Real-world experience of 12-week direct-acting antiviral regimen of glecaprevir and pibrentasvir in patients with chronic hepatitis C virus infection

J Gastroenterol Hepatol. 2020 May;35(5):855-861. doi: 10.1111/jgh.14874. Epub 2019 Nov 19.

Abstract

Background: In clinical trials, a pangenotype direct-acting antiviral (DAA) regimen consisting of glecaprevir (GLE) and pibrentasvir (PIB) exhibited high virologic efficacy and tolerability in patients with hepatitis C virus (HCV) infection. This study sought to confirm these findings in real-world settings, focusing on patients with cirrhosis, history of DAA failure, or HCV genotype 3 who were treated with a 12-week regimen in a large multicenter study from Japan.

Methods: In a nationwide multicenter prospective cohort study, we analyzed background characteristics, tolerability, and treatment outcome of patients who underwent a 12-week GLE/PIB regimen.

Results: Of 1190 patients, 509 (42.8%) underwent the 12-week regimen, and the remaining patients underwent an 8-week regimen. The rate of sustained virologic response (SVR) of patients treated with the 12-week regimen was 99.0%, comparable with that of patients treated with the 8-week regimen. The adverse events were observed in 29.1% of patients. The main adverse event was pruritus, which was observed in 14.7%. Ten patients (2.0%) discontinued therapy during treatment period.

Conclusion: The 12-week GLE/PIB regimen was well-tolerated with high virologic efficacy in patients with cirrhosis, experience of DAA, or HCV genotype 3; tolerability and SVR rate were comparable with those of DAA-naïve, non-cirrhotic, non-genotype 3 patients who underwent 8-week regimen.

Keywords: glecaprevir; hepatitis C virus; pibrentasvir; real world; sustained virological response; tolerability.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Aged
  • Antiviral Agents / administration & dosage*
  • Benzimidazoles / administration & dosage*
  • Cohort Studies
  • Drug Combinations
  • Female
  • Follow-Up Studies
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / virology
  • Humans
  • Japan
  • Male
  • Middle Aged
  • Prospective Studies
  • Pyrrolidines / administration & dosage*
  • Quinoxalines / administration & dosage*
  • Sulfonamides / administration & dosage*
  • Sustained Virologic Response
  • Time Factors
  • Treatment Outcome

Substances

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