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

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.

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Publication Details

Journal
Scientific Reports
Published
2025-11-28
DOI
https://doi.org/10.1038/s41598-025-26891-4
Primary Topic
Hepatitis C virus research
Type
article
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article

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

Naoya Sakamoto, Naohiro Yasuura, Shunichi Hosoda, Naoki Kawagishi et al.
Scientific Reports
Hepatitis C virus research
article

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

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

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.

Scientific ReportsVol. 15(1)
Hokkaido Information University (JP), Hokkaido University (JP), NTT Medical Center (JP), National Hospital Organization Hokkaido Medical Center (JP), Kushiro Rosai Hospital (JP), Hokkaido hospital (JP), Wakkanai Hokusei Gakuen College (JP), Hokkaido University Hospital (JP), Sapporo City General Hospital (JP), National Institute of Technology, Tomakomai College (JP), Hakodate National Hospital (JP)
Gilead Sciences, Japan Agency for Medical Research and Development, Soochow University
Openalex Percentile: Top 51%
Hepatitis C virus research
DOIOpen Access PDFOpenAlex
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