Diagnosed Patients With Chronic Hepatitis B and Delta Virus in Italy in 2024: An Estimation From a National Real-World Database

Background and Aims Hepatitis B (HBV) and Hepatitis Delta virus (HDV) infection have undergone significant changes in Italy over the past few decades, but reliable and updated prevalence of chronic hepatitis B (CHB) and Delta (CHD) data are lacking. The aim of the study was to describe the epidemiology of CHB and CHD in Italy in 2024, based on real-world data.Methods The number of patients with a healthcare expenditure exemption for CHB (016.070.32) and CHD (016.070.33) was obtained from 21 Regional Health Authorities. To understand how many CHB or CHD patients did not have these specific exemptions, a survey was conducted in 30 Gastroenterology, Hepatology and Infectious Diseases Units across the country.Results Health Authorities data reported 67 514 and 5216 subjects with an exemption for CHB and for CHD, respectively. However, among 6775 CHB and 504 CHD patients, only 60.3% and 55.7% of them had the specific exemption, respectively. Based on these results, we estimated 111 960 (95% CI: 109 780-114 240) CHB and 9360 (95% CI: 8690-10 150) CHD patients, with a prevalence of 0.22% and 0.019% of the adult overall population. Moreover, anti-HDV prevalence was 7.7% from this cohort.Conclusion Our study provides a plausible estimate of the current number of adult patients diagnosed with CHB and CHD in Italy and may be considered the basis for decision-making health policies.