1. National Hepatitis C Database
for infection acquired through blood and blood products
Dr Lelia Thornton, HPSC
European Hepatitis C Conference
5-7 June 2015

2. National Hepatitis C Database
Database project
Approx. 1,700 people infected with hepatitis C in Ireland through:
Anti-D immunoglobulin
Blood transfusion/treatment for renal disease
Blood clotting factors
Database established in 2004
HPSC and 8 specialist hepatology units
Steering Committee – including patient support groups
Database includes antibody pos and RNA pos

3. Objectives of the database
National Hepatitis C Database
Objectives of the database
To follow the natural history of hepatitis C infection in people infected through blood/blood products administered in Ireland
To evaluate the impact of host factors on disease progression
To evaluate the outcomes of treatment
To provide information for planning health services
To serve as a resource for research

4. Confidentiality and security
National Hepatitis C Database
Confidentiality and security
No names or addresses
Consent required except for deceased
Ethics approval from hospitals
Eligible patients identified by hepatology units
Data from medical records in hepatology units – no direct contact with patients
High levels of database security

5. National Hepatitis C Database
Type of data collected
Demographic and lifestyle data
Infection details
Laboratory results
Clinical status
Cause and date of death
Treatment details
Clinical management

6. National Hepatitis C Database
5 rounds of data collection: Baseline 2005 Follow-up 2007, 2008, 2009, 2013

7. National Hepatitis C Database
Latest data period
Definitions/assumptions:
Year of infection or year first received clotting factors or year of diagnosis
HCV RNA status
Ever chronic infection
Current chronic infection (includes deceased)
Alive and current chronic infection
Chronic infection in past
Never chronic infection (liver disease rare)
No RNA results (22% haemophiliacs, all deceased)

8. National Hepatitis C Database

9. National Hepatitis C Database
Number of haemophiliac participants by data collection period (latest participation=73.3%, 165/225)

10. National Hepatitis C Database
225 people identified as infected with hepatitis C through blood clotting factors in Ireland

11. Haemophiliac cohort by year of HCV infection and RNA status
National Hepatitis C Database
Haemophiliac cohort by year of HCV infection and RNA status

12. HCV infection status – Haemophiliac cohort
National Hepatitis C Database
HCV infection status – Haemophiliac cohort
RNA status – most recent
All haemophiliacs
Currently alive
No. %
Current chronic infection 61
37.0 28
30.8
Past chronic infection 46
27.9 43
47.2
Never chronic infection 21
12.7 20
22.0
No RNA results 37
22.4
Total
165
100 91

13. Hepatitis C status at diagnosis
National Hepatitis C Database
Hepatitis C status at diagnosis

14. Profile of haemophiliac cohort (n=165)
National Hepatitis C Database
Profile of haemophiliac cohort (n=165)
Males 154 (93%); females 11 (7%)
Median age at infection: 13 years
Median age now of those alive and chronically infected = 50 years
HIV co-infection: n=69 (42%)
22 HIV co-infected are alive
9 currently HCV infected
12 have cleared HCV through treatment
1 never had chronic HCV infection
Genotype 1=65%, genotype 3=22%, other=13%

15. Profile of haemophiliac cohort
National Hepatitis C Database
Profile of haemophiliac cohort
All haemophiliacs (n=165)
Alive, chronic infection (n=28)
No. %
Age at infection
<20
20-39
40+
111 45 9
67.3
27.3
5.5 21 6 1
75.0
21.4
3.6
Age at latest follow-up
0-44
45-64
65+ 83 70 12
50.3
42.4
7.3 10 15 3
35.7
53.6
10.7
Time since infection
<20 years
20-29 years
30+ years 24 54 87
14.5
32.7
52.7 4
14.3
85.7

16. National Hepatitis C Database
Alcohol consumption
Moderately high – 8% of chronically infected
High (>40 units) – 10% of chronically infected
Males>females
Younger>older
Differences by source of infection may be attributable to age and sex distribution:
Blood transfusion/renal: 21%
Haemophiliacs: 35%
Anti-D: 11%

