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 1. 2. 3. 4. 5.

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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Preliminary Unpublished Data, CSC 2014 6

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

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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

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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) 10

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) 12

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:

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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