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Article: A 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B

TitleA 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B
Authors
Issue Date2005
PublisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastro
Citation
Gastroenterology, 2005, v. 129 n. 2, p. 528-536 How to Cite?
AbstractBackground & Aims: A previous 4-week trial of telbivudine in patients with chronic hepatitis B indicated marked antiviral effects with good tolerability, leading to the present 1-year phase 2b trial. Methods: This randomized, double-blind, multicenter trial evaluated the efficacy and safety of telbivudine 400 or 600 mg/day and telbivudine 400 or 600 mg/day plus lamivudine 100 mg/day (Comb400 and Comb600) compared with lamivudine 100 mg/day in hepatitis B e antigen (HBeAg)-positive adults with compensated chronic hepatitis B. Results: A total of 104 patients were randomized 1:1:1:1:1 among the 5 groups. Median reductions in serum hepatitis B virus (HBV) DNA levels at week 52 (log 10 copies/mL) were as follows: lamivudine, 4.66; telbivudine 400 mg, 6.43; telbivudine 600 mg, 6.09; Comb400, 6.40; and Comb600, 6.05. At week 52, telbivudine monotherapy showed a significantly greater mean reduction in HBV DNA levels (6.01 vs 4.57 log 10 copies/mL; P < .05), clearance of polymerase chain reaction-detectable HBV DNA (61% vs 32%; P < .05), and normalization of alanine aminotransferase levels (86% vs 63%; P < .05) compared with lamivudine monotherapy, with proportionally greater HBeAg seroconversion (31% vs 22%) and less viral breakthrough (4.5% vs 15.8%) (P = NS for both). Combination treatment was not better than telbivudine alone. All treatments were well tolerated. In exploratory scientific analyses, clinical efficacy at 1 year appeared related to reduction in HBV DNA levels in the first 6 months of treatment. Conclusions: Patients with chronic hepatitis B treated with telbivudine exhibited significantly greater virologic and biochemical responses compared with lamivudine. Results with the combination regimens were similar to those obtained with telbivudine alone. These data support the ongoing phase 3 evaluation of telbivudine for treatment of patients with chronic hepatitis B. © 2005 by the American Gastroenterological Association.
Persistent Identifierhttp://hdl.handle.net/10722/78015
ISSN
2014 Impact Factor: 16.716
2014 SCImago Journal Rankings: 5.616
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorLai, CLen_HK
dc.contributor.authorLeung, Nen_HK
dc.contributor.authorTeo, EKen_HK
dc.contributor.authorTong, Men_HK
dc.contributor.authorWong, Fen_HK
dc.contributor.authorHann, HWen_HK
dc.contributor.authorHan, Sen_HK
dc.contributor.authorPoynard, Ten_HK
dc.contributor.authorMyers, Men_HK
dc.contributor.authorChao, Gen_HK
dc.contributor.authorLloyd, Den_HK
dc.contributor.authorBrown, NAen_HK
dc.date.accessioned2010-09-06T07:38:14Z-
dc.date.available2010-09-06T07:38:14Z-
dc.date.issued2005en_HK
dc.identifier.citationGastroenterology, 2005, v. 129 n. 2, p. 528-536en_HK
dc.identifier.issn0016-5085en_HK
dc.identifier.urihttp://hdl.handle.net/10722/78015-
dc.description.abstractBackground & Aims: A previous 4-week trial of telbivudine in patients with chronic hepatitis B indicated marked antiviral effects with good tolerability, leading to the present 1-year phase 2b trial. Methods: This randomized, double-blind, multicenter trial evaluated the efficacy and safety of telbivudine 400 or 600 mg/day and telbivudine 400 or 600 mg/day plus lamivudine 100 mg/day (Comb400 and Comb600) compared with lamivudine 100 mg/day in hepatitis B e antigen (HBeAg)-positive adults with compensated chronic hepatitis B. Results: A total of 104 patients were randomized 1:1:1:1:1 among the 5 groups. Median reductions in serum hepatitis B virus (HBV) DNA levels at week 52 (log 10 copies/mL) were as follows: lamivudine, 4.66; telbivudine 400 mg, 6.43; telbivudine 600 mg, 