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David Beking, BHSc, MPH Street Health Centre, Kingston ON Canadian Journal of Gastroenterology (accepted Sept. 2012) Treatment of Hepatitis C among IDUs: A multi- disciplinary care approach

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David Beking, BHSc, MPH Street Health Centre, Kingston ON

Canadian Journal of Gastroenterology (accepted Sept. 2012)

Treatment of Hepatitis C among IDUs: A multi-

disciplinary care approach

“Public health is the answer, what is the question?”

The Problem 170 million people infected worldwide [1]

250,000 in Canada, 111,000 in Ontario [3] A third are unaware they are infected [4]

75% to 80% of incidence due to Injection Drug Use (IDU) [2,5]

80% will develop chronic infection [2]

Treatment of IDUs Research has shown IDUs can adhere to

treatment as well as non-IDU populations and can be successfully treated [6-11]

Current clinical guidelines outline this.

Treatment uptake reaches fewer than 5% of infected IDUs [12]

Barriers to Treatment Active addiction & attendant instability [14]

Lack of access to providers [14]

Homelessness [15-17]

Fear & mistrust [15-17]

Stigmatization [15-17]

Treatment in Kingston (pre-2006)

Hospital-based Specialist-run

Required 6 months abstinence from drug use

Required referral from Family MD

Study Goals Establish treatment program for high-

risk populations served by SHC (IDU, homeless, sex workers)

Demonstrate acceptance and uptake among patients

Demonstrate safety and efficacy of treatment

Questions

Can we optimize social stability before

treatment?

Does a multi-disciplinary health care setting improve treatment of HCV?

HCV Treatment Team Nurse Practitioner – main primary care provider,

refers HCV+ patients, performs pre-treatment GA RN – draws blood, administers pegIFN weekly,

monitors therapy MD with CFPC Hepatitis C Fellowship –

assesses suitability of treatment, orders biopsy (if necessary), prescribes medications.

Psychiatrist – pre-treatment assessment and follow up through treatment with psych. meds as needed

Counselor – conducts ASI, BDI, provides support through treatment

METHODS

Convenience sample of 34 patients with chronic HCV interested in treatment

Enrolled between June 2006 and December 2008

18 years of age or older Current or former drug users Approved by Queen’s REB

Baseline Data Collected

Clinical characteristics: Genotype, liver functions, CBC, liver biopsy (where available)

Patient demographics, IDU history, transmission risk factors, medical & psych Hx

Beck Depression Inventory score Addiction Severity Index

ASI Categories

BECK Depression Index

Initial Assessment

Appointments with Family Physician, Nurse Practitioner, Psychiatrist & Counselor (took place over months)

Housing and income stability addressed (ODSP applications completed)

Readiness for treatment determined at weekly multi-disciplinary team meetings

Treatment Protocol

Weight-based Ribavirin (taken at home) Weekly injections of Peg-Interferon

Alpha 2a or 2b by RN in clinic: 48 weeks for Genotype 1 24 weeks for Genotypes 2 & 3

Monthly appts with FMD, Psychiatrist and Counselor (more frequently if needed)

Data Collected in Treatment Urine Drug Screening (UDS) Self-reported drug use Ribavirin compliance Medication prescribed (psychotropic and

other) BDI and ASI monthly Virological response: RVR @ 4, EVR @

12, ETR @ 24 or 48, SVR @ 24 weeks post Tx

BASELINE Study Population

59% male Median age 42 years All had a history of IDU 90% had been incarcerated 85% were unemployed Three quarters were taking psychotropic

medications Half had a history of having attempted suicide A third were living in unstable housing

Health

Social Exclusion

Unemployment and Job Security

Housing

Income and Income

Distribution

Health Services

Social Safety

Net

Social Determinants of Health

BASELINE Characteristics

Treatment (n=14) Not treated (n=20)

Length at current address (months)

21* 4*

Common-law or married

4(27%) 2(13%)

On ODSP 9(57%) 4(23%)

IDU in last 6 months 4(30%) 8(50%)

On MMT 8(61%) 11(55%)

*p=0.04

RESULTS HCV Treatment Outcomes

14 patients initiated

treatment (9 G1)

11 achieved ETR (7 G1)

8 achieved SVR (4 G1)

4 had viral relapse

3 failed to achieve ETR

1 dropped out early due to

adverse events (G1)

Harm Reduction 10 subjects had shared needles before treatment;

only 1 did so after treatment started.

8 reported sharing water, 9 shared spoons, 6 shared filters before treatment; none did so after treatment.

7 had shared straws or bills for inhaling drugs; none did so after commencement.

