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Citation |
Liu CH, Peng CY, Fang YJ, Kao WY, Yang SS, Lin CK, Lai HC, Su WP, Fang SU, Chang CC, Su TH, Liu CJ, Chen PJ, Chen DS, Kao JH. Sci. Rep. 2020; 10(1): e9180. |
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Copyright |
(Copyright © 2020, Nature Publishing Group) |
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DOI |
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PMID |
32513953 |
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PMCID |
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Abstract |
Data regarding the efficacy and tolerability of elbasvir/grazoprevir (EBR/GZR) for East-Asian hepatitis C virus genotype 1b (HCV GT1b) patients receiving hemodialysis were limited. We prospectively recruited 40 HCV GT1b hemodialysis patients who received EBR/GZR for 12 weeks at 6 academic centers in Taiwan. The efficacy endpoints were sustained virologic response 12 weeks off-therapy (SVR12) by intention-to-treat (ITT) modified ITT (mITT) analyses. Patients' baseline characteristics, early viral kinetics and HCV resistance-associated substitutions (RASs) at HCV non-structural 3 and 5 A (NS3 and NS5A) regions potentially affecting SVR12 were analyzed. The tolerability for EBR/GZR was also assessed. The SVR12 rates by ITT and mITT analyses were 95% (38 of 40 patients; 95% confidence interval (CI): 83.5-98.6%) and 100% (38 of 38 patients; 95% CI: 90.8-100%), respectively. Patients' baseline characteristics, on-treatment viral decline, and baseline HCV RASs did not affect SVR12. All patients tolerated treatment well. Among 5 patients who had serious adverse events (AEs) including one death due to on-treatment suicide and the other death due to off-therapy acute myocardial infarction, none of these events were judged related to EBR/GZR. The common AEs included upper respiratory tract infection (7.5%), fatigue (5.0%) and anorexia (5.0%). Nine (22.5%) and 8 (20.0%) patients had on-treatment hemoglobin levels of 9.0-10.0 g/dL and 7.0-9.0 g/dL. Three (7.5%) patients had on-treatment elevated alanine aminotransferase (ALT) quotient > 2.5, in whom one (2.5%) had EBR/GZR-induced late ALT elevation. No patients developed hyperbilirubinemia or hepatic decompensation. In conclusion, treatment with EBR/GZR is effective and well-tolerated for East-Asian HCV GT1b patients receiving hemodialysis. Language: en |
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Keywords |
Humans; Female; Male; Middle Aged; Renal Dialysis; Drug Therapy, Combination; Carbamates; Hepacivirus; Hepatitis C, Chronic; Antiviral Agents; Quinoxalines; Drug Resistance, Viral; Asian People; Cyclopropanes; Imidazoles; Amides; Benzofurans; Genotype; Sulfonamides; Sustained Virologic Response |