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<p>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; <i>p</i> = 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.</p>

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Simplified monitoring of sofosbuvir/velpatasvir in Japanese patients with chronic hepatitis C based on a retrospective analysis of a prospective multicenter cohort

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月28日

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  • Goki Suda,
  • Masaru Baba,
  • Yoshiya Yamamoto,
  • Sonoe Yoshida,
  • Tetsuhito Muranaka,
  • Takashi Meguro,
  • Katsumi Terashita,
  • Jun Ito,
  • Tomoe Kobayashi,
  • Takaaki Izumi,
  • Tomofumi Takagi,
  • Shunichi Hosoda,
  • Ren Yamada,
  • Qingjie Fu,
  • Zijian Yang,
  • Daisuke Yokoyama,
  • Takatsugu Tanaka,
  • Akimitsu Meno,
  • Naohiro Yasuura,
  • Takashi Kitagataya,
  • Masatsugu Ohara,
  • Naoki Kawagishi,
  • Masato Nakai,
  • Takuya Sho,
  • Koji Ogawa,
  • Naoya Sakamoto

摘要

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.