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Glecaprevir and pibrentasvir

(Mavyret®)

Mavyret®

Drug updated on 9/4/2024

Dosage FormTablet (oral; 100 mg glecaprevir and 40 mg pibrentasvir); Pellet (oral; 50 mg glecaprevir and 20 mg pibrentasvir)
Drug ClassHCV 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.

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Summary
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  • 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.