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

• Published in: Gut Vol. 71; no. 1; pp. 176 - 184
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd and British Society of Gastroenterology 01.01.2022; BMJ Publishing Group LTD
• Subjects: Adult; Adverse events; Aged; Aged, 80 and over; Alanine; Alanine transaminase; Antibodies; Antigens; Antiviral Agents - therapeutic use; Antiviral drugs; Architects; Bilirubin; Carbamates - therapeutic use; Chronic infection; chronic kidney disease; direct acting antiviral; Drug Combinations; Drug dosages; Drug Therapy, Combination; Female; Hemodialysis; Hepatitis B; Hepatitis C; hepatitis C virus; Hepatitis C, Chronic - complications; Hepatitis C, Chronic - drug therapy; Hepatology; Heterocyclic Compounds, 4 or More Rings - therapeutic use; Humans; Infections; Kidney diseases; Laboratories; Liver diseases; Male; Middle Aged; Nausea; Patients; Performance evaluation; Pharmacokinetics; Plasma; Pruritus; renal impairment; Renal Insufficiency, Chronic - classification; Renal Insufficiency, Chronic - complications; Retrospective Studies; Ribavirin; Ribavirin - therapeutic use; RNA polymerase; Sleep disorders; sofosbuvir; Sofosbuvir - therapeutic use; Sustained Virologic Response; Transplants & implants; velpatasvir; Young Adult; Abbott Park Illinois; United States > US; Germany; Taiwan; sofosbuvir; hepatitis C virus; chronic kidney disease; direct acting antiviral; velpatasvir; renal impairment
• ISSN: 0017-5749; 1468-3288; 1468-3288
• DOI: 10.1136/gutjnl-2020-323569

ObjectiveData 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.Design191 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.ResultsThe 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.ConclusionSOF/VEL with or without low-dose RBV is effective and well-tolerated in HCV-infected patients with severe RI.