National Health Burden of CLD in Italy

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1 National Health Burden of CLD in Italy 11,000 deaths due to liver cirrhosis or HCC in 2006 Direct costs for the National Health System for treating CLD patients: 420 M / year for hospital care 164 M / year for liver transplant Libro Bianco AISF, 2011 HBV and HCV (2.5 millions carriers) are involved in the majority of the cases

2 Chronic liver disease patients should be identified Liver disease is an important cause of morbidity and mortality in Italy Hepatitis C can be cured Hepatitis B can be controlled Advanced liver disease can be treated HBV vaccination is available 2

3 Efficacy vs. Effectiveness Example 1: Rx X Efficacy of Rx X 60% Access x 80% Correct diagnosis x 85% Recommend x 85% Acceptance x 85% Adherence x 70% Example 2: Rx Y Efficacy of Rx X 80% Access x 80% Correct diagnosis x 85% Recommend x 85% Acceptance x 85% Adherence x 70% Example 3: Rx X Modified Efficacy of Rx X 60% Access x 90% Correct diagnosis x 90% Recommend x 90% Acceptance x 90% Adherence x 80% Effectiveness of Rx X = 21% Effectiveness of Rx Y = 28% Effectiveness of Rx X modified = 32% El-Serag HB. Gastroenterology. 2007;132:8.

4 Definitions Screening: tests done in apparently well individuals to identify those with disease Case finding: tests in individuals with signs, symptoms or risk factors Surveillance: repeat tests over time These terms are not uniformly and properly used in medical literature Grimes and Schultz, Lancet 2002

5 Screening: a double edged sword If properly adopted: If improperly adopted: Can improve health May harm healthy individuals May waste precious resources

6 Siebert at al, VHPB Meeting, March 2010, Budapest

7 The screening strategy for viral hepatitis in Italy

8 Screening Strategy In Italy, it is currently agreed that testing for Hepatitis B and C among risk groups with elevated prevalence (i.e., case finding) is likely to be more cost effective than a mass screening approach. Well managed screening for signs and symptoms of liver disease and risk factors for infection is therefore seen as the a key instrument of prevention.

9 HBV and HCV: preventive measures currently adopted in Italy HBV vaccination in children and persons at risk (vaccine covers age Italian born individuals until 30 years) Mandatory HBsAg screening of pregnant women Highly sensitive tests for blood donations (including NAT for HBV and HCV) Screening for risk factors of viral hepatitis and subsequent testing (HBsAg, anti HCV) of those who are positive

10 Who should be screened Anti HCV and HBsAg: Signs of chronic liver disease Sexual partners and family members of infected individuals Sexually promiscuous subjects Current and former IV drug users Prisoners Immigrants from highly endemic areas Children born to positive mothers HIV carriers Patients on dialysis Healthcare workers Other parenteral risk factors (e.g., unsafe tattoo or piercing) HCV only: Blood transfusion and transplant recipients (before 1992) Hemophilia patients receiving blood derivatives before 1987

11 Who should be screened Anti HCV and HBsAg: Signs of chronic liver disease Sexual partners and family members of infected individuals Sexually promiscuous subjects Current and former IV drug users Prisoners Immigrants from highly endemic areas Children born to positive mothers HIV carriers Patients on dialysis Healthcare workers Other parenteral risk factors (e.g., unsafe tattoo or piercing) HCV only: Blood transfusion and transplant recipients (before 1992) Hemophilia patients receiving blood derivatives before 1987

12 Open issues Is case finding well managed in Italy? Subjects with increased ALT levels Vulnerable subjects Immigrants from endemic areas Prisoners Intravenous drug users How to improve the management of liver disease carriers in these subjects?

13 Poor yield of case finding strategies 40% of HBsAg carriers are unaware of their condition 1 No active screening approach in immigrates, IVDU, prisoners, despite prevalence are substantial 2. Subjects with elevated ALT are not systematically screened for hepatitis viruses by primary care physicians 3 1 Ippolito AM et al, J Vir Hepat Prati D, Viral Hepatitis Prevention Board Loguercio C et al, Dig Liv Dis 2011

14 Infectious Diseases and Borders

15 15

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