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Conference Paper: 12 months lamivudine (100mg od) therapy improves liver histology: results of a placebo controlled multicentre study in Asia

Title12 months lamivudine (100mg od) therapy improves liver histology: results of a placebo controlled multicentre study in Asia
Authors
Issue Date1997
PublisherElsevier BV. The Journal's web site is located at http://www.elsevier.com/locate/jhep
Citation
Postgraduate Course and the 32nd Annual Meeting of the European Association for the Study of the Liver, London, UK, 1997. In Journal of Hepatology, 1997. v. 26 n. S1, p. 79 Abstract no. P/C01/l0 How to Cite?
AbstractPhase II studies using lamivudine (2",3-dideoxy,3"-thiacytidine) demonstrated an excellent efficacy and safety profile with no major toxicities. To study whether longer term treatment would lead to histologic improvement, we initiated a placebo controlled study in adults with compensated chronic hepatitis B (HBsAg and HBeAg positive for >6m). Patients were randomised (2:2:1) to lamivudine 25mg (LAM25), lamivudine 100mg (LAM100) or placebo (PLB) given orally once daily for 12m. Efficacy was assessed by >_.2 point reduction in necro-inflammatory Knodell score. The results provided in this abstract are preliminary. Results: 358 Asian patients were randomised to PLB (73), LAM25 (142) and LAM100 (143). The groups were well matched at baseline; 73% male, median age 32y, median Knodell HAl score 7 and 5% cirrhotics, >95% patients were positive for HBV DNA and HBeAg and 68% had an abnormal ALT. Patients in the LAM100 group demonstrated the greatest histological improvement (66%) compared to either LAM25 (58%, p=NS) or PLB (30%, p<0.05). The LAM100 group also had the highest number of patients with a negative HBV DNA during treatment (96%) and normal ALT at the end of treatment (83%) compared to PLB (26% and 49% respectively). Conclusions: Lamivudine 100rag once daily treatment for ly was the most effective dosing regimen which significantly reduced necro-inflammatory activity compared to PLB (p<0.05) and induced ALT normalisation and HBV DNA negativity.
Persistent Identifierhttp://hdl.handle.net/10722/101050
ISSN
2014 Impact Factor: 11.336
2014 SCImago Journal Rankings: 3.477

 

DC FieldValueLanguage
dc.contributor.authorLai, CLen_HK
dc.contributor.authorLiaw, YFen_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.authorGray, DFen_HK
dc.date.accessioned2010-09-25T19:33:58Z-
dc.date.available2010-09-25T19:33:58Z-
dc.date.issued1997en_HK
dc.identifier.citationPostgraduate Course and the 32nd Annual Meeting of the European Association for the Study of the Liver, London, UK, 1997. In Journal of Hepatology, 1997. v. 26 n. S1, p. 79 Abstract no. P/C01/l0-
dc.identifier.issn0168-8278-
dc.identifier.urihttp://hdl.handle.net/10722/101050-
dc.description.abstractPhase II studies using lamivudine (2",3-dideoxy,3"-thiacytidine) demonstrated an excellent efficacy and safety profile with no major toxicities. To study whether longer term treatment would lead to histologic improvement, we initiated a placebo controlled study in adults with compensated chronic hepatitis B (HBsAg and HBeAg positive for >6m). Patients were randomised (2:2:1) to lamivudine 25mg (LAM25), lamivudine 100mg (LAM100) or placebo (PLB) given orally once daily for 12m. Efficacy was assessed by >_.2 point reduction in necro-inflammatory Knodell score. The results provided in this abstract are preliminary. Results: 358 Asian patients were randomised to PLB (73), LAM25 (142) and LAM100 (143). The groups were well matched at baseline; 73% male, median age 32y, median Knodell HAl score 7 and 5% cirrhotics, >95% patients were positive for HBV DNA and HBeAg and 68% had an abnormal ALT. Patients in the LAM100 group demonstrated the greatest histological improvement (66%) compared to either LAM25 (58%, p=NS) or PLB (30%, p<0.05). The LAM100 group also had the highest number of patients with a negative HBV DNA during treatment (96%) and normal ALT at the end of treatment (83%) compared to PLB (26% and 49% respectively). Conclusions: Lamivudine 100rag once daily treatment for ly was the most effective dosing regimen which significantly reduced necro-inflammatory activity compared to PLB (p<0.05) and induced ALT normalisation and HBV DNA negativity.-
dc.languageengen_HK
dc.publisherElsevier BV. The Journal's web site is located at http://www.elsevier.com/locate/jhep-
dc.relation.ispartofJournal of Hepatologyen_HK
dc.title12 months lamivudine (100mg od) therapy improves liver histology: results of a placebo controlled multicentre study in Asiaen_HK
dc.typeConference_Paperen_HK
dc.identifier.emailLai, CL: hrmelcl@hku.hken_HK
dc.identifier.authorityLai, CL=rp00314en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1016/S0168-8278(97)82336-7-
dc.identifier.hkuros22961en_HK

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