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Article: 2-Year GLOBE Trial Results: Telbivudine Is Superior to Lamivudine in Patients With Chronic Hepatitis B
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Title2-Year GLOBE Trial Results: Telbivudine Is Superior to Lamivudine in Patients With Chronic Hepatitis B
 
AuthorsLiaw, Y1
Gane, E9
Leung, N13
Zeuzem, S5
Wang, Y12
Lai, CL6
Heathcote, EJ14
Manns, M11
Bzowej, N10
Niu, J2
Han, S8
Hwang, SG3
Cakaloglu, Y4
Tong, MJ8
Papatheodoridis, G16
Chen, Y7
Brown, NA17
Albanis, E15
Galil, K17
Naoumov, NV15
 
Issue Date2009
 
PublisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastro
 
CitationGastroenterology, 2009, v. 136 n. 2, p. 486-495 [How to Cite?]
DOI: http://dx.doi.org/10.1053/j.gastro.2008.10.026
 
AbstractBackground & Aims: The GLOBE trial has compared the efficacy and safety of telbivudine versus lamivudine treatment over 2 years in patients with chronic hepatitis B. Methods: Hepatitis B e antigen (HBeAg)-positive (n = 921) and HBeAg-negative (n = 446) patients received telbivudine or lamivudine once daily for 104 weeks. The primary outcome, assessed in the intent-to-treat population, was therapeutic response (hepatitis B virus DNA <5 log 10 copies/mL and either HBeAg loss or normalization of alanine aminotransferase [ALT] level). Results: The therapeutic response to telbivudine was superior to that of lamivudine in HBeAg-positive (63% vs 48%; P < .001) and HBeAg-negative (78% vs 66%; P = .007) patients. HBeAg-positive patients given telbivudine also had better outcomes compared with lamivudine in terms of nondetectable viremia (<300 copies/mL) at 55.6% versus 38.5% (P < .001), HBeAg loss at 35.2% versus 29.2% (P = .056), and viral resistance at 25.1% versus 39.5% (P < .001). Hepatitis B e antigen seroconversion was 29.6% versus 24.7% (P = .095) in all patients and 36% versus 27% (P = .022) in patients with baseline ALT level ≥2 times normal. Telbivudine-treated HBeAg-negative patients showed higher rates of nondetectable viremia compared with lamivudine at 82.0% versus 56.7% (P < .001) and less resistance at 10.8% versus 25.9% (P < .001). Adverse events occurred with similar frequency, whereas grade 3/4 increases in creatine kinase levels were more common in patients given telbivudine (12.9% vs 4.1%, P < .001). Multivariate logistic regression analyses identified telbivudine treatment, among other variables, as an independent predictor of better week 104 outcomes. Conclusions: Telbivudine is superior to lamivudine in treating patients with chronic hepatitis B over a 2-year period. © 2009 AGA Institute.
 
ISSN0016-5085
2013 Impact Factor: 13.926
 
DOIhttp://dx.doi.org/10.1053/j.gastro.2008.10.026
 
ISI Accession Number IDWOS:000262967700020
Funding AgencyGrant Number
Idenix Pharmaceuticals, Inc
Novartis Pharma AG
Quartesian, LLC (Princeton, NJ)
Bristol-Myers Squibb
Idenix
Novartis
Gilead
Axcan Pharma
Gilead Sciences
GlaxoSmithKline
Hoffman-La Roche
Pharmasset
Schering-Plough
Vertex
Boehringer-Ingelheim
Roche
GSK
Valeant
Schering
Connatus
BMS
Funding Information:

