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Conference Paper: Three years of entecavir (etv) re-treatment of HBeAg(-) etv patients who previously discontinued ETV treatment: results from study ETV-901

TitleThree years of entecavir (etv) re-treatment of HBeAg(-) etv patients who previously discontinued ETV treatment: results from study ETV-901
Authors
Issue Date2008
PublisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://www.hepatology.org/
Citation
The 59th Annual Meeting of the American Association for the Study of Liver Diseases, San Francisco, CA, 31 October - 4 November 2008. Hepatology, 2008, v. 48 n. Suppl 1, p. 722A How to Cite?
AbstractBackground: Entecavir (ETV) 0.5 mg was superior to lamivu-dine 100 mg for virologic, histologic and biochemical end-points at Week 48 in nucleoside-naïve HBeAg(-) chronichepatitis B (CHB) patients (ETV-027). Patients that met protocol-defined endpoints were taken off therapy after 52 weeks. Sub-jects who relapsed within 6 months could re-enroll in ETV-901.We report results of ETV re-treatment through 3 years in studyETV-901. Methods: The HBeAg(-) ETV re-treatment cohort con-sists of patients who enrolled into ETV-901 with a treatmentgap of at least 60 days between studies and received re-treat-ment with 1 mg of ETV. The proportions of patients with HBVDNA <300 copies/mL by PCR assay and ALT normalizationwere evaluated among patients with available samples at 2years (96 weeks) and 3 years (144 weeks) of ETV re-treatment.Results: Ninety-nine ETV-treated subjects from study ETV-027met criteria for ETV re-treatment and enrolled in ETV-901; 76and 66 subjects met criteria for inclusion in the analyses of 2and 3 years of ETV re-treatment, respectively. Efficacy parame-ters for patients receiving up to 3 years ETV re-treatment arepresented in the table below. After 3 years of ETV treatment,57/57 (100%) patients had HBV DNA levels <104copies/mL.The safety profile of ETV in this re-treated population was con-sistent with the previously reported experience. Conclusions:ETV-027 demonstrated that discontinuation of effective antiviraltherapy in HBeAg(-) patients after 52 weeks of treatment resultsin rebound of viremia and increases in ALT. At 3 years of ETVre-treatment, 95% of HBeAg(-) patients who had previously dis-continued ETV therapy had undetectable HBV DNA and 86%achieved ALT normalization.
Persistent Identifierhttp://hdl.handle.net/10722/62438
ISSN
2015 Impact Factor: 11.711
2015 SCImago Journal Rankings: 4.752

 

DC FieldValueLanguage
dc.contributor.authorShouval, D-
dc.contributor.authorLai, CL-
dc.contributor.authorChang, TT-
dc.contributor.authorGadano, A-
dc.contributor.authorWu, SS-
dc.contributor.authorHalota, W-
dc.contributor.authorSievert, W-
dc.contributor.authorTsai, NCSC-
dc.contributor.authorZhang, H-
dc.contributor.authorIloeje, U-
dc.date.accessioned2010-07-13T04:01:14Z-
dc.date.available2010-07-13T04:01:14Z-
dc.date.issued2008-
dc.identifier.citationThe 59th Annual Meeting of the American Association for the Study of Liver Diseases, San Francisco, CA, 31 October - 4 November 2008. Hepatology, 2008, v. 48 n. Suppl 1, p. 722A-
dc.identifier.issn0270-9139-
dc.identifier.urihttp://hdl.handle.net/10722/62438-
dc.description.abstractBackground: Entecavir (ETV) 0.5 mg was superior to lamivu-dine 100 mg for virologic, histologic and biochemical end-points at Week 48 in nucleoside-naïve HBeAg(-) chronichepatitis B (CHB) patients (ETV-027). Patients that met protocol-defined endpoints were taken off therapy after 52 weeks. Sub-jects who relapsed within 6 months could re-enroll in ETV-901.We report results of ETV re-treatment through 3 years in studyETV-901. Methods: The HBeAg(-) ETV re-treatment cohort con-sists of patients who enrolled into ETV-901 with a treatmentgap of at least 60 days between studies and received re-treat-ment with 1 mg of ETV. The proportions of patients with HBVDNA <300 copies/mL by PCR assay and ALT normalizationwere evaluated among patients with available samples at 2years (96 weeks) and 3 years (144 weeks) of ETV re-treatment.Results: Ninety-nine ETV-treated subjects from study ETV-027met criteria for ETV re-treatment and enrolled in ETV-901; 76and 66 subjects met criteria for inclusion in the analyses of 2and 3 years of ETV re-treatment, respectively. Efficacy parame-ters for patients receiving up to 3 years ETV re-treatment arepresented in the table below. After 3 years of ETV treatment,57/57 (100%) patients had HBV DNA levels <104copies/mL.The safety profile of ETV in this re-treated population was con-sistent with the previously reported experience. Conclusions:ETV-027 demonstrated that discontinuation of effective antiviraltherapy in HBeAg(-) patients after 52 weeks of treatment resultsin rebound of viremia and increases in ALT. At 3 years of ETVre-treatment, 95% of HBeAg(-) patients who had previously dis-continued ETV therapy had undetectable HBV DNA and 86%achieved ALT normalization.-
dc.languageeng-
dc.publisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://www.hepatology.org/-
dc.relation.ispartofHepatology-
dc.rightsHepatology. Copyright © John Wiley & Sons, Inc.-
dc.rightsSpecial Statement for Preprint only Before publication: 'This is a preprint of an article accepted for publication in [The Journal of Pathology] Copyright © ([year]) ([Pathological Society of Great Britain and Ireland])'. After publication: the preprint notice should be amended to follows: 'This is a preprint of an article published in [include the complete citation information for the final version of the Contribution as published in the print edition of the Journal]' For Cochrane Library/ Cochrane Database of Systematic Reviews, add statement & acknowledgement : ‘This review is published as a Cochrane Review in the Cochrane Database of Systematic Reviews 20XX, Issue X. Cochrane Reviews are regularly updated as new evidence emerges and in response to comments and criticisms, and the Cochrane Database of Systematic Reviews should be consulted for the most recent version of the Review.’ Please include reference to the Review and hyperlink to the original version using the following format e.g. Authors. Title of Review. Cochrane Database of Systematic Reviews 20XX, Issue #. Art. No.: CD00XXXX. DOI: 10.1002/14651858.CD00XXXX (insert persistent link to the article by using the URL: http://dx.doi.org/10.1002/14651858.CD00XXXX) (This statement should refer to the most recent issue of the Cochrane Database of Systematic Reviews in which the Review published.)-
dc.titleThree years of entecavir (etv) re-treatment of HBeAg(-) etv patients who previously discontinued ETV treatment: results from study ETV-901-
dc.typeConference_Paper-
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0270-9139&volume=48&issue=Suppl 1&spage=722A&epage=&date=2008&atitle=Three+years+of+entecavir+(etv)+re-treatment+of+HBeAg(-)+etv+patients+who+previously+discontinued+ETV+treatment:+results+from+study+ETV-901en_HK
dc.identifier.emailLai, CL: hrmelcl@hku.hk-
dc.identifier.authorityLai, CL=rp00314-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1002/hep.22644-
dc.identifier.hkuros161365-
dc.identifier.volume48-
dc.identifier.issueSuppl 1-
dc.identifier.spage722A-
dc.identifier.epage722A-
dc.publisher.placeUnited States-

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