3. EU Monitoring Programme for Hepatitis

Monitoring the elimination of hepatitis B and C across EU/EEA countries

Erika Duffell, ECDC DRID meeting, EMCDDA, 24 September 2018 The political context

“The Commission will contribute by monitoring, reporting and reviewing progress towards the Sustainable Development Goals in an EU context” WHO Global reporting system for hepatitis Aims in developing an EU monitoring platform for hepatitis B and C

1. To support EU/EEA countries in monitoring their responses to tackling the epidemics of hepatitis B and C

2. To collect robust information to guide the European Commission, European Agencies and other organisations in working together to support countries achieve the goal of elimination Guiding principles

1. Produce useful and robust information for action for EU/EEA Member States

2. Collaboration with key stakeholders on the information to be collected and how to minimise the reporting burden

3. Keeping the system simple and wherever possible use existing data

4. Focus on indicators relevant to the EU context The development of a system for monitoring viral hepatitis at the EU level Defining the key areas for monitoring hepatitis

Assessment of relevance for EU countries

Mapping of existing data sources

Collation of data Collection of data from existing via online tool sources from countries

Production of country specific outputs The model for monitoring hepatitis B and C

Data to be collected by ECDC directly from countries

Infection Prevalence, Prevention of prevention & Prevention of Prevention co-infections mother to Vaccination control in sexual among Testing Treatment Incidence Mortality and key child Blood safety healthcare transmission PWIDs populations transmission settings

Epidemic Prevention The care Impact context continuum Summary of indicators

Number of Data collected Data collated from existing sources indicators by ECDC (Data source) SECTION I: EPIDEMIC CONTEXT EPIDEMIC CONTEXT 4 1 3 (ECDC, UNAIDS GAM, EMCDDA, EUROSTAT) SECTION II: PREVENTION VACCINATION 5 1 4 (WHO/UNICEF, EMIS, ECDC) PREVENTION OF MOTHER TO CHILD 2 1 1 (ECDC, WHO EURO) TRANSMISSION INFECTION PREVENTION AND 3 2 1 (ECDC) CONTROL IN HEALTHCARE SETTINGS BLOOD SAFETY 2 2 (Council of Europe) PREVENTION OF SEXUAL 1 1 (EMIS, UNAIDS GAM) TRANSMISSION PREVENTION AMONG PEOPLE WHO 2 2 (EMCDDA) INJECT DRUGS SECTION III: THE CARE CASCADE TESTING 6 3 3 (ECDC, EMCDDA) TREATMENT 8 8 SECTION IV: IMPACT INCIDENCE 2 2 (ECDC, WHO) MORTALITY 1 1 (EUROSTAT) Challenges and potential barriers

1. Resources available to collect and collate data at MS level

2. Lack of data across the monitoring framework

3. The tension between collecting political versus scientific data

4. Effective collaborations between key partners to synergise efforts and achieve optimal outcomes Process and timeline

2017 2018 2019 NDJFMAMJJASONDJFMAM 1st advisory group meeting ECDC Advisory Forum consultation Currently revising data collection tool in light of Data collection piloting and feedback tool from stakeholders developed

Data collection tool piloted

Data collection tool refined Data collection Country validation Data analysis and draft reports/online

2nd advisory group meeting Results from pilot study

1. Study piloted in four countries (Cyprus, Estonia, Romania, Sweden) 2. Survey tool considered acceptable and user friendly 3. Data unavailable for some data points along the care continuum, especially for HBV 4. Only subnational data reported to be available for some data points 5. Data provided along the care continuum relates to different points in time 6. General consensus around the importance of disaggregation of data on treatment for PWIDs Preliminary results based on data from existing sources

12 The epidemiological context: hepatitis B

Range of HBsAg prevalence among key population groups in EU/EEA countries (%)

People living with HIV

Prisoners Impact of migration Migrant populations Around 10% of the EU population are foreign born People who inject drugs

Haemodialysis patients 53% of this population are Recipients of substances of human origin born in countries of intermediate/high endemicity (>2% HBsAg) General population

Healthcare workers

Men who have sex with men

0 20 40

Source: ECDC reports - Hepatitis B and C epidemiology in Selected Populations and Systematic review on Hepatitis B and C prevalence in the EU/EEA https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/systematic-review-hepatitis-B-C-prevalence.pdf 13 The epidemiological context: hepatitis C

