HCV infects and affects a population in the EU who do not access care. The arrival of new curative HCV drugs are a great opportunity for those resourced to attend services and adhere to treatment, but this adherent population is the minority in the EU. If we aim to cure HCV in all risk groups we must take the treatment to the patient and vice-versa. The activities will support the development of national hepatitis strategies, screening and treatment guidelines, taking into account available treatment options. It will help to bridge primary, secondary care, and outreach in the community to facilitate access to and uptake of testing and treatment services particularly among key risk groups including drug users and homeless. It will also assess the potentially considerable economic impact of available treatment and testing strategies on health systems, which are under the responsibility of the EU Member States, with a view to inform decisions on balancing access to medicines with the financial sustainability of health systems. The HepCare project will contain six different components.HepCheck will aim at intensifying screening in the communityHepLink will link primary and secondary care HepEd will educate and up-skill healthcare professionals in the treatment of Hepatitis CHepFriend will provide a peer advocate support programme for patients to help treatment outcomesHepCost will assess the economic impact of the projectThe coordinator will have overall responsibility for disseminating the project impact and liaising with decision makers.The project will take place in 4 member states: Ireland, the UK, Spain and Romania.The HepCare Project will build on work undertaken by the European Commission, the European Centre for Disease Control and Prevention, and the European Monitoring Centre for Drugs and Drug Addiction with the aim of reducing morbidity and mortality related to hepatitis C and reducing the socioeconomic impact of hepatitis in the EU/EEA.

The EU Third Health Programme objectives include to “support EU Member States to improve access to hepatitis testing for those at risk and access to affordable high quality treatment with antivirals and to further specify appropriate prevention methods to prevent (re-)infections.” HepCare Europe is targetting difficult to access populations, to perform HCV diagnostic testing and identify potential HCV patients, at an early stage in disease progression, and determine the extent of disease progression in those that test positive. HepCare Europe assists primary care settings, through education and liaison nurse support for practices, in the subsequent treatment of patients with chronic hepatitis C infection. HepCare Europe is very much aligned with recently published document put forward by the European Centre for Disease Control and Prevention, and the European Monitoring Centre for Drugs and Drug Addiction at the EU HCV Policy summit which plans to eliminate HCV by 2030, specifically by “developing and implementing hepatitis C elimination strategies serving as the basis for people-centred health system based strategies that emphasise tailored implementation at the local level”, “make the development of integrated care pathways a core component of hepatitis C elimination strategies” and “strengthen efforts to harmonise and improve the surveillance of hepatitis C across the EU”. Through incorporation of cost analysis at each step, HepCare Europe will evaluate the likely cost savings associated with these methods of treatment and care, and ensure that the planned model of screening and treatment impacts this population through significant decreases in morbidity and mortality, and reducing new transmissions, as well as demonstrating the significant economic impact and cost savings associated.

Hepcare Europe has now been in operation for two years of a three year grant cycle and has initiated a range of activities through the Work Packages as outlined in the original grant application.
WP HepCheck: opportunistic rapid HCV testing in populations at risk have been successfully conducted in Dublin in Prison populations, in London in the Homeless, in Seville in the drug treatment centres and with NGO’s caring for such populations, and in Romania in night shelters and opiate substitution sites.
WP HepLink, partnering primary with secondary care, to ensure that HCV affected and infected populations will access care and treatment, has been successfully initiated in Dublin, London, and Seville, where primary care centres are dispensing opiated substitution therapy. This model does not apply to Bucharest as they have no OST dispensation in primary care, but nonetheless the clients identified in the projects in Bucharest are being linked into specialist services for care and treatment. Dublin was the first to pilot the HepLink project to establish a model of care, and to mentor the other sites based on ‘lessons learned’
WP Hepfriend, with London as lead, was initially started in London through UCL and the Hepatitis C Trust, and their model and training materials have been adapted at the other sites for training and planned scale up. To date London leads with successfully supporting HCV infected clients into care using the ‘buddy system’, Dublin is now training up staff and has started some pilots of ‘peer support’, and both Seville and Bucharest have early development of this work package with a small number of HCV peers trained, with planned expansion in year two.
WP HEPEd. Within this workpackage we have organised, at all four sites, a series of educational opportunities and ‘MasterClass’ events focused on training of healthcare providers, primarily, as part of year one milestones. WP HepCost. It was initially planned to undertake the first cost-effectiveness in Ireland by month 18. However, Bristol may do this partially in London and Ireland, because Bristol already have a lot of the nec

