Baseline characteristics and early on-treatment response predict the outcomes of 2
years of telbivudine treatment of chronic hepatitis B☆
Background/Aims
In the GLOBE trial, telbivudine treatment was identified as a significant, independent predictor of better outcomes at 2years. We analyzed all telbivudine recipients in this trial to determine the predictors of optimal outcomes.
Methods
The intent-to-treat population comprised 458 HBeAg-positive and 222 HBeAg-negative telbivudine-treated patients. Multivariate logistic regression analyses were employed to evaluate baseline and/or early on-treatment variables.
Results
Baseline HBV DNA<9log10copies/mL, or ALT levels ⩾2× above normal were strong pretreatment predictors for HBeAg-positive, but not for HBeAg-negative patients. However, non-detectable serum HBV DNA at treatment week 24 (TW24) was the strongest predictor for better outcomes for both groups. A combination of pretreatment characteristics plus TW24 response identified subgroups with the best outcomes: (1) HBeAg-positive patients with baseline HBV DNA<9log10copies/mL, ALT⩾2× above normal and non-detectable HBV DNA at TW24 achieved at 2years: non-detectable HBV DNA in 89%, HBeAg seroconversion in 52%, telbivudine resistance in 1.8%; and (2) HBeAg-negative patients with baseline HBV DNA<7log10copies/mL and non-detectable serum HBV DNA at TW24 achieved at 2years: non-detectable HBV DNA in 91%, telbivudine resistance in 2.3%.
Conclusion
During telbivudine treatment, non-detectable serum HBV DNA at treatment week 24 is the strongest predictor for optimal outcomes at 2years.
Keywords: Chronic hepatitis B, Predictors, Telbivudine, Lamivudine, GLOBE trial
☆ ClinicalTrials.gov Identifier: NCT00057265. Grant support: This study was sponsored by Idenix Pharmaceuticals, Inc. and Novartis Pharma AG. Financial disclosures: S. Zeuzem has received consulting fees from BMS, Gilead, GSK, Novartis, Roche and Schering-Plough and lecture fees from Idenix and Novartis. E. Gane has received consulting fees from Gilead, GSK and Novartis and honoraria from GSK, Idenix, Novartis and Roche. Y.-F. Liaw, Consultant for BMS, GSK, Novartis, Roche, Schering-Plough and SciClone; grant/research support from BMS, Idenix, Novartis, Roche, SciClone, and Gilead. S.-G. Lim has acted as a scientific advisor to Idenix, Novartis, and BMS and is on the speakers bureau for GSK and Schering-Plough. A. DiBisceglie: TBD. M Buti: Advisory board for Gilead, Novartis. Speaker: Gilead, Novartis, BMS, Schering-Plough. Editorial Board: Journal of Hepatology. A. Chuttaputti has no disclosures. J. Rasenack has no disclosures. J. Hou has provided scientific advice to Novartis, GSK and BMS. C. O’Brien: research grant support from Novartis, Idenix Pharmaceuticals. T.T. Nguyen: TBD. J. Jia is an investigator for the GLOBE trial and is the PI for the 015 study for Idenix and Novartis. T. Poynard: Investigator, speaker and advisory board for Idenix, Novartis, GSK, Schering, Vertex, Tibotec, BMS. B. Belanger is an employee of Idenix Pharmaceuticals. W. Bao is an employee of Novartis Pharmaceuticals. N.V. Naoumov is an employee of Novartis Pharma AG.
PII: S0168-8278(09)00063-4
doi:10.1016/j.jhep.2008.12.019
© 2009 European Association for the Study of the Liver. Published by Elsevier Inc. All rights reserved.
Refers to article:
- Treatment with nucleos(t)ide analogues in chronic hepatitis B: Where does the road map lead us? , 28 April 2009
