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Article: Efficacy of entecavir in chronic hepatitis b patients with mildly elevated alanine aminotransferase and biopsy-proven histological damage

TitleEfficacy of entecavir in chronic hepatitis b patients with mildly elevated alanine aminotransferase and biopsy-proven histological damage
Authors
Issue Date2010
PublisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://www.hepatology.org/
Citation
Hepatology, 2010, v. 51 n. 4, p. 1185-1189 How to Cite?
AbstractCurrent guidelines for management of chronic hepatitis B recommend treatment for patients presenting with elevated hepatitis B virus (HBV) DNA and alanine aminotransferase (ALT) >2 × upper limit of normal (ULN) or histological evidence of liver disease. Retrospective analyses have demonstrated that significant hepatic necroinflammation and fibrosis were present in a substantial proportion of patients with ALT 1 to 2×ULN. To assess therapeutic efficacy in this clinical setting, we retrospectively examined treatment endpoints among the subset of nucleoside-naïve chronic hepatitis B (CHB) patients treated in phase 3 clinical trials of entecavir who had both screening and baseline serum ALT 1.3 to 2×ULN. A total of 1347 patients were randomized to treatment with entecavir or lamivudine. Three hundred thirty-six patients, constituting 25% of the total study population, had screening and baseline ALT 1.3 to 2 × ULN. Clinically significant necroinflammation (Knodell necroinflammation score >7) was observed in 60% and 72% of hepatitis B e antigen (HBeAg)-positive and HBeAg-negative patients, respectively, whereas marked fibrosis (Ishak fibrosis score >4) was observed in 8% and 15% of HBeAg-positive and HBeAg-negative patients, respectively. Among entecavir-treated HBeAgnegative patients, the proportions of patients achieving histological improvement, HBV DNA <300 copies/mL, and ALT normalization were similar between patients with mildly elevated ALT and those with ALT>2×ULN. However, entecavir-treated HBeAg-positive patients with mildly elevated ALT had lower response rates for histological improvement,HBVDNAless than 300 copies/mL, ALT normalization, and HBeAg seroconversion than those with ALT greater than 2×ULN. Conclusion: This retrospective analysis demonstrated that HBeAg-negativeCHB patients treated with entecavir responded similarly irrespective of baseline ALT level. However, HBeAg-positive patients with mildly elevated ALT responded less well to treatment with entecavir than did those with ALT greater than 2 × ULN. Copyright © 2010 by the American Association for the Study of Liver Diseases.
Persistent Identifierhttp://hdl.handle.net/10722/163302
ISSN
2015 Impact Factor: 11.711
2015 SCImago Journal Rankings: 4.752
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorWu, ICen_US
dc.contributor.authorLai, CLen_US
dc.contributor.authorBui Han, SHen_US
dc.contributor.authorHan, KHen_US
dc.contributor.authorGordon, SCen_US
dc.contributor.authorChao, YCen_US
dc.contributor.authorTan, CKen_US
dc.contributor.authorSievert, Wen_US
dc.contributor.authorTanwandee, Ten_US
dc.contributor.authorXu, Den_US
dc.contributor.authorNeo, BLen_US
dc.contributor.authorChang, TTen_US
dc.date.accessioned2012-09-05T05:29:51Z-
dc.date.available2012-09-05T05:29:51Z-
dc.date.issued2010en_US
dc.identifier.citationHepatology, 2010, v. 51 n. 4, p. 1185-1189en_US
dc.identifier.issn0270-9139en_US
dc.identifier.urihttp://hdl.handle.net/10722/163302-