1. WP 1- Coordination

The overall coordination and management of the HepCare Europe project is the remit of Dr John Lambert, who is backed by Prof Walter Cullen. The main contact for the European Commission with our project is Ms Gordana Avramovic, who is identified as the ‘Project Manager’ for the work. Our project staff, located at the Mater Hospital Catherine Mcauley Educational and Research Centre, the teaching building for the UCD School of Medicine, is geographically together and work on a day to day basis to coordinate and manage this project.
The project manager, has direct contact with each of the clinical sites in Spain, Romania, and London, as well as the non-clinical site in Bristol UK. Each of these HepCare sites are linked to the Research Administrations of their respective institution, and it is the role of the Coordination and Management site to ensure that all aspects of the project, both technical and operational, are on target. We have set up a number of mechanisms to ensure compliance with this mandate.
The management group at UCD/Mater consists of the coordinator (Dr Lambert) and Prof Cullen and members of the Hepcare team, with similar structures set up at each clinical and non-clinical sites.
The Steering Committee set up in the first year consists of Dr Lambert and Prof Cullen with representatives from each lead of the respective Work Packages, to review progress of the project, and also to provide interim analysis and to troubleshoot issues that may arise over the conduct of the work of the project.
The Advisory Board set up in the first year consists of external members from a variety of disciplines from an international background, also representatives nominated from the European Commission, both scientific and community based, to ensure that appropriate oversight and advice is provided for the project. To maximise our ability to perform the work of the project, to align ourselves with local and national strategy in the EU and partner states, and to provide advice on appropriate dissemination of results upon the completion of the work and analysis of the results.

2. WP 2- Dissemination

The overarching aim of this WP is to maximise the dissemination of findings related to Hepcare Europe and impact on practice. Key to this work package are:
- To define a dissemination strategy
- HEPCARE brand development needs to be developed, e.g. a website logo to be incorporated on all posters presented at conferences and presentations etc ;
- Social media, e.g. linkedin group and twitter updates with outputs from the group;
- Printed materials advertising HepCare and what it will do at each site;
- Information event at the each participating site to engage patients;
- Regular Have a symposia/conferences throughout the duration of the project – e.g. lay people, clinicians;
- Proactive engagement with the Irish Hepatitis C Outcomes Research Network (ICORN) of which Dr Lambert is a member and National organisations in Spain, Romania and the UK.
- Conference attendance;
- Manuscript publication
In parallel, internal dissemination, specifically the sharing of knowledge between consortium members, will be facilitated by annual meetings and quarterly conference calls.

EUROPEAN DISSEMINATION
The project aims to liaise with on-going actions funded under the EU Health and DPIP Programmes and collaborate with them to promote the visibility of HEPCARE.
1. Correlation and HEP C network (peer support, HCV training)
2. EU HEP SCREEN network (screening for viral hepatitis among migrants, health care workers training tool)
3. Scale up Harm reduction by WHO EURO (evaluation of barriers for HCV testing and care)
4. Bordernetwork network (guidance for the treatment of HIV and viral infections)
5. EURO HIV EDAT - community base testing strategies
6. OPTEST HIE – early testing in clinical settings, using indicator conditions, and identification of barriers for testing provision
7. HA REACT JA -

