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.
Original language | English |
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Pages (from-to) | 9180 |
Journal | Scientific Reports |
Volume | 10 |
Issue number | 1 |
DOIs | |
Publication status | Published - Jun 8 2020 |
Keywords
- Amides/therapeutic use
- Antiviral Agents/therapeutic use
- Asian Continental Ancestry Group
- Benzofurans/therapeutic use
- Carbamates/therapeutic use
- Cyclopropanes/therapeutic use
- Drug Resistance, Viral/drug effects
- Drug Therapy, Combination/methods
- Female
- Genotype
- Hepacivirus/drug effects
- Hepatitis C, Chronic/drug therapy
- Humans
- Imidazoles/therapeutic use
- Male
- Middle Aged
- Quinoxalines/therapeutic use
- Renal Dialysis/adverse effects
- Sulfonamides/therapeutic use
- Sustained Virologic Response