Prevalence of hepatitis D virus antibody positivity in Chinese patients with chronic hepatitis B virus infection

Purpose: Large-scale data of the hepatitis D virus (HDV)/hepatitis B virus (HBV) co-infection rate is crucial to reveal the current epidemiology of HDV in China. Methods: Patients with chronic HBV infection with documented serum hepatitis B surface antigen (HBsAg) positivity for more than 6 months were enrolled across China. Blood samples were collected at baseline for central evaluations of HDV antibody and HBsAg quantification. Assessments of antibodies of hepatitis A virus, hepatitis C virus, hepatitis E virus, and human immunodeficiency virus and HDV RNA quantification were performed in patients who tested positive for HDV antibodies. Results: Of the 5,044 enrolled patients between 24 September 2021 and 28 December 2022, 4,936 patients were included in the analysis. The mean age (± standard deviation) was 42.9 ± 9.9 years and 69.8% of patients were male. The mean alanine aminotransferase was 34 ± 58 U/L, and 1,509 (30.6%) patients were hepatitis B e antigen (HBeAg) positive. The mean HBsAg level at baseline was 3,535 ± 11,292 IU/mL among 4,842 patients who had qualitative results. The rate of HBV infection and HDV antibody positivity was 0.24% (95% CI: 0.1–0.4%), and only one patient was HDV RNA positive. Conclusion: The prevalence of HDV antibody positivity was 0.24% in Chinese patients with chronic HBV infection and only one patient with anti-HDV antibody and HDV RNA positivity was observed in this study.