ASAP-12 Score Predicts HBsAg Seroclearance and Seroconversion in Chronic Hepatitis B Patients Receiving Peg-IFNα Add-On Therapy.

To develop new tools integrating host immune response and viral activity to predict Peg-IFNα therapy efficiency in nucleos(t)ide analogs (NUCs)-treated chronic hepatitis B (CHB) patients. This post-hoc study analyzed data from 758 NUCs-experienced, HBeAg-negative CHB patients with baseline HBsAg < 1500 IU/mL and undetectable serum HBV DNA who completed 48 weeks of Peg-IFNα add-on therapy in a prospective study. Clinical and biochemical data were collected every 12 weeks and evaluated for their predictive value of HBsAg seroclearance and seroconversion. Age, qHBsAg, and ALT levels at Week 12 were associated with both HBsAg seroclearance and seroconversion. The ASAP-12 score (ALT/[qHBsAg × Age] at Week 12), demonstrated strong discrimination for both endpoints (AUROCs: 0.802 [cut-off 0.07] and 0.787 [cut-off 0.12], respectively; p < 0.05). Patients with scores above the respective cut-offs had significantly higher cumulative probabilities of HBsAg seroclearance (63.4% vs. 17.8%, Log-rank test p < 0.001) and seroconversion (47.3% vs. 11.0%, Log-rank test p < 0.001). Higher ASAP-12 scores (β = 0.206, p = 0.006) independently correlated with elevated Week 48 HBsAb levels. The ASAP-12 score may serve as a useful tool to predict both HBsAg seroclearance and seroconversion at Week 48 of Peg-IFNα add-on therapy in NUCs-experienced CHB patients, supporting individualized therapeutic decisions.