HCV 2014: ICORN Prof Suzanne Norris Consultant HepatologistSt James’s Hospital Trinity College Dublin

1. HCV 2014:
ICORN
Prof Suzanne Norris
Consultant Hepatologist
St James’s Hospital
Trinity College Dublin

2. The Good News
IFN
6 mos
PegIFN/
RBV
12 mos
IFN
12 mos
IFN/RBV
12 mos
PegIFN
12 mos
2001
1998
2012
Standard
IFN
RBV
PegIFN
1991
DAAs
PegIFN/
RBV/
DAA
IFN/RBV
6 mos
6
16
34
42 39
55
70+
0
20
40
60
80
100

3. Patientsin,000s
Prevalence Under Specialist CareDiagnosed Treated
HCV mono-infection landscape in Ireland
0
50
100
Data from Prof Norris, sourced from HPSC 2013, ICORN 2014, PCRS 2013.
35,000
12,365
8,000
1,942
15.7%
The bad

4. HCV became notifiable disease in Ireland on 1st January 2004
Number of notifications hepatitis C 2004–2012,
by sex and mean age
Health Protection Surveillance Centre. Hepatitis C. May 2013.

5. Number of notifications of hepatitis C 2004-2010, by
sex and mean age
1121
1405
1213
1547 1516
1241 1239
0
5
10
15
20
25
30
35
40
0
200
400
600
800
1000
1200
1400
1600
1800
2004 2005 2006 2007 2008 2009 2010
Meanage
Numberofnotifications
Year
Male Female Unknown sex Mean age males Mean age females
Hepatitis C in Ireland
By 2013, 12,365 diagnosed
Prevalence is 20,000-50,000

6. Most likely risk factor (%) for cases of hepatitis C notified in 2012
(where data available, n=651, 63%)
Health Protection Surveillance Centre. Hepatitis C. May 2013.

7. Most likely risk factor (%) for cases of hepatitis C notified in 2012
(where data available, n=651, 63%)
Health Protection Surveillance Centre. Hepatitis C. May 2013.
HCV genotypes 1 and 3 are the most common

8. Mean annual notification rates per 100,000 for hepatitis C by
age and sex, 2004–2012
Health Protection Surveillance Centre. Hepatitis C. May 2013.

9. Burden of HCC in Ireland

10. Multiple Cohort Model of HCV Prevalence and
Disease Progression in USA
Davis G et al, Gastroenterology 2010

11. Risk factors that may affect
progression of HCV Infection
Factors contributing added risk to developing cirrhosis or HCC
Steatohepatitis/obesity1 Diabetes2
HIV coinfection1 Presence of varices2
Hepatitis B coinfection1 Low platelet count2
Alcohol intake1 Increasing age2
Smoking1 Black ethnic group2

12. • 36 recommendations
across four key areas:
– Surveillance
– Education & Prevention
– Screening
– Treatment access &
delivery

13. Current Challenges: Knowledge Gaps
• Epidemiological gaps
– Improving routine surveillance system
– Population prevalence study
– Historical trends in HCV diagnoses
– Modelling exercise to estimate burden of disease
– Follow-up studies among IDUs to identify seroconverters
– Connectivity between existing registries (methadone, S.I) to facilitate
national register
• Screening gaps
– Targeted antenatal screening, ?universal
– Promote screening for attendees of harm-reduction services
– Guidelines re screening new entrants to Irish HCS

14. • Key success factors in implementing national plans
– Modelling data
– Collection of available data
– Assignment of ownership and accountability
– User-friendly information to governments
– Ring fenced funding
Scottish Hepatitis C Action Plan

15. DAAs – decision to reimburse
• Approved April 2012
• Eligible to all genotype 1 patients (naive, experienced)
• Recognition that treatment regimens complex
• Dispensed only through hospital system, and through
hospitals with designated adult hepatology centres
• Patients receiving DAAs should be entered into a treatment
registry
• Funding provided solely for drugs

16. National Programme
Need for governance structure
• 2002-2011:
• No national HCV treatment guidelines
• No national standards
• No agreed national care pathways
• Clinical units working in silos

18. I.C.O.R.N.
• Irish Hepatitis C Outcomes Research Network. Established
February 2012.
• Collaboration between ISG, IDSI, NCPE and HPSC, research
networks, and pharma.
• The goal of this collaboration is to optimise the quality of
care of patients with hepatitis C (HCV) treated with direct-
acting antiviral therapy.

