Volume 136, Issue 2, Pages (February 2009)

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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  Yun–Fan Liaw, Edward Gane, Nancy Leung, Stefan Zeuzem, Yuming Wang, Ching Lung Lai, E. Jenny Heathcote, Michael Manns, Natalie Bzowej, Junqi Niu, Steven–Huy Han, Seong Gyu Hwang, Yilmaz Cakaloglu, Myron J. Tong, George Papatheodoridis, Yagang Chen, Nathaniel A. Brown, Efsevia Albanis, Karin Galil, Nikolai V. Naoumov  Gastroenterology  Volume 136, Issue 2, Pages 486-495 (February 2009) DOI: 10.1053/j.gastro.2008.10.026 Copyright © 2009 AGA Institute Terms and Conditions

Figure 1 Consort flowchart for all HBsAg patients enrolled into the GLOBE trial. IVRS, interactive voice response system; E+, HBeAg positive; E-ve, HBeAg negative; ITT, intent to treat; LOCF, last observation carried forward. Gastroenterology 2009 136, 486-495DOI: (10.1053/j.gastro.2008.10.026) Copyright © 2009 AGA Institute Terms and Conditions

Figure 2 Multivariate logistic regression analyses of the relationship of baseline virologic characteristics and type of treatment for week 104 outcomes for the intent-to-treat population. The figure shows the odds ratio (OR) ± 95% confidence interval (CI) of the parameters that are significant (P < .001) predictors of week 104 outcomes. (A) Baseline variables in HBeAg-positive patients identified by multivariate analysis as significant predictors of outcomes after 104 weeks of telbivudine treatment. ORs >1 indicate direct relationships; ORs ratios <1 indicate inverse relationships. Selection criteria were as follows: baseline HBV DNA level <9 vs ≥9 log10 copies/mL; baseline ALT level ≥2.0 times the ULN vs <2.0 times the ULN. (B) Baseline variables in HBeAg-negative patients identified by multivariate analysis as significant predictors of outcomes after 104 weeks of telbivudine treatment. Data indicate ORs ± 95% CIs. ORs >1 indicate direct relationships; ORs <1 indicate inverse relationships. Selection criteria were as follows: baseline HBV DNA level <7 vs ≥7 log10 copies/mL; baseline ALT level ≥2.0 times the ULN vs <2.0 times the ULN; baseline BMI <24.5 vs ≥24.5 kg/m2. BMI, body mass index. Gastroenterology 2009 136, 486-495DOI: (10.1053/j.gastro.2008.10.026) Copyright © 2009 AGA Institute Terms and Conditions

Figure 3 Relationship between early virologic response to telbivudine and week 104 outcomes. Data indicate rates of efficacy outcomes and resistance at week 104 according to serum HBV DNA level achieved after 24 weeks of telbivudine treatment. Resistance rates at week 104, calculated using the protocol definition of viral breakthrough (persistent increase of HBV DNA to >5 log10 copies/mL after suppression to below that level), were 4% and 3% for telbivudine-treated HBeAg-positive patients with ALT level 2 times the ULN and HBeAg-negative patients, respectively, who were PCR negative at week 24. Gastroenterology 2009 136, 486-495DOI: (10.1053/j.gastro.2008.10.026) Copyright © 2009 AGA Institute Terms and Conditions