Objectives

1. Objectives • To review surveillance systems in Italy for infectious diseases • To establish an up-to-date epidemiological picture of viral hepatitis in Italy • To evaluate current Italian prevention and control measures for viral hepatitis • To determine the lessons learnt from the Italian experience - successes, failures and obstacles to overcome • To map out the way forward generally: lessons for Europe.

2. Background • Hepatitis B had become a major public health problem by mid-1970s • Group of remarkable scientists, doctors and public health experts tackled the problem; impressive research output • 1980s: prevention programmes (e.g. HIV) including screening, selective immunization, improved living standards and medical care, changing demography and behavioural changes

3. Background (continued) • Public health held in high regard by public and politically • Other viral hepatitides than hepatitis B also a public health problem, with risks of clinically significant outbreaks • High economic costs, including outbreaks of hepatitis A • Immunization strategies are cost effective compared to other health interventions

4. Organization • Public health legislation: • 1978 (first mention of prevention), 1992 and 1999 stressing surveillance and risk assessment • National health system being revised • Ministry of Health orchestrating role of local units/Departments of Prevention • Public health system “federated” • economic and organizational autonomy at regional level, stewardship role, evidence-based prevention

5. Immunization • Policy specified in national guidelines • Region prepares local/regional health plans accordingly but adapted to local priorities • 1983: immunization of high risk groups started at regional level • Funding from regional sources • 1991: mandatory screening of pregnant women and immunization for all infants and 12-year-old adolescents introduced • By 2002, more than 10 million children immunized

6. Surveillance • Mandatory national level notification of notifiable diseases • Voluntary acute viral hepatitis surveillance (SEIEVA), established 1985 • to identify trends, risk factors, and to identify and monitor prevention strategies

7. Epidemiology • Hepatitis A: from 10/100,000 in 1985 to about 2 in 2001 • risk factors include travel and eating shellfish and local factors; person-to-person transmission • immunological status of population • male/female ratio to be resolved • still a North/Central - South/Islands divide • role of vaccine in shortening and ending outbreaks and preventing secondary cases

8. Epidemiology: hepatitis E • Hepatitis E: very low rate of anti-HEV in children but increasing trend with age - possible cohort effect • risk factor mainly travel and geographical divide • only a few cases in Italy

9. Epidemiology (continued) • Hepatitis B • to mid-1970s: unscreened blood, inadequate sterilization, large family size, high birth rate, increasing injecting drug use • 1980s: improved health practices (including screening), socioeconomic conditions and demographic patterns, benefits from AIDS prevention campaigns, selective immunization • between 1987 and 2001 incidence (/100,000) fell from 10.4 to 2.0 and from 2.1 to 0.1 in 0-14 yr age group

10. Epidemiology (continued) • Hepatitis B • in 1991-2001 new cases of infection fell by 40% compared with 1988-1991, higher in 0-14 and 15-24 yr age groups - immunization • present - historical low, but still some 500,000 HBsAg carriers and new infections in unvaccinated people - allows some circulation of D virus • risk factors: sexual intercourse, contact with HBsAg+ person, injecting drug use, surgical intervention, blood transfusion

11. Epidemiology - hepatitis D • Hepatitis D - marked declines but shift to long-standing advanced disease (acquired in past) • declines herald the end of the story

12. Hepatitis B - the future • Maintain immunization of infants and screening of pregnant women • Increase coverage of adults at risk • Maintain/improve safety of medical procedures • Improve public and professional awareness • Surveillance • Booster doses - are they needed?

