Transcript 1 - CADTH

Treatment Outcomes for Chronic Hepatitis C Infection with
Direct Acting Antivirals among Inmates in Federal Corrections
Smith JM, Boudreau H, Kom E, Tremblay T
Health Services, Correctional Services Canada
Disclosure
I am a federal public servant employed at the
Correctional Service Canada. My
responsibilities include the epidemiological
analysis of treatment data and providing
advice on policy and programs to senior
management.
I have no actual or potential conflict of interest
in relation to this topic or presentation.
Presentation Outline
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3.
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Overview of CSC
HCV Epidemiology in CSC
CSC Formulary
HCV Treatment - Results
Summary
1: Overview of CSC
Corrections and Conditional Release Act
• Offenders sentenced to 2 years or more are sent to
a federal institution to serve their sentence
• Under CCRA, CSC provides all essential health care
and access to non-essential mental health services
that conforms to professionally accepted standards.
• In fiscal year 2014-2015:
–
–
–
–
There were 4,871 new warrants of committal issued
15,043 incarcerated offenders on any given day
Total “flow through” of 22,958 inmates
80% of offenders had a sentence length of 2-5 years
(Source: CSC Report on Plans and Priorities 2015-16)
(Source: Corporate Reporting System, Inmate Movement and Admissions Models, April 2016)
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1: Overview of CSC
CSC Regions
(Moncton)
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2: HCV Epidemiology in CSC
HIV and HCV Testing on Admission
100.0%
90.0%
80.0%
PERCENT
70.0%
60.0%
50.0%
40.0%
30.0%
20.0%
10.0%
0.0%
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
HIV 37.1% 41.2% 55.7% 48.6% 47.9% 50.2% 52.1% 50.6% 59.4% 55.2% 64.5% 78.1% 88.5% 78.6%
HCV 36.8% 44.5% 55.5% 46.9% 47.0% 49.1% 49.4% 49.6% 58.9% 53.5% 62.2% 71.0% 89.9% 79.6%
Preliminary Unpublished Data, CSC 2014
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2: HCV Epidemiology in CSC
Newly Diagnosed HCV on Admission
Newly Diagnosed HCV Infections
160
250
140
120
200
100
150
80
60
100
40
50
20
0
2000
NEWLY Dx HCV 244
Diagnostic Yield 154
7
2001
195
102
2002
226
98
2003
220
111
2004
254
122
2005
178
75
2006
193
77
2007
113
47
2008
140
49
2009
137
50
2010
113
34
2011
138
39
2012
134
35
2013
177
37
0
Diagnostic Yield (per 1,000 Tests)
180
300
2: HCV Epidemiology in CSC
Year-end HCV Prevalence by Gender
Year-end HCV Prevalence among Inmates in CSC 2000-2013 by Gender
45.0%
Year-end Prevalence
40.0%
35.0%
30.0%
25.0%
20.0%
15.0%
10.0%
5.0%
0.0%
2000
FEMALE 42.4%
MALE
19.7%
TOTAL
20.1%
2001
41.2%
23.2%
23.6%
2002
38.6%
25.5%
25.8%
2003
37.0%
26.5%
26.8%
2004
37.6%
24.8%
25.2%
2005
39.5%
29.0%
29.3%
FEMALE
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2006
36.0%
27.3%
27.6%
2007
42.1%
32.3%
32.7%
MALE
2008
34.9%
30.0%
30.2%
2009
31.8%
24.7%
25.0%
TOTAL
2010
32.1%
23.7%
24.0%
2011
33.5%
21.6%
22.1%
2012
24.2%
18.6%
18.8%
2013
24.6%
17.8%
18.1%
2: HCV Epidemiology in CSC
Number of Inmates Initiated on HCV Treatment
HCV Treatment Initiation
1st Gen
Triple Therapy
Introduced
(e.g. boceprevir +
peginterferon + ribavirin)
400
350
300
250
200
150
100
50
0
# Initiated
9
All oral DAA
Therapy
Introduced
(e.g. Harvoni)
2010-2011
2011-2012
2012-2013
178
246
258
Year
2013-2014
2014-2015
2015-2016
241
142
305
3: CSC Formulary
HCV Treatment and Medications
• Inmates with Hepatitis C infection are referred to an infectious disease
specialist for consultation about treatment. Treatment for Hepatitis C is
voluntary and managed by the medical specialist.
