Elbasvir/grazoprevir for hepatitis C virus genotype 1b East-Asian patients receiving hemodialysis

Sci Rep. 2020 Jun 8;10(1):9180. doi: 10.1038/s41598-020-66182-8.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amides / therapeutic use*
  • Antiviral Agents / therapeutic use*
  • Asian People
  • 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

Substances

  • Amides
  • Antiviral Agents
  • Benzofurans
  • Carbamates
  • Cyclopropanes
  • Imidazoles
  • Quinoxalines
  • Sulfonamides
  • grazoprevir
  • elbasvir