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Article: Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B

TitleEntecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B
Authors
KeywordsMedical sciences
Issue Date2006
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
Citation
New England Journal Of Medicine, 2006, v. 354 n. 10, p. 1011-1020 How to Cite?
AbstractBACKGROUND: Entecavir is a potent and selective antiviral agent that has demonstrated efficacy in phase 2 studies in patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B. METHODS: In this phase 3, double-blind trial, we randomly assigned 648 patients with HBeAg-negative chronic hepatitis B who had not previously been treated with a nucleoside analogue to receive 0.5 mg of entecavir or 100 mg of lamivudine once daily for a minimum of 52 weeks. The primary efficacy end point was histologic improvement (a decrease by at least two points in the Knodell necroinflammatory score, without worsening of fibrosis). RESULTS: Histologic improvement after 48 weeks of treatment occurred in 208 of 296 patients in the entecavir group who had adequate baseline liver-biopsy specimens that could be evaluated (70 percent), as compared with 174 of 287 such patients in the lamivudine group (61 percent, P=0.01). More patients in the entecavir group than in the lamivudine group had undetectable serum hepatitis B virus (HBV) DNA levels according to a polymerase-chain- reaction assay (90 percent vs. 72 percent, P<0.001) and normalization of alanine aminotransferase levels (78 percent vs. 71 percent, P = 0.045). The mean reduction in serum HBV DNA levels from baseline to week 48 was greater with entecavir than with lamivudine (5.0 vs. 4.5 log [on a base-10 scale] copies per milliliter, P<0.001). There was no evidence of resistance to entecavir. Safety and adverse-event profiles were similar in the two groups. CONCLUSIONS: Among patients with HBeAg-negative chronic hepatitis B who had not previously been treated with a nucleoside analogue, the rates of histologic improvement, virologic response, and normalization of alanine aminotransferase levels were significantly higher at 48 weeks with entecavir than with lamivudine. The safety profile of the two agents was similar, and there was no evidence of viral resistance to entecavir. Copyright © 2006 Massachusetts Medical Society.
Persistent Identifierhttp://hdl.handle.net/10722/45018
ISSN
2015 Impact Factor: 59.558
2015 SCImago Journal Rankings: 14.619
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorLai, CLen_HK
dc.contributor.authorShouval, Den_HK
dc.contributor.authorLok, ASen_HK
dc.contributor.authorChang, TTen_HK
dc.contributor.authorCheinquer, Hen_HK
dc.contributor.authorGoodman, Zen_HK
dc.contributor.authorDeHertogh, Den_HK
dc.contributor.authorWilber, Ren_HK
dc.contributor.authorZink, RCen_HK
dc.contributor.authorCross, Aen_HK
dc.contributor.authorColonno, Ren_HK
dc.contributor.authorFernandes, Len_HK
dc.date.accessioned2007-10-30T06:15:43Z-
dc.date.available2007-10-30T06:15:43Z-
dc.date.issued2006en_HK
dc.identifier.citationNew England Journal Of Medicine, 2006, v. 354 n. 10, p. 1011-1020en_HK
dc.identifier.issn0028-4793en_HK
dc.identifier.urihttp://hdl.handle.net/10722/45018-
dc.description.abstractBACKGROUND: Entecavir is a potent and selective antiviral agent that has demonstrated efficacy in phase 2 studies in patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B. METHODS: In this phase 3, double-blind trial, we randomly assigned 648 patients with HBeAg-negative chronic hepatitis B who had not previously been treated with a nucleoside analogue to receive 0.5 mg of entecavir or 100 mg of lamivudine once daily for a minimum of 52 weeks. The primary efficacy end point was histologic improvement (a decrease by at least two points in the Knodell necroinflammatory score, without worsening of fibrosis). RESULTS: Histologic improvement after 48 weeks of treatment occurred in 208 of 296 patients in the entecavir group who had adequate baseline liver-biopsy specimens that