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A 96-week randomized trial of switching to entecavir in patients who achieved virological suppression on lamivudine therapy

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dc.contributor.authorAhn, Sang Hoon-
dc.contributor.authorHeo, Jeong-
dc.contributor.authorPark, Jun Yong-
dc.contributor.authorWoo, Hyun Young-
dc.contributor.authorLee, Heon Ju-
dc.contributor.authorTak, Won Young-
dc.contributor.authorUm, Soon Ho-
dc.contributor.authorYoon, Ki Tae-
dc.contributor.authorPark, Soo Young-
dc.contributor.authorKim, Chang Wook-
dc.contributor.authorKim, Hyung Hoi-
dc.contributor.authorHan, Kwang-Hyub-
dc.contributor.authorCho, Mong-
dc.date.available2020-11-02T12:42:23Z-
dc.date.issued2016-04-
dc.identifier.issn0815-9319-
dc.identifier.issn1440-1746-
dc.identifier.urihttps://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/6589-
dc.description.abstractBackground and Aim: There are limited data assessing whether patients who achieved virological suppression on lamivudine but remain hepatitis B “e” antigen-positive should be switched to a more potent antiviral with a high genetic barrier to resistance or continue with lamivudine. We compared the safety and efficacy of switching with entecavir versus continuing lamivudine. Methods: This was a Phase IV, randomized, open-label, prospective study in a tertiary care setting. Seventy-three chronic hepatitis B patients who achieved virological suppression on lamivudine (serum hepatitis B virus DNA < 60 International Unit (IU)/mL) were enrolled. Entecavir or lamivudine were administered orally for up to 96 weeks. Virologic and serologic responses were measured throughout the study. Results: A significantly higher proportion of patients in the entecavir group achieved hepatitis B virus DNA < 60 IU/mL at Weeks 48 (100% [38/38] vs 62.8% [22/35]; P < 0.001) and 96 (97.4% [37/38] vs 57.1% [20/35]; P<0.001). A greater number of patients had virologic breakthrough (Week 96 cumulative incidence 42.9% vs 2.6%; P<0.001) and genotypic lamivudine resistance (28.6% [10/35] vs 0% [0/38]; P<0.001) in the lamivudine group. No serious adverse events or laboratory abnormalities were reported. Conclusions: Even after achieving virological suppression on lamivudine therapy, the risk of emergent lamivudine resistance increases over time. Switching to entecavir resulted in a maintained virologic response and superior serologic responses versus continued lamivudine therapy. This study supports a rationale for switching to entecavir in chronic hepatitis B patients with virological suppression on lamivudine.-
dc.format.extent7-
dc.language영어-
dc.language.isoENG-
dc.publisherBlackwell Publishing Inc.-
dc.titleA 96-week randomized trial of switching to entecavir in patients who achieved virological suppression on lamivudine therapy-
dc.typeArticle-
dc.publisher.location미국-
dc.identifier.doi10.1111/jgh.13231-
dc.identifier.scopusid2-s2.0-84963877913-
dc.identifier.wosid000374702700027-
dc.identifier.bibliographicCitationJournal of Gastroenterology and Hepatology, v.31, no.4, pp 865 - 871-
dc.citation.titleJournal of Gastroenterology and Hepatology-
dc.citation.volume31-
dc.citation.number4-
dc.citation.startPage865-
dc.citation.endPage871-
dc.type.docTypeArticle-
dc.description.isOpenAccessN-
dc.description.journalRegisteredClasssci-
dc.description.journalRegisteredClassscie-
dc.description.journalRegisteredClassscopus-
dc.relation.journalResearchAreaGastroenterology & Hepatology-
dc.relation.journalWebOfScienceCategoryGastroenterology & Hepatology-
dc.subject.keywordPlusCHRONIC HEPATITIS-B-
dc.subject.keywordPlusVIRUS GENOTYPE-
dc.subject.keywordPlusINFECTION-
dc.subject.keywordPlusRESISTANT-
dc.subject.keywordAuthorentecavir-
dc.subject.keywordAuthorhepatitis B-
dc.subject.keywordAuthorlamivudine-
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