Author information

¹Center for Global Health, Istituto Superiore di Sanità, Rome, Italy; UniCamillus-Saint Camillus International University of Health Sciences, Rome, Italy. Electronic address: loreta.kondili@iss.it.

²Department of Molecular Medicine, Infectious Diseases, University of Padua, Padua, Italy.

³Center for Global Health, Istituto Superiore di Sanità, Rome, Italy.

⁴Hepatology Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.

⁵Department of Infectious Diseases, Sant'Anna Hospital, Caserta, Italy.

⁶Gastroenterology Unit, Città della Salute e della Scienza of Turin, University Hospital, Turin, Italy.

⁷Liver and Biliary System Unit, Department of Clinical Medicine and Surgery, University of Naples, Federico II, Naples, Italy.

⁸Hepatology Unit, Betania Hospital, Naples, Italy.

⁹Infectious Diseases Unit, Ospedali Riuniti, Foggia, Italy.

¹⁰Department of Internal Medicine, University Hospital of Messina, Messina, Italy.

¹¹Liver Unit, Digestive Disease Center, CEMAD Division of Internal Medicine and Gastroenterology, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.

¹²Department of Hepatology, Gragnano Hospital, Gragnano (NA), Italy.

¹³National Institute for Infectious Diseases, Lazzaro Spallanzani-IRCCS, Rome, Italy.

¹⁴Department of Medicine, Infectious Diseases Unit, University Hospital of Padua, Padua, Italy.

¹⁵Infectious Diseases Unit, Department of Mental Health and Public Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.

¹⁶Clinical Infectious Diseases, Polytechnic University of Marche, Ancona, Italy.

¹⁷Gastroenterology, Department of Medicine, University of Milan Bicocca & Gastroenterology Hepatology and Transplantation, Papa Giovanni XXIII Hospital, Bergamo, Italy.

¹⁸Malattie Infettive, Azienda Unità Sanitaria Locale, IRCCS di Reggio Emilia, Reggio Emilia, Italy.

¹⁹Department of Surgery, Oncology and Gastroenterology, Gastroenterology Unit, University of Padua, Padua, Italy.

²⁰Gastroenterology Unit, University Hospital Borgo Trento, Verona, Italy.

²¹Department of Medicine and Surgery, Università degli Studi di Parma, Parma, Italy.

²²Unit of Gastroenterology and Hepatology, Biomedical Department of Internal and Specialistic Medicine University of Palermo, Palermo, Italy.

²³Infectious Disease Unit, Santa Maria Annunziata Hospital, Florence, Italy.

²⁴Department of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.

²⁵Unit of Infectious Diseases, IRCCS Ospedale San Raffaele, Milan, Italy.

²⁶Hepato-Gastroenterology Division, Department of Precision Medicine University of Campania Luigi Vanvitelli, Naples, Italy.

²⁷Liver Unit, University Hospital of Verona, Verona, Italy.

²⁸Department of Clinical Medicine and Surgery, Hepato-Gastroenterology Unit, University of Naples Federico II, Naples, Italy.

²⁹Internal Medicine, Hospital of Faenza, A.U.S.L. of Romagna, Italy.

³⁰Clinic of Infectious Diseases, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.

³¹Infectious and Tropical Diseases Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.

³²Liver Unit, University Hospital, Monserrato, Cagliari, Italy.

³³Clinic of Infectious Diseases, University of Bari, University Hospital Policlinico, Bari, Italy.

³⁴Infectious Diseases Unit, Department for Integrated Infectious Risk Management, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

³⁵Department of Internal Medicine Villa Sofia-Cervello Hospital, Palermo, Italy.

³⁶Department of Medicine-DIMED, Padua University, University Hospital, Clinica Medica 5, Refering Regional Center for Liver Diseases, Padua, Italy.

³⁷Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.

³⁸Hepatology and Liver Transplant Unit, Azienda Sanitaria Universitaria Integrata di Udine, Udine, Italy.

³⁹Clinica Malattie Infettive, Università degli Studi di Genova, Policlinico S. Martino IRCCS, Genova, Italy.

⁴⁰Ambulatorio di Epatologia e Infettivologia, Azienda Sanitaria Provinciale CZ-Distretto del Lametino, Lamezia Terme (CZ), Italy.

⁴¹Hepatology Unit, University of Tor Vergata, Rome, Italy.

⁴²Hepatology Unit, Azienda Ospedaliera San Camillo Forlanini, Rome, Italy.

⁴³Department of Internal Medicine, Policlinico Umberto I Hospital, Sapienza University of Rome, Rome, Italy.

⁴⁴Infectious Disease Unit, Niguarda Hospital, Milan, Italy.

⁴⁵Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

⁴⁶Division of Gastroenterology and Endoscopy, Fondazione IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Foggia, Italy.

⁴⁷Department of Experimental and Clinical Medicine, Interdepartmental Centre MASVE, University of Florence, Italy.

⁴⁸Gastroenterology and Hepatology Unit, PROMISE, University of Palermo, Palermo, Italy.

⁴⁹Department of Clinical and Experimental Medicine, University Hospital of Pisa, Pisa, Italy.

⁵⁰Infectious Disease Unit, University L. Vanvitelli, Naples, Italy.

Abstract

Background and aims: We aimed to characterize the epidemiologic and comorbidities profiles of patients with chronic Hepatitis D (CHD) followed in clinical practice in Italy and explored their interferon (IFN) eligibility.

Methods: This was a cross-sectional study of the PITER cohort consisting of consecutive HBsAg-positive patients from 59 centers over the period 2019-2023. Multivariable analysis was performed by logistic regression model.

Results: Of 5,492 HBsAg-positive enrolled patients, 4,152 (75.6%) were screened for HDV, 422 (10.2%) were anti-HDV positive. Compared with HBsAg mono-infected, anti-HDV positive patients were more often younger, non-Italians, with a history of drug use, had elevated alanine transaminase (ALT), cirrhosis, or hepatocellular carcinoma (HCC). Compared with Italians, anti-HDV positive non-Italians were younger (42.2% age≤40 years vs. 2.1%; p<0.001), more often females (males 43.0% vs. 68.6%; p<0.001) with less frequent cirrhosis and HCC. HDV-RNA was detected in 63.2% of anti-HDV-positive patients, who were more likely to have elevated ALT, cirrhosis, and HCC. Extrahepatic comorbidities were present in 47.4% of anti-HDV positive patients and could affect the eligibility of IFN-containing therapies in at least 53.0% of patients in care.

Conclusions: CHD affects young, foreign-born patients and older Italians, of whom two-thirds had cirrhosis or HCC. Comorbidities were frequent in both Italians and non-Italians and impacted eligibility for IFN.