Sofosbuvir/velpatasvir with or without low-dose ribavirin for patients with chronic hepatitis C virus infection and severe renal impairment

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

Research output: Contribution to journalArticlepeer-review

11 Citations (Scopus)

Abstract

Objective: Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) with or without low-dose ribavirin (RBV) in patients with chronic hepatitis C virus (HCV) infection and severe renal impairment (RI) are limited. We evaluated the performance of SOF/VEL with or without low-dose RBV in HCV-infected patients with chronic kidney disease stage 4 or 5. Design: 191 patients with compensated (n=181) and decompensated (n=10) liver diseases receiving SOF/VEL (400/100 mg/day) alone and SOF/VEL with low-dose RBV (200 mg/day) for 12 weeks were retrospectively recruited at 15 academic centres in Taiwan. The effectiveness was determined by sustained virological response at off-Treatment week 12 (SVR12) in evaluable (EP) and per-protocol populations (PP). The safety profiles were assessed. Results: The SVR12 rates by EP and PP analyses were 94.8% (95% CI 90.6% to 97.1%) and 100% (95% CI 97.9% to 100%). In patients with compensated liver disease, the SVR12 rates were 95.0% and 100% by EP and PP analyses. In patients with decompensated liver disease, the SVR12 rates were 90.0% and 100% by EP and PP analyses. Ten patients who failed to achieve SVR12 were attributed to non-virological failures. Among the 20 serious adverse events (AEs), none were judged related to SOF/VEL or RBV. The AEs occurring in ≥10% included fatigue (14.7%), headache (14.1%), nausea (12.6%), insomnia (12.0%) and pruritus (10.5%). None had ≥grade 3 total bilirubin or alanine aminotransferase elevations. Conclusion: SOF/VEL with or without low-dose RBV is effective and well-Tolerated in HCV-infected patients with severe RI.

Original languageEnglish
JournalGut
DOIs
Publication statusAccepted/In press - 2020

Keywords

  • chronic kidney disease
  • direct acting antiviral
  • hepatitis C virus
  • renal impairment
  • sofosbuvir
  • velpatasvir

ASJC Scopus subject areas

  • Gastroenterology

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