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
- chronic kidney disease
- renal impairment
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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.
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