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

Research output: Contribution to journalArticle

7 Citations (Scopus)

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

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Chronic Hepatitis B
DNA
Hepatitis B e Antigens
telbivudine
Polymerase Chain Reaction

All Science Journal Classification (ASJC) codes

  • Gastroenterology

Cite this

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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",
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/).",
author = "Hsu, {Chao Wei} and Chao, {You Chen} and Lee, {Chuan Mo} and Ting-Tsung Chang and Chen, {Yi Cheng}",
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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.

In: BMC Gastroenterology, Vol. 12, 178, 13.12.2012.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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

AU - Hsu, Chao Wei

AU - Chao, You Chen

AU - Lee, Chuan Mo

AU - Chang, Ting-Tsung

AU - Chen, Yi Cheng

PY - 2012/12/13

Y1 - 2012/12/13

N2 - 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/).

AB - 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/).

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