• CSC National Formulary criteria are based on recommendations from the
Common Drug Review (CDR) of the Canadian Agency for Drugs and
Technologies in Health (CADTH) and the CSC National Pharmacy and
Therapeutics (NP&T) Committee.
• CSC listed the new all-oral Hepatitis C therapies on the CSC National
Formulary:
– Sovaldi (January 2015)
– Harvoni (March 2015)
– Holkira Pak (September 2015)
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3: CSC Formulary
HCV Treatment and Medications
• CSC criteria originally aligned with CDR recommendations on fibrosis (F2F4)
• In August 2015 CSC adopted a strategy of prioritizing treatments to
fibrosis F3-F4 (those with highest severity)
• A review process is in place to consider lower levels of fibrosis on an
exceptional case-by-case basis (i.e., F2 with extrahepatic complications)
• This approach was not unique to CSC. The U.S. Federal Bureau of Prisons
adopted a similar strategy
• As of April 1 2016 the prioritization has been lifted, criteria revert to F2-F4
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4: HCV Treatment - Results
Methods
Inmates initiated on HCV treatment are tracked
in an electronic database. Information collected
includes:
–
–
–
–
–
Genotype
Fibrosis
Treatment History
Treatment regimen / duration
Treatment status (discontinued, released on treatment,
completed)
– HCV RNA (end of treatment, 12 / 24 weeks post treatment)
– Treatment outcome (treatment failure, relapse, sustained viral
response)
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4: HCV Treatment - Results
Methods
• Information from the treatment registry were extracted for analysis on
April 5th 2016
– Includes initiations from February 1st 2015 to April 5, 2016
– Inmates with Genotype 1 (G1) on PI (boceprevir, telaprevir, or simeprevir)
were excluded
– Inmates on dual therapy (peginterferon + ribavirin) were excluded
• Descriptive demographic data
• Treatment status and outcome were analyzed by genotype
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4: HCV Treatment - Results
Demographics
• N=312 records were extracted for analysis
– Average age:
– Female:
– Aboriginal:
14
49 years (min: 25 max: 74)
4.4%
28.4%
4: HCV Treatment - Results
Treatment History
Of the 312 treatment initiations
• Treatment History available for n=275 (88%)
– 181 (66%) were treatment naïve
– 94 (34%) were re-treatments
• 49 null responders
• 9 partial responders
• 36 relapsers
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4: HCV Treatment - Results
Genotype
Genotype
Frequency
Proportion
G1
260
83%
G2
9
3%
G3
42
13%
G4
1
<1%
TOTAL
G1 includes coinfected patients (n=4)
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312
4: HCV Results: G1 (n=261)
Treatment Regimen by Fibrosis
Number of Treatment Starts*
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Fibrosis
Harvoni
Sovaldi
Holkira
Pak
Total
F0
0
0
0
0
F1
2
1
0
3
F2
32
5
0
37
F3
84
5
5
94
F4
113
7
5
125
Total
233**
18
10
261**
N=312
*Includes G1 co-infected (n=4) and G4 (n=1)
** Includes missing fibrosis (n=2)
4: HCV Results: G1 (n=261)
Treatment Outcome by Regimen
Outcome
Harvoni
Sovaldi
Initiated
233
18
Still On Treatment
44
1
Treatment Ended
189
17
Released on Treatment
6
2
Discontinued
5
1
178 (94%)
14 (82%)
107 (96%)
6 (86%)
SVR Not Achieved
4
1
SVR N/A
67
7
Completed
SVR Achieved
18
N=312
Holkira Pak (n=10) not shown as starts are too
recent (no completions)
