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, Gin‐Ho 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 Huang, Pei‐Lun Lee, Hsueh‐Chou Lai, Tsai‐Yuan Hsieh, Chung‐Hsin Chang, Yi‐Jie Huang, Fu‐Jen Lee, Chun‐Chao Chang, Jia‐Horng Kao
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 (SVR 12 ) in evaluable (EP) and per-protocol populations (PP). The safety profiles were assessed. Results The SVR 12 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 12 rates were 95.0% and 100% by EP and PP analyses. In patients with decompensated liver disease, the SVR 12 rates were 90.0% and 100% by EP and PP analyses. Ten patients who failed to achieve SVR 12 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.