Drug updated on 10/30/2024
Dosage Form | Tablet (oral; 100 mg glecaprevir and 40 mg pibrentasvir); Pellet (oral; 50 mg glecaprevir and 20 mg pibrentasvir) |
Drug Class | Hepatitis 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
Summary
- 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 Title | Year | Source |
---|---|---|
Mavyret (glecaprevir and pibrentasvir) Prescribing Information. | 2023 | AbbVie Inc., North Chicago, IL |
Systematic Reviews / Meta-Analyses
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 |