Efficacy of entecavir treatment for up to 96 weeks in nucleoside-naive HBeAg-positive chronic hepatitis B patients with high viral load.

Background And Aims: To evaluate the antiviral response of hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) patients who had baseline high viral load (HVL), defined as having hepatitis B virus (HBV) DNA>9log 10 copies/mL, after 96weeks of entecavir (ETV) treatment.

Methods: A total of 99 HBeAg-positive CHB patients (50 with HVL and 49 with non-HVL) were treated with ETV monotherapy for 96weeks.

Results: Virological response (VR) (HBVDNA<300copies/mL) was achieved in 42%, 62%, 68% of HVL patients and in 67.34%, 85.71%, 85.71% of non-HVL patients at weeks 48,72,96, respectively. The VR rates of the HVL group were lower than those of the non-HVL group (P=0.006, P=0.007, and P=0.037). In the HVL group, a total of 30 patients had HBV DNA<1000copies/mL at week 48 and those patients had a 93.3% chance of achieving VR at week 96, whereas the patients who had HBV DNA levels>1000copies/mL at week 48 only had a 30% chance to achieve VR at week 96. Among the 96weeks of treatment, one patient had virological breakthrough in the HVL group and this patient had HBVDNA>1000copies/mL at week48. The rates of biochemical responses (BR) and HBeAg seroconversion (SR) were similar between the HVL group and non-HVL group at weeks 48 and 96.

Conclusion: The baseline HVL was a negative predictor of virological response in CHB patients with ETV monotherapy. For those HVL patients treated by ETV with poor VR, which defined as HBVDNA>1000copies/mL at week48, the treatment strategies need to be adjusted.