Drug updated on 5/17/2024
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
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Summary
- Glecaprevir and pibrentasvir (Mavyret) is indicated for the treatment of adult and pediatric patients 3 years and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis. It is also used in treating those who have previously been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor.
- Four systematic reviews/meta-analyses were reviewed to gather information about Mavyret. These studies provided comprehensive analysis on its safety and effectiveness across various genotypes, treatment histories, patient conditions as well as compared it to other direct-acting antiviral regimens.
- The first study highlighted that glecaprevir/pibrentasvir had a significantly higher sustained virologic response rate of around approximately 98.54%, outperforming alternative treatments especially among non-cirrhotic patients and those naive to treatment.
- In retreating HCV patients who had previously failed DAA therapies, Mavyret showed strong effectiveness according to the second study; it demonstrated a high pooled SVR12 rate of nearly 96.8% along with a favorable safety profile including a low incidence of severe adverse events.
- According to the third study which analyzed data from multiple phase III clinical trials, gleaned that glecaprevir/pibrentasvir consistently proved effective across diverse patient demographics showing an overall intention-to-treat SVR12 rate at 97.5%. Safety analysis reaffirmed a good safety profile with very few related serious adverse events reported.
- The fourth systematic review revealed impressive overall SVR12 rates nearing 97.8% for a wide spectrum of chronic HCV infections treated by glecaprevir/pibrentasvir emphasizing its efficacy across various genotypes, treatment durations, and patient conditions including those with comorbid HIV 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 |