17. Main outcomes – haemophiliac cohort
National Hepatitis C Database
Main outcomes – haemophiliac cohort
Outcomes
Ever chronic infection
Alive and chronic infection
No. %
Clinical signs of serious liver disease* 39
36.5 11
39.3
Cirrhosis 21
19.6 4
14.3
Liver tumour/HCC 10
9.4 2
7.1
High fibrosis score on biopsy** 12
11.2
Deceased 36
33.6
Died from liver disease 13
12.4
*Cirrhosis, HCC, varices, portal hypertension, ascites, decompensated liver disease, encephalopathy, hepatosplenomegaly, hepatopulmonary syndrome, hepatic synthetic dysfunction, hepatorenal syndrome, portal gastropathy

18. Liver-related diagnostic procedures
National Hepatitis C Database
Liver-related diagnostic procedures

19. National Hepatitis C Database
Liver-related outcomes in database participants who are alive with chronic infection

20. National Hepatitis C Database
Changes in the prevalence of outcomes for chronically infected haemophiliacs since 2007

21. National Hepatitis C Database
Outcomes in haemophiliacs (ever chronic infection or no RNA results), by HIV status

22. National Hepatitis C Database
Ever chronically infected participants with clinical signs of serious liver disease, by duration of infection and alcohol

23. Clinical signs of serious liver disease – all database participants
National Hepatitis C Database
Clinical signs of serious liver disease – all database participants
Mainly cirrhosis, varices, portal hypertension and ascites
The factors independently associated with having serious liver disease were:
High alcohol intake
Longer duration of infection
Male sex
Older age at end of follow-up
Genotype 3
High alcohol intake - >5 times higher odds of having signs of serious liver disease

24. Cirrhosis – all database participants
National Hepatitis C Database
Cirrhosis – all database participants
High alcohol intake, being 50 years or older at last follow-up, being HCV infected for 20 years or longer and male sex were all independently associated with cirrhosis in those who had ever developed chronic infection.
Those with a high alcohol intake had 5 times higher odds of having cirrhosis

25. National Hepatitis C Database
Cirrhosis in ever chronically infected participants: age at diagnosis and duration of infection
Source of infection
Number (%) with cirrhosis
Median age at cirrhosis diagnosis
Median duration of infection at cirrhosis
Anti-D
77 (18%) 56 30
Transfusion/renal
82 (29.9%) 57 22
Haemophilia
21 (19.6%) 45

26. HCC – all database participants
National Hepatitis C Database
HCC – all database participants
Male sex and genotype 3 (vs genotype 1) were independently associated with HCC in chronically infected participants
Those infected through blood transfusion or clotting factors were significantly more likely to develop HCC than anti-D cohort

27. Deaths in haemophilia cohort
National Hepatitis C Database
Deaths in haemophilia cohort
74 had died by latest follow-up
47 were HIV positive, 27 HIV negative
Liver-related death in 23% HIV positive and 39% HIV negative
Many HIV positive had died from HIV-related causes prior to effective antiretroviral treatments

28. National Hepatitis C Database
HCV Treatment courses by type and %SVR, All database participants

29. HCV treatment in haemophiliac cohort
National Hepatitis C Database
HCV treatment in haemophiliac cohort
Sixty (56%) haemophiliacs had received anti-viral treatment for HCV by latest follow-up
Treatment outcome available for 55
– SVR 65.5% for last treatment
Peg-IFN & RBV in treatment naïve haemophiliacs
SVR 36% for genotype 1
SVR 69% for genotype 2/3

30. National Hepatitis C Database
Acknowledgements
All database participants
Patient support groups:
Irish Haemophilia Society, Transfusion Positive, Positive Action, Irish Kidney Association
Staff in the eight hepatology units
Database Steering Committee
My colleagues in HPSC:
Paula Flanagan, Niamh Murphy, Margaret McIver

31. National Hepatitis C Database