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Hepatology
Original research
Sofosbuvir/velpatasvir with or without low-dose ribavirin for patients with chronic hepatitis C virus infection and severe renal impairment
  1. Chen-Hua Liu1,2,3,
  2. Chi-Yi Chen4,
  3. Wei-Wen Su5,
  4. Kuo-Chih Tseng6,7,
  5. Ching-Chu Lo8,
  6. Chun-Jen Liu1,2,
  7. Jyh-Jou Chen9,
  8. Cheng-Yuan Peng10,11,
  9. Yu-Lueng Shih12,
  10. Sheng-Shun Yang13,14,15,
  11. Chia-Sheng Huang16,
  12. Ke-Jhang Huang17,
  13. Chi-Yang Chang18,
  14. Ming-Chang Tsai19,
  15. Wei-Yu Kao20,21,22,
  16. Yo-Jen Fang3,
  17. Po-Yueh Chen4,
  18. Pei-Yuan Su5,
  19. Chih-Wei Tseng6,7,
  20. Jow-Jyh Huang8,
  21. Pei-Lun Lee9,
  22. Hsueh-Chou Lai10,11,
  23. Tsai-Yuan Hsieh12,
  24. Chung-Hsin Chang13,
  25. Yi-Jie Huang13,
  26. Fu-Jen Lee18,
  27. Chun-Chao Chang20,21,22,
  28. Jia-Horng Kao1,2,23
  1. 1Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
  2. 2Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan
  3. 3Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yunlin, Taiwan
  4. 4Division of Gastroenterology and Hepatology, Department of Internal Medicine, Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi, Taiwan
  5. 5Division of Gastroenterology, Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan
  6. 6Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan
  7. 7School of Medicine, Tzuchi University, Hualien, Taiwan
  8. 8Department of Internal Medicine, St. Martin De Porres Hospital, Daya, Chiayi, Taiwan
  9. 9Division of Gastroenterology and Hepatology, Chi-Mei Medical Center, Liouying, Taiwan
  10. 10Center for Digestive Medicine, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan
  11. 11School of Medicine, China Medical University, Taichung, Taiwan
  12. 12Division of Gastroenterology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan
  13. 13Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan
  14. 14School of Medicine, Chung Shan Medical University, Taichung, Taiwan
  15. 15Institute of Biomedical Sciences, National Chung Hsing University, Taichung, Taiwan
  16. 16Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yang Ming Hospital, Chiayi, Taiwan
  17. 17Division of Gastroenterology and Hepatology, Department of Internal Medicine, China Medical University Beigang Hospital, Yunlin, Taiwan
  18. 18Division of Gastroenterology and Hepatology, Department of Internal Medicine, Fu Jen Catholic University Hospital, Taipei, Taiwan
  19. 19Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan
  20. 20Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan
  21. 21Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan
  22. 22Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan
  23. 23Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan
  1. Correspondence to Professor Jia-Horng Kao, Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taipei, Taiwan; kaojh{at}ntu.edu.tw

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.

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

https://doi.org/10.1136/gutjnl-2020-323569

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    Footnotes

    • Contributors Conception and design: C-HL, J-HK; analysis and interpretation of data: C-HL; drafting of the article: C-HL, J-HK; critical revision of the article for important intellectual content: C-HL, C-YC, W-WS, K-CT, C-CL, C-JL, J-JC, C-YP, Y-LS, S-SY, C-SH, K-JH, C-YC, M-CT, W-YK, Y-JF, P-YC, P-YS, C-WT, J-JH, P-LL, H-CL, T-YH, C-HC, Y-JH, F-JL, C-CC, J-HK; final approval of the article: C-HL, C-YC, W-WS, K-CT, C-CL, C-JL, J-JC, C-YP, Y-LS, S-SY, C-SH, K-JH, C-YC, M-CT, W-YK, Y-JF, P-YC, P-YS, C-WT, J-JH, P-LL, H-CL, T-YH, C-HC, Y-JH, F-JL, C-CC, J-HK; provision of study materials or patients: C-HL, C-YC, W-WS, K-CT, C-CL, C-JL, J-JC, C-YP, Y-LS, S-SY, C-SH, K-JH, C-YC, M-CT, W-YK, Y-JF, P-YC, P-YS, C-WT, J-JH, P-LL, H-CL, T-YH, C-HC, Y-JH, F-JL, C-CC, J-HK; statistical expertise: C-HL; administrative, technical, or logistic support: C-HL, J-HK; collection and assembly of data: C-HL.

    • Funding Ministry of Science and Technology, Taiwan (106-2314-B-002-138-MY3, 107-2314-B-002-038-MY2).

    • Competing interests C-HL: advisory board for Abbvie, Gilead Sciences, Merck Sharp & Dohme; speaker’s bureau for Abbott, Abbvie, Gilead Sciences, Merck Sharp & Dohme; research grant from Abbvie, Gilead Science, Merck Sharp & Dohme. S-SY: advisory board for Abbvie, Roche, Ipsen; speaker’s bureau for Abbvie, Bristol-Myers Squibb, Gilead Sciences, Ipsen, Merck Sharp & Dohme. P-YC: advisory board for Abbvie, Novartis, Roche; J-HK: advisory board for Abbott, Abbvie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Roche; speaker’s bureau for Abbott, Abbvie, Bayer, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Roche. All other authors declare no competing interests.

    • Patient consent for publication Not required.

    • Ethics approval The study was approved by the Research Ethics Committee of each participating centre and was conducted in accordance with the principles of Declaration of Helsinki.

    • Data availability statement Data sharing not applicable as no datasets generated and/or analysed for this study. Nil.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.