HBV-DNA level at 6 months of entecavir treatment predicts HBeAg loss in HBeAg-positive chronic hepatitis B patients

Background/Purpose

To evaluate whether on-treatment HBV-DNA level could predict the treatment response to entecavir in hepatitis B e antigen (HBe)-positive chronic hepatitis B (CHB) patients.

Methods

A total of 68 treatment-naïve HBeAg-positive patients (75% male, mean age at 46.6 ± 11.9 years) receiving at least 2 years of entecavir therapy were enrolled. The primary therapeutic endpoint was HBeAg loss. On-treatment complete virological response was defined as serum HBV-DNA < 63 IU/mL.

Results

The median baseline alanine aminotransferase (ALT) and HBV-DNA levels were 199.5 (27–1622) U/L and 7.7 (3.8–13.2) log₁₀ IU/mL, respectively. The median treatment duration was 31.7 (24.3–69.6) months. The rate of HBeAg loss at 2 years was 30.9%. By univariate analysis, on-treatment complete virological response at Month 6 was associated with HBeAg loss at 2 years (p = 0.019). After adjustment for age, sex, cirrhosis, baseline ALT, and HBV-DNA levels, this factor remained significant in multivariate analysis (odds ratio: 4.35; 95% confidence interval: 1.24–15.24, p = 0.021).

Conclusion

On-treatment complete virological response at Month 6 is a favorable factor predictive of HBeAg loss at 2 years of entecavir therapy. Therefore, measurement of serum HBV-DNA level at 6 months of entecavir therapy is optimal to predict HBeAg loss at 2 years of therapy in HBeAg-positive CHB patients.