INTRODUCTION

HepCare Europe is a three year EU funded project, that has multiple components, all of which must link up to guarantee that vulnerable populations access treatment. There is no one 'profile' of an HCV infected patient, and there is not one recipe that will guarantee successful treatment for all. Each clinical site that HepCare Europe has included (Dublin, London, Seville, and Bucharest) will need to adapt the Work packages from HepCare Europe and modify it to fit into the local situation. A critical first step is testing, as many do not know they are risk (HepCheck). And many who do know they are positive are not accessing care, as they have other priorities, or they have not been provided the opportunity of an appointment at the referral centre (HepLink). Ten years ago the treatment of hepatitis C consisted of toxic injections with interferon, administered for a period of 24 to 48 weeks. In order to get the treatments patients needed to get a liver biopsy. Many of these 'myths' of old treatment still exist in the community, and education of the community, as well as education of the health care providers is essential (HepEd).
And many barriers, some patient focused, some healthcare focused, and some institutional and governmental, still exist. Each of these barriers differs by risk population and geographic location. Thus further work on supporting the value of these new HCV drugs need to be done, and the HepCare Europe work packages HepCheck, HepLink, HepEd, Hepfriend, HepCost with the project dissemination will work over the next two years on putting together this data, to support the continued expansion of treatment to vulnerable populations.
Finally, there is no need to anymore take the patient to the hospital to evaluate and treat them. The new HCV drugs are safe and tolerable, and while in the past all HCV treatment had to be specialist lead at hospital centres, this is no longer the case. So HepCare Europe is developing a 'shared care' model of care to partner the specialists with the primary care takers. Only with such a partnership, will we be able to scale up treatment so that more will receive treatment. Ireland has signed up to 'HCV viral elimination by 2025', as have many of our partner countries. only by developing a 'scale up' model, that takes the treatment to the community, where vulnerable HCV populations are living (and not accessing hospital services); and partnering with community services in the community that are supporting such patients, will we succeed in reaching this target. The final component of the HepCare Europe project that is critically important is HepFriend. A peer educator in the community can mentor at least 10 HCV patients who need to go through the process of testing and assessment and treatment. Such a peer educator support model, which was been demonstrated to be successful in other disease areas, is now rolling out in Dublin, and will be replicated in the other clinical sites. Shared care partnerships, community support, advocacy, scale up, all are key concepts that will make HepCare Europe and its planned deliverables make a difference for vulnerable patients with HCV in the community, who are currently not in receipt of these new HCV drugs; and they will not have access to such drugs unless such advocacy continues and is shown in evidence based studies to be of merit.

During the first year of the project an additional partner and affiliated entity have been added to the consortium via an amendment request. The added partner is UCLH. The tasks given to UCL will be shared by UCLH. It was discovered at the kick off meeting that part of the personnel working on the project was actually linked to UCLH payroll. It was also discovered that although the coordinator Dr Lambert is a joint appointment with UCD his payroll comes out of the Mater Misericordiae University Hospital and therefore the Mater Hospital was added on the amendment request as an affiliated e

1- HepCheck
Site Numbers screened under WP 4 HEPCHECK
Dublin 618
Seville 490
London 461
Bucharest 510
TOTAL SCREENED TO DATE 2079
TOTAL PLANNED 2000

2- HepLink
Site Numbers recruited under WP 5 HEPLINK
Dublin 14 practices (135 patients)
Seville 4 5 practices (109 patients)
London 2 practices(35 patients)
Bucharest 9 sites (215 patients)
TOTAL RECRUITED TO DATE (29 practices) 485 patients
TOTAL PLANNED (24 practices), 240 patients

HepLink Dublin : At the end of reporting period two, 14 GP practices and 135 patients have been recruited to the study in Dublin. We have completed implementation of all aspects of the HepLink model of care to the 14 participating practices. Patient assessment is also complete and a high uptake by patients (102/135;76%) of the community-based clinical assessment by the HepLink nurse was observed. Baseline data has been collected, analysed and disseminated. Follow-up data collection is almost complete.


3- HepEd
Site Nb Masterclasses/ HCP trained (health care professionals)
Dublin 5 (153 HCPs trained)
Seville 5 (40 HCPs trained)
London 2 (5 HCPs trained)
Bucharest 2 (1st in march 2017 with 80 HCPs trained; the 2nd one in June 2018 with 70 HCPs trained)
TOTAL TO DATE 13 masterclasses (344 HCP trained)
TOTAL PLANNED 4 (120 HCPs trained)


4-HepFriend

Site Nb of peers recruited
Dublin 12
Seville 6
London 8*
Bucharest 3
TOTAL TO DATE 29 peers recruited
TOTAL PLANNED At least 4

5- HepCost: not applicable at present

6- Shared learning: Learning has been shared via 10 steering committee meetings to date. Further proposals and projects have been discussed.

