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Conference Paper: Long-term entecavir therapy results in reversal of fibrosis/cirrhosis and continued histologic improvement in patients with HBeAg(+) and (-) chronic hepatitis B: results from studies ETV-022, -027 and -901

TitleLong-term entecavir therapy results in reversal of fibrosis/cirrhosis and continued histologic improvement in patients with HBeAg(+) and (-) chronic hepatitis B: results from studies ETV-022, -027 and -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. In Hepatology, 2008, v. 48 n. Suppl 1, p. 706A How to Cite?
AbstractBackground: Entecavir (ETV) 0.5 mg resulted in improved liverhistology and was superior to lamivudine at 1 year in studiesETV-022 and ETV-027 (HBeAg(+) and (-) nucleoside-naïvepatients, respectively).1,2We present long term histologic resultsfor a subset of patients treated with ETV for a median of 6years. Methods: The long-term histology cohort consists of ETV-treated patients who completed study -022 or -027, subse-quently received ETV 1 mg daily in ETV-901, had an evaluablebiopsy at baseline (-022, -027) and had ≥3 years of cumulative ETV therapy (from phase III baseline to -901). Co-primary his-tology endpoints were proportions with histologic improvement(≥2-point decrease in Knodell necroinflammatory score and noworsening of Knodell fibrosis score) and improvement in Ishakfibrosis score (≥1 point decrease) compared to baseline. Keysecondary endpoints included proportions with HBV DNA <300 copies/mL, ALT normalization, and baseline HAI score ≥4that achieved a score of ≤3. Results: Sixty-three patients (47HBeAg(+);16 HBeAg(-)) met eligibility criteria for the long-termhistology cohort. Baseline characteristics of the cohort includedmean HBV DNA 9.2 log10copies/mL; mean Knodell necroin-flammatory score 7.9; and mean Ishak fibrosis score 2.4. Fifty-seven patients had evaluable long-term biopsy samples (mediantime of biopsy was 6 years; range:3−7 years). Among the fivepatients with baseline cirrhosis (Ishak fibrosis score ≥5), fourhad evaluable long term biopsies. All four demonstrated a ≥1-point improvement in Ishak fibrosis score with a median changefrom baseline of –3 (range: -1 to -4). Conclusions: Long-termtreatment with entecavir in a cohort of nucleoside-naïve chronichepatitis B patients treated for a median of 6 years resulted inprofound and durable virologic suppression, histologicimprovement, and normalization of liver histology, with regres-sion of fibrosis/cirrhosis. 1Chang TT, et al. N Engl J Med2006;354:1001-1010.2Lai CL, et al. N Engl J Med2006;354:1011-1020.
Persistent Identifierhttp://hdl.handle.net/10722/62298
ISSN
2015 Impact Factor: 11.711
2015 SCImago Journal Rankings: 4.752

 

DC FieldValueLanguage
dc.contributor.authorLiaw, YF-
dc.contributor.authorChang, TT-
dc.contributor.authorWu, SS-
dc.contributor.authorSchiff, ER-
dc.contributor.authorHan, KH-
dc.contributor.authorLai, CL-
dc.contributor.authorSafadi, R-
dc.contributor.authorLee, SS-
dc.contributor.authorHalota, W-
dc.contributor.authorGoodman, ZD-
dc.contributor.authorZhang, H-
dc.contributor.authorHindes, R-
dc.contributor.authorIloeje, U-
dc.contributor.authorBeebe, S-
dc.contributor.authorKreter, B-
dc.date.accessioned2010-07-13T03:58:16Z-
dc.date.available2010-07-13T03:58:16Z-
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. In Hepatology, 2008, v. 48 n. Suppl 1, p. 706A-
dc.identifier.issn0270-9139-
dc.identifier.urihttp://hdl.handle.net/10722/62298-
dc.description.abstractBackground: Entecavir (ETV) 0.5 mg resulted in improved liverhistology and was superior to lamivudine at 1 year in studiesETV-022 and ETV-027 (HBeAg(+) and (-) nucleoside-naïvepatients, respectively).1,2We present long term histologic resultsfor a subset of patients treated with ETV for a median of 6years. Methods: The long-term histology cohort consists of ETV-treated patients who completed study -022 or -027, subse-quently received ETV 1 mg daily in ETV-901, had an evaluablebiopsy at baseline (-022, -027) and had ≥3 years of cumulative ETV therapy (from phase III baseline to -901). Co-primary his-tology endpoints were proportions with histologic improvement(≥2-point decrease in Knodell necroinflammatory score and noworsening of Knodell fibrosis score) and improvement in Ishakfibrosis score (≥1 point decrease) compared to baseline. Keysecondary endpoints included proportions with HBV DNA <300 copies/mL, ALT normalization, and baseline HAI score ≥4that achieved a score of ≤3. Results: Sixty-three patients (47HBeAg(+);16 HBeAg(-)) met eligibility criteria for the long-termhistology cohort. Baseline characteristics of the cohort includedmean HBV DNA 9.2 log10copies/mL; mean Knodell necroin-flammatory score 7.9; and mean Ishak fibrosis score 2.4. Fifty-seven patients had evaluable long-term biopsy samples (mediantime of biopsy was 6 years; range:3−7 years). Among the fivepatients with baseline cirrhosis (Ishak fibrosis score ≥5), fourhad evaluable long term biopsies. All four demonstrated a ≥1-point improvement in Ishak fibrosis score with a median changefrom baseline of –3 (range: -1 to -4). Conclusions: Long-termtreatment with entecavir in a cohort of nucleoside-naïve chronichepatitis B patients treated for a median of 6 years resulted inprofound and durable virologic suppression, histologicimprovement, and normalization of liver histology, with regres-sion of fibrosis/cirrhosis. 1Chang TT, et al. N Engl J Med2006;354:1001-1010.2Lai CL, et al. N Engl J Med2006;354:1011-1020.-
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.titleLong-term entecavir therapy results in reversal of fibrosis/cirrhosis and continued histologic improvement in patients with HBeAg(+) and (-) chronic hepatitis B: results from studies ETV-022, -027 and -901-
dc.typeConference_Paper-
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0270-9139&volume=48&issue=Suppl 1&spage=706A&epage=&date=2008&atitle=Long-term+entecavir+therapy+results+in+reversal+of+fibrosis/cirrhosis+and+continued+histologic+improvement+in+patients+with+HBeAg(+)+and+(-)+chronic+hepatitis+B:+results+from+studies+ETV-022,+-027+and+-901.+en_HK
dc.identifier.emailLai, CL: hrmelcl@hku.hk-
dc.identifier.authorityLai, CL=rp00314-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1002/hep.22643-
dc.identifier.hkuros161360-
dc.identifier.volume48-
dc.identifier.issueSuppl 1-
dc.identifier.spage706A-
dc.identifier.epage706A-
dc.publisher.placeUnited States-

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