Safety and efficacy of glecaprevir and pibrentasvir in Japanese hemodialysis patients with genotype 2 hepatitis C virus infection

J Gastroenterol. 2019 Jul;54(7):641-649. doi: 10.1007/s00535-019-01556-y. Epub 2019 Feb 18.


Background: Until recently, interferon-free anti-hepatitis C virus (HCV) therapy for genotype 2 (GT2) HCV-infected hemodialysis patients was an unfulfilled medical need. Recent clinical trials of glecaprevir and pibrentasvir (G/P) for hemodialysis patients showed high efficacy and safety; however, the number of GT2 HCV-infected patients, especially Asian patients, was limited and most of them were treated with a 12-week regimen. In this prospective multicenter study, we aimed to investigate the efficacy and safety of G/P in Japanese hemodialysis patients with GT2 HCV infection.

Methods: Twenty-seven Japanese hemodialysis patients with GT2 HCV infection who were started on with 8- or 12-week G/P regimen between November 2017 and June 2018 were included and followed up for around 12 weeks after treatment completion.

Results: Among the 27 included patients, 13 non-liver cirrhosis (LC) and direct-acting antivirals (DAAs)-naïve patients were treated with 8 weeks of G/P and 14 patients with LC (n = 13) or history of failure of DAAs (n = 1) were treated with a 12-week regimen. The overall sustained virological response at 12 weeks after treatment completion (SVR 12) was 96.3% (26/27). All patients with 8 weeks of treatment achieved SVR12. Two patients discontinued the therapy at 2 and 11 weeks after treatment initiation. The patient who discontinued at 2 weeks due to pruritus alone failed to respond to G/P. No patients experienced lethal adverse events during the therapy, and the most common adverse event was pruritus.

Conclusions: An 8- or 12-week G/P regimen is highly effective and safe in GT2 HCV-infected hemodialysis patients.

Keywords: Genotype 2; Glecaprevir; HCV; Hemodialysis; Pibrentasvir.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Benzimidazoles / adverse effects
  • Benzimidazoles / therapeutic use*
  • Drug Combinations
  • Female
  • Genotype
  • Hepacivirus / genetics
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Japan
  • Liver Cirrhosis / drug therapy
  • Liver Cirrhosis / pathology
  • Male
  • Middle Aged
  • Prospective Studies
  • Pyrrolidines / adverse effects
  • Pyrrolidines / therapeutic use*
  • Quinoxalines / adverse effects
  • Quinoxalines / therapeutic use*
  • Renal Dialysis*
  • Sulfonamides / adverse effects
  • Sulfonamides / therapeutic use*
  • Sustained Virologic Response
  • Treatment Outcome


  • Antiviral Agents
  • Benzimidazoles
  • Drug Combinations
  • Pyrrolidines
  • Quinoxalines
  • Sulfonamides
  • glecaprevir and pibrentasvir