Real-world effectiveness and safety of glecaprevir/pibrentasvir in 723 patients with chronic hepatitis C.

Aminoisobutyric Acids Antiviral Agents / administration & dosage Benzimidazoles / administration & dosage Biopsy / methods Cohort Studies Cyclopropanes Drug Combinations Elasticity Imaging Techniques / methods Female Hepacivirus / drug effects Hepatitis C, Chronic / complications Humans Italy / epidemiology Lactams, Macrocyclic Leucine / analogs & derivatives Liver / pathology Liver Cirrhosis / diagnosis Male Middle Aged Proline / analogs & derivatives Pyrrolidines Quinoxalines / administration & dosage RNA, Viral / analysis Sulfonamides / administration & dosage Sustained Virologic Response Treatment Outcome

DAA Effectiveness Glecaprevir HCV Pibrentasvir RAS Real-life SVR Safety

Journal

Journal of hepatology

ISSN: 1600-0641

Titre abrégé: J Hepatol

Pays: Netherlands

ID NLM: 8503886

Informations de publication

Date de publication:
03 2019

Historique:

received: 08 08 2018

revised: 19 10 2018

accepted: 10 11 2018

pubmed: 26 11 2018

medline: 23 9 2020

entrez: 26 11 2018

Statut: ppublish

Résumé

The efficacy and safety of glecaprevir/pibrentasvir (G/P) for patients infected with hepatitis C virus (HCV) have only been investigated in clinical trials, with no real-world data currently available. The aim of our study was to investigate the effectiveness and safety of G/P in a real-world setting. All patients with HCV consecutively starting G/P between October 2017 and January 2018 within the NAVIGATORE-Lombardia Network were analyzed. G/P was administered according to drug label (8, 12 or 16 weeks). Fibrosis was staged either histologically or by liver stiffness measurement. Sustained virological response (SVR) was defined as undetectable HCV-RNA 12 weeks after the end of treatment. A total of 723 patients (50% males) were treated with G/P, 89% for 8 weeks. The median age of our cohort was 58 years, with a median body mass index of 23.9 kg/m In a large real-world cohort of Italian patients, we confirmed the excellent effectiveness and safety of G/P administered for 8, 12 or 16 weeks. A large number of patients with hepatitis C virus have been treated with glecaprevir/pibrentasvir (G/P) within the NAVIGATORE-Lombardia Network, in Italy. This is the first real-world study evaluating effectiveness and safety of G/P in patients with hepatitis C virus treated according to international recommendations. This study demonstrated excellent effectiveness (with sustained virological response rates of 99.3%) and safety profiles.

Sections du résumé

BACKGROUND AND AIMS

METHODS

All patients with HCV consecutively starting G/P between October 2017 and January 2018 within the NAVIGATORE-Lombardia Network were analyzed. G/P was administered according to drug label (8, 12 or 16 weeks). Fibrosis was staged either histologically or by liver stiffness measurement. Sustained virological response (SVR) was defined as undetectable HCV-RNA 12 weeks after the end of treatment.

RESULTS

A total of 723 patients (50% males) were treated with G/P, 89% for 8 weeks. The median age of our cohort was 58 years, with a median body mass index of 23.9 kg/m

CONCLUSIONS

In a large real-world cohort of Italian patients, we confirmed the excellent effectiveness and safety of G/P administered for 8, 12 or 16 weeks.

LAY SUMMARY

A large number of patients with hepatitis C virus have been treated with glecaprevir/pibrentasvir (G/P) within the NAVIGATORE-Lombardia Network, in Italy. This is the first real-world study evaluating effectiveness and safety of G/P in patients with hepatitis C virus treated according to international recommendations. This study demonstrated excellent effectiveness (with sustained virological response rates of 99.3%) and safety profiles.

Identifiants

DOI: 10.1016/j.jhep.2018.11.011 PMID: 30472321

pubmed: 30472321

pii: S0168-8278(18)32543-1

doi: 10.1016/j.jhep.2018.11.011

pii:

doi:

Substances chimiques

Aminoisobutyric Acids 0

Antiviral Agents 0

Benzimidazoles 0

Cyclopropanes 0

Drug Combinations 0

Lactams, Macrocyclic 0

Pyrrolidines 0

Quinoxalines 0

RNA, Viral 0

Sulfonamides 0

pibrentasvir 2WU922TK3L

Proline 9DLQ4CIU6V

Leucine GMW67QNF9C

glecaprevir K6BUU8J72P

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

379-387