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Article: A one-year trial of lamivudine for chronic hepatitis B

TitleA one-year trial of lamivudine for chronic hepatitis B
Authors
Issue Date1998
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
Citation
New England Journal Of Medicine, 1998, v. 339 n. 2, p. 61-68 How to Cite?
AbstractBackground and Methods: In preliminary trials, lamivudine, an oral nucleoside analogue, has shown promise for the treatment of chronic hepatitis B. We conducted a one-year double-blind trial of lamivudine in 358 Chinese patients with chronic hepatitis B. The patients were randomly assigned to receive 25 mg of lamivudine (142 patients), 100 mg of lamivudine (143), or placebo (73) orally once daily. The patients underwent liver biopsies before entering the study and after completing the assigned treatment regimen. The primary end point was a reduction of at least two points in the Knodell necroinflammatory score. Results: Hepatic necroinflammatory activity improved by two points or more in 56 percent of the patients receiving 100 mg of lamivudine, 49 percent of those receiving 25 mg of lamivudine, and 25 percent of those receiving placebo (P<0.001 and P=0.001, respectively, for the comparisons of lamivudine treatment with placebo). Necroinflammatory activity worsened in 7 percent of the patients receiving 100 mg of lamivudine, 8 percent of those receiving 25 mg, and 26 percent of those receiving placebo. The 100mg dose of lamivudine was associated with a reduced progression of fibrosis (P=0.01 for the comparison with placebo) and with the highest rate of hepatitis B e antigen (HBeAg) seroconversion (loss of HBeAg, development of antibody to HBeAg, and undetectable HBV DNA) (16 percent), the greatest suppression of HBV DNA (98 percent reduction at week 52 as compared with the base-line value), and the highest rate of sustained normalization of alanine aminotransferase levels (72 percent). Ninety-six percent of the patients completed the study. The incidence of adverse events was similar in all groups, and there were few serious events. Conclusions: In a one-year study, lamivudine was associated with substantial histologic improvement in many patients with chronic hepatitis B. A daily dose of 100 mg was more effective than a daily dose of 25 mg.
Persistent Identifierhttp://hdl.handle.net/10722/43085
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.authorChien, RNen_HK
dc.contributor.authorLeung, NWYen_HK
dc.contributor.authorChang, TTen_HK
dc.contributor.authorGuan, Ren_HK
dc.contributor.authorTai, DIen_HK
dc.contributor.authorNg, KYen_HK
dc.contributor.authorWu, PCen_HK
dc.contributor.authorDent, JCen_HK
dc.contributor.authorBarber, Jen_HK
dc.contributor.authorStephenson, SLen_HK
dc.contributor.authorGray, DFen_HK
dc.date.accessioned2007-03-23T04:38:32Z-
dc.date.available2007-03-23T04:38:32Z-
dc.date.issued1998en_HK
dc.identifier.citationNew England Journal Of Medicine, 1998, v. 339 n. 2, p. 61-68en_HK
dc.identifier.issn0028-4793en_HK
dc.identifier.urihttp://hdl.handle.net/10722/43085-
dc.description.abstractBackground and Methods: In preliminary trials, lamivudine, an oral nucleoside analogue, has shown promise for the treatment of chronic hepatitis B. We conducted a one-year double-blind trial of lamivudine in 358 Chinese patients with chronic hepatitis B. The patients were randomly assigned to receive 25 mg of lamivudine (142 patients), 100 mg of lamivudine (143), or placebo (73) orally once daily. The patients underwent liver biopsies before entering the study and after completing the assigned treatment regimen. The primary end point was a reduction of at least two points in the Knodell necroinflammatory score. Results: Hepatic necroinflammatory activity improved by two points or more in 56 percent of the patients receiving 100 mg of lamivudine, 49 percent of those receiving 25 mg of lamivudine, and 25 percent of those receiving placebo (P<0.001 and P=0.001, respectively, for the comparisons of lamivudine treatment with placebo). Necroinflammatory activity worsened in 7 percent of the patients receiving 100 mg of lamivudine, 8 percent of those receiving 25 mg, and 26 percent of those receiving placebo. The 100mg dose of lamivudine was associated with a reduced progression of fibrosis (P=0.01 for the comparison with placebo) and with the highest rate of hepatitis B e antigen (HBeAg) seroconversion (loss of HBeAg, development of antibody to HBeAg, and undetectable HBV DNA) (16 percent), the greatest suppression of HBV DNA (98 percent reduction at week 52 as compared with the base-line value), and the highest rate of sustained normalization of alanine aminotransferase levels (72 percent). Ninety-six percent of the patients completed the study. The incidence of adverse events was similar in all groups, and there were few serious events. Conclusions: In a one-year study, lamivudine was associated with substantial histologic improvement in many patients with chronic hepatitis B. A daily dose of 100 mg was more effective than a daily dose of 25 mg.en_HK
dc.format.extent168179 bytes-
dc.format.extent2507 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.subject.meshAlanine transaminaseen_HK
dc.subject.meshDouble-blind methoden_HK
dc.subject.meshDrug administration scheduleen_HK
dc.subject.meshHepatitis b e antigensen_HK
dc.subject.meshLamivudine - adverse effects - therapeutic useen_HK
dc.titleA one-year trial of lamivudine for chronic hepatitis Ben_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0028-4793&volume=339&issue=2&spage=61&epage=68&date=1998&atitle=A+One-Year+Trial+of+Lamivudine+for+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/NEJM199807093390201en_HK
dc.identifier.pmid9654535-
dc.identifier.scopuseid_2-s2.0-0032499913en_HK
dc.identifier.hkuros37174-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-0032499913&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume339en_HK
dc.identifier.issue2en_HK
dc.identifier.spage61en_HK
dc.identifier.epage68en_HK
dc.identifier.isiWOS:000074665300001-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridLai, CL=7403086396en_HK
dc.identifier.scopusauthoridChien, RN=12787728600en_HK
dc.identifier.scopusauthoridLeung, NWY=26643107200en_HK
dc.identifier.scopusauthoridChang, TT=7404725147en_HK
dc.identifier.scopusauthoridGuan, R=7102456913en_HK
dc.identifier.scopusauthoridTai, DI=7005048694en_HK
dc.identifier.scopusauthoridNg, KY=7403178546en_HK
dc.identifier.scopusauthoridWu, PC=7403119323en_HK
dc.identifier.scopusauthoridDent, JC=7201577625en_HK
dc.identifier.scopusauthoridBarber, J=7402350574en_HK
dc.identifier.scopusauthoridStephenson, SL=8123031400en_HK
dc.identifier.scopusauthoridGray, DF=7403494277en_HK

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