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 |
---|---|---|
dc.contributor.author | Lim, Young-Suk | - |
dc.contributor.author | Ahn, Sang Hoon | - |
dc.contributor.author | Lee, Kwan Sik | - |
dc.contributor.author | Paik, Seung Woon | - |
dc.contributor.author | Lee, Youn-Jae | - |
dc.contributor.author | Jeong, Sook-Hyang | - |
dc.contributor.author | Kim, Ju-Hyun | - |
dc.contributor.author | Yoon, Seung Kew | - |
dc.contributor.author | Yim, Hyung Joon | - |
dc.contributor.author | Tak, Won Young | - |
dc.contributor.author | Han, Sang-Young | - |
dc.contributor.author | Yang, Jenny C. | - |
dc.contributor.author | Mo, Hongmei | - |
dc.contributor.author | Garrison, Kimberly L. | - |
dc.contributor.author | Gao, Bing | - |
dc.contributor.author | Knox, Steven J. | - |
dc.contributor.author | Pang, Phillip S. | - |
dc.contributor.author | Kim, Yoon Jun | - |
dc.contributor.author | Byun, Kwan-Soo | - |
dc.contributor.author | Kim, Young Seok | - |
dc.contributor.author | Heo, Jeong | - |
dc.contributor.author | Han, Kwang-Hyub | - |
dc.date.accessioned | 2021-09-03T18:01:48Z | - |
dc.date.available | 2021-09-03T18:01:48Z | - |
dc.date.created | 2021-06-16 | - |
dc.date.issued | 2016-11 | - |
dc.identifier.issn | 1936-0533 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/87128 | - |
dc.description.abstract | 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. 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. 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. 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.language | English | - |
dc.language.iso | en | - |
dc.publisher | SPRINGER | - |
dc.subject | ALPHA-2A PLUS RIBAVIRIN | - |
dc.subject | PEGYLATED INTERFERON | - |
dc.subject | ANTIVIRAL THERAPY | - |
dc.subject | PEGINTERFERON ALPHA-2B | - |
dc.subject | VIROLOGICAL RESPONSE | - |
dc.subject | CIRRHOTIC-PATIENTS | - |
dc.subject | HCV | - |
dc.subject | LEDIPASVIR | - |
dc.subject | SOFOSBUVIR | - |
dc.subject | OLDER | - |
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.contributor.affiliatedAuthor | Yim, Hyung Joon | - |
dc.contributor.affiliatedAuthor | Byun, Kwan-Soo | - |
dc.identifier.doi | 10.1007/s12072-016-9726-5 | - |
dc.identifier.scopusid | 2-s2.0-84969792629 | - |
dc.identifier.wosid | 000387235900013 | - |
dc.identifier.bibliographicCitation | HEPATOLOGY INTERNATIONAL, v.10, no.6, pp.947 - 955 | - |
dc.relation.isPartOf | HEPATOLOGY INTERNATIONAL | - |
dc.citation.title | HEPATOLOGY INTERNATIONAL | - |
dc.citation.volume | 10 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 947 | - |
dc.citation.endPage | 955 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Gastroenterology & Hepatology | - |
dc.relation.journalWebOfScienceCategory | Gastroenterology & Hepatology | - |
dc.subject.keywordPlus | ALPHA-2A PLUS RIBAVIRIN | - |
dc.subject.keywordPlus | PEGYLATED INTERFERON | - |
dc.subject.keywordPlus | ANTIVIRAL THERAPY | - |
dc.subject.keywordPlus | PEGINTERFERON ALPHA-2B | - |
dc.subject.keywordPlus | VIROLOGICAL RESPONSE | - |
dc.subject.keywordPlus | CIRRHOTIC-PATIENTS | - |
dc.subject.keywordPlus | HCV | - |
dc.subject.keywordPlus | LEDIPASVIR | - |
dc.subject.keywordPlus | SOFOSBUVIR | - |
dc.subject.keywordPlus | OLDER | - |
dc.subject.keywordAuthor | Genotype 1 | - |
dc.subject.keywordAuthor | Hepatitis C virus (HCV) | - |
dc.subject.keywordAuthor | Korea | - |
dc.subject.keywordAuthor | Ledipasvir | - |
dc.subject.keywordAuthor | Sofosbuvir | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
(02841) 서울특별시 성북구 안암로 14502-3290-1114
COPYRIGHT © 2021 Korea University. All Rights Reserved.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.