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  • 1. Aims and Scope

    Gut and Liver is an international journal of gastroenterology, focusing on the gastrointestinal tract, liver, biliary tree, pancreas, motility, and neurogastroenterology. Gut atnd Liver delivers up-to-date, authoritative papers on both clinical and research-based topics in gastroenterology. The Journal publishes original articles, case reports, brief communications, letters to the editor and invited review articles in the field of gastroenterology. The Journal is operated by internationally renowned editorial boards and designed to provide a global opportunity to promote academic developments in the field of gastroenterology and hepatology. +MORE

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    Yong Chan Lee Professor of Medicine
    Director, Gastrointestinal Research Laboratory
    Veterans Affairs Medical Center, Univ. California San Francisco
    San Francisco, USA

    Deputy Editor

    Deputy Editor
    Jong Pil Im Seoul National University College of Medicine, Seoul, Korea
    Robert S. Bresalier University of Texas M. D. Anderson Cancer Center, Houston, USA
    Steven H. Itzkowitz Mount Sinai Medical Center, NY, USA
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    All papers submitted to Gut and Liver are reviewed by the editorial team before being sent out for an external peer review to rule out papers that have low priority, insufficient originality, scientific flaws, or the absence of a message of importance to the readers of the Journal. A decision about these papers will usually be made within two or three weeks.
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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

Jeong Heo1 , Yoon Jun Kim2 , Jin-Woo Lee3 , Ji Hoon Kim4 , Young-Suk Lim5 , Kwang-Hyub Han6 , Sook-Hyang Jeong7 , Mong Cho8 , Ki Tae Yoon8 , Si Hyun Bae9 , Eric D. Crown10 , Linda M. Fredrick10 , Negar Niki Alami10 , Armen Asatryan10 , Do Hyun Kim11 , Seung Woon Paik12 , and Youn-Jae Lee13

1Department of Internal Medicine, Pusan National University College of Medicine and Medical Research Institute, Pusan National University Hospital, Busan, 2Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, 3Department of Internal Medicine, Inha University School of Medicine, Incheon, 4Department of Internal Medicine, Korea University College of Medicine, 5Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, 6Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 7Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, 8Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University College of Medicine, Yangsan, 9Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea, 10Abbvie Inc., North Chicago, IL, USA, 11AbbVie Korea, Ltd., 12Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, and 13Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea

Correspondence to:Seung Woon Paik
ORCID https://orcid.org/0000-0002-6746-6652
E-mail swpaik@skku.edu

Youn-Jae Lee
ORCID https://orcid.org/0000-0002-6746-6652
E-mail yjyh0105@inje.ac.kr

Received: October 28, 2020; Revised: December 24, 2020; Accepted: January 4, 2021

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Gut and Liver

Published online June 2, 2021

Copyright © Gut and Liver.

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-naïve 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-naïve, 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.

Keywords: Glecaprevir and pibrentasvir, Pan-genotypic antivirals, Hepatitis C virus, Korea


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Gut and Liver

Published online June 2, 2021

Copyright © Gut and Liver.

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

Jeong Heo1 , Yoon Jun Kim2 , Jin-Woo Lee3 , Ji Hoon Kim4 , Young-Suk Lim5 , Kwang-Hyub Han6 , Sook-Hyang Jeong7 , Mong Cho8 , Ki Tae Yoon8 , Si Hyun Bae9 , Eric D. Crown10 , Linda M. Fredrick10 , Negar Niki Alami10 , Armen Asatryan10 , Do Hyun Kim11 , Seung Woon Paik12 , and Youn-Jae Lee13

1Department of Internal Medicine, Pusan National University College of Medicine and Medical Research Institute, Pusan National University Hospital, Busan, 2Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, 3Department of Internal Medicine, Inha University School of Medicine, Incheon, 4Department of Internal Medicine, Korea University College of Medicine, 5Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, 6Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 7Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, 8Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University College of Medicine, Yangsan, 9Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea, 10Abbvie Inc., North Chicago, IL, USA, 11AbbVie Korea, Ltd., 12Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, and 13Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea

Correspondence to:Seung Woon Paik
ORCID https://orcid.org/0000-0002-6746-6652
E-mail swpaik@skku.edu

Youn-Jae Lee
ORCID https://orcid.org/0000-0002-6746-6652
E-mail yjyh0105@inje.ac.kr

Received: October 28, 2020; Revised: December 24, 2020; Accepted: January 4, 2021

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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-naïve 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-naïve, 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.

Keywords: Glecaprevir and pibrentasvir, Pan-genotypic antivirals, Hepatitis C virus, Korea

Gut and Liver

Vol.15 No.3
May, 2021

pISSN 1976-2283
eISSN 2005-1212

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