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Open Access Research article

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 Hsu1*, You Chen Chao2, Chuan Mo Lee3, Ting Tsung Chang4 and Yi Cheng Chen1

Author Affiliations

1 Liver Research Unit, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, 199 Tung Hwa North Road, Taipei, 105, Taiwan

2 Buddhist Tzu Chi General Hospital, Taipei Branch, Taiwan

3 Liver Research Unit, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan

4 National Cheng Kung University Hospital, Tainan, Taiwan

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BMC Gastroenterology 2012, 12:178  doi:10.1186/1471-230X-12-178

Published: 13 December 2012

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/ webcite).

Keywords:
Chronic hepatitis B; HBV DNA kinetics; Roadmap concept