Retrospective Cohort Study
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. May 27, 2018; 10(5): 409-416
Published online May 27, 2018. doi: 10.4254/wjh.v10.i5.409
Clinical epidemiology of chronic viral hepatitis B: A Tuscany real-world large-scale cohort study
Cristina Stasi, Caterina Silvestri, Roberto Berni, Maurizia Rossana Brunetto, Anna Linda Zignego, Cristina Orsini, Stefano Milani, Liana Ricciardi, Andrea De Luca, Pierluigi Blanc, Cesira Nencioni, Donatella Aquilini, Alessandro Bartoloni, Giampaolo Bresci, Santino Marchi, Franco Filipponi, Piero Colombatto, Paolo Forte, Andrea Galli, Sauro Luchi, Silvia Chigiotti, Alessandro Nerli, Giampaolo Corti, Rodolfo Sacco, Paola Carrai, Angelo Ricchiuti, Massimo Giusti, Paolo Almi, Andrea Cozzi, Silvia Carloppi, Giacomo Laffi, Fabio Voller, Francesco Cipriani
Cristina Stasi, Caterina Silvestri, Fabio Voller, Observatory of Epidemiology, Regional Health Agency of Tuscany, Florence 50141, Italy
Cristina Stasi, Anna Linda Zignego, Center for Systemic Manifestations of Hepatitis Viruses (MaSVE), Internal Medicine and Liver Unit, Department of Experimental and Clinical Medicine, Careggi University Hospital, Florence 50134, Italy
Roberto Berni, Cristina Orsini, Web Solutions, Data Visualization and Scientific Documentation, Regional Health Agency of Tuscany, Florence 50141, Italy
Maurizia Rossana Brunetto, Piero Colombatto, Hepatology Unit, Department of Clinical and Experimental Medicine, University Hospital of Pisa, Pisa 56100, Italy
Stefano Milani, Paolo Forte, Andrea Galli, Andrea Cozzi, Gastroenterology Research Unit, Department of Experimental and Clinical Biomedical Sciences “Mario Serio”, Careggi University Hospital, Florence 50134, Italy
Liana Ricciardi, Sauro Luchi, Infectious Disease Unit, Hospital of Lucca, Lucca 55100, Italy
Andrea De Luca, Infectious Diseases Unit, Department of Medical Biotechnologies, Siena University Hospital, Siena 53100, Italy
Pierluigi Blanc, Infectious Disease Unit, “S. Maria Annunziata” Hospital, Ponte a Niccheri 50012, Italy
Cesira Nencioni, Silvia Chigiotti, Infectious Disease Unit, Hospital of Grosseto, Grosseto 58100, Italy
Donatella Aquilini, Alessandro Nerli, Infectious Disease Unit, Hospital of Prato, Prato 59100, Italy
Alessandro Bartoloni, Giampaolo Corti, Infectious and Tropical Diseases Unit, Department of Experimental and Clinical Medicine, Careggi University Hospital, Florence 50134, Italy
Giampaolo Bresci, Rodolfo Sacco, Gastroenterology and Metabolic Disorders, Department of Surgery, Cisanello University Hospital, Pisa 56100, Italy
Santino Marchi, Angelo Ricchiuti, Gastroenterology Unit, Department of Translational Research and New Technologies in Medicine and Surgery, Cisanello University Hospital of Pisa, Pisa 56100, Italy
Franco Filipponi, Paola Carrai, Liver Surgery and Transplantation Unit, Department of Surgical Pathology, Medicine, Molecular and Critical Area, Cisanello University Hospital, Pisa 56100, Italy
Massimo Giusti, Internal Medicine Unit, “San Jacopo” Hospital, Pistoia 51100, Italy
Paolo Almi, Infectious Diseases and Hepatology Unit, Department of Internal and Specialized Medicine, University Hospital of Siena, Siena 53100, Italy
Silvia Carloppi, Gastroenterology Unit, San Giuseppe Hospital, Empoli 50053, Italy
Giacomo Laffi, Internal Medicine and Liver Unit, Department of Experimental and Clinical Medicine, Careggi University Hospital, Florence 50135, Italy
Francesco Cipriani, Department of Prevention, Central Tuscany Local Unit, Florence 50100, Italy
Author contributions: Stasi C designed the study, wrote the paper, participated in acquisition, interpretation and analysis of the data and revised the article; Silvestri C participated in the study design and acquisition and analysis of the data and revised the article; Berni R and Orsini C designed and developed the software for data registration and revised statistical analysis; Brunetto MR, Zignego AL, Milani S, Ricciardi L, De Luca A, Blanc P, Nencioni C, Quilini D, Bartoloni A, Bresci G, Marchi S, Filipponi F, Colombatto P, Forte P, Galli A, Luchi S, Chigiotti S, Nerli A, Corti G, Sacco R, Carrai P, Ricchiuti A, Giusti M, Almi P, Cozzi A, Carloppi S and Laffi G participated in study design and acquisition of data and revised the article critically for important intellectual content; Voller F and Cipriani F participated in study design, were the guarantors of methods used, and revised the article critically for important intellectual content; all authors have reviewed and approved the final manuscript.
Institutional review board statement: This study was reviewed and approved by the Institutional Review Board.
Informed consent statement: The demographic data of the study were appropriately encrypted in the database and the exported file (containing the “anonymized” data) was sent from the system to the Regional Health Agency of Tuscany via a secure channel.
Conflict-of-interest statement: Professor Brunetto MR reports grants and personal fees from BMS, personal fees from Gilead, outside the submitted work; Professor De Luca A reports grants from ViiV Healthcare, grants from Gilead, personal fees from ViiV Healthcare, personal fees from Gilead, personal fees from Merck Sharp and Dohme, personal fees from Janssen Cilag, outside the submitted work. No other authors have relevant conflicts of interests to disclose.
STROBE statement: The guidelines of the STROBE Statement have been adopted.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Cristina Stasi, MD, PhD, Consultant Gastroenterologist, Observatory of Epidemiology, Regional Health Agency of Tuscany, Via P. Dazzi 1, Florence 50141, Italy. cristina.stasi@gmail.com
Telephone: +39-55-4624385
Received: February 20, 2018
Peer-review started: February 21, 2018
First decision: March 15, 2018
Revised: March 20, 2018
Accepted: April 15, 2018
Article in press: April 16, 2018
Published online: May 27, 2018
Processing time: 96 Days and 8 Hours
ARTICLE HIGHLIGHTS
Research background

