Estimation of the number of HCV-positive patients in Italy

Autoři: Ivan Gardini aff001;  Marco Bartoli aff001;  Massimiliano Conforti aff001;  Francesco Saverio Mennini aff002;  Andrea Marcellusi aff003
Působiště autorů: EpaC Onlus, Italian Liver Patient Association, Rome, Italy aff001;  Centre for Economic and International Study (CEIS), Faculty of Economics, University of Rome "Tor Vergata", Rome, Italy aff002;  Department of Accounting, Finance and Informatics, Kingston Business School, Kingston University London, London, United Kingdom aff003
Vyšlo v časopise: PLoS ONE 14(10)
Kategorie: Research Article
doi: 10.1371/journal.pone.0223668



HCV is one of the main causes of cirrhosis, hepatocellular carcinoma (HCC) and liver transplantation.


The aim of this study was to estimate the number of living individuals diagnosed with hepatitis C in Italy. This study also aimed to stratify these subjects as diagnosed and cured, diagnosed awaiting a cure, and undiagnosed (individuals who were not diagnosed, living or lived with hepatitis C).


To quantify the number of ill patients in Italy, an inquiry was conducted based on questionnaires submitted to three nationally representative regions, namely, Campania, Lazio and Piemonte, as representatives of the three main areas of Italy (North, Centre and South regions). The data were collected through a questionnaire to acquire demographic and clinical information on patients in the participating hospitals. The questionnaires contained 6 questions on sex, age, region of residence, disease condition, type of exemption and category. The questionnaires were administered individually to consecutive patients through face-to-face interviews conducted by specialised personnel in each centre. Data were collected between September 2017 and January 2018.


In total, 2,860 questionnaires were analysed. They were completed by the patients (55% male), who had an average age of 61 years (64 years for women and 59 years for men). In total, 54% of the sample declared that they were still infected with HCV (1,548 patients out of 2,860 respondents), while the remaining subjects declared that they had been cured. The inquiry showed that 46.6% of the sample had at least a 016 exemption (chronic hepatitis), while more than 51% (1,469 interviewed patients out of 2,860 respondents) had a different type of exemption. Only 2% of the respondents declared that they had no exemption. Assuming that the analysed sample is representative of the actual HCV-positive population in Italy and considering the number of 016 exempt patients in the regional data, the model estimates that there are 443,491 cured and HCV-positive living patients and 240,043 ill patients who have yet to be treated.


Although this study has limitations, it represents a considerable improvement over the previously available studies. This study can help decision-makers implement more effective strategic planning to eliminate hepatitis C.

Klíčová slova:

Drug addiction – Drug users – Hepatitis C – Hepatitis C virus – Hepatocellular carcinoma – Italian people – Italy – Anti-addiction drug therapy


1. Gane E, Kershenobich D, Seguin-Devaux C, Kristian P, Aho I, Dalgard O, et al. Strategies to manage hepatitis C virus (HCV) infection disease burden—volume 2. Journal of viral hepatitis. 2015;22 Suppl 1:46–73. doi: 10.1111/jvh.12352 25560841.

2. Razavi H, Waked I, Sarrazin C, Myers RP, Idilman R, Calinas F, et al. The present and future disease burden of hepatitis C virus (HCV) infection with today's treatment paradigm. Journal of viral hepatitis. 2014;21 Suppl 1:34–59. doi: 10.1111/jvh.12248 24713005.

3. Sievert W, Razavi H, Thompson A, Zekry A, Dore GJ, Roberts SK. HCV-infected patients need access now to new direct-acting antiviral agents to avert liver-related deaths. Med J Aust. 2015;202(9):479. doi: 10.5694/mja15.00165 25971570.

4. Papatheodoridis GV, Hatzakis A, Cholongitas E, Baptista-Leite R, Baskozos I, Chhatwal J, et al. Hepatitis C: The beginning of the end-key elements for successful European and national strategies to eliminate HCV in Europe. Journal of viral hepatitis. 2018;25 Suppl 1:6–17. doi: 10.1111/jvh.12875 29508946.