dc.description.abstractCurrent guidelines for management of chronic hepatitis B recommend treatment for patients presenting with elevated hepatitis B virus (HBV) DNA and alanine aminotransferase (ALT) >2 × upper limit of normal (ULN) or histological evidence of liver disease. Retrospective analyses have demonstrated that significant hepatic necroinflammation and fibrosis were present in a substantial proportion of patients with ALT 1 to 2×ULN. To assess therapeutic efficacy in this clinical setting, we retrospectively examined treatment endpoints among the subset of nucleoside-naïve chronic hepatitis B (CHB) patients treated in phase 3 clinical trials of entecavir who had both screening and baseline serum ALT 1.3 to 2×ULN. A total of 1347 patients were randomized to treatment with entecavir or lamivudine. Three hundred thirty-six patients, constituting 25% of the total study population, had screening and baseline ALT 1.3 to 2 × ULN. Clinically significant necroinflammation (Knodell necroinflammation score >7) was observed in 60% and 72% of hepatitis B e antigen (HBeAg)-positive and HBeAg-negative patients, respectively, whereas marked fibrosis (Ishak fibrosis score >4) was observed in 8% and 15% of HBeAg-positive and HBeAg-negative patients, respectively. Among entecavir-treated HBeAgnegative patients, the proportions of patients achieving histological improvement, HBV DNA <300 copies/mL, and ALT normalization were similar between patients with mildly elevated ALT and those with ALT>2×ULN. However, entecavir-treated HBeAg-positive patients with mildly elevated ALT had lower response rates for histological improvement,HBVDNAless than 300 copies/mL, ALT normalization, and HBeAg seroconversion than those with ALT greater than 2×ULN. Conclusion: This retrospective analysis demonstrated that HBeAg-negativeCHB patients treated with entecavir responded similarly irrespective of baseline ALT level. However, HBeAg-positive patients with mildly elevated ALT responded less well to treatment with entecavir than did those with ALT greater than 2 × ULN. Copyright © 2010 by the American Association for the Study of Liver Diseases.en_US
dc.languageengen_US
dc.publisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://www.hepatology.org/en_US
dc.relation.ispartofHepatologyen_US
dc.subject.meshAdulten_US
dc.subject.meshAlanine Transaminase - Blooden_US
dc.subject.meshAntiviral Agents - Therapeutic Useen_US
dc.subject.meshBiopsyen_US
dc.subject.meshFemaleen_US
dc.subject.meshGuanine - Analogs & Derivatives - Therapeutic Useen_US
dc.subject.meshHepatitis B E Antigens - Analysisen_US
dc.subject.meshHepatitis B, Chronic - Drug Therapy - Physiopathologyen_US
dc.subject.meshHumansen_US
dc.subject.meshLiver - Physiopathologyen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshRetrospective Studiesen_US
dc.titleEfficacy of entecavir in chronic hepatitis b patients with mildly elevated alanine aminotransferase and biopsy-proven histological damageen_US
dc.typeArticleen_US
dc.identifier.emailLai, CL:hrmelcl@hku.hken_US
dc.identifier.authorityLai, CL=rp00314en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1002/hep.23424en_US
dc.identifier.pmid20044806-
dc.identifier.scopuseid_2-s2.0-77950609092en_US
dc.identifier.hkuros181153-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-77950609092&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume51en_US
dc.identifier.issue4en_US
dc.identifier.spage1185en_US
dc.identifier.epage1189en_US
dc.identifier.isiWOS:000276538100014-
dc.publisher.placeUnited Statesen_US
dc.identifier.scopusauthoridWu, IC=15128207400en_US
dc.identifier.scopusauthoridLai, CL=7403086396en_US
dc.identifier.scopusauthoridBui Han, SH=6504060721en_US
dc.identifier.scopusauthoridHan, KH=7402963689en_US
dc.identifier.scopusauthoridGordon, SC=7401828663en_US
dc.identifier.scopusauthoridChao, YC=23117629900en_US
dc.identifier.scopusauthoridTan, CK=15768583000en_US
dc.identifier.scopusauthoridSievert, W=7004049384en_US
dc.identifier.scopusauthoridTanwandee, T=7801658735en_US
dc.identifier.scopusauthoridXu, D=15761595300en_US
dc.identifier.scopusauthoridNeo, BL=26653618800en_US
dc.identifier.scopusauthoridChang, TT=7404725147en_US

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