The authors disclose the following: Y.-F.L. was a consultant for Bristol-Myers Squibb, GlaxoSmithKline, and Novartis and has received grant/research support from Bristol-Myers Squibb, Idenix, Novartis, and Gilead. E.G. received consulting fees from Gilead, GlaxoSmithKline, Merck, and Novartis and honoraria from GlaxoSmithKline, Idenix, Novartis, and Roche. N.L. is a speaker for Bristol-Myers Squibb, GlaxoSmithKline, Novartis, and Schering-Plough. S.Z. received consulting fees and/or lecture from Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Novartis, Roche, and Schering-Plough. C.L.L. has received research grants from Idenix-Novartis. E.J.H. served on advisory board for Axcan Pharma, Gilead Sciences, Hoffman-La Roche, Novartis, Schering-Plough; received research grants/funding from Axcan Pharma, Bristol-Myers-Squibb, Gilead Sciences, GlaxoSmithKline, Hoffman-LaRoche, Idenix, Novartis, Pharmasset, Schering-Plough, Vertex. M.M. received research grants, honoraria, and/or consultancy fees from Bristol-Myers Squibb, Boehringer-Ingelheim, Gilead, Idenix, Novartis, Roche, Schering-Plough, GSK, and Valeant. N.B. has received funding from Roche, Vertex, Schering, Gilead, Pharmasset, Connatus, Idenix, Novartis and speaker bureau fees from Gilead and Novartis. S.-H.H. received grant support, consultancy fees, and lecture fees from Novartis/Idenix. S.G.H. received consulting fees from Bukwang and research grants from Idenix, Valeant, BMS, and GSK. G.P. serves on advisory boards for Bristol-Myers Squibb, Gilead Sciences, Hoffmann-La Roche, Idenix-Novartis, has received research grants (from participation in phase 2/3 trials) from Gilead Sciences and Idenix-Novartis, has received unrestricted research grants from Hoffmann-La Roche, and is a speaker for Bristol-Myers Squibb, Gilead Sciences, Hoffmann-La Roche, and Idenix-Novartis. N.A.B. and K.G. were employees of Idenix at the time of this study. E.A. was an employee of Novartis at the time of the study. N.V.N. is an employee of Novartis. J.N., M.J.T., Y.W., Y. Cakaloglu, and Y. Chen report no conflicts of interest.

 
ReferencesReferences in Scopus
 
DC FieldValue
dc.contributor.authorLiaw, Y
 
dc.contributor.authorGane, E
 
dc.contributor.authorLeung, N
 
dc.contributor.authorZeuzem, S
 
dc.contributor.authorWang, Y
 
dc.contributor.authorLai, CL
 
dc.contributor.authorHeathcote, EJ
 
dc.contributor.authorManns, M
 
dc.contributor.authorBzowej, N
 
dc.contributor.authorNiu, J
 
dc.contributor.authorHan, S
 
dc.contributor.authorHwang, SG
 
dc.contributor.authorCakaloglu, Y
 
dc.contributor.authorTong, MJ
 
dc.contributor.authorPapatheodoridis, G
 
dc.contributor.authorChen, Y
 
dc.contributor.authorBrown, NA
 
dc.contributor.authorAlbanis, E
 
dc.contributor.authorGalil, K
 
dc.contributor.authorNaoumov, NV
 
dc.date.accessioned2010-05-31T03:48:05Z
 
dc.date.available2010-05-31T03:48:05Z
 
dc.date.issued2009
 
dc.description.abstractBackground & Aims: The GLOBE trial has compared the efficacy and safety of telbivudine versus lamivudine treatment over 2 years in patients with chronic hepatitis B. Methods: Hepatitis B e antigen (HBeAg)-positive (n = 921) and HBeAg-negative (n = 446) patients received telbivudine or lamivudine once daily for 104 weeks. The primary outcome, assessed in the intent-to-treat population, was therapeutic response (hepatitis B virus DNA <5 log 10 copies/mL and either HBeAg loss or normalization of alanine aminotransferase [ALT] level). Results: The therapeutic response to telbivudine was superior to that of lamivudine in HBeAg-positive (63% vs 48%; P < .001) and HBeAg-negative (78% vs 66%; P = .007) patients. HBeAg-positive patients given telbivudine also had better outcomes compared with lamivudine in terms of nondetectable viremia (<300 copies/mL) at 55.6% versus 38.5% (P < .001), HBeAg loss at 35.2% versus 29.2% (P = .056), and viral resistance at 25.1% versus 39.5% (P < .001). Hepatitis B e antigen seroconversion was 29.6% versus 24.7% (P = .095) in all patients and 36% versus 27% (P = .022) in patients with baseline ALT level ≥2 times normal. Telbivudine-treated HBeAg-negative patients showed higher rates of nondetectable viremia compared with lamivudine at 82.0% versus 56.7% (P < .001) and less resistance at 10.8% versus 25.9% (P < .001). Adverse events occurred with similar frequency, whereas grade 3/4 increases in creatine kinase levels were more common in patients given telbivudine (12.9% vs 4.1%, P < .001). Multivariate logistic regression analyses identified telbivudine treatment, among other variables, as an independent predictor of better week 104 outcomes. Conclusions: Telbivudine is superior to lamivudine in treating patients with chronic hepatitis B over a 2-year period. © 2009 AGA Institute.
 
