Safety and Effectiveness of Glecaprevir/Pibrentasvir in Children and Adolescents With Chronic Hepatitis C: Reports From All‐Case Post‐Marketing Surveillance in Japan

AIM: The aim of this all-case post-marketing study was to evaluate the real-world safety and effectiveness in all children and adolescents with chronic hepatitis C with or without compensated cirrhosis treated with glecaprevir/pibrentasvir (G/P) in Japan. METHODS: This prospective, observational post-marketing surveillance study was conducted at 67 medical institutions from 2019 to 2024. Eligible patients were aged 3 to < 18 years (children: 3 to < 12 years; and adolescents: 12 to < 18 years), with chronic Hepatitis C virus (HCV) infection with or without compensated cirrhosis. Patients were treated with G/P for 8 or 12 weeks and followed-up for 24 weeks. The primary endpoints included adverse drug reactions (ADRs) and serious adverse events (AEs). The secondary endpoints included sustained virologic response at 12 weeks after treatment completion (SVR12). RESULTS: None of the 103 patients had compensated cirrhosis or prior exposure to direct-acting antiviral therapy; the majority had either genotype 1/serogroup 1 or genotype 2/serogroup 2 HCV infections. All children (100.0%, 26/26) and most adolescents (97.4%, 75/77) completed G/P treatment; the two adolescents discontinued owing to pregnancy/transfer and insufficient drug administration. No AEs led to treatment discontinuation. No serious AEs were observed. ADRs did not occur in children (0.0%, 0/26) but occurred in nine adolescents (11.7%, 9/77). Post-treatment virologic failure (relapse) was observed in one child and no adolescents, and the remaining children (96.2%, 25/26) and all adolescents (100%, 66/66) achieved SVR12. CONCLUSIONS: Our real-world findings suggest that G/P is a potentially safe and efficacious treatment option for children and adolescents with chronic HCV infection. Further data on patients with compensated cirrhosis and long-term post-SVR outcomes would be valuable.