6.09; Comb400, 6.40; and Comb600, 6.05. At week 52, telbivudine monotherapy showed a significantly greater mean reduction in HBV DNA levels (6.01 vs 4.57 log 10 copies/mL; P < .05), clearance of polymerase chain reaction-detectable HBV DNA (61% vs 32%; P < .05), and normalization of alanine aminotransferase levels (86% vs 63%; P < .05) compared with lamivudine monotherapy, with proportionally greater HBeAg seroconversion (31% vs 22%) and less viral breakthrough (4.5% vs 15.8%) (P = NS for both). Combination treatment was not better than telbivudine alone. All treatments were well tolerated. In exploratory scientific analyses, clinical efficacy at 1 year appeared related to reduction in HBV DNA levels in the first 6 months of treatment. Conclusions: Patients with chronic hepatitis B treated with telbivudine exhibited significantly greater virologic and biochemical responses compared with lamivudine. Results with the combination regimens were similar to those obtained with telbivudine alone. These data support the ongoing phase 3 evaluation of telbivudine for treatment of patients with chronic hepatitis B. © 2005 by the American Gastroenterological Association.en_HK
dc.languageengen_HK
dc.publisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastroen_HK
dc.relation.ispartofGastroenterologyen_HK
dc.subject.meshAdolescenten_HK
dc.subject.meshAdulten_HK
dc.subject.meshAge Factorsen_HK
dc.subject.meshAgeden_HK
dc.subject.meshDNA, Viral - analysisen_HK
dc.subject.meshDose-Response Relationship, Drugen_HK
dc.subject.meshDouble-Blind Methoden_HK
dc.subject.meshDrug Administration Scheduleen_HK
dc.subject.meshDrug Therapy, Combinationen_HK
dc.subject.meshFemaleen_HK
dc.subject.meshFollow-Up Studiesen_HK
dc.subject.meshHepatitis B e Antigens - analysis - immunologyen_HK
dc.subject.meshHepatitis B, Chronic - diagnosis - drug therapy - immunologyen_HK
dc.subject.meshHumansen_HK
dc.subject.meshLamivudine - administration & dosage - adverse effectsen_HK
dc.subject.meshLiver Function Testsen_HK
dc.subject.meshLong-Term Careen_HK
dc.subject.meshMaleen_HK
dc.subject.meshMaximum Tolerated Doseen_HK
dc.subject.meshMiddle Ageden_HK
dc.subject.meshNucleosides - administration & dosage - adverse effectsen_HK
dc.subject.meshPyrimidinones - administration & dosage - adverse effectsen_HK
dc.subject.meshReference Valuesen_HK
dc.subject.meshRisk Assessmenten_HK
dc.subject.meshSeverity of Illness Indexen_HK
dc.subject.meshSex Factorsen_HK
dc.subject.meshTreatment Outcomeen_HK
dc.titleA 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis Ben_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0016-5085&volume=129&spage=528&epage=536&date=2005&atitle=A+1-year+trial+of+telbivudine,+lamivudine,+and+the+combination+in+patients+with+hepatitis+B+e+antigen-positive+chronic+hepatitis+B.en_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/j.gastro.2005.05.053en_HK
dc.identifier.pmid16083710en_HK
dc.identifier.scopuseid_2-s2.0-23244453590en_HK
dc.identifier.hkuros121885en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-23244453590&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume129en_HK
dc.identifier.issue2en_HK
dc.identifier.spage528en_HK
dc.identifier.epage536en_HK
dc.identifier.isiWOS:000231070600017-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridLai, CL=7403086396en_HK
dc.identifier.scopusauthoridLeung, N=26643107200en_HK
dc.identifier.scopusauthoridTeo, EK=7006574269en_HK
dc.identifier.scopusauthoridTong, M=7202033792en_HK
dc.identifier.scopusauthoridWong, F=7201409671en_HK
dc.identifier.scopusauthoridHann, HW=23080190400en_HK
dc.identifier.scopusauthoridHan, S=8060394800en_HK
dc.identifier.scopusauthoridPoynard, T=7103155394en_HK
dc.identifier.scopusauthoridMyers, M=7402143002en_HK
dc.identifier.scopusauthoridChao, G=36643443300en_HK
dc.identifier.scopusauthoridLloyd, D=7402321593en_HK
dc.identifier.scopusauthoridBrown, NA=7403548663en_HK

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