National Hepatitis C Database
National Hepatitis C Database
Dr Lelia Thornton
Health Protection Surveillance Centre
December 2012
Background
• The National Hepatitis C Database was set up
in 2004 in association with eight specialist
hepatology units
• Any person (alive or dead) who contracted
HCV infection through the administration of
blood or blood products within the state is
eligible to be included
• 4th Round of data collection completed
(contains data to 31st December 2009)
Hepatitis C RNA results for all participants
and by source of infection
100
3.8
1.2
0.9
5.5
90
80
34.3
43.5
45.3
% of participants
70
42.5
0.9
18.1
22.4
23.4
12.7
60
50
16.0
20.6
8.5
12.0
40
30
20
45.2
46.0
57.6
47.1
41.5
44.2
10
6.9
0
All participants
Anti-D all
Anti-D 77-79
Anti-D 91-94
RNA status and source of infection
Currently chronically infected
Chronically infected in past
Transfusion or
renal
Never chronically infected
Clotting factors
No RNA results
Distribution of hepatitis C genotypes by
source of infection (n=722, genotype 4&5 omitted,
n=4)
% of participants with genotype results
120
100
18.5
80
10
0.2
31.3
4.7
22.5
10.1
10
60
40
76.8
100
89.8
100
58.7
67.4
20
0
All participants
Anti-D all
Anti-D 77-79
Anti-D 91-94
Source of infection and genotype
Genotype 1
Genotype 2
Genotype 3
Blood transfusion
Blood clotting
factors
Summary of age at infection, age at end of latest
follow-up, years since infection by source of infection
Source of infection
and RNA status
Age at infection
Age at end of follow
up
Duration of infection
(years since infection)
Median (range)
Median (range)
Median (range)
Anti-D
28 (16-44)
57 (26-76)
32 (4-45)
Anti-D 1977-1979
28 (17-44)
58 (33-76)
32 (17-33)
Anti-D 1991-1994
30 (18-39)
46 (26-56)
16 (4-18)
Transfusion or renal
32 (0-77)
61 (16-91)
23 (1-48)
Clotting factors
13 (0-59)
42 (12-81)
27 (8-50)
Distribution of the highest reported alcohol
consumption by gender for participants who became
chronically infected (where data available, n=761, 93%)
% of chronically infected patients
70
65.9
60
50
45.1
40
30
24.4
23.1
20
14.9
10
4.4
5.3
0
Female
Male
Alcohol consumption and gender
Non drinker
Within recommended limits
Moderately high
High
16.9
Liver related outcomes for participants
who are currently RNA positive
Cirrhosis
• 137 ever chronically infected participants had
developed cirrhosis*
– 86 (14.5%) were female and 51 (23.2%) were male
– Median duration of RNA positivity at the
estimated date of cirrhosis was 24 years
– Median age at cirrhosis was 53 years
– There was no cases of cirrhosis in those who
never developed chronic HCV infection
– After RNA status, alcohol consumption was the
biggest determinant of risk of cirrhosis
Hepatocellular carcinoma (HCC)
• 32 ever chronically infected participants had developed HCC
• Prevalence was significantly higher in males (n=20, 9%)
• Median duration of infection at time of HCC diagnosis was
27.5 yrs and the median age at diagnosis of HCC was 63 yrs
• The median time from estimated date of diagnosis of
cirrhosis to estimated date of diagnosis of HCC was three
years
Comparison of rates of cirrhosis
0.00
0.20
0.40
0.60
0.8
1.0
Cumulative cirrhosis by RNA status
0
10
20
Time since infection (years)
30
Never chronically infected
Currently chronically infected
Chronically infected in the past, cleared virus
Summary of main outcomes by hepatitis C RNA
status for all participants (excludes n=50 with no RNA results)
Outcomes
All
(n=1316)
Ever chronically infected *
(n=815)
Never chronically
infected † (n=451)
Num
%
Num
%
Num
%
187
14.2
175
21.5
5
1.1
142
10.8
137
16.8
0
0.0
Liver tumours or
