HepCare Europe No-one gets left behind: addressing the

HepCare Europe No-one gets left behind: addressing the

HepCare Europe No-one gets left behind: addressing the hidden burden of HCV related advanced liver disease in PWID in the community Dr John Lambert, Professor of Medicine and Consultant in Infectious Diseases, Mater Hospital and UCD Dublin 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

WP 6: HepED (inter-professional education) WP4: HepCheck (screening) WP5: HepLink (linkage to care) WP 7: HepFriend (peer advocacy support) Secondary care 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) WP8: HepCost WP 1 Coordination; WP 2 Dissemination; WP3 Evaluation How to make HCV a rare disease in the EU Community Education Community Fibroscan testing strategy

Preparing the at risk population for testing, assessment and treatment) Implementation and evaluation of the strategy, and assessment for advanced disease patients the reasons for non-attendance. Point of Care Testing Linking Services across Diseases Evaluation of point of care testing with HCV oral tests in diverse populations and different countries/settings and assessment of cost effectiveness Address key conditions in vulnerable populations in a linked up fashion (drug and alcohol addiction, primary care, STD, blood borne virus testing, TB, Hepatitis B vaccination) Educational tools and pathways Community nurse outreach and peer advocacy support To help HCV negative people to minimise their risk of HCV infection and other blood borne viruses Community focused assessment for HCV disease in HCV+ as vulnerable communities do not access secondary care services.

Education of Community Health Care Workers Improve understanding of new treatments, and prepare them to act as partners in treatment and support in a shared care primary/secondary integrated partnership. Evolution of Hepatitis C care Old Model New Model Screening Blood test (invasive) Mouth Swabs (non invasive) Medication route administration Injection Oral Diagnosis of disease severity Liver biopsy (invasive)

Fibroscan (non invasive) Cost (direct) +++ +++++ Cost effectiveness Moderate High Efficiency of treatment: Sustained viral response Moderate High Place of care Hospital Specialist Clinic Primary care and Specialist clinic

HCV elimination is on the global agenda Sept. 2015 Feb. 2016 Glasgow Declaration It is possible and essential to set as a goal the elimination of both hepatitis B and C as public health concerns Elimination Manifesto "Our vision for a Hepatitis C-free Europe May 2016 Global Health Sector Strategy on Viral Hepatitis Eliminating viral hepatitis as a major public health threat by 2030 Sept. 2016 Action plan for the prevention and control of Viral Hepatitis A WHO European Region that is free of new hepatitis infections 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 HepCheck Homeless, Hep C & Competing Priorities John S. Lambert 1 2, Carol Murphy 1, Eileen F. OConnor 2, Dee Menezes1, Walter Cullen 2, Tina McHugh 1, Geoff McCombe 2, Gordana Avramovic Misericordiae University Hospital, Dublin, Ireland. 2. University College Dublin, Ireland. 3. Safetynet Primary Care Network, Dublin, Ireland. HOMELESS HEPCHECK SCREENING RESULTS 619 OFFERED SCREENING 547 SCREENED 38% Ab positive (206) Of Of which: which: 112 112 "new

"new positives" positives" 94 "known "known positives positives 94 51 referrals 57% Ab negative (310) 72 NOT SCREENED Previous HCV Ab test? Yes Yes +ve: +ve: 12 12 Yes -ve: 11 Yes, Yes, unsure unsure of of result: result: 3 3 No/missing: No/missing: 46

46 31 31 no no result/awaiting result/awaiting result result (5%) (5%) , Austin OCarroll, 1. Mater 12 RESULTS ACKNOWLEDGEMENTS A total of 619 individuals were offered screening. HEPCARE EUROPE : Bridging the gap in the treatment of Hepatitis C . Their ages ranged from 17 to 86, with the average age being 36.7 years and were 74% male (455 male, 163 female, 1 missing). Of the 619 offered screening, just under a third reported having had a previous HCV test before (216) of which half recalled a positive result, 36%

negative (79) & 13% unsure of the result (29). Screening 547 HCV Antibody tests were performed 38% (n=206) tested positive 57% (n=310) tested negative 5% (n=31) recorded as no result/awaiting result Of the 206 testing positive, 54% (112) were new positives while the remaining were known positives Following a positive test 51 patients were referred to specialist care and 33 attended 2 or more appointments. One individual completed treatment whilst another is still on treatment at the time of writing. METHOD The target population was homeless people accessing the Safetynet primary healthcare services in Dublin. Individuals were invited to undertake a short questionnaire and HCV antibody test. Qualitative interviews were also carried out with selected patients. (n=49) exploring a broader range of health and lifestyle issues. Qualitative interviews The most common reasons for homelessness were alcohol and/or drugs, and for some, this was combined with family/relationship problems and mental health problems. CONCLUSIONS Community based screening intervention can enhance HCV diagnosis for at risk populations.

