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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
DC Field | Value | Language |
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dc.contributor.author | 안상훈 | - |
dc.contributor.author | 한광협 | - |
dc.contributor.author | 이관식 | - |
dc.date.accessioned | 2017-10-26T08:11:42Z | - |
dc.date.available | 2017-10-26T08:11:42Z | - |
dc.date.issued | 2016 | - |
dc.identifier.issn | 1936-0533 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/153107 | - |
dc.description.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. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Springer | - |
dc.relation.isPartOf | HEPATOLOGY INTERNATIONAL | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.publisher.location | United States | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | Young-Suk Lim | - |
dc.contributor.googleauthor | Sang Hoon Ahn | - |
dc.contributor.googleauthor | Kwan Sik Lee | - |
dc.contributor.googleauthor | Seung Woon Paik | - |
dc.contributor.googleauthor | Youn-Jae Lee | - |
dc.contributor.googleauthor | Sook-Hyang Jeong | - |
dc.contributor.googleauthor | Ju-Hyun Kim | - |
dc.contributor.googleauthor | Seung Kew Yoon | - |
dc.contributor.googleauthor | Hyung Joon Yim | - |
dc.contributor.googleauthor | Won Young Tak | - |
dc.contributor.googleauthor | Sang-Young Han | - |
dc.contributor.googleauthor | Jenny C. Yang | - |
dc.contributor.googleauthor | Hongmei Mo | - |
dc.contributor.googleauthor | Kimberly L. Garrison | - |
dc.contributor.googleauthor | Bing Gao | - |
dc.contributor.googleauthor | Steven J. Knox | - |
dc.contributor.googleauthor | Phillip S. Pang | - |
dc.contributor.googleauthor | Yoon Jun Kim | - |
dc.contributor.googleauthor | Kwan-Soo Byun | - |
dc.contributor.googleauthor | Young Seok Kim | - |
dc.contributor.googleauthor | Jeong Heo | - |
dc.contributor.googleauthor | Kwang-Hyub Han | - |
dc.identifier.doi | 10.1007/s12072-016-9726-5 | - |
dc.contributor.localId | A04268 | - |
dc.contributor.localId | A02666 | - |
dc.contributor.localId | A02226 | - |
dc.relation.journalcode | J00986 | - |
dc.identifier.eissn | 1936-0541 | - |
dc.identifier.pmid | 27198664 | - |
dc.identifier.url | https://link.springer.com/article/10.1007%2Fs12072-016-9726-5 | - |
dc.subject.keyword | Genotype 1 | - |
dc.subject.keyword | Hepatitis C virus (HCV) | - |
dc.subject.keyword | Korea | - |
dc.subject.keyword | Ledipasvir | - |
dc.subject.keyword | Sofosbuvir | - |
dc.contributor.alternativeName | Ahn, Sang Hoon | - |
dc.contributor.alternativeName | Han, Kwang Hyup | - |
dc.contributor.alternativeName | Lee, Kwan Sik | - |
dc.contributor.affiliatedAuthor | Han, Kwang Hyup | - |
dc.contributor.affiliatedAuthor | Lee, Kwan Sik | - |
dc.contributor.affiliatedAuthor | Ahn, Sang Hoon | - |
dc.citation.volume | 10 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 947 | - |
dc.citation.endPage | 955 | - |
dc.identifier.bibliographicCitation | HEPATOLOGY INTERNATIONAL, Vol.10(6) : 947-955, 2016 | - |
dc.date.modified | 2017-10-24 | - |
dc.identifier.rimsid | 41109 | - |
dc.type.rims | ART | - |
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