Tenofovir monotherapy versus tenofovir and entecavir combination therapy in patients with entecavir-resistant chronic hepatitis B with multiple drug failure: results of a randomised trial
DC Field | Value | Language |
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dc.contributor.author | Lim, Young-Suk | - |
dc.contributor.author | Byun, Kwan Soo | - |
dc.contributor.author | Yoo, Byung Chul | - |
dc.contributor.author | Kwon, So Young | - |
dc.contributor.author | Kim, Yoon Jun | - |
dc.contributor.author | An, Jihyun | - |
dc.contributor.author | Lee, Han Chu | - |
dc.contributor.author | Lee, Yung Sang | - |
dc.date.accessioned | 2021-09-04T00:17:31Z | - |
dc.date.available | 2021-09-04T00:17:31Z | - |
dc.date.created | 2021-06-18 | - |
dc.date.issued | 2016-05 | - |
dc.identifier.issn | 0017-5749 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/88835 | - |
dc.description.abstract | Objective Little clinical data are available regarding the optimal treatment of patients who harbour entecavir (ETV)-resistant HBV. Design In this multicentre randomised trial, patients who had HBV with ETV resistance-associated mutations and serum HBV DNA concentrations > 60 IU/mL were randomised to receive tenofovir disoproxil fumarate (TDF, 300 mg/day) monotherapy (n= 45) or TDF and ETV (1 mg/day) combination therapy (n= 45) for 48 weeks. Results Baseline characteristics were comparable between groups, including HBV DNA levels (median, 4.02 log(10) IU/mL) and hepatitis B e antigen-positivity (89%). All patients had at least one ETV-resistance mutation: rtT184A/C/F/G/I/L/S (n= 49), rtS202G (n= 43) and rtM250L/V (n= 7), in addition to rtM204V/I (n= 90). All except one patient in the TDF group completed 48 weeks of treatment. At week 48, the proportion of patients with HBV DNA < 15 IU/mL, the primary efficacy endpoint, was not significantly different between the TDF and TDF+ ETV groups (71% vs 73%; p> 0.99). The mean change in HBV DNA levels from baseline was not significantly different between groups (-3.66 vs -3.74 log10 IU/mL; p= 0.81). Virological breakthrough occurred in one patient on TDF, which was attributed to poor drug adherence. At week 48, six and three patients in the TDF and TDF+ ETV groups, respectively, retained their baseline resistance mutations (p> 0.99). None developed additional resistance mutations. Safety profiles were comparable in the two groups. Conclusions TDF monotherapy for 48 weeks provided a virological response comparable to that of TDF and ETV combination therapy in patients infected with ETV-resistant HBV. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | BMJ PUBLISHING GROUP | - |
dc.subject | NUCLEOS(T)IDE ANALOG THERAPY | - |
dc.subject | TERM LAMIVUDINE THERAPY | - |
dc.subject | HEPATOCELLULAR-CARCINOMA | - |
dc.subject | DISOPROXIL FUMARATE | - |
dc.subject | ADEFOVIR DIPIVOXIL | - |
dc.subject | RESCUE THERAPY | - |
dc.subject | CLINICAL-OUTCOMES | - |
dc.subject | VIRUS RESISTANCE | - |
dc.subject | RISK | - |
dc.subject | EFFICACY | - |
dc.title | Tenofovir monotherapy versus tenofovir and entecavir combination therapy in patients with entecavir-resistant chronic hepatitis B with multiple drug failure: results of a randomised trial | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Byun, Kwan Soo | - |
dc.identifier.doi | 10.1136/gutjnl-2014-308353 | - |
dc.identifier.scopusid | 2-s2.0-84929929100 | - |
dc.identifier.wosid | 000374119400019 | - |
dc.identifier.bibliographicCitation | GUT, v.65, no.5, pp.852 - 860 | - |
dc.relation.isPartOf | GUT | - |
dc.citation.title | GUT | - |
dc.citation.volume | 65 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 852 | - |
dc.citation.endPage | 860 | - |
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 | NUCLEOS(T)IDE ANALOG THERAPY | - |
dc.subject.keywordPlus | TERM LAMIVUDINE THERAPY | - |
dc.subject.keywordPlus | HEPATOCELLULAR-CARCINOMA | - |
dc.subject.keywordPlus | DISOPROXIL FUMARATE | - |
dc.subject.keywordPlus | ADEFOVIR DIPIVOXIL | - |
dc.subject.keywordPlus | RESCUE THERAPY | - |
dc.subject.keywordPlus | CLINICAL-OUTCOMES | - |
dc.subject.keywordPlus | VIRUS RESISTANCE | - |
dc.subject.keywordPlus | RISK | - |
dc.subject.keywordPlus | EFFICACY | - |
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