Hepatitis |
| Efficacy and safety of direct acting antiviral regimens for hepatitis C virus and human immunodeficiency virus co-infection: systematic review and network meta-analysis | 2020 | Journal of Gastroenterology and Hepatology |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| KDIGO 2022 clinical practice guideline update for the prevention, diagnosis, evaluation, and treatment of hepatitis C in chronic kidney disease. | 2022 | Kidney Disease – Improving Global Outcomes |
| APASL clinical practice recommendation: how to treat HCV-infected patients with renal impairment? | 2019 | Hepatology International |