Abstract

Simplified (“minimal monitoring”) pathways can expand access to direct-acting antivirals (DAAs) by reducing visit burden. In Japan, where hepatitis C virus (HCV) patients are among the oldest worldwide, whether DAA regimens can be delivered safely and effectively with fewer visits remains unclear, and real-world outcomes with sofosbuvir/velpatasvir are scarce. We evaluated effectiveness, safety, and visit frequency in a multicenter cohort. Sixty patients with HCV-infection, with or without compensated liver cirrhosis, received 12 weeks of sofosbuvir/velpatasvir with follow-up to sustained virologic response at 12 weeks post-treatment (SVR12). The visit number was set with no schedule and analyzed post hoc (≤ 3 vs. ≥4 visits). There were 1–8 outpatient visits (median 3). SVR12 was 96.7% by intention-to-treat (ITT; 58/60; 95% CI, 88.6–99.6) and 100% per protocol (57/57; 95% CI, 90.0–100.0). Cure rates were comparable (ITT 95.8–97.2% for ≤ 3 vs. ≥4 visits; p = 1.00; PP 100% in both). Sofosbuvir/velpatasvir was well-tolerated: adverse events were recorded in 10%, none grade ≥ 3, no treatment-related serious events, and no toxicity-related discontinuations. Two patients were lost to follow-up; one who discontinued treatment achieved SVR12. This is the first Japanese real-world evaluation of DAA under simplified monitoring and supports low-burden pathways with high efficacy and safety.

Credit: Suda et al., Scientific Reports, 15, 42628 (2025), https://doi.org/10.1038/s41598-025-26891-4. © The Author(s) 2025. Licensed under CC BY-NC-ND 4.0.