Glecaprevir and pibrentasvir

(Mavyret®)

Glecaprevir and pibrentasvir

Drug updated on 10/30/2024

Dosage FormTablet (oral; 100 mg glecaprevir and 40 mg pibrentasvir); Pellet (oral; 50 mg glecaprevir and 20 mg pibrentasvir)
Drug ClassHepatitis C virus (HCV) NS3/4A protease inhibitors and HCV NS5A inhibitors
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)
  • Indicated 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
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  • This summary is based on the review of 12 systematic review(s)/meta-analysis(es). [1-12]
  • Glecaprevir plus Pibrentasvir (G/P) demonstrated consistently high sustained virological response at 12 weeks (SVR12) across multiple studies, with rates ranging from 96% to 100% in various populations, including chronic hepatitis C virus (HCV) genotype 2 patients (100%), end-stage renal disease patients (99.4%), and those with previous DAA therapy failures (96.8%).
  • Comparative effectiveness analyses indicated that G/P outperformed several other regimens in specific contexts. For instance, G/P achieved an SVR12 of 98.54% in HCV genotype 3 patients, compared to 84.97% with Sofosbuvir/Velpatasvir/Voxilaprevir (SOF+VEL+VOX).
  • G/P was highly effective across diverse populations, including adolescents, children, patients with HCV infection and end-stage renal disease, and those with varying genotypes and cirrhosis statuses. The regimen was especially effective in retreatment scenarios for patients who had experienced previous DAA therapy failures, achieving a pooled SVR12 of 96.8%.
  • The most common adverse events (AEs) for Glecaprevir plus Pibrentasvir (G/P) were fatigue (14.0%) and headache (13.1%), with serious AEs being uncommon. In pediatric populations, the overall rate of AEs increased with younger age, from 50% in adolescents to 72% in young children, though serious AEs remained rare (<1%, with 3% in young children).
  • In HCV-infected end-stage renal disease (ESRD) patients, G/P demonstrated a favorable safety profile with lower rates of AEs (49.9%) compared to other regimens. Grade ≥3 hepatic laboratory abnormalities were rare across studies, occurring in 0.8% of patients treated with G/P.
  • Hyperbilirubinemia was more frequent in patients with cirrhosis, while serious AEs and AEs leading to discontinuation occurred in less than 1% of patients. Alcohol use was identified as a risk factor for non-adherence, potentially affecting safety outcomes.
  • Glecaprevir plus Pibrentasvir (G/P) demonstrated high sustained virological response (SVR12) rates across various population subgroups, achieving 100% SVR12 in adolescents (95% CI: 96-100), 96% in older children (95% CI: 90-100), and 96% in young children (95% CI: 83-100). It was also highly effective in specific populations such as HCV-infected end-stage renal disease (ESRD) patients (pooled SVR12 of 99.4%, 95% CI: 98.6%-100%), Korean patients (98.9%), and in those who had previous direct-acting antiviral (DAA) therapy failures (96.8%, 95% CI: 95.1-98.2%). G/P consistently achieved high SVR12 rates across different genotypes, cirrhosis status, HIV co-infection, and renal impairment status.

Product Monograph / Prescribing Information

Document TitleYearSource
Mavyret (glecaprevir and pibrentasvir) Prescribing Information.2023AbbVie Inc., North Chicago, IL

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of direct-acting antiviral regimen for patients with hepatitis C virus genotype 2: a systematic review and meta-analysis2024BMC Gastroenterology
Efficacy and safety of DAA in children and adolescents with chronic HCV infection: A systematic review and meta-analysis2024Liver International
The efficacy and safety of direct-acting antiviral regimens for end-stage renal disease patients with HCV infection: a systematic review and network meta-analysis2023Frontiers in Public Health
Drug-induced liver injury by glecaprevir/pibrentasvir treatment for chronic hepatitis C infection: a systematic review and meta-analysis2022Annals of Medicine
Efficacy and Safety of Glecaprevir/Pibrentasvir in Korean Patients with Chronic Hepatitis C: A Pooled Analysis of Five Phase II/III Trials2021Gut and Liver
Real-World Effectiveness of Direct-Acting Antiviral Regimens against Hepatitis C Virus (HCV) Genotype 3 Infection: A Systematic Review and Meta-Analysis2021Annals of Hepatology
Efficacy and Safety of Glecaprevir/Pibrentasvir in HCV Patients With Previous Direct-Acting Antiviral Therapy Failures: A Meta-Analysis2020Frontiers in Medicine
Efficacy and Safety of Glecaprevir/Pibrentasvir for Chronic Hepatitis C Patients: A Systematic Review and Meta-analysis2020Journal of Clinical and Translational Hepatology
Eight Weeks of Treatment With Glecaprevir/Pibrentasvir Is Safe and Efficacious in an Integrated Analysis of Treatment-Naive Patients With Hepatitis C Virus Infection2020Clinical Gastroenterology and Hepatology
Systematic review with meta-analysis: impact of baseline resistance-associated substitutions on the efficacy of glecaprevir/pibrentasvir among chronic hepatitis C patients2020Alimentary Pharmacology & Therapeutics
Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials2020Liver International
Efficacy and safety of glecaprevir/pibrentasvir for chronic hepatitis C virus genotypes 1-6 infection: A systematic review and meta-analysis2019International Journal of Antimicrobial Agents

Clinical Practice Guidelines