4: HCV Results: G1 on Harvoni (n=233)
Treatment Outcome by Treatment History
Tx Naive
Outcome
8 weeks
12 weeks
12 weeks
+RBV
24 weeks
44
91
37
36
Still On Treatment
7
18
4
10
Treatment Ended
37
73
33
21
Released on Treatment
0
3
0
1
Discontinued
1
3
0
0
36 (97%)
67 (92%)
33 (100%)
20 (95%)
18 (95%)
47 (94%)
21 (100%)
12 (100%)
SVR Not Achieved
1
3
0
0
SVR N/A
17
17
12
8
Initiated
Completed
SVR Achieved
19
Tx Experienced
N=312
* Missing treatment history (n=25)
4: HCV Results: G1 on Harvoni (n=233)
Treatment Outcome by Fibrosis
Outcome*
Initiated
F0-F2
34
F3
84
F4
113
Still On Treatment
5
20
17
Treatment Ended
29
64
96
Released on Treatment
1
1
4
Discontinued
1
0
4
27 (93%)
63 (98%)
88 (92%)
17 (89%)
35 (97%)
55 (98%)
SVR Not Achieved
2
1
1
SVR N/A
8
27
32
Completed
SVR Achieved
N=312
* Missing fibrosis (n=2)
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4: HCV Results: G1 (n=261)
Treatment Outcome Summary
• Majority of patients had moderate or severe fibrosis
(83% with F3 / F4)
• Majority of patients with G1 were treated with Harvoni
• Discontinuation (n=6, 2%) was seen infrequently
– 4 of 6 due to non-adherence (1 due to side effects, 1 unknown)
• Early preliminary results indicate overall treatment success of
SVR 113/118 (96%)
– Non-SVR observed among treatment naïve
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4: HCV Results: G2&G3 (n=51)
By Fibrosis
Fibrosis
N=312
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Number of Sovaldi Treatment Starts
G2
G3
Total
F0
0
1
1
F1
1
2
3
F2
4
3
7
F3
3
5
8
F4
1
31
32
Total
9
42
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4: HCV Results: G2&G3 (n=51)
Treatment Outcome by Genotype
Sovaldi
G2 (12wks) G3 (24wks)
Outcome
Initiated
9
42
Still On Treatment
2
10
Treatment Ended
7
32
Released on Treatment
0
3
Discontinued
0
3
7 (100%)
26 (81%)
4 (100%)
14 (88%)
SVR Not Achieved
0
2
SVR N/A
3
10
Completed
SVR Achieved
N=312
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HCV Results: G2&G3 on Sovaldi (n=51)
Treatment Outcome by Fibrosis
Outcome
Initiated
F0-F2
11
F3
8
F4
32
Still On Treatment
1
2
9
Treatment Ended
10
6
23
Released on Treatment
0
1
2
Discontinued
1
0
2
9 (90%)
5 (83%)
19 (83%)
7 (100%)
3 (100%)
9 (82%)
SVR Not Achieved
0
0
2
SVR N/A
2
2
8
Completed
SVR Achieved
N=312
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4: HCV Results: G2&G3 (n=51)
Treatment Outcome Summary
• Majority of patients had moderate or severe fibrosis (78% with F3 / F4)
• Discontinuation of treatment (n=3, 4%) very infrequent
– 2 of 3 due to non-adherence (G3 24-wk)
• Early preliminary results based on small numbers indicate overall
SVR 19 / 21 (90%) treatment success with Sovaldi
– Non-SVR associated with G3, F4 patients
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5: Summary
• New all-oral DAA medications are well
tolerated and discontinuation due to side
effects is minimal.
• Treatment outcomes using the new all-oral
DAA medications of 90-95% were observed in
a patient group characterized by moderate to
severe fibrosis.
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Questions?
Jonathan Smith
Manager, Epidemiology Services
613-720-3768
[email protected]
Emily Kom
Epidemiologist
613-992-9856
[email protected]
Harold Boudreau
National Pharmacist
613-996-7437
[email protected]
Tara Tremblay
Operations Supervisor
613-992-8801
[email protected]
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