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2007.01.03.Hrc.Ppt.V.5.Ibogaine.Org Presentation Transcript

  • 1. Hepatitis C Treatment Among Community-Recruited Active Drug Users: Establishing a Collaborative, Multidisciplinary Model of Care Michael R. Carden Brian R. Edlin Center for the Study of Hepatitis C Weill Medical College of Cornell University 6 th National Harm Reduction Conference Oakland, CA November 9, 2006
  • 2. Persons Who Inject Drugs: the Core of the Hepatitis C Epidemic
    • Largest group of infected persons
    • Source of most HCV transmission
    • Highest prevalence (80%-90%)
    • Highest incidence (10%-30% per year)
    • Developing, testing, and implementing prevention and treatment strategies effective with drug users are critical
    • Few IDUs are in care; fewer receive treatment
    • Until 2002, NIH guidelines recommended against rx
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University
  • 3. Persons Who Inject Drugs : the Invisible Core of the Hepatitis C Epidemic
    • Epidemiology: Undercounted
    • ► Incidence ► Prevalence
    • Basic Science: Understudied
    • ► Acute HCV Infection
    • Treatment: Undertreated
    • ► Clinical Trials ► Clinical Practice
    • Prevention: Underserved
    • ► Outreach ► Counseling and Testing
    • ► Sterile Needle Access ► Substance Abuse Treatment
    • Edlin, Carden. Clin Infect Dis 2006;42(5):673-6
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University
  • 4. Hepatitis C in Persons Using Illicit Drugs: Treatment Policy, United States, 1997
    • NIH Consensus Development Conference Statement on Management of Hepatitis C (24-26 March 1997):
    • “ Treatment of patients who are drinking significant amounts of alcohol or who are actively using illicit drugs should be delayed until these habits are discontinued for at least 6 months.”
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University
  • 5. Center for the Study of Hepatitis C, Weill Medical College, Cornell University
      • NIH Consensus Development Conference Statement on Management of Hepatitis C : 2002
      • Final Statement released September 10, 2002
      • Treatment
      • Treatment decisions for active IDUs on a case-by-case basis
      • Active IDU in and of itself not a reason to exclude patients from antiviral therapy
      • Active IDUs can be successfully treated for hepatitis C
      • Methadone is not a contraindication to HCV treatment
      • Treatment for drug and alcohol dependence should be made available to all patients who want and need it
      • Experts in HCV and substance abuse should collaborate
  • 6. Center for the Study of Hepatitis C, Weill Medical College, Cornell University
      • Treatment of Hepatitis C in Persons Who Use Illicit Drugs
      • NIH Consensus Development Conference Statement on Management of Hepatitis C: 2002
      • The guidelines changed.
      • When will practice change?
  • 7. Treatment of HIV and Hepatitis C in Persons Who Use Illicit Drugs
    • Barriers to Care: Drug Users
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University
    • Poverty
    • Homelessness
    • Addiction
    • Mental health
    • Negative experiences with health care system
    • Mistrust of authorities
    • Unpredictable follow-through
  • 8. Treatment of HIV and Hepatitis C in Persons Who Use Illicit Drugs
    • Barriers to Care: Physicians
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University
    • Ignorance
    • Inexperience
    • Unrealistic expectations
    • Frustration
    • Negative attitudes
    • Moralizing, patient blaming
  • 9. Treatment of HIV and Hepatitis C in Persons Who Use Illicit Drugs
    • Barriers to Care: Lack of available services
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University
    • Comprehensive, continuing primary care
    • Subspecialty care: HIV, HCV
    • Mental health services
    • Substance use services
    • Housing
    • Social services
    • Integrated multidisciplinary models
  • 10. Center for the Study of Hepatitis C, Weill Medical College, Cornell University Treatment of Hepatitis C in Persons Actively Using Illicit Drugs
    • Data are needed on:
    • Successful methods of treating drug users for HCV
    • Critical elements of successful programs
    • Characteristics of patients who can be successfully treated
    • Adherence, side effects, effectiveness, reinfection
    • Pharmacokinetic interactions between HCV medications and illicit drugs and methadone
    • Cost effectiveness
    Research Gaps
  • 11. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs
    • A Pilot Study
    • Objective: To assess the feasibility of treating hepatitis C in persons actively using illicit drugs recruited from the community
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University
    • One million infected persons actively using illicit drugs in U.S. with no access to antiviral treatment for hepatitis C.
