Objectives: This study aims to assess whether quantitative HBsAg can predict durability of chronic hepatitis B (CHB) patients stopping entecavir (ETV) treatment.
Methods: We conducted a multicenter study on non-cirrhotic CHB patients who discontinued ETV treatment. The primary end points were clinical relapse and sustained viral response (SVR), which was defined as undetectable serum hepatitis B virus (HBV) DNA levels (<6 IU/ml) at 12 months off-therapy.
Results: A total of 117 consecutive CHB patients were enrolled. Among them, 93 patients who received more than 1-year off-therapy follow-up were included for the final analysis. The duration of off-therapy follow-up was 24.8±11.6 months. All 12 patients who did not achieve therapeutic end points had clinical relapse. In 81 patients who achieved therapeutic end points, clinical relapse and SVR were observed in 44 (54.3%) and 11 (13.6%) patients, respectively. The serum HBV DNA at 3 months and 6 months off-therapy were associated with clinical relapse over time, whereas quantitative hepatitis B surface antigen (qHBsAg) level at 6 months off-therapy had a marginal effect. Furthermore, end-of-treatment qHBsAg levels were associated with SVR (P=0.009).
Conclusions: The serum qHBsAg level off-therapy can predict durability of ETV-treated CHB patients. It may guide clinicians to select which patients can maintain sustained viral suppression or need retreatment after discontinuing ETV treatment.