5. Saraswat V, Norris S, de Knegt RJ, Sanchez Avila JF, Sonderup M, Zuckerman E, et al. Historical epidemiology of hepatitis C virus (HCV) in select countries—volume 2. Journal of viral hepatitis. 2015;22 Suppl 1:6–25. doi: 10.1111/jvh.12350 25560839.

6. (WHO) WHO. global health sector strategy on viral hepatitis 2016–2021 towards ending viral hepatitis 2016.

7. Wedemeyer H, Duberg AS, Buti M, Rosenberg WM, Frankova S, Esmat G, et al. Strategies to manage hepatitis C virus (HCV) disease burden. Journal of viral hepatitis. 2014;21 Suppl 1:60–89. doi: 10.1111/jvh.12249 24713006.

8. Cozzolongo R, Osella AR, Elba S, Petruzzi J, Buongiorno G, Giannuzzi V, et al. Epidemiology of HCV infection in the general population: a survey in a southern Italian town. The American journal of gastroenterology. 2009;104(11):2740–6. doi: 10.1038/ajg.2009.428 19638964.

9. Liakina V, Hamid S, Tanaka J, Olafsson S, Sharara AI, Alavian SM, et al. Historical epidemiology of hepatitis C virus (HCV) in select countries—volume 3. Journal of viral hepatitis. 2015;22 Suppl 4:4–20. doi: 10.1111/jvh.12475 26513445.

10. Pizzillo P, Almasio PL, Ferraro D, Craxi A, Di Stefano R. HCV genotypes in Sicily: is there any evidence of a shift? Journal of medical virology. 2009;81(6):1040–6. doi: 10.1002/jmv.21498 19382266.

11. Gardini I, Bartoli M, Conforti M, Mennini FS, Marcellusi A, Lanati E. HCV—Estimation of the number of diagnosed patients eligible to the new anti-HCV therapies in Italy. Eur Rev Med Pharmacol Sci. 2016;20(1 Suppl):7–10. doi: 10.1016/j.jval.2016.09.948 28083865.

12. Istituto Nazionale di Statistica (ISTAT). L'evoluzione Della Mortalità per Causa 2003–2014: Le Prime 25 Cause Di Morte 2017. Available from: Cited January 2019.

13. Agenzia Italiana del Farmaco (AIFA). Data Updating of AIFA DAAs Registers–Chronic Hepatitis C 2018. Available from: Cited January 2019.

14. Leone S, Shanyinde M, Cozzi Lepri A, Lampe FC, Caramello P, Costantini A, et al. Incidence and predictors of single drug discontinuation according to the presence of HCV coinfection in HIV patients from the ICONA Foundation Cohort Study. Eur J Clin Microbiol Infect Dis. 2018;37(5):871–81. doi: 10.1007/s10096-017-3180-8 29318459.

15. Nozza S, Cozzi-Lepri A, Bai F, Rusconi S, Gori A, Cinque P, et al. Proportion and factors associated with recent HIV infection in a cohort of patients seen for care in Italy over 1996–2014: Data from the ICONA Foundation Study cohort. PloS one. 2017;12(12):e0189045. doi: 10.1371/journal.pone.0189045 29206853; PubMed Central PMCID: PMC5716540.

16. d'Arminio Monforte A, Cozzi-Lepri A, Ceccherini-Silberstein F, De Luca A, Lo Caputo S, Castagna A, et al. Access and response to direct antiviral agents (DAA) in HIV-HCV co-infected patients in Italy: Data from the Icona cohort. PloS one. 2017;12(5):e0177402. doi: 10.1371/journal.pone.0177402 28520749; PubMed Central PMCID: PMC5435319.