could be evaluated (70 percent), as compared with 174 of 287 such patients in the lamivudine group (61 percent, P=0.01). More patients in the entecavir group than in the lamivudine group had undetectable serum hepatitis B virus (HBV) DNA levels according to a polymerase-chain- reaction assay (90 percent vs. 72 percent, P<0.001) and normalization of alanine aminotransferase levels (78 percent vs. 71 percent, P = 0.045). The mean reduction in serum HBV DNA levels from baseline to week 48 was greater with entecavir than with lamivudine (5.0 vs. 4.5 log [on a base-10 scale] copies per milliliter, P<0.001). There was no evidence of resistance to entecavir. Safety and adverse-event profiles were similar in the two groups. CONCLUSIONS: Among patients with HBeAg-negative chronic hepatitis B who had not previously been treated with a nucleoside analogue, the rates of histologic improvement, virologic response, and normalization of alanine aminotransferase levels were significantly higher at 48 weeks with entecavir than with lamivudine. The safety profile of the two agents was similar, and there was no evidence of viral resistance to entecavir. Copyright © 2006 Massachusetts Medical Society.en_HK
dc.format.extent209717 bytes-
dc.format.extent3020 bytes-
dc.format.mimetypeapplication/pdf-
dc.format.mimetypetext/plain-
dc.languageengen_HK
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/en_HK
dc.relation.ispartofNew England Journal of Medicineen_HK
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License-
dc.rightsNew England Journal of Medicine. Copyright © Massachusetts Medical Society.en_HK
dc.subjectMedical sciencesen_HK
dc.subject.meshAdulten_HK
dc.subject.meshAntiviral Agents - adverse effects - therapeutic useen_HK
dc.subject.meshDNA, Viral - blooden_HK
dc.subject.meshDouble-Blind Methoden_HK
dc.subject.meshDrug Resistance, Viralen_HK
dc.subject.meshFemaleen_HK
dc.subject.meshGuanine - adverse effects - analogs & derivatives - therapeutic useen_HK
dc.subject.meshHepatitis B e Antigens - blooden_HK
dc.subject.meshHepatitis B virus - genetics - isolation & purificationen_HK
dc.subject.meshHepatitis B, Chronic - blood - drug therapy - pathologyen_HK
dc.subject.meshHumansen_HK
dc.subject.meshLamivudine - adverse effects - therapeutic useen_HK
dc.subject.meshLiver - pathologyen_HK
dc.subject.meshMaleen_HK
dc.subject.meshMiddle Ageden_HK
dc.subject.meshMolecular Sequence Dataen_HK
dc.subject.meshTreatment Outcomeen_HK
dc.titleEntecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis Ben_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0028-4793&volume=354&issue=10&spage=1011&epage=1020&date=2006&atitle=Entecavir+Versus+Lamivudine+for+Patients+with+HBeAg-Negative+Chronic+Hepatitis+Ben_HK
dc.identifier.emailLai, CL:hrmelcl@hku.hken_HK
dc.identifier.authorityLai, CL=rp00314en_HK
dc.description.naturepublished_or_final_versionen_HK
dc.identifier.doi10.1056/NEJMoa051287en_HK
dc.identifier.pmid16525138-
dc.identifier.scopuseid_2-s2.0-33644822860en_HK
dc.identifier.hkuros115271-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-33644822860&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume354en_HK
dc.identifier.issue10en_HK
dc.identifier.spage1011en_HK
dc.identifier.epage1020en_HK
dc.identifier.eissn1533-4406-
dc.identifier.isiWOS:000235822200005-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridLai, CL=7403086396en_HK
dc.identifier.scopusauthoridShouval, D=7006175997en_HK
dc.identifier.scopusauthoridLok, AS=35379868500en_HK
dc.identifier.scopusauthoridChang, TT=7404725147en_HK
dc.identifier.scopusauthoridCheinquer, H=6602829370en_HK
dc.identifier.scopusauthoridGoodman, Z=35418729400en_HK
dc.identifier.scopusauthoridDeHertogh, D=6601941025en_HK
dc.identifier.scopusauthoridWilber, R=7006167856en_HK
dc.identifier.scopusauthoridZink, RC=36342089100en_HK
dc.identifier.scopusauthoridCross, A=7202736404en_HK
dc.identifier.scopusauthoridColonno, R=7006362594en_HK
dc.identifier.scopusauthoridFernandes, L=36339154200en_HK

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