The Danish Database for Hepatitis B and C (DANHEP): A Nationwide, Prospective, Ongoing Cohort Study

Introduction: The Danish Database for Chronic Hepatitis B and C (DANHEP) was established in 2002 to support research into the clinical, epidemiological, virological, and immunological aspects of chronic viral hepatitis in Denmark. The objective of this paper is to describe methods of data acquisition, content, completeness and accuracy of data in DANHEP. Methods: Since 2002 all individuals with chronic viral hepatitis B or C at least 16 years of age, who has presented to a hospital department specialized in infectious diseases or gastroenterology in Denmark, have been enrolled in DANHEP. Information on co-infections, viral DNA/RNA detection, serology, liver parameters, liver fibrosis, treatment initiation, -cessation and -efficacy is manually transferred from electronic patient files and recorded in DANHEP annually. In 2004, a biobank storing annual blood samples was established. Results: By December 2023 DANHEP stored data on 15,886 individuals with chronic hepatitis B or C and the biobank held approximately 38,180 samples. We verified a random sample of key variables by comparing with electronic patient files and found an error proportion of less than 5%. Conclusion: DANHEP is well suited for studying the epidemiology, virology and immunology of chronic viral hepatitis. We encourage future collaborations to address the many remaining questions in the field of viral hepatitis.