19. Mayo
Beaumont Hospital
Prof.McConkey, Prof Murray
Mater
Hospital
Dr. Stewart, Dr
Lambert
St. James’s
Hospital
Prof. Bergin
Prof. Norris
Prof McKiernan
Cork University
Hospital DR O Crosbie
University College
Hospital Galway
Dr. Fleming, Dr Lee
HPSC Dr Lelia Thornton
Geographical representation
St Lukes’s
Kilkenny
Dr Courtney
SVUH
Dr. Houlihan,
Prof McCormick
NVRL Dr Cillian de Gascun
Dr Jeff Connell

20. Membership
• Clinicians:
o Beaumont Hospital: Prof. F Murray, Prof. S McConkey
o Mater Misericordiae University Hospital: Dr. S Stewart, Dr. J Lambert
o St. Vincent’s University Hospital: Prof. A McCormick, Dr. D Houlihan
o St. James’ Hospital: Prof. S Norris (Executive Lead), Prof. S. McKiernan, Prof. C Bergin
o Cork University Hospital: Dr. O Crosbie
o St. Luke’s Hospital, Kilkenny: Dr. G Courtney
o Galway University Hospital: Dr. J Lee, Dr C Fleming
• HTA: Dr. A O’Leary, Dr. J Kieran
• Disease Surveillance: Dr. L Thornton (HPSC)
• Dept of Immunology & Biochemistry, TCD: Prof. C O’Farrelly, Dr N Stevenson, DR M
Robinson, Dr C Gardner
• Virology: Dr C deGascun and Dr J Connell (NVRL), Dr L Fanning (UCC)
• Statistics: Prof. C Walsh (TCD)
• Hepatology Nurses Forum: CNS Helena Irish, Caroline Walsh
• Patient Representative: Irish Haemophilia Society
• Drug Treatment Services: Dr S Keating, S Heffernan, N Perry
• HSE Hepatitis C Liaison: M Tait
• Prison Service: F Nangle Connor
• Hosptal Pharmacists: K Feeley

21. I.C.O.R.N.
• to provide a governance structure and anti-viral stewardship
programme for clinicians and clinical nurse specialists
• develop national treatment guidelines
• establishment of national treatment HCV registry
• platform for HCV clinical trials and HCV related research
• R&D models of care to enhance equitable access to services
for all assess differing treatment models

22. C it Off 2025
Mission Statement

23. ICORN HCV Treatment registry
• Ethical approval from October 2012
• Prospective, longitudinal collection of outcomes
• Electronic data capture tool
• Embedding of logic to facilitate adherence to complex
treatment paradigms, futility rules
• Real time data capture (monitoring)
• Restricted administrative access
• Active at all hospital treatment sites
• 300 patients enrolled to Q2 2014

24. • 36 recommendations
across four key areas:
– Surveillance
– Education & Prevention
– Screening
– Treatment access & delivery
Recognises need for a
national hepatitis C
register
• To determine true prevalence,
acquisition risks & treatment
progress

25. Current Challenges - unmet need
General Population – Population Health : Education
Unknown Status – HCV Negative – High Risk
Unknown Status – HCV positive
HCV positive – Not engaged in care
HCV Positive – Engaged in Care
Therapeutics
Diagnostics
Location of Care
MDT
Late
Presenters
•Cirrhosis
•Liver cancer
•ICU & hospital
•Transmissions
Model of Care
•IDUs
•Migrants
•Prisioners
Complications
Universal
Or
Targeted
Testing
Prevention
EXCEL-1 :2012 – Hepatitis C Infection
Courtesy of Prof C Bergin

26. HCV in Ireland: where is it?
Three big reservoirs
• Current injectors
• Ex-injectors
• Hidden
• Finding them may take a screening campaign
(‘baby boomers’)
• Immigrants
• Pattern of infection unpredictable (‘healthy migrant’ effect)
• Access can be difficult
• Not everyone wants to be associated with these virus

27. Screening

28. EDVS Project
• To assess the feasibility
and acceptability of
expanded approach to BBV
testing in ED departments
• Dublin and Galway
• To determine prevalence of
HIV, HBV and HCV in
patients attending the ED
• To determine current
linkage to care
• To promptly link the newly
diagnosed to services and
re-engage the known
patients to care

29. Research
• Population health focus
– In-treatment population, untreated population, undiagnosed
population, on-going prevention strategies
– True prevalence
– Screening
– Enhanced engagement in care
• Health services research
– Model of care
– ECHO project

30. Expanding Access to Hepatitis C Virus Treatment
Extension for Community Healthcare Outcomes (ECHO):
Disruptive Innovation in Specialty Care

32. ICORN HCV Roadmap 2015
• Development of Model of Care
- Network of treatment sites
• Expansion of Registry to National Disease Registry
• Advocacy for Implementation of National HCV Strategy
– Education and awareness
– Surveillance and screening

33. Challenge for Ireland 2015

34. Acknowledgements
• ICORN project team ( A O’Leary, E Gray)
• ICORN Steering Committee
• Hepatology and ID nursing colleagues
• St James’s ED staff
• Diane West SIU, HSE
• Patients
• ECHO team, New Mexico