Abstract: Objective To evaluate the off-treatment efficacy of entecavir (ETV) therapy and to investigate the treatment and withdrawal standard of antiviral therapy for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) patients.Methods In the retrospective analysis, 121 HBeAg-negative CHB patients with ETV withdrawal for more than 6 months from January 2006 to December 2015 in our hospital were enrolled. Hepatitis B virus (HBV) DNA levels, liver function and HBV markers at month 6 and 12 after ETV withdrawal were measured.Results After ETV withdrawal, HBV DNA load was increased (>5×10² copies/mL) in 33% and 45.5% patients at month 6 and 12, respectively, and alanine aminotransferase (ALT) was elevated in 19.8% and 30.6% patients. Patients with more than 5-year ETV administration had the lowest recurrence rate. In addition, HBV DNA load <2×10⁵ copies/mL at baseline showed a lower recurrence rate at both month 6 and 12 after ETV withdrawal than the HBV DNA load >10⁷ copies/ml at baseline.Conclusion The recurrence rate was negatively correlated with ETV treatment course in HBeAg-negative CHB patients, and positively correlated with the HBV DNA load at baseline.

Key words: Chronic hepatitis B, Entecavir, Hepatitis B e antigen-negative, Drug withdrawal