Reliability of self-reporting # & gender Weeks

completed Drug use ? UDS+ %

compliance response

1 F 48 Yes Yes 98.2 SVR

2 M 48 No No 100 SVR

3 M 20 relapse Yes No 97.1 N/A

4 M 13 No Yes 100 SVR

5 F 22 ΨA/E No Yes 99 SVR

6 M 33 Yes Yes 96 ETR

7 F 9 med. A/E No No 97.4 N/A

8 F 24 No No 97 SVR

9 F 24 Yes Yes 76 SVR

10 M 12 No No 100 ETR

11 M 11 med. A/E No No 99.8 ETR

12 F 48 Yes Yes 99.8 SVR

13 F 39 null resp. Yes Yes 100 N/A

14 M 24 No No 100 SVR

LIMITS

Small sample size – pilot study

Not generalizable to other populations and centres

Reliance on self-reported data may lead to recall bias

CONCLUSIONS Treatment of high-risk, marginalized patients is

possible in carefully designed, intensive model Multidisciplinary collaborative care model

allows for optimization of social stability before initiating treatment

Patients in treatment show signs of decreasing high-risk behaviors during therapy

Benefits of treatment may extend beyond narrowly defined virological outcomes

FUTURE STUDY

Large scale prospective study

Provincial wide

Durability of reduction in harm-related

behaviours needs long-term follow-up

References [1] Schaefer M, Heinz A, Backmund M. Treatment of chronic hepatitis C in patients with drug

dependence: time to change the rules? Addiction 2004 Sep:99(9):1167-75. [2] Grebely J, deVlaming S, Duncan F, Viljoen M, Conway B. Current approaches to HCV infection in

current and former injection drug users. J Addict Dis. 2008;27(2):25-35. [3] Public Health Agency of Canada. http://www.phac-aspc.gc.ca/hepc/index-eng.php. Accessed March

23, 2009. [4] Ontario Ministry of Health and Long-term Care. Health Care Professionals. Hepatitis C.

http://www.health.gov.on.ca/english/providers/program/hepc/hepc_mn.html. Accessed March 23, 2009. [5] Remis RS. The epidemiology of hepatitis C infection in Ontario, 2004: final report. Toronto: Hepatitis

C Secretariat, Ontario Ministry of Health and Long-Term Care. January 2007 [6] Backmund M, Meyer K, von Zielonka M, & Eichenlaub, D. Treatment of hepatitis C infection in

injection drug users. Hepatology 2001;34:188-183. [7] Edlin BR. Hepatitis C prevention and treatment for injection drug users. Hepatology 2002;36(Suppl

1):S210-219 [8] Van Thiel DH, Anantharaju A, Creech S. Response to treatment of hepatitis C individuals with a

recent history of intravenous drug abuse. Am J Gastroenterol 2003; 98(10): 2281-2288. [9] Cournot M, Glibert A, Castel F, Druart F, Imani K, Lauwers-Cances V, Morin T. Management of

hepatitis C in active drug users: experience of an addiction care hepatology unit. Gastroenterol Clin Biol. 2004 Jun-Jul;28(6-7 Pt 1):533-9.

[10] Sylvestre DL, Clements BJ,. Adherence to hepatitis C treatment in recovering heroin users maintained on methadone. Eur J Gastroen Hepatol 2007; 19(9): 741-747.

References (2) [11] Bruggmann P, Falcato L, Dober S, Helbling B, Keiser O, Negro F, Meili D; Swiss Hepatitis C

Cohort Study. Active intravenous drug use during chronic hepatitis C therapy does not reduce sustained virological response rates in adherent patients. J Viral Hepat. 2008 Oct;15(10):747-52.

[12] Fischer B, Kalousek K, Rehm J. et al. Hepatitis C, illicit drug use public health – Does Canada really have a viable plan? Can J of Public Health. 2006;97:485-488.

[14] Cooper CL. Obstacles to successful HCV treatment in substance addicted patients. J Addict Dis. 2008;27(2):61-8.

[15] Edlin BR, Kresina,TF, Raymond DB, Carden MR, Gourevitch MN, Rich JD, Cheever LW, & Cargill VA. Overcoming barriers to prevention, care, and treatment of hepatitis C in illicit drug users. Clin Infect Dis 2005; 40: S276-S285.

[16] Newman A, Mackenzie M & Shore R. Hepatitis C and injection drug use: treatment is possible. Ont Med Rev 2007;74:33-36.

[17] Zevin B. Managing chronic Hepatitis C in primary-care settings: more than antiviral therapy. Public Health Reports 2007;122(suppl 2):78-82.