33 attendances 2 2 completed completed treatment treatment Referrals to/attendance to secondary care remains a challenge for this cohort. Psychosocial factors at the core of why patients do not attend secondary care for HCV management. Addiction, mental health and homelessness were especially problematic Future research should examine interventions to improve attendance rates at secondary care. Qualitative Interviews with selected patients 49 participants were administered the questionnaire, of which most (78%) were currently living in a hostel. The remaining were sofa surfing, sleeping rough or staying with friends. The average time period of homelessness was 6.2 years, with a range of 2 months to 20 years. The most common reasons for homelessness were co-morbidities such as alcohol and/or drugs, and for some, this was combined with family/relationship problems and mental health problems. Most (42%) saw a GP once a week. When asked about their HCV antibody result, 63% said they had previously received a specialist appointment. When asked about their HCV healthcare pathway, the most common theme was stable accommodation: participants reported this to be a barrier to

attending specialist appointments and accessing treatment. The most common other reasons for non-attendance were active drug use, being in prison, fear of side effects of treatment and forgetfulness. WP - HEPCHECK- OVERVIEW DUBLIN LONDON BUCHARES SEVILLE TOTA T L 1. No. of individuals offered/screened 712/56 9 -/310 -/469 657/401 1,749 2. Proportion of individuals with positive HCV antibody on screening 137/56 9

123/310 166/469 140/401 41.8% 35% 34% 559 24% 3. No. of individuals screened Pending (Ab only, bloods only, both Ab and bloods) Pending 4. No. of HCV Ab+ individuals Pending (either new or previously diagnosed) attending specialist appointment for HCV assessment.

60 Ab 365 Ab + bloods 104 65 Ab: 264 Bloods:116 Ab + bloods: 21 - 51 222+ Seek an Treat: community Fibroscan Rapid test allows POCT: Entire scan 5-7 minutes to complete Non invasive procedure/ No pain/No sedation required No requirement to admit as a day case

Allows clinicians to arrange OGD or liver ultrasound urgently if evidence of cirrhosis Inexpensive scan 96% specificity when compared to liver biopsy staging. No risk of bleeding or infection which are potential complications of biopsy Progression of untreated fibrosis in OAT patients Serial Transient Elastography Readings Indicate Progression of Untreated Fibrosis Among Patients Attending Opioid Substitution Treatment Clinic in South County Dublin J. Moloney1, G. Hawthorn1, P.A. McCormick2, E. Feeney3, D. Houlihan3, S. Keating1, C. Murphy4, T. McHugh4, J.S. Lambert4 2008: 84 patients scanned - 77% were HCV Ab positive and 58% of this group were HCV viraemic. - By 2016, all of the 2008 patients with TE scores > 13 Kilopascal (Kpa) had died (a total of 13 patients) and 11 of these patients died as a result of liver failure associated with hepatitis C viraemia and alcohol. 2016: 105 scans in surviving patients - Cohort from 2008 who still attended the clinic and new patients attending the clinic. - 16 patients (15%) of the 2016 population had TE scores > 13 Kpa, the previous

threshold for death at eight years The Hidden Burden: HCV-related advanced liver disease in the community The hidden burden of hepatitis C related advanced liver disease in the community Nadeem Iqbal , John S Lambert3,4, Des Crowley1,2, Hugh Gallagher2, Fidelma Savage2, John Moloney2, Carol Murphy1,3, Tina McHugh3, Aileen Singleton2, Shay Keating2, Audrey Dillon2, Stephen Stewart3. 3 Background for the Study Large number of HCV+ patients receiving methadone substitution therapy in drug treatment centre who do not attend specialist hepatology services Most of these patients have never had their liver disease staged, hence we postulated that many of these may have underlying advanced liver disease Fibroscan (FS) used to assess the liver stiffness. Cut-offs 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 1- Irish Prison Service 2- HSE Addiction Service 3- Mater Misericordiae University Hospital 4- University College Dublin Hidden burden of HCV: Results (1)

P = 0.001 P = 0.02 HepCare Europe: Reaching vulnerable patients High incidence of HCV in the homeless community Many have past/active IDU as risk factor; alcohol is additional risk HCV previously diagnosed in many, but not accessing care HCV common in all marginalised populations in the EU (21-40+ %) Still a significant burden of HCV related liver disease undiagnosed in the community, a time bomb for liver disease progression Treatment of disease is priority is Ireland with limited resources/DAA availability, treatment of infection (treatment for prevention priority if unlimited DAA availability). 30 million is ring-fenced annually for treatment. Treatment of disease/treatment for prevention concepts are not mutually exclusive 30,000 in Ireland with HCV, we have treated the easy first 2000, so how do we reach the remaining 28,000 HCV Elimination agenda : what will it take..? Energy, Commitment and Resources

A public health approach (simplification, integration, decentralization, equitable access) Innovations: HBV cure, HCV vaccine, pan-genotypic oral treatments Partnerships (governments, civil society, private sector involvement) Concrete and tailored action in countries, guided by national plans The Irish Experience to date: vulnerable patients dont go to hospital clinics for care; we must go to them; there is still a large burden of HCV related liver disease out there, and they are not accessing care and treatment: we must Seek and Treat. Acknowledgements Co-funded by the European Commission through its EU Third Health Programme and Irelands Health Services Executive Participating GPs, Addiction Services, and patients Our partners: UCL, Bucharest, U Bristol, SAS Seville HEPCARE EUROPE 2017 NO ONE LEFT BEHIND Hepcare Team: Dublin: PIs Drs Lambert and Cullen (Co Investigators Drs Stewart, Feeney, Houlihan) London: Drs Alistair Story and Julian Surey Bucharest: Dr Cristiana Oprea Spain: Dr Juan Macias Sanchez

Bristol: Drs Peter Vickerman and Matthew Hartman Primary Care WP 6: HepED (inter-professional education) WP4: HepCheck (screening) WP5: HepLink (linkage to care) WP 7: HepFriend (peer advocacy support) Secondary care WP8: HepCost WP 1 Coordination; WP 2 Dissemination; WP3 Evaluation

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