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An integrated analysis of elbasvir/grazoprevir in Korean patients with hepatitis C virus genotype 1b infection

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Affiliated Author(s)
정우진
Alternative Author(s)
Chung, Woo Jin
Journal Title
Clinical and Molecular Hepatology
ISSN
2287-285X
Issued Date
2019
Keyword
Hepatitis CChronicAntiviral agentsSustained virologic response
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.
Department
Dept. of Internal Medicine (내과학)
Publisher
School of Medicine (의과대학)
Citation
Barbara Haber et al. (2019). An integrated analysis of elbasvir/grazoprevir in Korean patients with hepatitis C virus genotype 1b infection. Clinical and Molecular Hepatology. doi: 10.3350/cmh.2019.0006
Type
Article
ISSN
2287-285X
DOI
10.3350/cmh.2019.0006
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/42019
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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