Clinical outcomes and predictors for relapse after cessation of oral antiviral treatment in chronic hepatitis B patients.

Abstract

Little is known about stopping rules of nucelos(t)ide analog (NA) treatment for chronic hepatitis B (CHB). A total of 113 consecutive patients with CHB (45 HBeAg-positive and 68 HBeAg-negative CHB patients), who met the cessation criteria of NA treatment as per the Asian-Pacific Association for the Study of the Liver (APASL) guideline, were enrolled in this prospective cohort study. The primary endpoint was to evaluate virological relapse (VR) rate within 1year, which was defined as reappearance of hepatitis B virus (HBV)-DNA>2000IU/mL after cessation of NA treatment. In this cohort, entecavir was used in 81 (71.7%) and lamivudine in 32 (28.3%) patients. Within 1year after NA treatment, VR occurred in 26 (57.8%) HBeAg-positive patients and in 37 (54.4%) HBeAg-negative patients. In univariate and subsequent multivariate analysis, age>40years [odds ratio (OR) 10.959; 95% confidence interval (CI) 2.211-54.320; P=0.003) and a pre-treatment HBV DNA level >2000,000IU/mL (OR 9.285; 95% CI 1.545-55.795; P=0.036) were identified as independent risk factors for VR in HBeAg-positive patients, and age>40years (OR 6.690; 95% CI 1.314-34.057; P=0.022) and an end-of-treatment HBcrAg level >3.7logIU/mL (OR 3.751; 95% CI 1.187-11.856; P=0.024) were identified in HBeAg-negative patients. During follow up, neither hepatic decompensation nor hepatocellular carcinoma (HCC) occurred, and HBV DNA suppression was achieved in all patients who received antiviral re-treatment. Our data suggested that the APASL stopping rule could be applied if a candidate was properly selected using individual risk factors. However, regular monitoring should be performed after cessation of NA treatment and long-term outcomes need to be evaluated further.