Liver and Bile
Clin Gastroenterol Hepatol. 2023;21(6):1513–22.e4
Differential relapse patterns after discontinuation of entecavir vs. tenofovir disoproxil fumarate in chronic hepatitis B
Background and aims: Whether entecavir (ETV) and tenofovir disoproxil fumarate (TDF) differentially affect relapse and outcomes following treatment discontinuation across different patient subpopulations remains unclear. The authors aimed to compare rates of off-therapy hepatitis B surface antigen (HBsAg) loss, virological and clinical relapse, and retreatment between chronic hepatitis B (CHB) patients who discontinued TDF or ETV therapy.
Methods: This study included 1402 virally suppressed CHB patients who stopped either ETV (n = 981) or TDF (n = 421) therapy between 2001 and 2020 from 13 participating centers across North America, Europe, and Asia. All patients were hepatitis B e antigen-negative at treatment discontinuation. Inverse probability of treatment weighting was used to balance the treatment groups. Outcomes were analyzed using survival methods.
Results: During a median off-treatment follow-up of 18 months, HBsAg loss occurred in 96 patients (6.8%) overall. Compared with ETV, TDF was associated with a higher rate of HBsAg loss (p = 0.03); however, the association was no longer significant after statistical adjustment (p = 0.61). Virological relapse occurred earlier among TDF-treated patients (p < 0.01); nonetheless, rates became comparable after the first year off therapy (p = 0.49). TDF was significantly associated with a higher clinical relapse rate than ETV throughout follow-up (p < 0.01). The development of a virological or clinical relapse did not affect the rate of HBsAg loss. Retreatment rates were not significantly different between the treatment groups.
Conclusions: Tenofovir disoproxil fumarate (TDF) and entecavir (ETV) have differential relapse patterns but are associated with similar rates of hepatitis B surface antigen (HBsAg) loss and retreatment following discontinuation. Finite therapy can be considered for chronic hepatitis B patients on either TDF or ETV therapy.