1. 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

2. 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.

3. Presentation Outline Overview of CSC HCV Epidemiology in CSC
CSC Formulary
HCV Treatment - Results
Summary

4. 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 :
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 )
(Source: Corporate Reporting System, Inmate Movement and Admissions Models, April 2016)

5. 1: Overview of CSC CSC Regions
(Moncton)

6. 2: HCV Epidemiology in CSC HIV and HCV Testing on Admission
Preliminary Unpublished Data, CSC 2014

7. 2: HCV Epidemiology in CSC Newly Diagnosed HCV on Admission

8. 2: HCV Epidemiology in CSC Year-end HCV Prevalence by Gender

9. 2: HCV Epidemiology in CSC HCV Treatment Initiation
All oral DAA Therapy Introduced
(e.g. Harvoni)
1st Gen Triple Therapy Introduced
(e.g. boceprevir +
peginterferon + ribavirin)

10. 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)

11. 3: CSC Formulary HCV Treatment and Medications
CSC criteria originally aligned with CDR recommendations on fibrosis (F2- F4)
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 the prioritization has been lifted, criteria revert to F2-F4

12. 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)

13. 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

14. 4: HCV Treatment - Results Demographics
N=312 records were extracted for analysis
Average age: 49 years (min: 25 max: 74)
Female: 4.4%
Aboriginal: 28.4%

15. 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
Compares to 17% retreatment pre interferon-free regimens
Compares with 12 / 229 (5%) were reinfection pre interferon-free regimens

16. 4: HCV Treatment - Results Genotype
Frequency
Proportion G1
260
83% G2 9 3% G3 42
13% G4 1
<1%
TOTAL
312
G1 includes coinfected patients (n=4)

17. 4: HCV Results: G1 (n=261) Treatment Regimen by Fibrosis
Number of Treatment Starts*
Harvoni
Sovaldi
Holkira Pak
Total F0 F1 2 1 3 F2 32 5 37 F3 84 94 F4
113 7
125
233** 18 10
261**
N=312
*Includes G1 co-infected (n=4) and G4 (n=1)
** Includes missing fibrosis (n=2)

18. 4: HCV Results: G1 (n=261) Treatment Outcome by Regimen
Harvoni
Sovaldi
Initiated
233 18
Still On Treatment 44 1
Treatment Ended
189 17
Released on Treatment 6 2
Discontinued 5
Completed
178 (94%)
14 (82%)
SVR Achieved
107 (96%)
6 (86%)
SVR Not Achieved 4
SVR N/A 67 7
N=312
Holkira Pak (n=10) not shown as starts are too recent (no completions)

19. 4: HCV Results: G1 on Harvoni (n=233) Treatment Outcome by Treatment History
Tx Naive
Tx Experienced
8 weeks
12 weeks
12 weeks +RBV
24 weeks
Initiated 44 91 37 36
Still On Treatment 7 18 4 10
Treatment Ended 73 33 21
Released on Treatment 3 1
Discontinued
Completed
36 (97%)
67 (92%)
33 (100%)
20 (95%)
SVR Achieved
18 (95%)
47 (94%)
21 (100%)
12 (100%)
SVR Not Achieved
SVR N/A 17 12 8
N=312
* Missing treatment history (n=25)

20. 4: HCV Results: G1 on Harvoni (n=233) Treatment Outcome by Fibrosis
F0-F2 F3 F4
Initiated 34 84
113
Still On Treatment 5 20 17
Treatment Ended 29 64 96
Released on Treatment 1 4
Discontinued
Completed
27 (93%)
63 (98%)
88 (92%)
SVR Achieved
17 (89%)
35 (97%)
55 (98%)
SVR Not Achieved 2
SVR N/A 8 27 32
N=312
* Missing fibrosis (n=2)

21. 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

22. 4: HCV Results: G2&G3 (n=51) By Fibrosis
Number of Sovaldi Treatment Starts G2 G3
Total F0 1 F1 2 3 F2 4 7 F3 5 8 F4 31 32 9 42 51
N=312

23. 4: HCV Results: G2&G3 (n=51) Treatment Outcome by Genotype
Sovaldi
G2 (12wks)
G3 (24wks)
Initiated 9 42
Still On Treatment 2 10
Treatment Ended 7 32
Released on Treatment 3
Discontinued
Completed
7 (100%)
26 (81%)
SVR Achieved
4 (100%)
14 (88%)
SVR Not Achieved
SVR N/A
N=312

24. HCV Results: G2&G3 on Sovaldi (n=51) Treatment Outcome by Fibrosis
F0-F2 F3 F4
Initiated 11 8 32
Still On Treatment 1 2 9
Treatment Ended 10 6 23
Released on Treatment
Discontinued
Completed
9 (90%)
5 (83%)
19 (83%)
SVR Achieved
7 (100%)
3 (100%)
9 (82%)
SVR Not Achieved
SVR N/A
N=312

25. 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

26. 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.

27. Operations Supervisor
Questions?
Jonathan Smith Manager, Epidemiology Services Harold Boudreau National Pharmacist
Emily Kom
Epidemiologist
Tara Tremblay
Operations Supervisor