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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.

ABSTRACT: 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.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.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.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.ClinicalTrials.gov Identifier: NCT00142298 (http://clinicaltrials.gov/).

SUBMITTER: Hsu CW

PROVIDER: S-EPMC3563525 | biostudies-literature | 2012 Dec

REPOSITORIES: biostudies-literature

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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 CW Chao You Chen YC Lee Chuan Mo CM Chang Ting Tsung TT Chen Yi Cheng YC

BMC gastroenterology 20121213

<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>All 7 HBeAg-positive patients with undetectable HBV DNA levels at Week 24 sustained this re ...[more]

PMID: 23234302

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Project description:Abstract Objective To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy. Research Design and Methods Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period. On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet. The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition. Trial NCT03845075. Results The most common adverse events following the 24-week double-blind period and the 24-week open-label extension period were sleep disorder, dizziness, dry mouth, and headache; the majority of these adverse events were mild to moderate in severity. No significant nor clinically meaningful changes in heart rate or blood pressure were observed during the study. On completion of the double-blind period mean change in body weight (kg) was -7.84 for the Tesomet group versus -0.34 kg for the placebo group (P=0. 03). At the end of the open-label extension period mean change in body weight (kg) from baseline was -6.34 for the Tesomet-Tesomet group and -6. 03 for the placebo-Tesomet group. On completion of the double-blind period mean change in waist circumference (cm) was -7. 09 cm for the Tesomet group versus -1.16 for the placebo group (P=NS). At the end of the open-label extension period mean change in waist circumference (cm) from baseline was -5.73 for the Tesomet-Tesomet group and -3. 04 for the placebo-Tesomet group. On completion of the double-blind period mean change in fat mass (kg) was -5.28 for the Tesomet group versus -1.11 for the placebo group (P=NS). At the end of the open-label extension period mean change in fat mass (kg) from baseline was -4.84 for the Tesomet-Tesomet group and -3.85 for the placebo-Tesomet group. On completion of the double-blind period mean change in lean tissue mass (kg) was -2.76 for the Tesomet group versus 0.36 for the placebo group (P<0. 01). At the end of the open-label extension period mean change in lean mass (kg) from baseline was -1.64 for the Tesomet-Tesomet group and -2.22 for the placebo-Tesomet group. Discussion Tesomet was generally well tolerated after 48 weeks treatment and resulted in clinically meaningful improvements in body weight and body composition measures in adults with hypothalamic obesity. In contrast to previous studies of tesofensine monotherapy in general obesity, no significant nor clinically meaningful changes in cardiovascular measures were observed during the study. Conclusion Tesomet is a promising new experimental treatment for hypothalamic obesity. A randomized, placebo controlled, multi-center, dose-finding, Phase 2b study has now been initiated. Presentation: No date and time listed

Dataset Information

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.

Publications

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.

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