Background & Aims: This study aimed to define the relapse frequency and risk determinants in chronic hepatitis B (CHB) patients who discontinued nucleos(t)ide analog (NA) treatment, were HBeAg-negative, and had a virological and biochemical response.
Material and Methods: This retrospective cohort study reviewed patients with HBeAg-negative CHB who received antiviral therapy for at least 65 months between January 1, 2013, and December 31, 2020, discontinued treatment, and had a biochemical and virological response. Patients were evaluated at 6, 12, and 24 months after treatment discontinuation.
Results: 67 patients with CHB who received NA therapy for at least 65 months but discontinued treatment and had negative HBV DNA and normal ALT values were evaluated. After NA cessation, relapse was observed in 38 patients (56.7%). The relapse rate was 71.0% in patients treated with tenofovir disoproxil fumarate (TDF) as the last NA type and 37.9% in patients treated with entecavir (ETV) (p=0.017). The cutoff value for the best estimate of age for relapse was 42 years. The relapse rate was 69.2% in patients aged ≥42 years and 39.2% in patients aged <42 years (p=0.007). The relapse rate was 51.3% in patients with a pre-treatment fibrosis score of 2, 56.0% in those with a fibrosis score of 3, and 100% in those with a fibrosis score of 4 (p=0.089).
Conclusion: Among HBeAg-negative CHB patients who achieved a virological and biochemical response to long-term antiviral therapy, those aged 42 years and older, those with high fibrosis scores before treatment, and those who used TDF before treatment cessation should be closely followed for relapse, especially in the first 12 months after stopping NA treatment.