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.