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

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 st...

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Autores principales: Hsu, Chao Wei, Chao, You Chen, Lee, Chuan Mo, Chang, Ting Tsung, Chen, Yi Cheng
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3563525/
https://www.ncbi.nlm.nih.gov/pubmed/23234302
http://dx.doi.org/10.1186/1471-230X-12-178
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author Hsu, Chao Wei
Chao, You Chen
Lee, Chuan Mo
Chang, Ting Tsung
Chen, Yi Cheng
author_facet Hsu, Chao Wei
Chao, You Chen
Lee, Chuan Mo
Chang, Ting Tsung
Chen, Yi Cheng
author_sort Hsu, Chao Wei
collection PubMed
description 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 log(10) 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 log(10) 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/).
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spelling pubmed-35635252013-02-08 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 Hsu, Chao Wei Chao, You Chen Lee, Chuan Mo Chang, Ting Tsung Chen, Yi Cheng BMC Gastroenterol Research Article 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 log(10) 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 log(10) 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/). BioMed Central 2012-12-13 /pmc/articles/PMC3563525/ /pubmed/23234302 http://dx.doi.org/10.1186/1471-230X-12-178 Text en Copyright ©2012 Hsu et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Hsu, Chao Wei
Chao, You Chen
Lee, Chuan Mo
Chang, Ting Tsung
Chen, Yi Cheng
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3563525/
https://www.ncbi.nlm.nih.gov/pubmed/23234302
http://dx.doi.org/10.1186/1471-230X-12-178
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