Efficacy and Safety of Glecaprevir/Pibrentasvir in Korean Patients with Chronic Hepatitis C: A Pooled Analysis of Five Phase II/III Trials
Jeong Heo,
Yoon Jun Kim,
Jin-Woo Lee,
Ji Hoon Kim,
Young-Suk Lim,
Kwang-Hyub Han,
Sook-Hyang Jeong,
Mong Cho,
Ki Tae Yoon,
Si Hyun Bae,
Eric D. Crown,
Linda M. Fredrick,
Negar Niki Alami,
Armen Asatryan,
Do Hyun Kim,
Seung Woon Paik,
Youn-Jae Lee
Affiliations
Jeong Heo
Department of Internal Medicine, Pusan National University College of Medicine and Medical Research Institute, Pusan National University Hospital, Busan, Korea
Yoon Jun Kim
Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
Jin-Woo Lee
Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea
Ji Hoon Kim
Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea
Young-Suk Lim
Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Kwang-Hyub Han
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
Sook-Hyang Jeong
Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
Mong Cho
Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University College of Medicine, Yangsan, Korea
Ki Tae Yoon
Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University College of Medicine, Yangsan, Korea
Si Hyun Bae
Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea
Eric D. Crown
Abbvie Inc., North Chicago, IL, USA
Linda M. Fredrick
Abbvie Inc., North Chicago, IL, USA
Negar Niki Alami
Abbvie Inc., North Chicago, IL, USA
Armen Asatryan
Abbvie Inc., North Chicago, IL, USA
Do Hyun Kim
AbbVie Korea, Ltd., Korea
Seung Woon Paik
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Youn-Jae Lee
Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea
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.