Treatment of Hepatitis C. David Beking, BHSc, MPH Street Health Centre, Kingston ON Canadian Journal of Gastroenterology (accepted Sept.

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

2 Public health is the answer, what is the question?

3 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]

4 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]

5 Barriers to Treatment Active addiction & attendant instability [14] Lack of access to providers [14] Homelessness [15-17] Fear & mistrust [15-17] Stigmatization [15-17]

6 Treatment in Kingston (pre-2006) Hospital-based Specialist-run Required 6 months abstinence from drug use Required referral from Family MD

7 Study Goals Establish treatment program for highrisk populations served by SHC (IDU, homeless, sex workers) Demonstrate acceptance and uptake among patients Demonstrate safety and efficacy of treatment

8 Questions Can we optimize social stability before treatment? Does a multi-disciplinary health care setting improve treatment of HCV?

9 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

10 METHODS Convenience sample of 34 patients with chronic HCV interested in treatment Enrolled between June 2006 and December years of age or older Current or former drug users Approved by Queen s REB

11 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

12 ASI Categories

13 BECK Depression Index

14 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

15 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)

17 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: 4, 12, 24 or 48, 24 weeks post Tx

18 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

19 Social Determinants of Health Health Health Services Housing Social Exclusion Unemployment and Job Security Income and Income Distribution Social Safety Net

20 BASELINE Characteristics Treatment (n=14) Not treated (n=20) Length at current address (months) Common-law or married 21* 4* 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

21 RESULTS HCV Treatment Outcomes 14 patients initiated treatment (9 G1) 11 achieved ETR (7 G1) 3 failed to achieve ETR 8 achieved SVR (4 G1) 4 had viral relapse 1 dropped out early due to adverse events (G1)

22 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.

23 Reliability of self-reporting # & gender Weeks completed Drug use? UDS+ % compliance 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 response

24 LIMITS Small sample size pilot study Not generalizable to other populations and centres Reliance on self-reported data may lead to recall bias

25 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

26 FUTURE STUDY Large scale prospective study Provincial wide Durability of reduction in harm-related behaviours needs long-term follow-up

27 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): [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): [3] Public Health Agency of Canada. Accessed March 23, [4] Ontario Ministry of Health and Long-term Care. Health Care Professionals. Hepatitis C. Accessed March 23, [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: [7] Edlin BR. Hepatitis C prevention and treatment for injection drug users. Hepatology 2002;36(Suppl 1):S [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): [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 Jun-Jul;28(6-7 Pt 1): [10] Sylvestre DL, Clements BJ,. Adherence to hepatitis C treatment in recovering heroin users maintained on methadone. Eur J Gastroen Hepatol 2007; 19(9):

28 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 Oct;15(10): [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: [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: [17] Zevin B. Managing chronic Hepatitis C in primary-care settings: more than antiviral therapy. Public Health Reports 2007;122(suppl 2):78-82.

HEPATITIS C: CANADIAN CONTEXT

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