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Liu, Chen-Hua; Chen, Chi-Yi; Su, Wei-Wen; Tseng, Kuo-Chih; Lo, Ching-Chu; Liu, Chun-Jen; Chen, Jyh-Jou; Peng, Cheng-Yuan; Shih, Yu-Lueng; Yang, Sheng-Shun; Huang, Chia-Sheng; Huang, Ke-Jhang; Chang, Chi-Yang; Tsai, Ming-Chang; Kao, Wei-Yu; Fang, Yo-Jen; Chen, Po-Yueh; Su, Pei-Yuan; Tseng, Chih-Wei; Huang, Jow-Jyh; Lee, Pei-Lun; Lai, Hsueh-Chou; Hsieh, Tsai-Yuan; Chang, Chung-Hsin; Huang, Yi-Jie; Lee, Fu-Jen; Chang, Chun-Chao; Kao, Jia-Horng
Gut, 01/2022, Volume: 71, Issue: 1Journal Article
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. 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 (SVR ) in evaluable (EP) and per-protocol populations (PP). The safety profiles were assessed. The SVR 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 SVR rates were 95.0% and 100% by EP and PP analyses. In patients with decompensated liver disease, the SVR rates were 90.0% and 100% by EP and PP analyses. Ten patients who failed to achieve SVR 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. SOF/VEL with or without low-dose RBV is effective and well-tolerated in HCV-infected patients with severe RI.
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