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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

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dc.contributor.author안상훈-
dc.contributor.author한광협-
dc.contributor.author이관식-
dc.date.accessioned2017-10-26T08:11:42Z-
dc.date.available2017-10-26T08:11:42Z-
dc.date.issued2016-
dc.identifier.issn1936-0533-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/153107-
dc.description.abstractBACKGROUND: 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.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherSpringer-
dc.relation.isPartOfHEPATOLOGY INTERNATIONAL-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.titleA 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-
dc.typeArticle-
dc.publisher.locationUnited States-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Internal Medicine-
dc.contributor.googleauthorYoung-Suk Lim-
dc.contributor.googleauthorSang Hoon Ahn-
dc.contributor.googleauthorKwan Sik Lee-
dc.contributor.googleauthorSeung Woon Paik-
dc.contributor.googleauthorYoun-Jae Lee-
dc.contributor.googleauthorSook-Hyang Jeong-
dc.contributor.googleauthorJu-Hyun Kim-
dc.contributor.googleauthorSeung Kew Yoon-
dc.contributor.googleauthorHyung Joon Yim-
dc.contributor.googleauthorWon Young Tak-
dc.contributor.googleauthorSang-Young Han-
dc.contributor.googleauthorJenny C. Yang-
dc.contributor.googleauthorHongmei Mo-
dc.contributor.googleauthorKimberly L. Garrison-
dc.contributor.googleauthorBing Gao-
dc.contributor.googleauthorSteven J. Knox-
dc.contributor.googleauthorPhillip S. Pang-
dc.contributor.googleauthorYoon Jun Kim-
dc.contributor.googleauthorKwan-Soo Byun-
dc.contributor.googleauthorYoung Seok Kim-
dc.contributor.googleauthorJeong Heo-
dc.contributor.googleauthorKwang-Hyub Han-
dc.identifier.doi10.1007/s12072-016-9726-5-
dc.contributor.localIdA04268-
dc.contributor.localIdA02666-
dc.contributor.localIdA02226-
dc.relation.journalcodeJ00986-
dc.identifier.eissn1936-0541-
dc.identifier.pmid27198664-
dc.identifier.urlhttps://link.springer.com/article/10.1007%2Fs12072-016-9726-5-
dc.subject.keywordGenotype 1-
dc.subject.keywordHepatitis C virus (HCV)-
dc.subject.keywordKorea-
dc.subject.keywordLedipasvir-
dc.subject.keywordSofosbuvir-
dc.contributor.alternativeNameAhn, Sang Hoon-
dc.contributor.alternativeNameHan, Kwang Hyup-
dc.contributor.alternativeNameLee, Kwan Sik-
dc.contributor.affiliatedAuthorHan, Kwang Hyup-
dc.contributor.affiliatedAuthorLee, Kwan Sik-
dc.contributor.affiliatedAuthorAhn, Sang Hoon-
dc.citation.volume10-
dc.citation.number6-
dc.citation.startPage947-
dc.citation.endPage955-
dc.identifier.bibliographicCitationHEPATOLOGY INTERNATIONAL, Vol.10(6) : 947-955, 2016-
dc.date.modified2017-10-24-
dc.identifier.rimsid41109-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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