Integrating Hepatitis C and Drug Treatment in a Community-Based Setting

1. Integrating Hepatitis C and Drug Treatment in a Community-Based Setting Diana L. Sylvestre, MD O.A.S.I.S. Organization to Achieve Solutions in Substance-Abuse

2. Who we are:

3. A nonprofit organization located in Oakland, CA HIV TB STDs And especially: Hepatitis C Mental Illness Dedicated to addressing addiction-related medical conditions including:

4. “Treatment of patients…who are actively using illicit drugs should be delayed until these habits are discontinued for at least 6 months.” --NIH Consensus Statement on HCV, 1997

6. The O.A.S.I.S. Group Model

7. One Stop Shopping

8. Peer-based education

9. Support

10. Contemporaneous medical intervention

11. Requirements • Honesty • Show up on time • Respect • Peers • Staff

12. O.A.S.I.S. HCV Patients • >2,000 patients screened to date • Mean age 46 (16-76) • 56% male • Race: • 48% Caucasian • 28% African American • 17% Latino

13. Drug Use at Engagement • At engagement: • 35% are using heroin • 22% currently using cocaine • 13% currently using methamphetamines • 36% are drinking alcohol • 42% on MMT • 61% report a pre-existing psychiatric condition

14. Studies • IFN/Ribavirin in methadone patients • PEG-IFN/Riba in methadone patients • Neuropsychiatric monitoring during HCV treatment: building a better Beck • Buprenorphine to transition street-recruited heroin users to HCV treatment • Development of a video-based HCV curriculum for in- and out- of treatment IDUs

15. HCV Treatment in Methadone Patients • Multicenter study: • Subsites: Gourevitch/Litwin, Bronx, NY A. Williams, Philadelphia, PA • IFN alfa-2b 3mu tiw, ribavirin 1000-1200 qd • Standard monitoring • Group encouraged • Treatment criteria • Interested MMT with active HCV • Reliable attendance

16. Study Subjects (n=76) • 50 yr • 47 (62%) male • 45 (59%) self-reported psychiatric illness • 23 (30%) had been abstinent < 6mo

17. Substance Use History • Median lifetime heroin use = 20 yr (3-50) • 27/65 (42%) history of regular cocaine use • Median 3 yr (1-30) • 27/65 (42%) history of regular methamphetamine use • Median 5 yr (1-41) • 41/65 (63%) history of regular MJ use • Median 10 yr (1-46) • 44/69 (64%) history of heavy alcohol use • Median 12 yr (1-43)

18. Substance Use Behaviors • 15 (20%) drank EtOH during treatment • 27 (36%) used heroin, cocaine, or methamphetamine during treatment • 45 (61%) used any illicit drug during treatment • 33 (45%) increased methadone dose by median of 15 mg (0-180)

19. Overall Impact of Barriers on Virologic Outcomes p=0.035

20. Duration of Abstinence vs HCV Treatment Outcomes p=0.18 n=53 n=76 n=23

21. Drug Use vs HCV Treatment Outcomes p=0.09 n=49 n=8 n=19

22. Impact of MJ Use on HCV Treatment (p=0.006) n=23 n=74 n=51

24. The Impact of Preexisting Psychiatric Disease p=0.01 n=31 n=76 n=45

25. Drug Use vs. Adherence

26. Factors Contributing to Adherence

27. Study 2 PEG-IFN/Riba in Methadone-maintained patients

28. PEG Preliminary Outcomes (n=30)

29. Caution:Site-based differences in outcomes

30. Study 3 Bridging Active Heroin Users to HCV Treatment with Buprenorphine

31. Study Design

32. RelevanceAll Screened: n=299

33. Engagement By Race/Ethnicity

34. Preliminary Treatment Retention (n=92)

35. Self-reported Drug Use

36. Self-reported Drug Use

37. Urine Toxicology

38. Study 4: Neuropsychiatric Monitoring During HCV Treatment

39. Pilot Study Design • 40 patient, double-blind • Patients randomized to: • PegIFN alfa-2a plus riba • PegIFN alfa-2b plus riba • Tools: BDI, POMS, HADS, SF-36, MMSE qmo. • Main goal: to look for individual measures that might be predictive of useful outcomes • Secondary goal: to assess whether true differences exist btw the 2 interferons

40. The Data Looks Fine Sylvestre D, unpublished data

41. BDI vs Reported Symptoms Psychiatric Symptoms Reported: Depressed Irritable Anxious None Treatment Week

42. BDI vs Discontinuation Completed Treatment vs Dropouts Treatment Week

43. Study 5: A Video-based HCV Curriculum for IDUs

44. Aims • Improve knowledge • Improved attitudes toward change • Improve motivations toward healthy behaviors • Short and long term • In- and out-of-treatment drug users

45. Current O.A.S.I.S. HCV Curriculum • 4 short peer-based videos • Companion workbook • Positive, educational, upbeat

46. Study Design • Year 1: Curriculum development • 2 cohorts • In-treatment drug users on methadone maintenance • Out of treatment drug users at syringe exchange • Single session vs multi-session • Standard-of-care comparator • KAM test: before and after

47. “HCV therapy has been successful even when the patients have not abstained from continued drug or alcohol use... Thus, it is recommended that treatment of active injection drug use be considered on a case-by-case basis, and that active injection drug use in and of itself not be used to exclude such patients from antiviral therapy.” --NIH Consensus Statement on HCV, 2002

49. Additional Comments • Highly efficient • Not all that hard • Multidisciplinary medical training • ID • Addiction • Psychiatry • BEHAVIOR

50. Deborah Greene, MD Chris McNeil Many patient volunteers Larry Galindo Tim Maginnis Gerard Wallace Barry Clements, PA-C Alice Asher Laphyne Barrett Beth Klem Lisa Hartfield EBCRP TCHC HEPPAC Acknowledgements