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Efficacy and Safety of Glecaprevir/Pibrentasvir in Korean Patients with Chronic Hepatitis C: A Pooled Analysis of Five Phase II/III Trials

Authors
Heo, JeongKim, Yoon JunLee, Jin-WooKim, Ji HoonLim, Young-SukHan, Kwang-HyubJeong, Sook-HyangCho, MongYoon, Ki TaeBae, Si HyunCrown, Eric D.Fredrick, Linda M.Alami, Negar NikiAsatryan, ArmenKim, Do HyunPaik, Seung WoonLee, Youn-Jae
Issue Date
Nov-2021
Publisher
거트앤리버 발행위원회
Keywords
Glecaprevir and pibrentasvir; Pan-genotypic antivirals; Hepatitis C virus; Korea
Citation
Gut and Liver, v.15, no.6, pp 895 - 903
Pages
9
Indexed
SCIE
SCOPUS
KCI
Journal Title
Gut and Liver
Volume
15
Number
6
Start Page
895
End Page
903
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/54517
DOI
10.5009/gnl20321
ISSN
1976-2283
2005-1212
Abstract
Background/Aims: Glecaprevir/pibrentasvir (G/P) is the first pan-genotypic direct-acting antiviral combination therapy approved in Korea. An integrated analysis of five phase II and III trials was conducted to evaluate the efficacy and safety of G/P in Korean patients with chronic hepatitis C virus (HCV) infection. Methods: The study analyzed pooled data on Korean patients with HCV infection enrolled in the ENDURANCE 1 and 2, SURVEYOR II part 4 and VOYAGE I and II trials, which evaluated the efficacy and safety of 8 or 12 weeks of G/P treatment. The patients were either treatment-naive or had received sofosbuvir or interferon-based treatment. Efficacy was evaluated by assessing the rate of sustained virologic response at 12 weeks posttreatment (SVR12). Safety was evaluated by monitoring adverse events (AEs) and laboratory assessments. Results: The analysis included 265 patients; 179 (67.5%) were HCV treatment-naive, and most patients were either subgenotype 1B (48.7%) or 2A (44.5%). In the intention-to-treat population, 262 patients (98.9%) achieved SVR12. Three patients did not achieve SVR12: one had virologic failure and two had non-virologic failures. Most AEs were grade 1/2; eight patients (3.0%) experienced at least one grade >_3 AE. No serious AEs related to G/P treatment were reported, and grade >_3 hepatic laboratory abnormalities were rare (0.8%). Conclusions: G/P therapy was highly efficacious and well tolerated in Korean patients with HCV infection, with most patients achieving SVR12. The safety profile was comparable to that observed in a pooled analysis of a global pan-genotypic population of patients with HCV infection who received G/P. (Gut Liver, Published online June 2, 2021)
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Kim, Ji Hoon
Guro Hospital (Department of Gastroenterology and Hepatology, Guro Hospital)
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