Abstract: Objective To investigate the dynamic changes of serum exosomal HBV-miR-3 in patients with chronic hepatitis B (CHB) treated with antiviral therapy and its relationship with virological indicators.Methods A total of 116 patients with CHB who were admitted from June 2020 to June 2021 were selected, all received antiviral therapy for 12 months. The patients were divided into a virological response group (VR⁺ group) and a non-viral response group (VR^- group) according to their levels of HBV DNA after treatment. The general data and dynamic changes of virological parameters and serum exosomal HBV-miR-3 before and after antiviral therapy were compared between VR⁺ and VR^- groups. The relationship between exosomal HBV-miR-3 levels and virological indicators was investigated by Pearson correlation analysis, and the predictive efficacy of exosomal HBV-miR-3 levels on virological response was analyzed by receiver operating characteristic (ROC) curve analysis. Results After 12 months of antiviral treatment, 54 cases had virological response (VR⁺ group) and 62 cases did not obtain viral response (VR^- group). The virological response rate was 46.55%. The level of ALT in the VR⁺ group was higher than that in the VR^- group, while the HBsAg concentration, HBV DNA load and exosomal HBV-miR-3 levels were lower than those in the VR^- group (P<0.05). The HBsAg concentration, HBV DNA load and exosomal HBV-miR-3 level in the VR⁺ group decreased significantly after receiving antiviral treatment, while the VR^- group decreased but did not change significantly, and was always higher than the VR⁺ group (P<0.05). Serum exosomal HBV-miR-3 levels were not significantly correlated with ALT (r=0.049, P=0.241), but were positively correlated with HBV DNA and HBsAg (r=0.314, 0.809, P<0.05). The ROC curve results showed that at 3 months of treatment, the AUC (0.857) (95% CI: 0.716-0.962) with 4.52 lg copies/ml as the optimal cutoff value was the largest, and the sensitivity and specificity were the highest, which were 82.70% and 82.70%, respectively. Conclusion The level of serum exosomal HBV-miR-3 in CHB patients decreased with the prolongation of antiviral treatment time, and was positively correlated with virological indicators of HBV DNA and HBsAg, and HBV-miR-3≤4.52 lg copies/ml at 3 months of antiviral therapy can be used as an indicator to predict the virological response of CHB patients with 12 months of antiviral therapy.

Key words: Antiviral therapy, Chronic hepatitis B, Exosomal HBV-miR-3, Virological indicators