TY - JOUR T1 - Sofosbuvir/velpatasvir with or without low-dose ribavirin for patients with chronic hepatitis C virus infection and severe renal impairment JF - Gut JO - Gut DO - 10.1136/gutjnl-2020-323569 SP - gutjnl-2020-323569 AU - Chen-Hua Liu AU - Chi-Yi Chen AU - Wei-Wen Su AU - Kuo-Chih Tseng AU - Ching-Chu Lo AU - Chun-Jen Liu AU - Jyh-Jou Chen AU - Cheng-Yuan Peng AU - Yu-Lueng Shih AU - Sheng-Shun Yang AU - Chia-Sheng Huang AU - Ke-Jhang Huang AU - Chi-Yang Chang AU - Ming-Chang Tsai AU - Wei-Yu Kao AU - Yo-Jen Fang AU - Po-Yueh Chen AU - Pei-Yuan Su AU - Chih-Wei Tseng AU - Jow-Jyh Huang AU - Pei-Lun Lee AU - Hsueh-Chou Lai AU - Tsai-Yuan Hsieh AU - Chung-Hsin Chang AU - Yi-Jie Huang AU - Fu-Jen Lee AU - Chun-Chao Chang AU - Jia-Horng Kao Y1 - 2021/01/05 UR - http://gut.bmj.com/content/early/2021/10/07/gutjnl-2020-323569.abstract N2 - 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.Data sharing not applicable as no datasets generated and/or analysed for this study. Nil. ER -