Significance of HBV DNA levels at 12 weeks of telbivudine treatment and the 3 years treatment outcome

Background & Aims: The significance of early HBV DNA suppression during telbivudine treatment in predicting long-term outcomes needs further investigation. Methods: We determined the cumulative rates of HBeAg sero-conversion, ALT normalization, HBV DNA suppression (< 12 IU/ml) and telbivudine resistant mutations (using the highly sensitive line probe assay) for 117 treatment-native chronic hepatitis B (CHB) patients (61.5% HBeAg-positive) on telbivudine for 3 years. The significance of serum HBV DNA at week 12 and 24 was compared. Results: The median age and duration of follow-up were 39 years and 24.2 months, respectively. 117, 105, 69, and 43 patients had been followed up for at least 6 months and 1, 2, and 3 years, respectively. The cumulative rates of HBeAg sero-conversion, ALT normalization, HBV DNA undetectability were 46.8%, 80.5%, and 51.2%, respectively, at 3 years. There was an incremental increase in virologic breakthroughs to 39.5% by year 3. The cumulative rate of telbivudine resistant mutations was 4.8%, 17.6%, and 34.0% for year 1, 2, and 3, respectively. Week 12 HBV DNA of < 200 IU/ml was predictive of a higher chance of HBV DNA undetectability (p = 0.022) and lower chance of resistance (p = 0.001) by year 3. Undetectable HBV DNA at week 24 was predictive of viral suppression at year 2 (p < 0.001) but not at year 3 (p = 0.241). Conclusions: Continuous telbivudine resulted in improved biochemical and virologic outcomes, although there was an incremental increase in cumulative rate of resistance up to year 3. Week 12 HBV DNA of < 200 IU/ml was predictive of favorable long-term outcomes. (C) 2010 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.