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

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

glecaprevir hepatitis C virus pibrentasvir real world sustained virological response tolerability

Journal

Journal of gastroenterology and hepatology

ISSN: 1440-1746

Titre abrégé: J Gastroenterol Hepatol

Pays: Australia

ID NLM: 8607909

Informations de publication

Date de publication:
May 2020

Historique:

received: 10 07 2019

revised: 04 09 2019

accepted: 16 09 2019

pubmed: 15 10 2019

medline: 8 10 2020

entrez: 15 10 2019

Statut: ppublish

Résumé

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. 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. 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. 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.

Sections du résumé

BACKGROUND BACKGROUND

METHODS 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 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 CONCLUSIONS

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.

Identifiants

DOI: 10.1111/jgh.14874 PMID: 31609495

pubmed: 31609495

doi: 10.1111/jgh.14874

doi:

Substances chimiques

Antiviral Agents 0

Benzimidazoles 0

Drug Combinations 0

Pyrrolidines 0

Quinoxalines 0

Sulfonamides 0

glecaprevir and pibrentasvir 0

Types de publication

Clinical Trial Journal Article Multicenter Study Observational Study

Langues

eng

Sous-ensembles de citation

Pagination

855-861

Informations de copyright

Références

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