Baseline characteristics and early on-treatment response predict the outcomes of 2 years of telbivudine treatment of chronic hepatitis B

Stefan Zeuzem, Edward Gane, Yun Fan Liaw, Seng G. Lim, Adrian DiBisceglie, Maria Buti, Anuchit Chutaputti, Jens Rasenack, Jinlin Hou, Christopher O'Brien, Tuan T. Nguyen, Jidong Jia, Thierry Poynard, Bruce Belanger, Weibin Bao, Nikolai V. Naoumov

Research output: Contribution to journalArticlepeer-review

178 Scopus citations

Abstract

Background/Aims: In the GLOBE trial, telbivudine treatment was identified as a significant, independent predictor of better outcomes at 2 years. 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 < 9 log10 copies/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 < 9 log10 copies/mL, ALT ≥ 2× above normal and non-detectable HBV DNA at TW24 achieved at 2 years: non-detectable HBV DNA in 89%, HBeAg seroconversion in 52%, telbivudine resistance in 1.8%; and (2) HBeAg-negative patients with baseline HBV DNA < 7 log10 copies/mL and non-detectable serum HBV DNA at TW24 achieved at 2 years: 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 2 years.

Original languageEnglish (US)
Pages (from-to)11-20
Number of pages10
JournalJournal of Hepatology
Volume51
Issue number1
DOIs
StatePublished - Jul 2009

Keywords

  • Chronic hepatitis B
  • GLOBE trial
  • Lamivudine
  • Predictors
  • Telbivudine

ASJC Scopus subject areas

  • Hepatology

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