Drug updated on 4/26/2024
| Dosage Form | Tablet (oral; elbasvir/grazoprevir: 50 mg/100 mg) |
| Drug Class | Antivirals |
| 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.
Summary
- Elbasvir and grazoprevir (Zepatier) is indicated for the treatment of chronic HCV genotype 1 or 4 infection in patients aged 12 years and older, or weighing at least 30 kg. It can also be used with ribavirin in certain populations.
- Three studies provided information on Zepatier's effectiveness and safety, focusing on patients with chronic kidney disease (CKD) on dialysis, HIV/HCV co-infected patients, as well as those with comorbidities.
- For CKD patients on dialysis, elbasvir/grazoprevir significantly improved end-of-treatment response compared to placebo. However, data was insufficient regarding sustained virological response (SVR), a critical endpoint for this group.
- In HIV/HCV co-infected individuals, elbasvir/grazoprevir showed one of the highest SVR rates among various all-oral DAA therapies, making it an optimal choice due to excellent treatment effects and insignificant adverse events.
- Safety data from clinical trials indicates that the elbasvir/grazoprevir combination is generally safe for adults with HCV infection, including those having challenging comorbidities like CKD stages 4/5 or inherited blood disorders; however, adding ribavirin increases the frequencies of common side effects such as fatigue, headache, and nausea.
- The studies indicate variations in effectiveness across treatments like standard interferon, pegylated interferon combinations with ribavirin, but overall suggest that Zepatier has a favorable safety profile even in populations with additional health challenges.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Zepatier (elbasvir and grazoprevir) prescribing information. | 2022 | 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 |
| 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 |
| Safety and tolerability of elbasvir/grazoprevir in chronic hepatitis C virus therapy: integrated analysis from clinical trials. | 2020 | Journal of Viral Hepatitis |
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 |