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A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-na?ve and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus

Authors
 Young-Suk Lim  ;  Sang Hoon Ahn  ;  Kwan Sik Lee  ;  Seung Woon Paik  ;  Youn-Jae Lee  ;  Sook-Hyang Jeong  ;  Ju-Hyun Kim  ;  Seung Kew Yoon  ;  Hyung Joon Yim  ;  Won Young Tak  ;  Sang-Young Han  ;  Jenny C. Yang  ;  Hongmei Mo  ;  Kimberly L. Garrison  ;  Bing Gao  ;  Steven J. Knox  ;  Phillip S. Pang  ;  Yoon Jun Kim  ;  Kwan-Soo Byun  ;  Young Seok Kim  ;  Jeong Heo  ;  Kwang-Hyub Han 
Citation
 HEPATOLOGY INTERNATIONAL, Vol.10(6) : 947-955, 2016 
Journal Title
HEPATOLOGY INTERNATIONAL
ISSN
 1936-0533 
Issue Date
2016
Keywords
Genotype 1 ; Hepatitis C virus (HCV) ; Korea ; Ledipasvir ; Sofosbuvir
Abstract
BACKGROUND: The standard-of-care regimen for chronic hepatitis C virus (HCV) infection in Korea, pegylated-interferon-alpha plus ribavirin, is poorly tolerated. Ledipasvir/sofosbuvir is a two-drug, fixed-dose combination tablet approved in the USA, European Union, and Japan for chronic genotype 1 HCV infection.

METHODS: This single-arm, phase IIIb study (NCT02021656) investigated the efficacy and safety of ledipasvir/sofosbuvir fixed-dose combination tablet for 12 weeks in treatment-na?ve and treatment-experienced Korean patients chronically infected with genotype 1 HCV with or without compensated cirrhosis.

RESULTS: The proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 99 % (92/93), with rates of 100 % (46/46) and 98 % (46/47) in treatment-na?ve and treatment-experienced patients, respectively. There were no on-treatment failures. One patient relapsed after the end of treatment. The most common treatment-emergent adverse events were headache (8 %, 7/93) and fatigue (6 %, 6/93). There were no grade 3 or 4 adverse events, seven grade 3 laboratory abnormalities, and one premature discontinuation of study treatment (due to nonserious mouth ulceration). None of the three reported serious adverse events were related to treatment.

CONCLUSIONS: These data suggest that 12 weeks of ledipasvir/sofosbuvir is effective and well tolerated in treatment-na?ve and treatment-experienced Korean patients with chronic genotype 1 HCV infection.
Full Text
https://link.springer.com/article/10.1007%2Fs12072-016-9726-5
DOI
10.1007/s12072-016-9726-5
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
Lee, Kwan Sik(이관식) ORCID logo https://orcid.org/0000-0002-3672-1198
Han, Kwang-Hyub(한광협) ORCID logo https://orcid.org/0000-0003-3960-6539
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/153107
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