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

Abstract

BACKGROUND:

Glecaprevir/pibrentasvir (GLE/PIB) is a pangenotypic direct-acting antiviral agent for the treatment of chronic hepatitis C virus (HCV) infection. Real-world data of GLE/PIB in Asian patients other than Japanese are limited. We thus investigated the effectiveness and safety profile of GLE/PIB in Taiwanese patients with chronic hepatitis C (CHC).

METHODS:

CHC patients who received 8, 12, or 16 weeks of GLE/PIB between August and October of 2018 were consecutively enrolled. The treatment duration was determined according to drug label. The hepatic fibrosis was staged according to liver histology, transient elastography, fibrosis index based on 4 factors (FIB-4), or findings of ultrasonography/endoscopy. The primary endpoint was sustained virological response at week 12 off therapy (SVR12). The safety profiles were also assessed.

RESULTS:

A total of 110 CHC patients with 51% of males were enrolled. The median age was 70 years. A majority (82%) of patients were infected with HCV genotype 2. Forty-six (42%) and 64 (58%) patients had advanced hepatic fibrosis and compensated cirrhosis, respectively. Forty-five (41%) non-cirrhotic patients were treated for 8 weeks. The overall SVR12 rates were 100%, regardless of baseline clinical characteristics. The common adverse events (AEs) were pruritus (12%), anorexia (6%), and fatigue (5%). Nine (8%) serious AEs unrelated to GLE/PIB occurred. Three (2%) patients had Grade 3 elevation of total bilirubin level. None had premature treatment termination, hepatic decompensation, or death.

CONCLUSION:

Interferon-free GLE/PIB regimen is highly effective and safe for Asian chronic hepatitis C patients with advanced hepatic fibrosis or compensated cirrhosis.

• Authors: Shih-Jer Hsu, Min-Chin Chiu, Yu-Jen Fang, Tsung-Hua Yang, Jian-Jyun Yu, Chieh-Chang Chen, Chia-Chi Kuo, Ji-Yuh Lee, Chien-Hung Chen, Ding-Shinn Chen, Jia-Horng Kao
• Journal: Journal of the Formosan Medical Association = Taiwan yi zhi (J Formos Med Assoc) Vol. 118 Issue 8 Pg. 1187-1192 (Aug 2019) ISSN: 0929-6646 [Print] Singapore
• PMID: 31279502 (Publication Type: Journal Article)
• Copyright: Copyright © 2019 Formosan Medical Association. Published by Elsevier B.V. All rights reserved.

Chemical References

• Aminoisobutyric Acids
• Antiviral Agents
• Benzimidazoles
• Cyclopropanes
• Lactams, Macrocyclic
• Pyrrolidines
• Quinoxalines
• Sulfonamides
• pibrentasvir
• Proline
• Leucine
• glecaprevir

Topics

• Adult
• Aged
• Aged, 80 and over
• Aminoisobutyric Acids
• Antiviral Agents (adverse effects, therapeutic use)
• Benzimidazoles (adverse effects, therapeutic use)
• Cyclopropanes
• Drug Therapy, Combination
• Female
• Hepacivirus (drug effects)
• Hepatitis C, Chronic (drug therapy)
• Humans
• Lactams, Macrocyclic
• Leucine (analogs & derivatives)
• Liver Cirrhosis (pathology, virology)
• Male
• Middle Aged
• Proline (analogs & derivatives)
• Pyrrolidines
• Quinoxalines (adverse effects, therapeutic use)
• Retrospective Studies
• Sulfonamides (adverse effects, therapeutic use)
• Sustained Virologic Response
• Taiwan