7- Policy makers/stakeholders: Numerous meetings have been held with key people responsible for HCV policy in Dublin, Bucharest, London and Seville.
Ireland: Nine stakeholder meetings were held to date with community and service user organisations as part of the development and implementation of the HepFriend model of peer support (i.e., 22nd, 23rd, 24th November 2016, 19th Jan 2017, 2nd Feb 2017, 6th Apr 2017, 30th Jun 2017, 13th Sep 2017, 7th Dec 2017) and 3-monthly meetings will be held going forward. UK: The London team have been collaborating with the North Central London Operational Delivery Network (ODN) and the South London ODN to develop an outreach model of HCV Care, and has met with the London Joint Working Group on Substance Use and Hepatitis C (LJWG). Romania: A multi stakeholder meeting on viral hepatitis and HIV co-infection was organised in October 2017. Spain: Nine collaborative meetings were held with doctors and nurses working in drug addiction units and one meeting with NGOs working with homeless people to set up HepCheck; four meetings were held with doctors and nurses working in primary care centres to set up HepLink; and four meetings have been held with service users from a therapeutic community and a drug service to initiate HepFriend.
Key people responsible for regional and national HCV policy have been briefed on Hepcare at all sites. Ireland: There is ongoing sharing of Hepcare findings and progress with the Health Service Executive Ireland, the Programme Manager of the National Hepatitis C Treatment Programme, and a Hospital Group leadership team. Romania: Due to socio-political issues there were continuous transformations in the national hepatitis programmes and HCV key persons. However, key people from the "Matei Bals" National Institute for Infectious Diseases, Bucharest (Prof. Adrian Streinu-Cercel), the Hepatitis Commission for DAA at the National Insurance House (Prof. Ceausu Emanoil and Dr.Popescu Corneliu),and the President of the National Commission for Infectious Diseases from the Ministry of Health (Prof. Egidia Miftode and also Associate Prof. Irina Dumitru who is a member of the same Commission) have been briefed on the Hepcare Project. A written information was also sent to the Ministry of Health and the National ID Committee. UK: In London, there is ongoing engagement with the North Central London Oper

1- Hepcheck has achieved full recruitment. The target recruitment sample has been reached, but screening and inclusion in HepCheck is still ongoing as patients with active HCV infection detected within HepCheck are candidates fro treatment and could be included in HepLink. The initial number estimated of anti-HCV positive patients has been reached and exceeded.

2- HepLink protocols have been developed and published. Healthcare professional education and patient assessment has been completed in Dublin and is ongoing in other sites. The target number of practices has been reached and the pre-planned sample size for HepLink has been accomplished. Inclusion of patients continues as the HepLink model of care has been adopted in the participating practices.

3- 344 HCPs have been trained attending 13 masterclasses. These exceeds initial expectations.
4- A Network of peers is established. This component is still in progress. The initial plan to recruit a small and conservative number of peers was reached and exceeded.

5- Cost effectiveness is still to be completed.

6- Share learning: Two proposals for further work have been developed and submitted with MSD and Gilead but not funded to date.

7- Policymakers/stakeholders: More than the planned 24 meetings with key people responsible for HCV policy have taken place. Hepcare Europe is cited in Irish HCV policy documentation.

8- Dissemination to scientific community: Hepcare Europe is cited in scientific literature: e g McCombe G, Leahy D, Klimas J, Lambert JS, Henihan AM, Cullen W. Commentary on Zeremski et al. (2016): Improvements in HCV-related Knowledge Among Substance Users on Opioid Agonist Therapy After an Educational Intervention. Journal of Addiction Medicine. 2016;10(5):363-4.

9- HCPs awareness: 12 masterclasses and 1 launch. Leaflets have been distributed at those events and during conferences and meetings with key people responsible with policy. Website hits: 1600 page views. Tweeter: Tweets, 33; Followers: 54.

