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 direct-acting antiviral (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.
• 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 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.