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

*Corresponding author for this work

Research output: Contribution to journalJournal Article peer-review

509 Scopus citations

Abstract

Background & 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 log10 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.

Original languageEnglish
Pages (from-to)486-495
Number of pages10
JournalGastroenterology
Volume136
Issue number2
DOIs
StatePublished - 02 2009
Externally publishedYes

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