Sofosbuvir/Velpatasvir in Chronic Hepatitis C, Compensated and Decompensated Cirrhosis, and Retreatment Settings

Objective Sofosbuvir/velpatasvir (SOF/VEL) has been approved for various stages of hepatitis C virus (HCV) infection; however, real-world data on Japanese patients remain limited. We evaluated the efficacy of SOF/VEL treatment in Japanese patients with chronic hepatitis, compensated cirrhosis, decompensated cirrhosis, and direct-acting antiviral (DAA) retreatment. Methods This multicenter prospective study enrolled 236 patients treated with SOF/VEL (with ribavirin for retreatment) at 21 Japanese institutions (chronic hepatitis, n=35; compensated cirrhosis, n=43; decompensated cirrhosis, n=134; undergoing DAA retreatment, n=24). The primary outcome was the sustained virologic response (SVR) rate at 24 weeks post-treatment (SVR24). In decompensated cirrhosis, liver function changes were assessed using the modified albumin-bilirubin (ALBI) score. Results The overall SVR24 rate was 97%, with SVR24 achieved in 100% of the patients with chronic hepatitis and compensated cirrhosis, 96% of those with decompensated cirrhosis, and 92% of those undergoing DAA retreatment. In the decompensated cirrhosis group, a significant improvement in the modified ALBI scores was observed from baseline to SVR24, and this improvement was sustained for two years after treatment. The proportion of patients with modified ALBI grades 1 or 2a increased from 5.2% at baseline to 23% at the end of treatment, 31% at SVR12, 35% at SVR24, 37% at 1 year, and 44% at 2 years post-treatment. Conclusion SOF/VEL has demonstrated high efficacy in all stages of hepatitis C, including patients with chronic hepatitis, compensated cirrhosis, decompensated cirrhosis, and prior DAA failure. The ability to achieve high efficacy at any stage of chronic hepatitis C is expected to improve the prognosis for a wide range of patients.