Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection: Real‐world effectiveness and safety in Taiwan

摘要

Abstract Background & Aims Large‐scale data regarding the real‐world effectiveness and safety of glecaprevir/pibrentasvir (GLE/PIB) for patients with chronic hepatitis C virus (HCV) infection were limited in East Asia. We aimed to evaluate the clinical performance of GLE/PIB in different HCV populations in Taiwan. Methods A total of 658 chronic HCV patients with compensated liver diseases receiving GLE/PIB for 8 (n?=?549), 12 (n?=?103) or 16 (n?=?6) weeks were retrospectively enrolled. The effectiveness was determined by sustained virologic response at off‐therapy 12?weeks (SVR 12 ). Patient characteristics potentially related to SVR 12 and the safety profiles were also assessed. Results By evaluable population (EP) and per‐protocol (PP) analyses, the overall SVR 12 rate was 98.2% (95% confidence interval (CI): 96.8%‐99.0%) and 99.4% (95% CI: 98.4%‐99.8%). The SVR 12 rates were 98.9% (95% CI: 97.6%‐99.5%), 94.2% (95% CI: 87.9%‐97.3%) and 100% (95% CI: 60.1%‐100%) in patients receiving 8, 12 and 16?weeks of treatment respectively. A total of 656 (99.7%) patients completed the scheduled treatment. The SVR 12 rates were comparable regardless of baseline characteristics or week 4 viral decline. Twenty (3.0%) patients had serious adverse events (AEs), but none were not related to GLE/PIB. The two most common AEs were pruritus (7.8%) and fatigue (5.5%). Two (0.3%) and no patients had ≥3‐fold upper limit of normal (ULN) for total bilirubin and alanine aminotransferase (ALT) levels. Conclusions GLE/PIB for 8‐16?weeks is effective and well‐tolerated for patients with chronic HCV infection in Taiwan.