dc.description.natureLink_to_subscribed_fulltext
 
dc.identifier.citationGastroenterology, 2009, v. 136 n. 2, p. 486-495 [How to Cite?]
DOI: http://dx.doi.org/10.1053/j.gastro.2008.10.026
 
dc.identifier.doihttp://dx.doi.org/10.1053/j.gastro.2008.10.026
 
dc.identifier.epage495
 
dc.identifier.hkuros161305
 
dc.identifier.isiWOS:000262967700020
Funding AgencyGrant Number
Idenix Pharmaceuticals, Inc
Novartis Pharma AG
Quartesian, LLC (Princeton, NJ)
Bristol-Myers Squibb
Idenix
Novartis
Gilead
Axcan Pharma
Gilead Sciences
GlaxoSmithKline
Hoffman-La Roche
Pharmasset
Schering-Plough
Vertex
Boehringer-Ingelheim
Roche
GSK
Valeant
Schering
Connatus
BMS
Funding Information:

The authors disclose the following: Y.-F.L. was a consultant for Bristol-Myers Squibb, GlaxoSmithKline, and Novartis and has received grant/research support from Bristol-Myers Squibb, Idenix, Novartis, and Gilead. E.G. received consulting fees from Gilead, GlaxoSmithKline, Merck, and Novartis and honoraria from GlaxoSmithKline, Idenix, Novartis, and Roche. N.L. is a speaker for Bristol-Myers Squibb, GlaxoSmithKline, Novartis, and Schering-Plough. S.Z. received consulting fees and/or lecture from Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Novartis, Roche, and Schering-Plough. C.L.L. has received research grants from Idenix-Novartis. E.J.H. served on advisory board for Axcan Pharma, Gilead Sciences, Hoffman-La Roche, Novartis, Schering-Plough; received research grants/funding from Axcan Pharma, Bristol-Myers-Squibb, Gilead Sciences, GlaxoSmithKline, Hoffman-LaRoche, Idenix, Novartis, Pharmasset, Schering-Plough, Vertex. M.M. received research grants, honoraria, and/or consultancy fees from Bristol-Myers Squibb, Boehringer-Ingelheim, Gilead, Idenix, Novartis, Roche, Schering-Plough, GSK, and Valeant. N.B. has received funding from Roche, Vertex, Schering, Gilead, Pharmasset, Connatus, Idenix, Novartis and speaker bureau fees from Gilead and Novartis. S.-H.H. received grant support, consultancy fees, and lecture fees from Novartis/Idenix. S.G.H. received consulting fees from Bukwang and research grants from Idenix, Valeant, BMS, and GSK. G.P. serves on advisory boards for Bristol-Myers Squibb, Gilead Sciences, Hoffmann-La Roche, Idenix-Novartis, has received research grants (from participation in phase 2/3 trials) from Gilead Sciences and Idenix-Novartis, has received unrestricted research grants from Hoffmann-La Roche, and is a speaker for Bristol-Myers Squibb, Gilead Sciences, Hoffmann-La Roche, and Idenix-Novartis. N.A.B. and K.G. were employees of Idenix at the time of this study. E.A. was an employee of Novartis at the time of the study. N.V.N. is an employee of Novartis. J.N., M.J.T., Y.W., Y. Cakaloglu, and Y. Chen report no conflicts of interest.

