Abstract
BackgroundThe 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.MethodsForty-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.ResultsAll 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.ConclusionsLong-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 registrationClinicalTrials.gov Identifier: NCT00142298 (http://clinicaltrials.gov/).
Highlights
The aims of this study were to compare results from a Taiwanese sub-study of the GLOBE 2303 telbivudine study and evaluate the hepatitis B virus (HBV) DNA kinetics
Study design and patients A total of 59 Taiwanese patients in the telbivudine arm and 56 Taiwanese patients in the lamivudine arm from the intent to treat (ITT) population of the GLOBE study were included in this study
Considering the significant superiority of telbivudine over lamivudine demonstrated by the international GLOBE trial, all patients who entered the 2303 study were treated with telbivudine for an additional two years due to ethical concerns
Summary
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. The prevalence of hepatitis B virus (HBV) in Taiwan (>10%) is the highest in Asia, with 76% of chronic hepatitis patients being infected with HBV [1]. The Phase III GLOBE trial demonstrated the superior efficacy of telbivudine over lamivudine over a period of two years in a population of 1370 patients who had both HBeAg-positive and HBeAg-negative CHB [5,6]. The Phase IIIb extension study involved an additional two years of telbivudine therapy with continued monitoring of therapeutic responses, and further demonstrated a higher rate of viral suppression along with better durability and favourable safety profile of telbivudine compared to lamivudine [7,8]. The roadmap concept uses a treatment algorithm based on patient outcomes at
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