While the introduction of an effective vaccine has been highly effective in reducing the incidence and prevalence of hepatitis B virus (HBV) infection in many countries, an estimated 257 million people worldwide are still chronically infected. In 2015, WHO published guidelines for the prevention, care and treatment of persons with chronic HBV infection. These promote the use of simple, noninvasive tests to assess liver disease stage and eligibility for treatment.

Research motivation

Few data are currently available concerning the real-word large-scale staging and treatment of HBV patients followed in specialised outpatient services. The knowledge of the specific characteristics of patients could lead to appropriate planning for public health programs, thus contributing to the successful, efficient translation of this knowledge to management and treatment of HBV patients to eradicate HBV.

Research objectives

The main objective of this study was to build a regional database of patients diagnosed with chronic HBV infection in specialised outpatient services in our region to define the clinical epidemiology of HBV-infected patients in the Tuscan public health care system.

Research methods

This prospective observational study is fully in line with the objectives of the National Plan for the Prevention of Viral Hepatitis, in particular with those outlining the importance of the quality of reporting system data and of the monitoring of HBV and hepatitis C virus as acute or chronic infections. This study used a cross-sectional cohort design to evaluate all patients with HBV-related chronic liver disease referred to the hepatology outpatient services of 16 hospital units from January 1, 2015, to December 31, 2015. A computerised clinical database was used to collect the main socio-demographic, clinical and treatment data for all patients with chronic HBV infection admitted at each centre. The exported file (containing the “anonymized” data) was then sent to the Regional Health Agency of Tuscany via a secure channel (SSL).

Research results

The results of this study demonstrated that 27.3% of chronic viral hepatitis patients were HBV infected. Of these HBV-infected patients, 73% were Caucasian, 21% Asian, 4% Central African, 1% North African and 1% American. Stratifying patients by age and nationality, we found that 21.7% of HBV-infected patients were aged < 34 years. Among these only 2.8% were Italian. The most represented routes of transmission were nosocomial/dental procedures (23%), mother-to-child (17%) and sexual transmission (12%). The most represented HBV genotypes were D (72%) and A (14%). Of the patients, 24.7% were HBeAg positive, and 75.3% were HBeAg negative. Of the HBV patients, 7% were anti-HDV positive. In the whole cohort, 26.9% were cirrhotic (35.8% aged < 45 years), and 47% were eligible for or currently undergoing treatment, of whom 41.9% were cirrhotic.

Research conclusions

The informatization of clinical data and the real-word large-scale staging and treatment of these kinds of patients would allow health planners to assign specific healthcare resources to targeted populations. This observational research may provide a public health opportunity to screen and treat specific groups of patients. In particular, to eradicate HBV infection further efforts are necessary to increase vaccine coverage in immigrant populations.

Research perspectives

Based on the data collected in the course of this investigation, it is necessary to implement a series of preventive measures and strengthen the entire care process to eliminate, or at least reduce, risk factors for HBV infection and progression toward advanced liver fibrosis stages and to adopt care protocols suitable for immigrant populations.