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Article: 2-Year GLOBE Trial Results: Telbivudine Is Superior to Lamivudine in Patients With Chronic Hepatitis B

Title2-Year GLOBE Trial Results: Telbivudine Is Superior to Lamivudine in Patients With Chronic Hepatitis B
Authors
Issue Date2009
PublisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastro
Citation
Gastroenterology, 2009, v. 136 n. 2, p. 486-495 How to Cite?
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.
Persistent Identifierhttp://hdl.handle.net/10722/59343
ISSN
2014 Impact Factor: 16.716
ISI Accession Number ID
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.

References

 

DC FieldValueLanguage
dc.contributor.authorLiaw, Yen_HK
dc.contributor.authorGane, Een_HK
dc.contributor.authorLeung, Nen_HK
dc.contributor.authorZeuzem, Sen_HK
dc.contributor.authorWang, Yen_HK
dc.contributor.authorLai, CLen_HK
dc.contributor.authorHeathcote, EJen_HK
dc.contributor.authorManns, Men_HK
dc.contributor.authorBzowej, Nen_HK
dc.contributor.authorNiu, Jen_HK
dc.contributor.authorHan, Sen_HK
dc.contributor.authorHwang, SGen_HK
dc.contributor.authorCakaloglu, Yen_HK
dc.contributor.authorTong, MJen_HK
dc.contributor.authorPapatheodoridis, Gen_HK
dc.contributor.authorChen, Yen_HK
dc.contributor.authorBrown, NAen_HK
dc.contributor.authorAlbanis, Een_HK
dc.contributor.authorGalil, Ken_HK
dc.contributor.authorNaoumov, NVen_HK
dc.date.accessioned2010-05-31T03:48:05Z-
dc.date.available2010-05-31T03:48:05Z-
dc.date.issued2009en_HK
dc.identifier.citationGastroenterology, 2009, v. 136 n. 2, p. 486-495en_HK
dc.identifier.issn0016-5085en_HK
dc.identifier.urihttp://hdl.handle.net/10722/59343-
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.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.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 Ben_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0016-5085&volume=136&spage=486&epage=95&date=2009&atitle=2-Year+GLOBE+trial+results:+telbivudine+Is+superior+to+lamivudine+in+patients+with+chronic+hepatitis+Ben_HK
dc.identifier.emailLai, CL:hrmelcl@hku.hken_HK
dc.identifier.authorityLai, CL=rp00314en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1053/j.gastro.2008.10.026en_HK
dc.identifier.pmid19027013en_HK
dc.identifier.scopuseid_2-s2.0-58649096155en_HK
dc.identifier.hkuros161305en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-58649096155&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume136en_HK
dc.identifier.issue2en_HK
dc.identifier.spage486en_HK
dc.identifier.epage495en_HK
dc.identifier.isiWOS:000262967700020-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridLiaw, Y=7202451038en_HK
dc.identifier.scopusauthoridGane, E=7003720102en_HK
dc.identifier.scopusauthoridLeung, N=26643107200en_HK
dc.identifier.scopusauthoridZeuzem, S=7103125178en_HK
dc.identifier.scopusauthoridWang, Y=8095259900en_HK
dc.identifier.scopusauthoridLai, CL=7403086396en_HK
dc.identifier.scopusauthoridHeathcote, EJ=16232754400en_HK
dc.identifier.scopusauthoridManns, M=7202889076en_HK
dc.identifier.scopusauthoridBzowej, N=6602102815en_HK
dc.identifier.scopusauthoridNiu, J=8329820300en_HK
dc.identifier.scopusauthoridHan, S=8060394800en_HK
dc.identifier.scopusauthoridHwang, SG=7404626618en_HK
dc.identifier.scopusauthoridCakaloglu, Y=6603954907en_HK
dc.identifier.scopusauthoridTong, MJ=7202033792en_HK
dc.identifier.scopusauthoridPapatheodoridis, G=7003883848en_HK
dc.identifier.scopusauthoridChen, Y=7601442337en_HK
dc.identifier.scopusauthoridBrown, NA=7403548663en_HK
dc.identifier.scopusauthoridAlbanis, E=6507076516en_HK
dc.identifier.scopusauthoridGalil, K=7004103912en_HK
dc.identifier.scopusauthoridNaoumov, NV=7006460467en_HK

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