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Cited 14 time in webofscience Cited 15 time in scopus
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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
Lim, Young-SukAhn, Sang HoonLee, Kwan SikPaik, Seung WoonLee, Youn-JaeJeong, Sook-HyangKim, Ju-HyunYoon, Seung KewYim, Hyung JoonTak, Won YoungHan, Sang-YoungYang, Jenny C.Mo, HongmeiGarrison, Kimberly L.Gao, BingKnox, Steven J.Pang, Phillip S.Kim, Yoon JunByun, Kwan-SooKim, Young SeokHeo, JeongHan, Kwang-Hyub
Issue Date
Nov-2016
Publisher
Springer Pub. Co.
Keywords
Genotype 1; Hepatitis C virus (HCV); Korea; Ledipasvir; Sofosbuvir
Citation
Hepatology International, v.10, no.6, pp 947 - 955
Pages
9
Indexed
SCIE
SCOPUS
Journal Title
Hepatology International
Volume
10
Number
6
Start Page
947
End Page
955
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/5941
DOI
10.1007/s12072-016-9726-5
ISSN
1936-0533
1936-0541
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-naïve 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-naïve 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-naïve and treatment-experienced Korean patients with chronic genotype 1 HCV infection.
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Byun, Kwan Soo
Guro Hospital (Department of Gastroenterology and Hepatology, Guro Hospital)
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