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. 2025 Oct;45(10):e70336.
doi: 10.1111/liv.70336.

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

Alessandro Loglio  1 , Ivan Gardini  2 , Massimiliano Conforti  2 , Marco Bartoli  2 , Francesco Silvia  2 , Carmine Coppola  3 , Luchino Chessa  4 , Gianluca Svegliati-Baroni  5 , Laura Schiadà  5 , Ivan Gentile  6 , Biagio Pinchera  6 , Maurizia Rossana Brunetto  7 , Piero Colombatto  7 , Alessio Aghemo  8 , Stella De Nicola  8 , Pierluigi Toniutto  9 , Edoardo Giovanni Giannini  10 , Antonio Colecchia  11 , Dante Romagnoli  11 , Loredana Sarmati  12 , Francesca Romana Ponziani  13 , Filomena Morisco  14 , Calogero Cammà  15 , Giuseppe Cabibbo  15 , Pietro Lampertico  16   17 , Elisabetta Degasperi  16 , Pietro Invernizzi  18   19 , Antonio Ciaccio  18 , Francesco Paolo Russo  20 , Antonio Massimo Ippolito  21 , Grazia Anna Niro  21 , Natalia Terreni  22 , Gerardo Nardone  23 , Alba Rocco  23 , Maria D'Antò  24 , David Sacerdoti  25 , Donatella Ieluzzi  25 , Alessia Ciancio  26 , Adriano Pellicelli  27 , Alessandro Federico  28 , Loredana Simone  29 , Vincenzo Messina  30 , Ernesto Claar  31 , Valerio Rosato  31 , Gianpiero D'Offizi  32 , Paolo Caraceni  33   34 , Paolo Muratori  35 , Cinzia Giaccherini  36 , Stefano Fagiuoli  1   37 , Mauro Viganò  1   37
Affiliations

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

Alessandro Loglio et al. Liver Int. 2025 Oct.

Abstract

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.

Keywords: HBV; HDV; Italy; epidemiology; prevalence.

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Conflict of interest statement

Alessandro Loglio: Speaker bureau and received grants from Gilead Sciences and Roche. Laura Schiadà: travel grants from Astra Zeneca, Roche, MSD. Fee for lectures and expertise from Astra Zeneca. Ivan Gentile: consultant for MSD, AbbVie, Gilead, Pfizer, GSK, Astrazeneca, Basilea, SOBI, Nordic/InfectoPharm, Angelini, Moderna, Shionogi, Advanz Pharma, Abbott and Mundipharma Pharmaceuticals. Maurizia Rossana Brunetto: Advisory for Gilead, Roche; Speakers Bureau: AbbVie, Gilead, EISAI‐MSd, AstraZeneca. Loredana Sarmati: travel grants from Gilead, Merck, Pfizer, fee for lectures and expertise from Merck, Gilead, Abbvie, Angelini, Astra Zeneca, GSK. Francesca Romana Ponziani: received speaker fees, advisory board fees and travel grants from Bayer, MSD, Roche, Eisai, Ipsen, Astra‐Zeneca, Gilead, Abbvie. Morisco Filomena: Advisory board for Gilead, Ipsen, Astra Zeneca, Mirum, Roche Diagnostic, Aboca, Alfa‐Sigma. Pierluigi Toniutto: Advisory Gilead, Roche, Astra Zeneca; Speakers Bureau: AbbVie, Gilead, EISAI‐MSd, AstraZeneca. Edoardo Giovanni Giannini: Advisory Board, AstraZeneca, Gilead, Ipsen, Roche; Teaching & Speaking: AstraZeneca, Gilead, Ipsen, Roche. Dante Romagnoli: Advisory Board for AbbVie and Gilead Sciences. Giuseppe Cabibbo: Advisory board/Speaker for Bayer, Eisai, Ipsen, and AstraZeneca, MSD, Roche, Gilead. Pietro Lampertico: Advisory Board/Speaker Bureau for: Roche Pharma/Diagnostics, Gilead Sciences, GSK, Abbvie, Janssen, MYR, Eiger, Antios, Aligos, VIR, Grifols, Altona, Roboscreen. Pietro Invernizzi: travel grants from Gilead, Ipsen, fee for lectures and expertise from Calliditas, Gilead, Zydus, Ipsen, GSK. Antonio Ciaccio: Speaker bureau for Gilead, Abbvie, AlfaSigma. Gerardo Nardone: Speaker for Allergosan, Alfasigma. Alessandro Federico: Advisory Board for Gilead, Alfasigma. Vincenzo Messina: Advisory Board for Abbvie, Gilead, MSD, Roche. Ernesto Claar: research grant from Gilead Sciences. Valerio Rosato: research grants from Gilead, advisory board from Gilead and MSD. Gianpiero D'Offizzi: Advisory Board for AbbVie, Gilead, Viatris, GSK. Paolo Caraceni: Advisory Board for Abbvie, lecturer for Gilead. Mauro Viganò: Advisory Board/Speaker Bureau for: Gilead Sciences, Ipsen. Others declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
New estimates on diagnosed HBV and HDV patients living in Italy in 2024.
FIGURE 2
FIGURE 2
HBV and HDV epidemiology in Italy according to different periods and study population.
See this image and copyright information in PMC

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