13. Epidemiology (continued) • Medical research vs public health • mutant viruses detected in successfully vaccinated people but no data on person-to-person transmission and no evidence of a threat to established vaccination programmes • greater likelihood of emergence of S-gene mutants after post-exposure prophylaxis with HBIG and vaccine • change in HBeAg and anti-HBe distribution in chronic HBsAg carriers, with proportional increase in HB core mutants

14. Epidemiology (continued) • Hepatitis C • picture unclear, but North-South gradient with overall prevalence of about 3%; rate increases with age, especially over 50 • screening has secured blood supply • risk factors: injecting drug use far outweighs others - principally surgical intervention (ophthalmological, cardiovascular and gynaecological) and haemodialysis

15. Hepatitis C • Transmission • no link with mode of delivery or breast-feeding • concomitant HIV infection increases risk of neonatal infection from mother • injecting drug use main risk factor • alcohol increases risk of hepatocellular carcinoma/cirrhosis • in 30-40% of cases source remains unidentified • molecular epidemiology demonstrates nosocomial transmission between patients in haemodialysis centres and other clinical settings - failure of preventive measures • epidemiology is changing

16. Epidemiology and public health • Blood supply has never been so safe, but residual risk defined (HBV, HCV and HIV) • Sensitive diagnostic tools but very expensive way to detect 14 instances of HCV in some 15 million blood donations in 5 European countries • Ethical and political issues surrounding use of resources, priority setting, liability, litigation, etc

17. Lessons learnt - successes • Clear early identification of a public health burden and response • Expertise in Italy: powerful team of scientists, doctors and public health specialists • Prevention plan embraced all appropriate public health measures including then new vaccine; continued political commitment and support up to today

18. Lessons learnt - successes (continued) • Prevention plans evidence based • Case for immunization evident and clear • National guidelines but flexibility, adaptation and autonomy at regional level; development of guidelines recognized to be an iterative process • Good solid surveillance systems and data • feedback and involvement important elements • SEIEVA picks up outbreaks

19. Lessons learnt - successes (continued) • Hepatitis A: decrease with changing epidemiological pattern in South; risk factors identified; safe vaccine • Hepatitis B: historical low levels of infection, but residual reservoir of carriers • Hepatitis C: low level, changing epidemiology • Hepatitis D: an ending problem, but changing disease pattern • Hepatitis E: very low prevalence

20. Lessons learnt - successes (continued) • Blood supply is secure

21. Lessons learnt - issues • Departments of Prevention need clear and agreed mandates and staff need training • Changing context in terms of restructuring of national health service

22. Lessons learnt - issues (continued) • Epidemiology • risk factors remain especially through failure of prevention in medical practice and interventions (e.g. gynaecology/cardiovascular) • escape mutants exist and circulate - doubtful public health significance? • clusters/outbreaks in hospitals may be underestimated • privacy laws in other countries may limit tracing in surveillance

23. Lessons learnt - issues (continued) • Hepatitis A may be underestimated; vaccine may be considered as a supplement to education and hygiene • Hepatitis C - more cost-effective diagnostic tools and options needed, particularly for non-endemic situations • Case definitions need international harmonization

24. Lessons learnt - issues (continued) • Reducing incidence of disease and number of cases makes it difficult to argue about importance of disease and enthuse medical students and professionals about value of immunization and dangers of disease • Surveillance systems need to be in place for immediate interventions (e.g. HAV outbreaks) and motivation needs to be maintained

25. Needs identified • General needs • to list what is now known and what we need to know • to determine relative importance of socioeconomic factors, improved hygiene, and immunization to successes in prevention • to increase coverage even with mandatory immunization programmes • to reach members of risk groups who remain unvaccinated despite free vaccine

26. Needs identified - continued • To increase awareness of disease and vaccine to persuade HBsAg+ mothers to immunize their children • to consider universal newborn immunization with vaccine only as a valuable alternative to universal infant immunization • to consider vaccination of blood donors as an additional means of securing the blood supply

27. Needs identified - continued • Epidemiological studies: • from transmissibility of and susceptibility to escape mutants of HBV • factors underlying increase in anti-HBe-positive chronic hepatitis B • on transmissibility of and susceptibility to escape mutants of HBV • seroprevalence studies of HAV, including documentation of occupational risks

28. Needs identified - continued • For hepatitis A and other food-borne diseases improve hygiene and food preparation - with education at personal and societal levels

29. Conclusion • Italy is a model for other countries: • surveillance and data collection • excellent research and effective use of data • tightly defined guidelines should be considered by other European countries • multidisciplinary expertise and excellent research • firm policy process • good programme evaluation