« Previous
Next »
Gastroenterology
Volume 136, Issue 2
, Pages 486-495
, February 2009
2-Year GLOBE Trial Results: Telbivudine Is Superior to Lamivudine in Patients With Chronic Hepatitis B
References
- . Epidemiology and natural history of hepatitis B. Semin Liver Dis. 2005;25(Suppl 1):3–8
- . Chronic hepatitis B—AASLD Practice Guidelines. Hepatology. 2001;34:1225–1241
- . Natural history of hepatitis B. J Hepatol. 2003;39(Suppl 1):S50–S58
- Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA. 2006;295:65–73
- Risk and predictors of mortality associated with chronic hepatitis B infection. Clin Gastroenterol Hepatol. 2007;5:921–931
- Predicting cirrhosis risk based on the level of circulating hepatitis B viral load. Gastroenterology. 2006;130:678–686
- Past HBV viral load as predictor of mortality and morbidity from HCC and chronic liver disease in a prospective study. Am J Gastroenterol. 2006;101:1797–1803
- Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2008 update. Hepatology Int. 2008;2:263–283
- . Chronic hepatitis B. Hepatology. 2007;45:507–539
- A one-year trial of lamivudine for chronic hepatitis B (Asia Hepatitis Lamivudine Study Group). N Engl J Med. 1998;339:61–68
- Efficacy of lamivudine in patients with hepatitis B e antigen-negative/hepatitis B virus DNA-positive (precore mutant) chronic hepatitis B. Hepatology. 1999;29:889–896
- Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B. N Engl J Med. 2003;348:800–807
- Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. N Engl J Med. 2003;348:808–816
- A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med. 2006;354:1001–1010
- Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med. 2006;354:1011–1020
- A comparison of telbivudine and lamivudine in patients with chronic hepatitis B. N Engl J Med. 2007;357:2576–2588
- Tenofovir EMEA approval. http://www.emea.europa.eu/humandocs/PDFs/EPAR/viread/H-419-PI-en.pdf
- Tenofovir FDA approval. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
- Factors associated with hepatitis B virus DNA breakthrough in patients receiving prolonged lamivudine therapy. Hepatology. 2001;34:785–791
- Quantitation of hepatitis B viremia and emergence of YMDD variants in patients with chronic hepatitis B treated with lamivudine. J Infect Dis. 1999;180:1757–1762
- A 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B. Gastroenterology. 2005;129:528–536
- Treatment of hepatitis B e antigen-positive chronic hepatitis with telbivudine or adefovir: a randomized trial. Ann Intern Med. 2007;147:745–754
- Correlation of hepatitis B virus load with loss of e antigen and emerging drug-resistant variants during lamivudine therapy. J Med Virol. 2001;65:659–663
- Division of AIDS table for grading severity of adult adverse experiences. Bethesda, MD: National Institute of Allergy and Infectious Diseases; 1992;
- Management of antiviral resistance in patients with chronic hepatitis B. Antivir Ther. 2004;9:679–693
- . Strategies for comparing treatments on a binary response with multi-centre data. Stat Med. 2000;19:1135–1139
- Effects of extended lamivudine therapy in Asian patients with chronic hepatitis B. Gastroenterology. 2000;119:172–180
- Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: results at 1 year of a randomized, double-blind trial. Hepatology. 2008;47:447–454
- Entecavir therapy for up to 96 weeks in patients with HBeAg-positive chronic hepatitis B. Gastroenterology. 2007;133:1437–1444
- Determinants for sustained HBeAg response to lamivudine therapy. Hepatology. 2003;38:1267–1273
- Sustained biochemical and virological remission after discontinuation of 4 to 5 years of adefovir dipivoxil (ADV) treatment in HBeAg negative chronic hepatitis B. Hepatology. 2006;44(Suppl 1):231A
- Prevalence and clinical correlates of YMDD variants during lamivudine therapy for patients with chronic hepatitis B. Clin Infect Dis. 2003;36:687–696
- Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B for up to 5 years. Gastroenterology. 2006;131:1743–1751
- Entecavir resistance is rare in nucleoside naïve patients with hepatitis B. Hepatology. 2006;44:1656–1665
- HBV resistance determination from the telbivudine GLOBE registration trial. (abstr) J Hepatol. 2006;44(Suppl 2):S191
- Antiviral drug-resistant HBV: standardization of nomenclature and assays and recommendations for management. Hepatology. 2007;46:254–265
- Adding-on versus switching-to adefovir therapy in lamivudine-resistant HBeAg-negative chronic hepatitis B. Hepatology. 2007;45:307–313
- Dynamics of lamivudine-resistant hepatitis B virus during adefovir monotherapy versus lamivudine plus adefovir combination therapy. J Med Virol. 2008;80:1160–1170
- . Rescue therapy for lamivudine-resistant chronic hepatitis B: when and how?. Hepatology. 2007;45:266–268
- . Telbivudine preclinical safety studies suggest minimal risk of chronic toxicity, reproductive toxicity or carcinogenicity. (abstr) J Hepatol. 2006;44:S147
Supported by Idenix Pharmaceuticals, Inc and Novartis Pharma AG. The corresponding author had full access to all of the data and takes full responsibility for the veracity of the data and analysis. Statistical analyses were performed by the study sponsor and independently by Quartesian, LLC (Princeton, NJ).
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-LaRoche, 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.
PII: S0016-5085(08)01861-1
doi: 10.1053/j.gastro.2008.10.026
© 2009 AGA Institute. Published by Elsevier Inc. All rights reserved.
« Previous
Next »
Gastroenterology
Volume 136, Issue 2
, Pages 486-495
, February 2009

