Monitoring Viral Hepatitis Elimination Generating Reliable Estimates of Hepatitis C Prevalence

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1 Monitoring Viral Hepatitis Elimination Generating Reliable Estimates of Hepatitis C Prevalence Ida Sperle-Heupel Department for Infectious Disease Epidemiology Robert Koch Institute

2 Epidemiological context Surveillance data on HCV in the EU HCV prevalence studies in the EU Background ECDC systematic review: Anti-HCV prevalence in the general population, EU/EEA Member States, (N= 13 countries) Range: 0.1% (Belgium, Ireland, Netherlands) - 5.9% (Italy) Examples: Spain: Valladolid, N=364 (2003) Greece: Province in Crete, N=876 (mean age 52) Croatia: Convenience sample, medical check-ups, N=1,930 Hungary: Prison staff, N=1,066 8 December 2018 The Viral Hepatitis Elimination Meeting

3 Purpose and scope of the SPHERE-C Project Development of a detailed technical protocol for undertaking HCV prevalence surveys in EU/EEA Member States SPHERE-C Sero-Prevalence survey for Hepatitis C in Europe Aim: to contribute to the standardisation of HCV prevalence surveys and estimates 8 December 2018 The Viral Hepatitis Elimination Meeting

4 Considerations for planning an HCV prevalence survey in the general population Pilot 1: Italy Pilot 2: Finland Pilot 3: Bulgaria 8 December 2018 The Viral Hepatitis Elimination Meeting

5 Nested survey in Catanzaro, Italy HCV prevalence survey nested into a prospective cross-sectional survey on salt consumption in the general population in several regions of Italy Sample size calculation: 890 persons, age-stratified for the general population of Catanzaro Data: HCV specific questions in questionnaire & venous blood samples, tested for anti-hcv (HCV RNA if reactive) Invitation by letter in 3 rounds (June/Oct/Dec) 8 December 2018 The Viral Hepatitis Elimination Meeting

6 Preliminary results Nested survey in Catanzaro, Italy In total, 4000 people were invited and 836 have been enrolled (93% of sample size), with an effective participation rate of around 21% Of the 511 samples tested to date 5 were anti-hcv-reactive (0.6%), and 1 HCV RNA positive. Anti-HCV prevalence 0.7% (35-64 years); 2.3% ( 60 years) 2 of the 5 anti-hcv those positive were aware of their infection 8 December 2018 The Viral Hepatitis Elimination Meeting

7 Retrospective & nested survey in Finland HCV prevalence survey nested into the FinHealth survey conducted in Data: HCV specific questions in questionnaire & venous blood samples Retrospective testing for anti HCV (HCV RNA if reactive) 10,305 people were included in FinHealth survey, and 5917 blood samples were obtained. All were tested for anti-hcv, RNA testing ongoing Challenges Change of lab was required, transportation and defreezing of stored samples, (more work for the lab to rehandle samples) Delay of the FinHealth survey 8 December 2018 The Viral Hepatitis Elimination Meeting

8 Stand alone survey in Stara Zagora, Bulgaria Probability-based random sample of the general population aged +18 years, stratified by age and sex drawn from local population registry Sample size: 999, 1998 were invited (non-response of 50% expected) Data collection: and was conducted by the Regional Health Inspectorate in Stara Zagora Local media campaign: posters and press conference 8 December 2018 The Viral Hepatitis Elimination Meeting

9 Results Stara Zagora 252 participants of the 1998 people invited took part in the survey (12.6%) Age Male (n,%) Female (n,%) (3.4%) 7 (5.5%) (6.1%) 13 (6.3%) (9.4%) 30 (14.6%) (10.3%) 36 (19.8%) (19.9%) 42 (24.1%) (19.8%) 23 (13.3%) Total 101 (10.8%) 151 (14.2%) 8 December 2018 The Viral Hepatitis Elimination Meeting

10 Results Stara Zagora Prevalence N % Anti-HCV (Elisa) (N=252) Reactive 3 1.2% Negative % HCV PCR (N=3) Positive % Negative % The one anti-hcv positive participant: Male, 73 years old. Was never previously tested, and reported no known risk factors The two RNA positive participants: 1. Female, 68 years old, never previously tested, no known risk factors. 2. Male, 58 years old, never previously tested, reported having injected drugs, and prison experience (this person is the only one (of the 252 participants) who reported IDU). 8 December 2018 The Viral Hepatitis Elimination Meeting

11 Next steps Evaluation following pilot through: Indicator-based questionnaire Semi-structured interview Writing of a pilot report including the evaluation results and lessons learnt April 2019: Third expert group meeting (sharing of the findings & experiences of pilots) Revision of protocol June 2019: Submission of the final document to ECDC 8 December 2018 The Viral Hepatitis Elimination Meeting

12 Acknowledgements ECDC: Erika Duffel and Andrew Amato-Gauci The international expert group RKI: Ruth Zimmermann, Martyna Gassowski, Yanita Simeonova, Viviane Bremer, Sandra Dudareva, Matthias an der Heiden, Antje Gösswald, Martin Schlaud Stine Nielsen, individual consultant Bulgaria: The project team at the Municipality of Stara Zagora, the Regional Health Inspectorate and the Ministry of Health THL Finland: Salla Toikkanen, Henrikki Brummer-Korvenkontio, Hanna Tolonnen ISS Italy: Anna Rita Ciccaglione and colleagues All participants in the three surveys 8 December 2018 The Viral Hepatitis Elimination Meeting