Efficacy of telbivudine in Taiwanese chronic hepatitis B patients compared with GLOBE extension study and predicting treatment outcome by HBV DNA kinetics at Week 24

Chao Wei Hsu, You Chen Chao, Chuan Mo Lee, Ting Tsung Chang, Yi Cheng Chen

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Abstract

Background: The aims of this study were to compare results from a Taiwanese sub-study of the GLOBE 2303 telbivudine study and evaluate the HBV DNA kinetics.Methods: Forty-one Taiwanese patients were treated for an additional 2 years with telbivudine. Efficacy endpoints were the same as the GLOBE study. The correlations of reductions in HBV DNA levels at Week 24 were evaluated.Results: All 7 HBeAg-positive patients with undetectable HBV DNA levels at Week 24 sustained this response at Year 4 with rates of ALT normalization 71%, HBeAg seroconversion 57%, and cumulative resistance 0%. Out of 16 HBeAg-negative patients with undetectable HBV DNA levels at Week 24, 11 (78%) sustained this response at Year 4 with rates of ALT normalization 83% and cumulative resistance 8.7%. There were significant correlations between reductions of DNA of ≥5 log10 copies/mL at Week 24 with maintained PCR negativity at Years 2-4 and a lack of resistance at Year 2.Conclusions: Long-term telbivudine efficacy in Taiwanese patients was comparable to the GLOBE 2303 study. A reduction in HBV DNA levels by ≥5 log10 copies/mL at Week 24 represented the optimal cut-off point, which may predict favourable outcomes in patients with high baseline HBV DNA levels.Trial registration: ClinicalTrials.gov Identifier: NCT00142298 (http://clinicaltrials.gov/).

Original languageEnglish
Article number178
JournalBMC Gastroenterology
Volume12
DOIs
Publication statusPublished - 2012 Dec 13

All Science Journal Classification (ASJC) codes

  • Gastroenterology

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