Abstract: Objective The aim of this study was to investigate serum hepatitis B virus pregenomic RNA (HBV pgRNA) level changes in patients with chronic hepatitis B (CHB) receiving nucleos(t)ide analogues (NAs) treatment. Methods 78 patients with CHB were recruited in our hospital between September 2019 and September 2021, and all were treated with NAs for 12 months. Serum HBV DNA and HBV pgRNA levels were detected by fluorescence quantitative PCR. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels were observed. Serum HBsAg level was assayed by enzyme-linked immunosorbent assay. The factors influencing complete response (CR) to antiviral therapy were analyzed by Cox regression analysis, and the the predictive performance of serum HBV pgRNA for NAs treatment efficacy was evaluated by receiver operating characteristic (ROC) curves. Results At the end of 48 week observation of antiviral treatment, 66 patients with CHB obtained CR in our series; at presentation, serum HBV DNA loads, HBsAg levels and HBV pgRNA lads in patients with CR were (6.0±0.7)lg IU/mL, (2.4±0.5)lg IU/mL and (3.0±0.9)lg copies/mL, significantly lower than [(7.1±1.3)lg IU/mL, (3.8±0.9)lg IU/mL and (6.8±0.4)lg copies/mL, respectively, P＜0.05) in patients without CR; the Cox analysis showed that serum HBsAg levels (HR=1.432, 95%CI:1.022-2.006) and HBV pgRNA(HR=1.237, 95%CI:1.060-1.445) at admission were the factors influencing antiviral response (P＜0.05), and the ROC analysis demonstrated that the AUC was 0.825(95%CI:0.722-0.902), with the sensitivity of 89.4% and the specificity of 83.3% when serum HBV pgRNA loads equal to 4.8 lg copies/mL was set as the cut-off-value in predicting the antiviral response in patients with CHB. Conclusion The monitoring of serum HBV pgRNA loads has certain clinical predictive efficacy for antiviral therapy with NAs in patients with CHB, which needs further clinical investigation.

Key words: Hepatitis B, Nucleos(t)ide analogue, HBV pregenomic RNA, Therapy, Response