The Levels of Serum HBV Pre-Genomic RNA and Its Associated Factors Among HBV-Infected Patients: A Retrospective Cohort Study in Hangzhou, Zhejiang, China

Zhongbao Zuo,1,&ast; Jing Wu,1,&ast; Miaochan Wang,1 Rui Wu,2 Xiaojing Zhang,2 Lanlan Hu,1 Huaizhong Cui,1 Ting Feng,3 Aifang Xu,1 Shourong Liu2 1Department of Clinical Laboratory, Hangzhou Xixi Hospital, Zhejiang, 310023, People’s Republic of China; 2Department of Hepatology, Hangzhou Xixi Hospital, Zhejiang, 310023, People’s Republic of China; 3Ultrasound Department, Hangzhou Xixi Hospital, Zhejiang, 310023, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Aifang Xu; Shourong Liu, Email [email protected]; [email protected]: This study aimed to explore serum HBV pre-genomic RNA (pgRNA) levels and its associated factors among HBV-infected patients in the real world.Methods: This retrospective cohort study was conducted from May 10, 2023, to January 15, 2024. Univariate logistic analysis for positive serum HBV pgRNA was performed first, and variables with statistical significance were included in a multivariate logistic model. A decreasing trend of serum HBV pgRNA and HBV DNA levels was also detected first by univariate logistic regression and then by multivariate logistic regression.Results: 482 patients were included in our analysis at baseline, and 191 patients were followed up. Multivariate logistic regression revealed that positive HBV DNA (AOR: 2.63, 95% CI: 1.46– 4.75, P=0.001), ≥ 1000 hBsAg (AOR: 2.29, 95% CI: 1.08– 4.89, P=0.03), positive HBeAg (AOR: 28.26, 95% CI: 15.2– 52.55, P< 0.001), and ALP (AOR: 1.01, 95% CI: 1.001– 1.02, P=0.03) were positively correlated with positive HBV pgRNA at baseline. Two independent multivariate logistic regression models were constructed for the decreasing trend of serum HBV pgRNA and HBV DNA for the 191 follow-up patients. Results showed that the decreasing trend of HBV pgRNA was positively correlated with positive baseline HBV DNA (AOR: 4.60, 95% CI: 1.84– 11.51, P=0.001), baseline HBsAg ≥ 1000 IU/mL (AOR: 8.74, 95% CI: 1.09– 70.10, P=0.04), and HDL (AOR: 5.01, 95% CI: 1.28– 19.66, P=0.02). The decreasing trend of HBV DNA was positively correlated with positive baseline HBV pgRNA (AOR: 3.80, 95% CI: 2.00– 8.83, P< 0.001) and AST (AOR: 1.06, 95% CI: 1.03– 1.08, P< 0.001).Conclusion: Our study revealed that HBV DNA, HBsAg, HBeAg, and ALP were significantly correlated with positive HBV pgRNA at baseline. The baseline HBV DNA, HBsAg, and HDL were significantly correlated with decreasing levels of HBV pgRNA. A decreasing trend of HBV DNA significantly correlated with patients’ baseline HBV pgRNA and AST.Keywords: chronic hepatitis B, HBsAg, HBV pgRNA, HBV DNA