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KMID : 1188320210150060895
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Gut and Liver
2021 Volume.15 No. 6 p.895 ~ p.903
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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
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Heo Jeong
Kim Yoon-Jung
Lee Jin-Woo
Kim Ji-Hoon
Lim Young-Suk
Han Kwang-Hyub
Jeong Sook-Hyang
Cho Mong
Yoon Ki-Tae
Bae Si-Hyun
Crown Eric D.
Fredrick Linda M.
Alami Negar Niki
Asatryan Armen
Kim Do-Hyun
Paik Seung-Woon
Lee Youn-Jae
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Abstract
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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.
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KEYWORD
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Glecaprevir and pibrentasvir, Pan-genotypic antivirals, Hepatitis C virus, Korea
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