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

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TitleA 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B
AuthorsLai, CL3
Leung, N7
Teo, EK6
Tong, M1
Wong, F5
Hann, HW2
Han, S4
Poynard, T8
Myers, M9
Chao, G9
Lloyd, D9
Brown, NA9
Issue Date2005
PublisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastro
CitationGastroenterology, 2005, v. 129 n. 2, p. 528-536 [How to Cite?]
DOI: http://dx.doi.org/10.1016/j.gastro.2005.05.053
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.
ISSN0016-5085
2011 Impact Factor: 11.675
2011 SCImago Journal Rankings: 1.055
DOIhttp://dx.doi.org/10.1016/j.gastro.2005.05.053
ISI Accession Number IDWOS:000231070600017
ReferencesReferences in Scopus
DC Field
Value
dc.contributor.authorLai, CL
dc.contributor.authorLeung, N
dc.contributor.authorTeo, EK
dc.contributor.authorTong, M
dc.contributor.authorWong, F
dc.contributor.authorHann, HW
dc.contributor.authorHan, S
dc.contributor.authorPoynard, T
dc.contributor.authorMyers, M
dc.contributor.authorChao, G
dc.contributor.authorLloyd, D
dc.contributor.authorBrown, NA
dc.date.accessioned2010-09-06T07:38:14Z
dc.date.available2010-09-06T07:38:14Z
dc.date.issued2005
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.
dc.description.natureLink_to_subscribed_fulltext
dc.identifier.citationGastroenterology, 2005, v. 129 n. 2, p. 528-536 [How to Cite?]
DOI: http://dx.doi.org/10.1016/j.gastro.2005.05.053
dc.identifier.doihttp://dx.doi.org/10.1016/j.gastro.2005.05.053
dc.identifier.epage536
dc.identifier.hkuros121885
dc.identifier.isiWOS:000231070600017
dc.identifier.issn0016-5085
2011 Impact Factor: 11.675
2011 SCImago Journal Rankings: 1.055
dc.identifier.issue2
dc.identifier.openurl
dc.identifier.pmid16083710
dc.identifier.scopuseid_2-s2.0-23244453590
dc.identifier.spage528
dc.identifier.urihttp://hdl.handle.net/10722/78015
dc.identifier.volume129
dc.languageeng
dc.publisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastro
dc.publisher.placeUnited States
dc.relation.ispartofGastroenterology
dc.relation.referencesReferences in Scopus
dc.subject.meshAdolescent
dc.subject.meshAdult
dc.subject.meshAge Factors
dc.subject.meshAged
dc.subject.meshDNA, Viral - analysis
dc.subject.meshDose-Response Relationship, Drug
dc.subject.meshDouble-Blind Method
dc.subject.meshDrug Administration Schedule
dc.subject.meshDrug Therapy, Combination
dc.subject.meshFemale
dc.subject.meshFollow-Up Studies
dc.subject.meshHepatitis B e Antigens - analysis - immunology
dc.subject.meshHepatitis B, Chronic - diagnosis - drug therapy - immunology
dc.subject.meshHumans
dc.subject.meshLamivudine - administration & dosage - adverse effects
dc.subject.meshLiver Function Tests
dc.subject.meshLong-Term Care
dc.subject.meshMale
dc.subject.meshMaximum Tolerated Dose
dc.subject.meshMiddle Aged
dc.subject.meshNucleosides - administration & dosage - adverse effects
dc.subject.meshPyrimidinones - administration & dosage - adverse effects
dc.subject.meshReference Values
dc.subject.meshRisk Assessment
dc.subject.meshSeverity of Illness Index
dc.subject.meshSex Factors
dc.subject.meshTreatment Outcome
dc.titleA 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B
dc.typeArticle
Author Affiliations
  1. Huntington Hospital
  2. Jefferson Medical College
  3. The University of Hong Kong
  4. David Geffen School of Medicine at UCLA
  5. Toronto General Hospital
  6. Changi General Hospital
  7. Chinese University of Hong Kong
  8. null
  9. Idenix Pharmaceuticals, Inc.