Range of anti-HCV prevalence among key population groups in EU/EEA countries (%)

People who inject drugs Dynamic impact of drug Prisoners use in Europe

People living with HIV

Haemodialysis patients

Migrants Declines in injecting among heroin users - but recent Recipients of substances of human origin outbreaks of HIV among users who are injecting

Healthcare workers stimulants and new psychoactive substances

General population

Men who have sex with men

0 20 40 60 80 100

Estimates of the proportion diagnosed

Hepatitis B Hepatitis C

Source: http://ecdc.europa.eu/en/publications/Publications/HepatitisBC-testing-in-EU-May2017.pdf; European Centre for Disease Prevention and Control. Hepatitis B and C epidemiology in selected population groups in the EU/EEA. Stockholm: ECDC; 2018 (awaiting publication); The Polaris Observatory Collaborators. Lancet Gastroenterol 15 Hepatol. 2018; & European Union HCV Collaborators. Lancet Gastroenterol Hepatol. 2017. Treatment in the EU

120000 Reported consumption of drugs to treat hepatitis C, 2011-2016, EU/EEA*

100000

80000

60000

40000 Defined Defined daily dose per 100,000 persons per year 20000

0 2011 2012 2013 2014 2015 2016 Ribavirin Teleprevir Boceprevir Simeprevir Daclatasvir Sofosbuvir

Dasabuvir Sofosbuvir + Ledipasvir Ritonavir + Ombitasvir + Dasabuvir + Paritaprevir Ritonavir + Ombitasvir + Paritaprevir Elbasvir + Grazoprevir Sofosbuvir + Velpatasvir

Source: Data reported to ESAC-NET https://ecdc.europa.eu/en/antimicrobial-consumption/database/distribution-by-antimicrobial-group *Reporting countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, 16 Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovakia, Sweden. Incidence in the EU Downward trend in the incidence of new chronic hepatitis B cases arising in EU/EEA countries 8000 400

7000 350

6000 300 Impact of migration

5000 250

4000 200 Recent estimate from Finland* suggesting 3000 150 Number of chronic

Number of acute infections chronic infections resulting

2000 100 from acute infections acquired in Finland 1000 50 account for only 1.2% of the total incidence of 0 0 chronic infections 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Acute infections - based on notifications Acute infections - ajusted for under-reporting New chronic infections resulting from acute cases

Source: Annual notification data reported to ECDC by EU/EEA countries and *Karvonen T et al. Vaccine, 2017 17 Mortality in the EU

Around 70,000 deaths from cirrhosis, hepatocellular carcinoma, chronic viral hepatitis reported in 2015 from EU/EEA countries

Standardised mortality rate EU countries for Deaths from hepatocellular carcinoma chronic liver disease and primary liver cancer across EU/EEA countries 25000 30

25 Better estimates of 20000

20 the attributable 15000

15 fraction are needed

to apply to10000 the 100 100 000 inhabitants 10

Standardised mortality rate per mortality data 5 5000

0 2011 2012 2013 2014 2015 0 Chronic liver disease 2011 2012 2013 2014 2015

Malignant neoplasms of the liver and intra-hepatic bile duct Male Female

Source: Eurostat (http://ec.europa.eu/eurostat/data/database) Conclusions ° The epidemiological, demographic and socio-political situation relating to hepatitis B and C in European countries is complex

° Many European countries lack a comprehensive overview of their local situation to inform an effective response

° ECDC, in collaboration with WHO and EMCDDA, aims to support EU countries in monitoring their responses to elimination

° The next steps are for ECDC to further refine the data collection tool prior to collecting data from all EU/EEA countries during October 2018 Acknowledgements

° The European Hepatitis B and C Network

° The ECDC Advisory Group on monitoring hepatitis in the EU/EEA

° WHO: Antons Mozalevskis, Yvan Hutin

° EMCDDA: Thomas Seyler

° ECDC: Andrew Amato-Gauci, Lina Nerlander, Teymur Noori, Otilia Mardh, Klaus Weist www.ecdc.europa.eu

Contact: [email protected]