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 seroconversion, ALT normalization, HBV DNA suppression (<12IU/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 3years. The significance of serum HBV DNA at week 12 and 24 was compared. RESULTS The median age and duration of follow-up were 39years and 24.2months, respectively. 117, 105, 69, and 43 patients had been followed up for at least 6months and 1, 2, and 3years, respectively. The cumulative rates of HBeAg seroconversion, ALT normalization, HBV DNA undetectability were 46.8%, 80.5%, and 51.2%, respectively, at 3years. 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 <200IU/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 <200IU/ml was predictive of favorable long-term outcomes.