Department of Hepatology, Buddhist Tzu Chi General Hospital, Taipei Branch and School of Medicine, Tzu Chi University, Hualien, Taiwan.
BACKGROUND AND AIM:
Although entecavir has been shown to have good efficacy and low resistance for the treatment of chronic hepatitis B (CHB), factors associated with a favorable response remain unknown.
This was a retrospective, multicenter study of 248 treatment-naïve HBeAg-positive patients (69.4% male; median age, 39.4 years) treated with entecavir for more than 1 year, and 15.7% of them had cirrhosis at baseline. The primary endpoints were HBeAg loss and/or seroconversion.
The median baseline levels of alanine aminotransferase (ALT) and HBV DNA were 201 U/L (range, 27-2,415 U/L) and 7.6 log(10) IU/mL (range, 2.2-13.18), respectively. The median treatment period was 25.3 months (range, 12-69.6). The rates of ALT normalization at years 1, 2 and 3 were 83.1%, 87.9% and 94.9%, respectively. The cumulative rates of HBeAg loss at years 1, 2 and 3 were 20.3%, 38.0% and 48.9%, respectively. The rates of undetectable HBV DNA at years 1, 2 and 3 were 52.1%, 78.9% and 82.5%, respectively. Using Cox proportional hazards model, multivariate analysis showed that baseline ALT >5-time the upper limit of normal, and viral load were independent factors associated with HBeAg loss (hazard ratio: 1.81, and 0.812; 95% confidence interval: 1.062-3.085; 0.7-0.942, respectively).
Entecavir treatment for 3 years can achieve good biochemical and virologic responses in HBeAg-positive CHB patients, but has a modest effect on HHBeAg loss and/or seroconversion. In addition, baseline serum ALT and HBV DNA levels are independent factors associated with favorable treatment responses.