Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 100 mg glecaprevir and 40 mg pibrentasvir); Pellet (oral; 50 mg glecaprevir and 20 mg pibrentasvir) |
Drug Class | HCV NS3/4A protease inhibitor and HCV NS5A inhibitor |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult and pediatric patients 3 years and older with chronic HCV genotype (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A).
- Indicator for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both.
Latest News
Summary
- Mavyret (glecaprevir and pibrentasvir) is indicated for the treatment of adult and pediatric patients 3 years and older with chronic HCV genotype (GT) 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). It is also indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who were previously treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both.
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- The meta-analysis of 34 studies involving 7,328 patients reported an overall pooled SVR rate of 92.07% (95% CI: 90.39-93.61%). SVR rates varied by regimen, with GLE+PIB achieving 98.54% (95% CI: 96.40-99.82%), while SOF+VEL+VOX had the lowest at 84.97% (95% CI: 73.32-93.91%).
- In a pooled analysis of 14 studies with 1,294 subjects, the overall SVR12 rate was 96.8% (95% CI: 95.1-98.2%), with subgroup rates ranging from 91.1% (95% CI: 87.3-94.3%) in the United States to 100% (95% CI: 99.6-100%) for GT2 patients.
- Across 21 phase III clinical trials including 4,817 patients, the overall SVR12 rate was 97.5%, with SVR12 rates exceeding 95% in all patient subgroups.
- Adverse events (AEs) were reported in 47.1% (95% CI: 26.0-69.3%) to 64.1% of patients.
- Serious adverse events (SAEs) were reported at a rate of 1.8% (95% CI: 0.7-3.4%) to <0.1%, with serious drug-related adverse events being rare.
- Subgroups considered include non-cirrhotic vs. cirrhotic patients, treatment-naive vs. treatment-experienced patients, geographic regions (Japan vs. United States), HCV genotypes (GT1, GT2, GT3, GT4-6), treatment duration, HIV co-infection, and severe renal impairment; key findings indicate higher SVR rates in non-cirrhotic, treatment-naive, GT2 patients, those from Japan, and patients with HIV co-infection or severe renal impairment.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Mavyret (glecaprevir and pibrentasvir) Prescribing Information. | 2023 | AbbVie Inc., North Chicago, IL |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Real-world effectiveness of direct-acting antiviral regimens against hepatitis C virus (HCV) genotype 3 infection: a systematic review and meta-analysis. | 2021 | Annals of Hepatology |
Efficacy and safety of glecaprevir/pibrentasvir in HCV patients with previous direct-acting antiviral therapy failures: a meta-analysis. | 2020 | Frontiers in Medicine |
Efficacy and safety of glecaprevir/pibrentasvir for chronic hepatitis C patients: a systematic review and meta-analysis. | 2020 | Journal of Clinical and Translational Hepatology |
Efficacy and safety of glecaprevir/pibrentasvir for chronic hepatitis C virus genotypes 1–6 infection: A systematic review and meta-analysis. | 2019 | International Journal of Antimicrobial Agents |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Clinical practice guidance for testing, managing, and treating hepatitis C virus infection: 2023 update by AASLD-IDSA. | 2023 | Clinical Infectious Diseases |
Hepatitis C management in primary care has changed. | 2019 | Better Practice Advocacy Centre New Zealand |
Management of chronic hepatitis C in adults: clinical practice guidelines. | 2019 | Ministry of Health Malaysia |