Abstract: Objective To evaluate the diagnostic value of early preggnancy bile acid profiling in detecting intrahepatic cholestasis of pregnancy (ICP) among pregnant women infected with the hepatitis B virus(HBV). Methods Between January 2020 and December 2022, a retrospective analysis was conducted on 186 pregnant women with HBV infection admitted to our hospital. Based on the diagnostic criteria for ICP, participants were categorized into two groups: those with HBV infection alone(124 cases) and those with HBV infection complicated by ICP group (62 cases). We collected and compared the general demographic information, peri-protective liver function indices, and early pregnancy bile acid profiles between the two groups. Through univariate and multivariate logistic regression analyses, we identified the primary factors influencing the occurrence of ICP in HBV-infected pregnant women. Additionally, the fiagnostic efficacy for ICP was evaluated using ROC curve analysis. Results In the comparative analysis between the HBV-alone group and the HBV plus ICP group, significant differences were observed in several biochemical parameters. AST levels were notably higher in the HBV plus ICP group[(46.60±38.98) U/L] compared to the HBV-alone group[(30.97±31.49) U/L, P=0.004]. Similarly, ALT [(50.80±36.81) U/L vs (40.32±29.45) U/L, P=0.0037], DBil [(6.07±2.34) μmol/L vs (4.73±1.83) μmol/L, P<0.001], and TBA [(16.98±2.48) μmol/L vs (6.01±2.34) μmol/L, P=0.010] were significantly elevated in the HBV plus ICP group. Concentrations of cholic acid(CA) , (glycocholic acid)GCA, glycodeoxrycholic acid(GDCA), glycochenodeoxycholic acid(GCDCA) also showed significant increases, with P-values of 0.007, <0.001, <0.001, and <0.001, respectively. Multivariate analysis identified AST, DBil, GCA, GDCA, and GCDCA as major risk factors for the development of ICP in HBV-infected pregnant women(P<0.05). Among these, AST, DBil and GCA demonstrated higher diagnostic values for HBV-complicated ICP with AUCs of 0.747, 0.725 and 0.761, respectively. The diagnostic efficiency of GCDCA and GDCA was moderate, with AUC values of 0.667 and 0.688. Conclusion The study identifies the elevation of GCA, GCDCA, GDCA subtypes in the bile acid profile, along with increases in AST and DBil, as principal risk factors for ICP in HBV-infected pregnant women. Notably, GCA emerges as the biomarker with the highest predictive diagnostic value for ICP. These findings underscore the importance of integrating liver function tests with bile acid spectrum analysis in the clinical diagnosis of ICP among this patient population.

Key words: Hepatitis B virus, Bile acid spectrum detection, Bile acid, Intrahepatic cholestasis of pregnancy, Diagnosis