Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis.

Abstract

Background/Aims\nReal-world studies assessing the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) plus ribavirin (RBV) for Child-Pugh B/C hepatitis C virus (HCV)-related cirrhosis are limited.\n\n\nMethods\nWe included 107 patients with Child-Pugh B/C HCV-related cirrhosis receiving SOF/VEL plus RBV for 12 weeks in Taiwan. The sustained virologic response rates at off-treatment week 12 (SVR12) for the evaluable population (EP), modified EP, and per-protocol population (PP) were assessed. The safety profiles were reported.\n\n\nResults\nThe SVR12 rates in the EP, modified EP and PP were 89.7% (95% confidence interval (CI): 82.5%-94.2%), 94.1% (95% CI: 87.8%-97.3%), and 100% (96 of 96 patients; 95% CI: 96.2%-100%). No patients who failed to achieve SVR12 were attributed to virologic failures. The SVR12 rates were comparable regardless of patient characteristics. One patient discontinued treatment because of adverse events (AEs). Twenty-four patients had serious AEs and six died, but none were related to SOF/VEL or RBV. Among the 96 patients achieving SVR12, 84.4% and 64.6% had improved Child-Pugh and Model for End-Stage Liver Disease (MELD) scores. Multivariate analysis revealed that a baseline MELD score ≥ 15 was associated with an improved MELD score of ≥ 3 (odds ratio (OR): 4.13, 95% CI: 1.16-14.71; p = 0.02). Patients with chronic kidney disease (CKD) stage 1 had more significant estimated glomerular filtration rate (eGFR) declines than patients with CKD stage 2 (-0.42 mL/min/1.73m2/month; p = 0.01) or stage 3 (-0.56 mL/min/1.73m2/month; p < 0.001).\n\n\nConclusions\nSOF/VEL plus RBV for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related cirrhosis.