No one gets left behind: Addressing the hidden burden of hepatitis C related advanced liver disease in PWID in the community John S Lambert, MD, PhD Professor of Medicine and Consultant Infectious Diseases, Dublin, Ireland Session organized by

Nothing to disclaim This meeting is part of the joint action ‘677085 / HA-REACT,’ which has received funding from the European Union’s Health Programme (2014-2020).

HCV in Ireland 30,000 in Ireland with HCV Ireland has ‘ringfenced’ 30M annually for tx Ireland one of first to sign EU manifesto, ‘HCV elimination by 2030’ 2000 have been treated to date with new DAAs 9000 are in OST of whom 60% are HCV positive 850 HCV are on the ‘waiting list’ of the 9 ‘treating hospital centres’ in Ireland Fibroscan has replaced liver biopsy to assess degree of liver disease HCV clinical lead June 2016 ‘all cirrhotics are treated’

WHO strategy comes with targets, by 2030 Incidence targets 30% reduction in new HCV infections by 2020 90% reduction in new HCV infections by 2030 Mortality targets 10% reduction in mortality by 2020 65% reduction in mortality by 2030 Harm reduction Increase in sterile needle and syringes provided per PWID/year from 20 in 2015 to: 200 by 2020 and 300 by 2030 Testing targets 90% of people aware of HCV infection by 2030 Treatment targets 80% of people treated by 2030

HEPCARE: A new Hepatitis C Care service model VISION: Create an innovative, integrated system for HCV treatment, based on the joint participation of primary and speciality care practitioners OBJECTIVE: Improve access to HCV testing and treatment among key risk groups, including drug users and homeless, through outreach to the community and integration of primary and secondary care services Primary Care Secondary care WP4: HepCheck (screening) WP5: HepLink (linkage to care) WP 7: HepFriend (peer advocacy support) WP 6: HepED (inter-professional education) WP8: HepCost WP 1 Coordination; WP 2 Dissemination; WP3 Evaluation   HEPCARE EUROPE is a €1.8M 3-year EU-supported project at 4 member state sites Consortium members: UCD (Ireland); SAS (Spain); SVB (Romania); University of Bristol (UK); University College London (UK)

Seek and Treat Community Fibroscan Project: In Ireland there are large numbers of hepatitis C (HCV) positive patients receiving methadone substitution therapy in drug treatment centre (DTCs) and in GP OST prescribing practices who do not attend specialist hepatology or infectious diseases services. Fibroscan™ (FS) used to assess the liver stiffness. Three clinically relevant cut-offs are used for disease staging. 8.5 kPa, which allowed access to direct acting antivirals (DAAs) in Ireland before Feb 2017. 25kPa , which has a 90% positive predictive value for clinically significant portal hypertension. 35kPa, which is associated with a 10-20% risk of decompensation per year.

HepLink Study: Methods Methadone prescribing GP practices in North Dublin were recruited from the professional networks / databases of the research team Patients were eligible to participate if: ≥ 18 years of age on MMT attend the practice for any reason during the recruitment period Baseline data on HCV care processes / outcomes were extracted from the clinical records of participating patients

Practice Flow Patient Flow GP Practices recruited n=14 Patients recruited n=135 (14 practices) Baseline Data Collected n=134 (14 practices) GP Practices received HepLink intervention n=14 OST patients assessed by Nurse n=100 HCV positive patients undergone fibroscan n=45 Patients referred to secondary care n=21 8

Fibroscan Results The integrated model of HCV care has been piloted in 14 practices 45 HCV Ab+ patients have undergone a fibroscan 21/45 (46.7%) scored ≥8.5 kPa 13/45 (28.9%) were cirrhotic, i.e. scored > 12.5 kPa 9

‘Seek and Treat’ (6 DTC N Dublin) Hidden burden of HCV: Results (1) ‘Seek and Treat’ (6 DTC N Dublin) Total assessed (618) 75% male, mean age 38 ±7.2 HCV status known (561) HCV positive (391) Mean FS 11 Alcohol consumption (136) Mean FS 13.2 Abstinent (255) Mean FS 9.7 HCV negative (170) Mean FS 5.6 HCV status unknown (57) P = 0.001 P = 0.02

Hidden burden of HCV: Results (2) 391 HCV positive 128 FS ≥8.5 kPa 34 FS ≥25 21 FS ≥35

Summary of ‘Seek and Treat’ Hidden burden of HCV: Conclusions Summary of ‘Seek and Treat’ A large number of HCV+ patients did not attend specialist infectious diseases/hepatology services yet qualified for DAA treatment. Within this group there were significant numbers of patients at high risk of decompensation. On-going alcohol use was associated with a significantly higher FS score. While these patients may have significant comorbidities, including addiction, which limits access to specialist hospital services

Summary of HepCare Europe Dublin: We have performed pilot community ‘Seek and Treat’ studies, and estimate there are at least 2200 out there in the community with significant liver disease due to HCV not accessing care HepCare Europe is establishing a model for partnering the community with the hospital services Patients do not attend the hospital for HCV care: go to them The process of ‘HCV viral elimination by 2030’ in Ireland will require a new model of care, and new ways to find patients at risk. The DAAs are safe and efficacious and can be delivered safely in the community

Acknowledgements Co-funded by the European Commission through its EU Third Health Programme and Ireland’s Health Services Executive Participating GPs, Addiction Services, and patients Our partners: UCL, Bucharest, U Bristol, SAS Seville

Action plan for the health sector response to viral hepatitis Transmission of new viral hepatitis infections is halted, testing is accessible, and people living with chronic viral hepatitis have access to care and affordable and effective treatment 2030 Vision Elimination of viral hepatitis as a public health threat by 2030 through: reduction of transmission reduction in morbidity and mortality ensuring equitable access 2030 Goal Frameworks for action: universal health coverage, the continuum of services, a public health approach The vision is a WHO European Region in which the transmission of new viral hepatitis infections is halted, testing is accessible, and people living with chronic viral hepatitis have access to care and affordable and effective treatment. Our goal is aligned with the global goal of elimination of viral hepatitis as a public health threat by 2030 through: - reduction of transmission; - reduction in morbidity and mortality due to viral hepatitis and its complications; - ensuring equitable access to comprehensive prevention, and recommended testing, care and treatment services for all. The Action plan is built on three organizing frameworks for action: universal health coverage; the continuum of services; and the promotion of a public health approach.