Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan

Chen Hua Liu, Po Yueh Chen, Jyh Jou Chen, Ching Chu Lo, Wei Wen Su, Kuo Chih Tseng, Chun Jen Liu, Chia Sheng Huang, Ke Jhang Huang, Sheng Shun Yang, Cheng Yuan Peng, Ming Chang Tsai, Wei Yu Kao, Chi Yang Chang, Yu Lueng Shih, Yu Jen Fang, Chi Yi Chen, Pei Lun Lee, Jow Jyh Huang, Pei Yuan SuChi Wei Tseng, Chien Ching Hung, Chung Hsin Chang, Yi Jie Huang, Hsueh Chou Lai, Chun Chao Chang, Fu Jen Lee, Tsai‐Yuan ‐Y Hsieh, Jia Horng Kao

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) for East Asian patients with chronic hepatitis C virus (HCV) infection and compensated liver disease are limited. We evaluated the performance of SOF/VEL for 12 weeks for HCV-infected patients with compensated liver disease in a large real-world cohort in Taiwan. Methods: Between July 2019 and March 2020, 1880 HCV-infected patients with compensated liver disease who received SOF/VEL 400/100 mg once daily for 12 weeks were included at 15 academic centers in Taiwan. The sustained virologic response at off-treatment week 12 (SVR12) was assessed for evaluable (EP) and per-protocol populations (PP). The tolerance was also reported. Results: The SVR12 rates by EP and PP analyses were 95.6% [1798 of 1880 patients; 95% confidence interval (CI) 94.6–96.5%] and 99.3% (1798 of 1811 patients; 95% CI 98.8–99.6%), respectively. Among 82 patients who failed to achieve SVR12, 13 (15.9%) were attributed to virologic failures. The SVR12 rates were comparable regardless of baseline characteristics. A total of 1859 (98.9%) patients completed 12-week SOF/VEL treatment. Four (0.2%) patients discontinued treatment due to adverse events (AEs). All patients with serious AEs or deaths were judged not related to SOF/VEL. The AEs occurring in ≥ 10% included headache (16.8%), fatigue (16.2%), nausea (11.8%), and insomnia (11.1%). Nine (0.5%) and 2 (0.1%) patients had grade 3 total bilirubin and alanine aminotransferase elevations. Conclusions: SOF/VEL for 12 weeks is efficacious and well-tolerated by chronic HCV-infected patients with compensated liver disease in Taiwan.

Original languageEnglish
JournalHepatology International
DOIs
Publication statusAccepted/In press - 2021

Keywords

  • Adverse event
  • Direct acting antiviral
  • East Asian
  • Effectiveness
  • Hepatitis C virus
  • Pangenotypic
  • Safety
  • Sofosbuvir
  • Sustained virologic response
  • Velpatasvir

ASJC Scopus subject areas

  • Hepatology

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