Conference presentations given to date:

DUBLIN

Month 0-12

Lambert J., Murphy C., Patel A., McKenna-Barry M., Crowley, D., Stewart S., Farrell J., Cullen W. Opportunistic Fibroscan® testing in a Dublin general practice (GP) managing opiate substitution therapy: The Hepcare study. EASL, 13-17 April 2016, Barcelona, Spain

Ni Cheallaig C., Lambert J., Murphy C., O'Carroll A., Farrell J., Patel A., McHugh, T., Avramovic G., Cullen W. The Dublin Hepcheck Study: Community based testing of HCV by point of care OraQuick® HCV saliva test in homeless populations. EASL, 13-17 April 2016, Barcelona, Spain

Lambert J., Avramovic G.,McCombe G., Stewart S., Cullen W. Integrating Primary and Secondary Care to Optimise Hepatitis C Treatment: Implementation and Evaluation of a Multidisciplinary Educational Symposium. Infectious Diseases Society of Ireland (IDSI) Annual Scientific Meeting; 12-14 May 2016, Dublin, Ireland

Ni Cheallaig C., Lambert J., Murphy C., O'Carroll A., Farrell J., Patel A., Avramovic G., McCombe G., Cullen W. Community based testing of HCV by point of care OraQuick® HCV saliva test in homeless populations. Infectious Diseases Society of Ireland (IDSI) Annual Scientific Meeting; 12-14 May 2016, Dublin, Ireland

Crowley D., Murphy C., Farrell J., Stewart S., Keegan D., Lambert J., Cullen W. To evaluate the effectiveness of an opportunistic outreach fibroscanning service to a community based drug treatment clinic and general practice in Dublin. International Symposium on Hepatitis Care in Substance Users (INHSU); 7-9 September 2016, Oslo, Norway.

Cullen W., McCombe G., Swan D., O’Connor E., Murphy C., Avramovic G., Lambert J.S. Heplink: An Overview. Irish Street Medicine Symposium, 24th September 2016, Cork, Ireland

Lambert J. Seek and Treat and Hepcare Europe. Irish Street Medicine Symposium, 24th September 2016, Cork, Ireland

Crowley D., Murphy C., McHugh T., Farrell J., Stewart S., McCombe G., Cotter A., Cullen W., Lambert J.S. To evaluate the effectiveness of an opportunistic outreach fibroscanning service to a community based drug treatment clinic in Dublin. Society for the Study of Addiction (SSA) Annual Symposium; 10-11 November 2016, York, UK.

McCombe G., Almaazmi B., Lambert J.S., Avramovic G., Murphy C., O'Connor M., Perry N., Cullen W. Integrating Primary and Secondary Care to Optimise Hepatitis C Treatment: Development and Evaluation of a Multidisciplinary Educational ‘Masterclass’ Series. Society for the Study of Addiction (SSA) Annual Symposium; 10-11 November 2016, York, UK.

Lambert J. Hepcare Europe: How to Reach the Risk Groups. HepHIV 2017 Conference; 31 January-2 February 2017, Malta

Lambert J.S., Murphy C., Menezes D.L., Cullen W., McHugh T., McCombe G., O’Carroll A. Hepcheck: Homeless, Hep C & Competing Priorities in Dublin. Association of University Departments of General Practice in Ireland (AUDGPI) Annual Scientific Meeting, 9-10 March 2017, Limerick, Ireland

McCombe G., Almaazmi B., Lambert J.S., Avramovic G., Murphy C., O'Connor M., Perry N., Cullen W. Integrating Primary and Secondary Care to Optimise Hepatitis C Treatment: Development and Evaluation of a Multidisciplinary Educational ‘Masterclass’ Series. Association of University Departments of General Practice in Ireland (AUDGPI) Annual Scientific Meeting, 9-10 March 2017, Limerick, Ireland

Swan D., O’Connor E., McCombe G., Murphy C., Lambert J.S., Avramovic G., Cullen W. HepLink Study: Bridging the gap in the treatment of Hepatitis C in general practice. Association of University Departments of General Practice in Ireland (AUDGPI) Annual Scientific Meeting, 9-10 March 2017, Limerick, Ireland

Lambert J.S. Working with marginal populations (I): the HEPCARE community project. EASL, 19-23 April 2017, Amsterdam, The Netherlands

Lambert J.S., Murphy C., O’Connor E., Menezes D., Cullen W., McHugh T., McCombe G., Avramovic G., O’Carroll A. HepCheck: Homeless, Hep C & Competing Priorities in Dublin. EASL, 19-23 April