Please cite this article in press as: Cuomo G, et al. Missed treatment in an Italian HBV infected patients cohort: HBV RER. Dig Liver Dis (2016), http://dx.doi.org/10.1016/j.dld.2016.07.016 ARTICLE IN PRESS G Model YDLD-3219; No. of Pages 5 Digestive and Liver Disease xxx (2016) xxx–xxx Contents lists available at ScienceDirect Digestive and Liver Disease jou rnal h om epage: www.elsevier.com/locate/dld Liver, Pancreas and Biliary Tract Missed treatment in an Italian HBV infected patients cohort: HBV RER Gianluca Cuomo a,∗ , Vanni Borghi a , Pietro Andreone b , Marco Massari c , Erica Villa d , Antonello Pietrangelo e , Gabriella Verucchi f , Carlo Ferrari g , HBV-RER Group 1 a Infectious Disease, Azienda Ospedaliero Universitaria di Modena, Modena, Italy b Internal Medicine, Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy c Infectious Disease, IRCCS – ASMN Reggio Emilia, Reggio Emilia, Italy d Gastroenterology, Azienda Ospedaliero Universitaria di Modena, Italy e Internal Medicine, Azienda Ospedaliero Universitaria Modena, Modena, Italy f Infectious Disease, Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy g Infectious Disease and Hepatology, Azienda Ospedaliero Universitaria di Parma, Parma, Italy a r t i c l e i n f o Article history: Received 2 March 2016 Accepted 13 July 2016 Available online xxx Keywords: HBV Hepatitis B treatment Liver fibrosis a b s t r a c t Background and aims: Very little is known about the access to treatment for Chronic Hepatitis B in the real clinical practice and the characteristics of the patients who do not receive antiviral therapy. Methods: HBV-RER is an observational multicenter network that collected data of patients with HBV infection during a 3 years observational period (2009–2012). Results: Among 2527 HBsAg positive patients, 1099 were never treated (NT); only 280 were included in the analysis due to different exclusion causes A minority was HBeAg-positive. The median age was 42. At liver biopsy most patients had Metavir score of F0-F1. Univariate analysis between 280 NT patients and the 290 naïve to treatment showed that NT patients were mostly female (P = 0.002), not Italian (P = 0.044), younger (P < 0.001). Metavir score was lower in NT (P0.002), such as the Fib4 score (P < 0.001). HBV DNA level was significantly higher in NT. At multivariate analysis, independent variables associated with no- treatment were younger age, female gender, Metavir score F0-F1, Fib4 lower than 1.6 and lower blood level of HBV-DNA. Conclusions: There is a large number of patients eligible to treatment who do not receive it. A younger age and a less severe disease seem to be associated to deferral of treatment. © 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved. 1. Introduction Chronic Hepatitis B virus (HBV) infection is a worldwide spread disease. It can present in different patterns such as HBV inactive carrier and progressive Chronic Hepatitis B (CHB), that may evolve in liver cirrhosis and hepatocellular carcinoma (HCC) [1]. At present, six treatments are available for hepatitis B: inter- feron (pegylated or not) and five nucleotide/nucleoside analogues (NUCs): lamivudine, telbivudine, adefovir, entecavir and tenofovir. National and international guidelines suggest the use in first line treatment of both pegylated interferon (PEG-IFN) or nucleot(s)ide analogues (entecavir or tenofovir). The use of PEG-INF is indicated from a stage of minimal liver fibrosis up to a stage of a well com- pensated cirrhosis [2,3]. The use of NUCs is allowed in all the stages ∗ Corresponding author at: Infectious Disease, Azienda Ospedaliero Universitaria di Modena, Largo del Pozzo, 71, 41126 Modena, Italy. Fax: +39 0594223709. E-mail address: gian.cuomo@gmail.com (G. Cuomo). 1 See Appendix A of the HBV disease up to decompensated cirrhosis. The ideal goal of therapy is the HBsAg loss and seroconversion to HBsAb, but this end-point is obtained in a very low percentage of patients treated with the different available drugs [4]. Therapeutic intervention is currently aiming at suppression of HBV replication, that is key to decrease liver injury and disease progression, in order to prevent cirrhosis, decompensation and to reduce the risk of HCC [5]. Very little is known about the access to treatment for CHB in the clinical practice and mainly of the epidemiological and clinical characteris- tics of the patients who do not receive any antiviral therapy. Aim of our study was to analyze the clinical and epidemiological features of the “missing treatments” in a multicenter observational study con- ducted on an Hepatitis B surface antigen (HBsAg) positive cohort of patients. 2. Patients and methods HBV-RER is an observational multicenter Italian network that collects clinical and virological data of patients with CHB coming http://dx.doi.org/10.1016/j.dld.2016.07.016 1590-8658/© 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.