Artigo Revisado por pares

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

2009; Elsevier BV; Volume: 51; Issue: 1 Linguagem: Inglês

10.1016/j.jhep.2008.12.019

ISSN

1600-0641

Autores

Stefan Zeuzem, Edward Gane, Yun‐Fan Liaw, Seng Gee Lim, A DIBISCEGLIE, Marı́a Buti, Anuchit Chutaputti, J. Rasenack, Jinlin Hou, Christopher O’Brien, Tuan Nguyen, Jidong Jia, Thierry Poynard, Bruce Belanger, Weibin Bao, Nikolai V. Naoumov,

Tópico(s)

Liver Disease Diagnosis and Treatment

Resumo

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 < 9log10 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 < 9log10 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 < 7log10 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. 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. 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. Baseline HBV DNA < 9log10 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 < 9log10 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 < 7log10 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%. During telbivudine treatment, non-detectable serum HBV DNA at treatment week 24 is the strongest predictor for optimal outcomes at 2 years.

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