HCC
34
2.6
32
3.9
0
0.0
High fibrosis score
on biopsy ‡
167
12.7
160
19.6
4
0.9
212
16.1
145
17.8
26
5.8
55
4.2
45
5.6
2
0.4
Signs of liver
disease
Cirrhosis
Deceased
Died from liver
disease §
Comparison of all-cause mortality rates
Comparison of liver-related mortality rates
0.1
0.5
1
Cumulative liver-related death by RNA status
0
10
20
Time since infection (years)
30
Never chronically infected
Currently chronically infected
Chronically infected in the past, cleared virus
Changes in the prevalence of all cause mortality and
liver-related outcomes for chronically infected
participants since baseline data were collected
% of chronically infected patients
25
19.1
20
17.2
18.0
17.5
15
14.8
14.8
11.9
10
12.2
10.6
5
3.5
1.7
4.2
2.6
19.2
16.0
21.5
19.6
17.8
16.8
13.8
4.8
2.9
5.9
3.9
0
Baseline:
Yr 1 follow up:
Yr 2 follow up:
Yr3 follow up:
data up to end 2005
data up to end 2007
data up to end 2008
data up to end 2009
Changes in liver-related outcomes since the start of database project
Signs liver disease
Cirrhosis
Liver tumour/HCC
High fibrosis scores on biopsy
Deceased
Liver related deaths
Factors associated with severe liver disease in chronically infected
participants-logistic regression model including gender (n=727)
Factors associated with having severe liver disease
(including Gender n=727)
Odds Ratio
P-value
95% Confidence interval
1
Reference
Reference
5.6
<0.001
3.02 - 10.52
1
2.7
3.7
Reference
<0.001
<0.001
Reference
1.60 - 4.55
2.11 - 6.53
1
Reference
Reference
2.8
<0.001
1.83 - 4.37
1
0.9
2.2
Reference
0.762
0.002
Reference
0.35 - 2.14
1.32 - 3.61
<20 years
1
Reference
Reference
20+ years
2.2
0.002
1.32 - 3.58
Alcohol consumption
Non drinker/within recommended limits/moderately
high
High (>40 units per week or alcohol abuse in chart)
Age at end of latest follow-up
<50 years
50 to 64 years
65+ years
Gender
Female
Male
Genotype
Genotype 1
Genotype 2
Genotype 3
Duration of RNA positivity
Factors associated with severe liver disease in chronically infected
participants-logistic regression model including source of infection (n=725)
Odds Ratio
P-value
95% Confidence
interval
1
Reference
Reference
5.5
<0.001
2.97 - 10.36
1
Reference
Reference
50 to 64 years
2.2
0.003
1.31 - 3.66
65+ years
2.6
0.001
1.47 - 4.55
1
Reference
Reference
Transfusion or renal
2.8
<0.001
1.85 - 4.35
Clotting factors
2.1
0.025
1.09 - 3.93
Genotype 1
1
Reference
Reference
Genotype 2
0.6
0.286
0.25 - 1.51
Genotype 3
1.9
0.016
1.12 - 3.10
<20 years
1
Reference
Reference
20+ years
2.4
0.001
1.47 - 4.02
Factors associated with having severe liver disease
Alcohol consumption
Non drinker/within recommended limits/moderately high
High (>40 units per week or alcohol abuse in chart)
Age at end of latest follow-up
<50 years
Source of infection
Anti-D
Genotype
Duration of RNA positivity
Treatment courses by type of treatment and
percentage sustained virological response, 1992-2009
60
80
60
40
50
30
40
30
20
20
10
10
0
0
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
Year of commencement of treatment
Monotherapy with IFN or Peg-IFN
Combination therapy with Peg-IFN & RBN
Combination therapy with IFN & RBN
% SVR
% SVR
Number of treatment courses
70
50
Percentage sustained virological response for
treatment-naïve participants treated with
combination therapy with Peg-IFN and RBN (n=124), by
genotype and duration of therapy
90
80
80
75
68.2
70
57.1
% SVR
60
50
50
40
30
20
10
0
<24 weeks
Treated =19
24-47 weeks
Treated =28
48+ weeks
Treated =36
<24 weeks
Treated = 22
Genotype 1
24-47 weeks
Treated =15
Genotypes 2 or 3
Genotype and duration of treatment
48+ weeks
Treated =4