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

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

Format: Article
Diterbitkan: BMC 2012-12-01

Deskripsi

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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<sub>10</sub> copies/mL at Week 24 with maintained PCR negativity at Years 2–4 and a lack of resistance at Year 2.</p> <p>Conclusions</p> <p>Long-term telbivudine efficacy in Taiwanese patients was comparable to the GLOBE 2303 study. A reduction in HBV DNA levels by ≥5 log<sub>10</sub> copies/mL at Week 24 represented the optimal cut-off point, which may predict favourable outcomes in patients with high baseline HBV DNA levels.</p> <p>Trial registration</p> <p>ClinicalTrials.gov Identifier: NCT00142298 (<url>http://clinicaltrials.gov/</url>).</p>