Elbasvir/grazoprevir for hepatitis C virus genotype 1b East-Asian patients receiving hemodialysis
Journal
Scientific Reports
Journal Volume
10
Journal Issue
1
Date Issued
2020
Author(s)
Peng C.-Y.
Kao W.-Y.
Yang S.-S.
Lin C.-K.
Lai H.-C.
Su W.-P.
Fang S.-U.
Chang C.-C.
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. ? 2020, The Author(s).
SDGs
Other Subjects
2-(pyrrolidin-2-yl)-5-(2-(4-(5-(pyrrolidin-2-yl)-1H-imidazol-2-yl)phenyl)benzofuran-5-yl)-1H-imidazole; amide; antivirus agent; benzofuran derivative; carbamic acid derivative; cyclopropane derivative; grazoprevir; imidazole derivative; quinoxaline derivative; sulfonamide; adverse event; antiviral resistance; Asian continental ancestry group; chronic hepatitis C; combination drug therapy; drug effect; female; genotype; hemodialysis; Hepacivirus; human; male; middle aged; procedures; sustained virologic response; Amides; Antiviral Agents; Asian Continental Ancestry Group; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Male; Middle Aged; Quinoxalines; Renal Dialysis; Sulfonamides; Sustained Virologic Response
Publisher
Nature Research
Type
journal article