To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Early Viral Replication Is Predictive of Long-Term Outcome With Telbivudine in Chronic Hepatitis B Infection: Presented at AASLD URL: http://www.pslgroup.com/dg/216D0A.htm Doctor's Guide November 7, 2007
By Maria Bishop BOSTON, MA -- November 7, 2007 -- Undetectable serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) level after 24 weeks of telbivudine therapy in chronic HBV patients is the strongest predictor of long-term outcome, according to researchers for The GLOBE Study who reported their findings here at the 58th Annual Scientific Meeting of the American Association for the Study of Liver Disease (AASLD). This prediction is effective both for patients who are hepatitis B e antigen (HBeAg)-positive and those who are HBeAg-negative. Stefan Zeuzem, MD, Professor of Medicine and Chief, Department of Medicine, J.W. Goethe University Hospital, Frankfurt, Germany, stated that patients with a high viral load at week 24 have poorer long-term outcomes, suggesting that modification of the therapeutic regimen should be considered. The GLOBE Study is an ongoing 2-year Phase 3 clinical trial comparing telbivudine (600 mg/day) with lamivudine (100 mg/day) in the treatment of 1,367 adults with chronic hepatitis B. For a multivariate regression analysis of on-treatment predictive factors, patients were categorised according to serum HBV DNA level at weeks 12 and 24, and by baseline alanine aminotransferase (ALT) level. At week 104, significantly more telbivudine recipients (vs lamivudine) achieved therapeutic response. For a multivariate regression analysis of baseline predictive factors, the researchers considered age, body mass index, serum ALT, Ishak fibrosis score, serum HBV DNA level, Knodell histologic activity index score, gender, and HBV genotype. In HBeAg-positive patients, baseline serum ALT levels were predictive of treatment outcome at 2 years. Baseline viraemia was also found to be predictive, as serum HBV DNA levels < 9 log10 copies/mL in HBeAg-positive patients or serum HBV DNA levels < 7 log10 copies/mL in HBeAg-negative patients were associated with greater efficacy and less resistance after 2 years with telbivudine. By combining these baseline and on-treatment predictors, Dr. Zeuzem concluded, it is possible to identify telbivudine-treated patients who will achieve the highest rate of efficacy and lowest resistance. This trial was sponsored by Novartis. [Presentation title: Identification of Baseline Clnical Characteristics and Early On-Treatment Parameters Predicting Long-Term Outcomes for Telbivudine-Treated Patients With Chronic Hepatitis B (The Globe Study). Abstract 994] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.