LAUSR

OBJECTIVE To investigate the virological relapse (VR) rate and prognostic value of the HBsAg level at treatment completion for predicting sustained off-treatment response in HBeAg-negative patients after neucleos(t)ide analog (NA) therapy. STUDY DESIGN Prospective observational cohort study. PLACE AND DURATION OF STUDY The Second Hospital of Shandong University, Ji'nan, China, between December 2001 and January 2020. METHODOLOGY Eighty-one HBeAg-negative chronic hepatitis B patients who stopped NA treatment were included. Factors associated with the VR were identified using univariate and multivariate Cox regression models. RESULTS Of the 81 patients, 42 had sustained off-treatment response with a median follow-up of 60.0 months (interquartile range [IQR] 33.0-111.0 months). Thirty-nine patients relapsed and 32 relapsed within the first year. The cumulative VR rates were 34.6%, 41.0%, 42.5%, 48.1%, and 55.8% at 1, 2, 3, 5, and 10 years off-therapy, respectively. For patients with end-of-treatment (EOT) HBsAg <250 IU/mL, the 10-year cumulative VR rate was 26.0%. Time to HBV DNA negativity (median, 2 months [IQR 1.0-3.0 months]) and age at EOT were also independent predictors of sustained off-treatment response. CONCLUSION Discontinuing long-term NA treatment is a feasible option for HBeAg-negative chronic hepatitis B patients whose HBsAg levels are low, and HBsAg <250 IU/mL may be an acceptable cut-off value. Younger age at EOT and shorter time to HBV DNA negativity are also independent factors associated with sustained off-treatment response. KEY WORDS Hepatitis B surface antigen, Nucleos(t)ide analogs, Cessation, Relapse.