 
dc.identifier.issn0016-5085
2013 Impact Factor: 13.926
 
dc.identifier.issue2
 
dc.identifier.openurl
 
dc.identifier.pmid19027013
 
dc.identifier.scopuseid_2-s2.0-58649096155
 
dc.identifier.spage486
 
dc.identifier.urihttp://hdl.handle.net/10722/59343
 
dc.identifier.volume136
 
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.meshAntiviral Agents - adverse effects - pharmacology - therapeutic use
 
dc.subject.meshHepatitis B, Chronic - blood - drug therapy
 
dc.subject.meshLamivudine - adverse effects - pharmacology - therapeutic use
 
dc.subject.meshNucleosides - adverse effects - pharmacology - therapeutic use
 
dc.subject.meshPyrimidinones - adverse effects - pharmacology - therapeutic use
 
dc.title2-Year GLOBE Trial Results: Telbivudine Is Superior to Lamivudine in Patients With Chronic Hepatitis B
 
dc.typeArticle
 
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<contributor.author>Zeuzem, S</contributor.author>
<contributor.author>Wang, Y</contributor.author>
<contributor.author>Lai, CL</contributor.author>
<contributor.author>Heathcote, EJ</contributor.author>
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<description.abstract>Background &amp; Aims: The GLOBE trial has compared the efficacy and safety of telbivudine versus lamivudine treatment over 2 years in patients with chronic hepatitis B. Methods: Hepatitis B e antigen (HBeAg)-positive (n = 921) and HBeAg-negative (n = 446) patients received telbivudine or lamivudine once daily for 104 weeks. The primary outcome, assessed in the intent-to-treat population, was therapeutic response (hepatitis B virus DNA &lt;5 log 10 copies/mL and either HBeAg loss or normalization of alanine aminotransferase [ALT] level). Results: The therapeutic response to telbivudine was superior to that of lamivudine in HBeAg-positive (63% vs 48%; P &lt; .001) and HBeAg-negative (78% vs 66%; P = .007) patients. HBeAg-positive patients given telbivudine also had better outcomes compared with lamivudine in terms of nondetectable viremia (&lt;300 copies/mL) at 55.6% versus 38.5% (P &lt; .001), HBeAg loss at 35.2% versus 29.2% (P = .056), and viral resistance at 25.1% versus 39.5% (P &lt; .001). Hepatitis B e antigen seroconversion was 29.6% versus 24.7% (P = .095) in all patients and 36% versus 27% (P = .022) in patients with baseline ALT level &#8805;2 times normal. Telbivudine-treated HBeAg-negative patients showed higher rates of nondetectable viremia compared with lamivudine at 82.0% versus 56.7% (P &lt; .001) and less resistance at 10.8% versus 25.9% (P &lt; .001). Adverse events occurred with similar frequency, whereas grade 3/4 increases in creatine kinase levels were more common in patients given telbivudine (12.9% vs 4.1%, P &lt; .001). Multivariate logistic regression analyses identified telbivudine treatment, among other variables, as an independent predictor of better week 104 outcomes. Conclusions: Telbivudine is superior to lamivudine in treating patients with chronic hepatitis B over a 2-year period. &#169; 2009 AGA Institute.</description.abstract>
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Author Affiliations
  1. Chang Gung University College of Medicine
  2. Jilin University
  3. College of Medicine, Pochon CHA University
  4. Istanbul Üniversitesi
  5. null
  6. The University of Hong Kong
  7. Zhejiang University
  8. David Geffen School of Medicine at UCLA
  9. Middlemore Hospital, Auckland
  10. California Pacific Medical Center
  11. Medizinische Hochschule Hannover (MHH)
  12. Third Military Medical University
  13. Alice Ho Miu Ling Nethersole Hospital
  14. University of Toronto
  15. Novartis
  16. University of Athens Medical School
  17. Idenix Pharmaceuticals, Inc.