Aim: To assess the role of consolidation therapy after cessation of nucleoside/nucleotide analogs (NAs) for off-treatment outcome and to explore the optimal consolidation period in hepatitis B e-antigen (HBeAg) positive chronic hepatitis B (CHB) patients.
Methods: We undertook a prospective, observational cohort study including HBeAg positive CHB patients discontinuing NAs. Virological relapse was the primary endpoint of the current study and was defined as a serum hepatitis B virus DNA more than 104 copies/ml (another assay was carried out for confirmation at least 2 weeks later). Propensity score matching analysis was used to balance the baseline characteristics between HBeAg positive CHB patients with different consolidation periods.
Results: A total of 190 HBeAg positive CHB patients were included. Fifty-four patients relapsed during follow-up and the cumulative relapse rates at years 1, 3, 5, and 10 were 19.5%, 24.1%, 27.2%, and 32.1%, respectively. Most patients (61.1%) relapsed in the first 6 months. After propensity score matching, significantly lower cumulative relapse rates were observed in patients with consolidation period ≥36 months compared with patients with consolidation period more than 36 months (29.3% vs. 52.8% at year 10; p = 0.012).
Conclusions: Cessation of NAs after HBeAg seroconversion and long-term consolidation is generally safe and feasible in HBeAg positive CHB patients. Three years of consolidation should be preferred in clinical practice.
Keywords: cessation; chronic hepatitis B; consolidation therapy; nucleoside/nucleotide analogs.
© 2021 The Japan Society of Hepatology.