Clin Mol Hepatol.
2019 Dec;25(4):400-407. 10.3350/cmh.2019.0006.
An integrated analysis of elbasvir/grazoprevir in Korean patients with hepatitis C virus genotype 1b infection
- Affiliations
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- 1Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.
- 2Department of Internal Medicine, College of Medicine, Pusan National University, Busan, Korea.
- 3Medical Research Institute, Pusan National University Hospital, Busan, Korea.
- 4Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
- 5Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
- 6Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.
- 7Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
- 8Department of Medicine, Samsung Medical Center, School of Medicine, Sungkyunkwan University, Seoul, Korea. sw.paik@samsung.com
- 9Merck & Co., Inc., Kenilworth, NJ, USA.
- KMID: 2467250
- DOI: http://doi.org/10.3350/cmh.2019.0006
Abstract
- BACKGROUND/AIMS
In the Republic of Korea, an estimated 231,000 individuals have chronic hepatitis C virus (HCV) infection. The aim of the present analysis was to evaluate the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) administered for 12 weeks in Korean patients who were enrolled in international clinical trial phase 3 studies.
METHODS
This was a retrospective, integrated analysis of data from patients with HCV genotype (GT) 1b infection enrolled at Korean study sites in four EBR/GZR phase 3 clinical trials. Patients were treatment-naive or had previously failed interferon-based HCV therapy, and included those with human immunodeficiency virus coinfection or Child-Pugh class A cirrhosis. All patients received EBR 50 mg/GZR 100 mg once daily for 12 weeks. The primary endpoint was sustained virologic response at 12 weeks after completion of therapy (SVR12, HCV RNA <15 IU/mL).
RESULTS
SVR12 was achieved by 73 of 74 (98.6%) patients. No patients had virologic failure and one discontinued from the study after withdrawing consent. SVR12 rates were uniformly high across all patient subgroups. A total of 16 patients had nonstructural protein 5A resistance-associated substitutions at baseline (16/73, 22%), all of whom achieved SVR12. Adverse events (AEs) reported in >5% of patients were fatigue (6.8%), upper respiratory tract infection (5.4%), headache (5.4%), and nausea (5.4%). Thirteen patients (17.6%) reported drug-related AEs, two serious AEs occurred, and two patients discontinued treatment owing to an AEs.
CONCLUSIONS
In this retrospective analysis, EBR/GZR administered for 12 weeks was well-tolerated and highly effective in Korean patients with HCV GT1b infection.
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