File Download
 
Links for fulltext
(May Require Subscription)
 
Supplementary

Article: A 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B
  • Basic View
  • Metadata View
  • XML View
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
2013 Impact Factor: 13.926
 
DOIhttp://dx.doi.org/10.1016/j.gastro.2005.05.053
 
ISI Accession Number IDWOS:000231070600017
 
ReferencesReferences in Scopus
 
DC FieldValue
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
2013 Impact Factor: 13.926
 
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
 
<?xml encoding="utf-8" version="1.0"?>
<item><contributor.author>Lai, CL</contributor.author>
<contributor.author>Leung, N</contributor.author>
<contributor.author>Teo, EK</contributor.author>
<contributor.author>Tong, M</contributor.author>
<contributor.author>Wong, F</contributor.author>
<contributor.author>Hann, HW</contributor.author>
<contributor.author>Han, S</contributor.author>
<contributor.author>Poynard, T</contributor.author>
<contributor.author>Myers, M</contributor.author>
<contributor.author>Chao, G</contributor.author>
<contributor.author>Lloyd, D</contributor.author>
<contributor.author>Brown, NA</contributor.author>
<date.accessioned>2010-09-06T07:38:14Z</date.accessioned>
<date.available>2010-09-06T07:38:14Z</date.available>
<date.issued>2005</date.issued>
<identifier.citation>Gastroenterology, 2005, v. 129 n. 2, p. 528-536</identifier.citation>
<identifier.issn>0016-5085</identifier.issn>
<identifier.uri>http://hdl.handle.net/10722/78015</identifier.uri>
<description.abstract>Background &amp; 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 &lt; .05), clearance of polymerase chain reaction-detectable HBV DNA (61% vs 32%; P &lt; .05), and normalization of alanine aminotransferase levels (86% vs 63%; P &lt; .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. &#169; 2005 by the American Gastroenterological Association.</description.abstract>
<language>eng</language>
<publisher>WB Saunders Co. The Journal&apos;s web site is located at http://www.elsevier.com/locate/gastro</publisher>
<relation.ispartof>Gastroenterology</relation.ispartof>
<subject.mesh>Adolescent</subject.mesh>
<subject.mesh>Adult</subject.mesh>
<subject.mesh>Age Factors</subject.mesh>
<subject.mesh>Aged</subject.mesh>
<subject.mesh>DNA, Viral - analysis</subject.mesh>
<subject.mesh>Dose-Response Relationship, Drug</subject.mesh>
<subject.mesh>Double-Blind Method</subject.mesh>
<subject.mesh>Drug Administration Schedule</subject.mesh>
<subject.mesh>Drug Therapy, Combination</subject.mesh>
<subject.mesh>Female</subject.mesh>
<subject.mesh>Follow-Up Studies</subject.mesh>
<subject.mesh>Hepatitis B e Antigens - analysis - immunology</subject.mesh>
<subject.mesh>Hepatitis B, Chronic - diagnosis - drug therapy - immunology</subject.mesh>
<subject.mesh>Humans</subject.mesh>
<subject.mesh>Lamivudine - administration &amp; dosage - adverse effects</subject.mesh>
<subject.mesh>Liver Function Tests</subject.mesh>
<subject.mesh>Long-Term Care</subject.mesh>
<subject.mesh>Male</subject.mesh>
<subject.mesh>Maximum Tolerated Dose</subject.mesh>
<subject.mesh>Middle Aged</subject.mesh>
<subject.mesh>Nucleosides - administration &amp; dosage - adverse effects</subject.mesh>
<subject.mesh>Pyrimidinones - administration &amp; dosage - adverse effects</subject.mesh>
<subject.mesh>Reference Values</subject.mesh>
<subject.mesh>Risk Assessment</subject.mesh>
<subject.mesh>Severity of Illness Index</subject.mesh>
<subject.mesh>Sex Factors</subject.mesh>
<subject.mesh>Treatment Outcome</subject.mesh>
<title>A 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B</title>
<type>Article</type>
<identifier.openurl>http://library.hku.hk:4550/resserv?sid=HKU:IR&amp;issn=0016-5085&amp;volume=129&amp;spage=528&amp;epage=536&amp;date=2005&amp;atitle=A+1-year+trial+of+telbivudine,+lamivudine,+and+the+combination+in+patients+with+hepatitis+B+e+antigen-positive+chronic+hepatitis+B.</identifier.openurl>
<description.nature>link_to_subscribed_fulltext</description.nature>
<identifier.doi>10.1016/j.gastro.2005.05.053</identifier.doi>
<identifier.pmid>16083710</identifier.pmid>
<identifier.scopus>eid_2-s2.0-23244453590</identifier.scopus>
<identifier.hkuros>121885</identifier.hkuros>
<relation.references>http://www.scopus.com/mlt/select.url?eid=2-s2.0-23244453590&amp;selection=ref&amp;src=s&amp;origin=recordpage</relation.references>
<identifier.volume>129</identifier.volume>
<identifier.issue>2</identifier.issue>
<identifier.spage>528</identifier.spage>
<identifier.epage>536</identifier.epage>
<identifier.isi>WOS:000231070600017</identifier.isi>
<publisher.place>United States</publisher.place>
</item>
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.