17. Governo Italiano. Relazione Annuale al Parlamento 2015 sullo Stato delle Tossicodipendenze in Italia 2015. Available from:

18. Senato della Repubblica. Relazione sui Dati Relativi allo Stato delle Tossicodipendenze in Italia 2016. Available from:

19. Stroffolini T, D'Egidio PF, Aceti A, Filippini P, Puoti M, Leonardi C, et al. Hepatitis C virus infection among drug addicts in Italy. J Med Virol. 2012;84(10):1608–12. doi: 10.1002/jmv.23370 22930509.

20. Dipartimento Politiche Antidroga (Presidenza del Consiglio dei Ministri). Relazione Annuale al Parlamento sullo stato delle Tossicodipendenze in Italia 2008. Available from:

21. SINTESI. Relazione Annuale al Parlamento 2011 Sull'uso di Sostanze Stupefacenti e sullo Stato delle Tossicodipendenze in Italia 2011. Available from:

22. Camoni L, Regine V, Stanecki K, Salfa MC, Raimondo M, Suligoi B. Estimates of the number of people living with HIV in Italy. Biomed Res Int. 2014;2014:209619. doi: 10.1155/2014/209619 Epub 2014 Jul 17. 25136562

23. Agenzia Regionale di Sanità della Toscana. La Salute dei Detenuti in Italia: I Risultati di Uno Studio Multicentrico—Documenti dell’Agenzia Regionale di Sanità della Toscana. Toscana: ARS; 2015.

24. Babudieri S, Longo B, Sarmati L, Starnini G, Dori L, Suligoi B, et al. Correlates of HIV, HBV, and HCV infections in a prison inmate population: results from a multicentre study in Italy. Journal of medical virology. 2005;76(3):311–7. doi: 10.1002/jmv.20375 15902712.

25. Sagnelli E, Starnini G, Sagnelli C, Monarca R, Zumbo G, Pontali E, et al. Blood born viral infections, sexually transmitted diseases and latent tuberculosis in italian prisons: a preliminary report of a large multicenter study. Eur Rev Med Pharmacol Sci. 2012;16(15):2142–6. 23280032.

26. Ministero delal Giustizia. Detenuti Presenti—Aggiornamento al 31 Maggio 2018. Available from:

27. Sistema Epidemiologico Integrato dell'Epatite Virale Acuta (SEIEVA). Tassi Annuali /100.000 per ETÀ, SEsso ed Area Geografica Delle Epatiti Virali Acute 2016. Available from:

28. Associazione EpaC onlus. Epatite C: Stima del Numero di Pazienti con Diagnosi Nota e Non Nota Residenti in Italia. Aggiornamento 2018. Italy: Associazione EpaC Onlus; 2018.

29. Epidemiology of acute and chronic hepatic diseases in Italy, AISF 2007. Available( - Last access June 2019).

30. Epidemiology of acute hepatic and chronic diseases in Italy, AISF 2007 (Available - Last access June 2019).

31. Piccinini F, Pupella, Lanzoni, Catalano, Grazzini. ISTISAN Reports–transmissible diseases with blood transfusion and blood component in Italy: epidemiologic monitoring of donors (2009–2015)—–Blood national centre, Institute of Health. ].

32. Andriulli A, Stroffolini T, Mariano A, Valvano MR, Grattagliano I, Ippolito AM et al. Declining prevalence and increasing awareness of HCV infection in Italy: A population-based survey in five metropolitan areas. Eur J Intern Med. 2018 Jul;53:79–84. doi: 10.1016/j.ejim.2018.02.015 29475770

33. Morisco F, Loperto I, Stroffolini T, Lombardo FL, Cossiga V, Guarino M et al. Prevalence and risk factors of HCV infection in a metropolitan area in southern Italy: Tail of a cohort infected in past decades. J Med Virol. 2017 Feb;89(2):291–297. doi: 10.1002/jmv.24635 27431017

34. Mennini F, Marcellusi A, Andreoni M. Health Policy Model: Long-Term Predictive Results Associated with the Management of HCV-Induced Diseases in Italy. CEIS Working Paper No 308. 2014.

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2019 Číslo 10