  • 12. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs
    • Model
    • Collaborative
      • Community-based needle exchange programs
      • Tertiary care hepatitis C center
    • Multidisciplinary
      • Case Management
      • Hepatitis C specialty care
      • Mental health
      • Primary care
      • Substance abuse treatment
    • Integrated care
      • Staff cross institutional boundaries
      • Tertiary care provided in community-based locations
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University
  • 13. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs
    • Program Design
    • Recruitment: Community, So. Bronx, E. Harlem, Lower East Side
      • Referred from agency staff
      • Community Outreach
    • Eligibility:
      • Age ≥ 18 yrs
      • HCV RNA (+)
      • Heroin, cocaine, methamphetamine in past 30 days
      • I nterested in being evaluated for hepatitis C treatment
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University
  • 14. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs
    • Program Design
    • Initial Meeting:
      • Provide education on:
      • HCV natural history
      • HCV medical evaluation
      • HCV treatment
    • Assess:
      • Motivational factors
      • Potential barriers to follow-through and treatment
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University
  • 15. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs Center for the Study of Hepatitis C, Weill Medical College, Cornell University
    • Program Design
    • Needs Assessment
      • Other medical conditions
      • Mental health
      • Health insurance
      • Housing
      • Income
      • Substance use services
      • Social support
      • Additional supportive services
  • 16. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs
    • Program Design
    • Medical evaluation: lab work, liver biopsy (not required)
    • Psychiatric evaluation
    • Ongoing care coordination and monitoring
      • Assist with securing needed services and benefits
      • Coordinate among providers of multiple disciplines
      • Provide ongoing education, counseling and support
      • Escort participants to appointments
      • Provide directly observed therapy once treatment is initiated
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University
  • 17.
    • Program Design
    • During evaluation period meet with participants at least once every 30 days:
    • Discuss:
      • Drug use
      • Psychosocial functioning
      • Barriers to treatment
      • Progress made on eliminating barriers to treatment, including addressing primary health care issues and obtaining concrete resources
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University Treatment of Hepatitis C in Persons Actively Using Illicit Drugs
  • 18. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs Center for the Study of Hepatitis C, Weill Medical College, Cornell University
    • Recruited (≥18 yo, heroin, cocaine, methamphetamine/30 days) 30
    • HCV RNA-negative (ineligible) 8
    • Enrolled 22
    • (N=22)
    • Median age (IQR) 40 yrs (30-50 yrs)
    • Male 64%
    • Ethnicity White: 50%, African American: 32%, Latino: 23%
    • Homeless in past 6 months 68%
    • Axis I Psychiatric Diagnosis 68%
    • Jail or prison in past 6 months 46%
    • Inpatient drug treatment in past 6 months (incl. detox) 32%
  • 19. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs Center for the Study of Hepatitis C, Weill Medical College, Cornell University
    • Baseline Characteristics (N=22)
            • Mean Median (IQR)
    • Age at first injection (years) 19 18 (16 – 22)
    • Time since first injection (years) 21 19 (10 – 31)
    • Time since initial HCV diagnosis (years) 4.4 3.8 (.7 – 7)
  • 20. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs: Substance Use Center for the Study of Hepatitis C, Weill Medical College, Cornell University
    • Baseline Characteristics (N=22)
    • Injected drugs in past 30 days 77% (17)
    • Injected heroin in past 30 days 64% (14)
    • Injected cocaine in past 30 days 50% (11)
      • Median # injections in past 30 days (N=17) 30 (IQR, 9 – 123)
      • Median # injections in past 6 months (N=19) 168 (IQR, 42 – 897)
    • Smoked crack in past 30 days 36% (8)
      • Median # days smoked crack
      • in past 30 days (N=8) 10 (IQR, 4 – 19)
    • Drank ≥ 5 drinks > 1x in past 30 days 41% (9)
  • 21. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs Center for the Study of Hepatitis C, Weill Medical College, Cornell University
    • Baseline Characteristics (N=22)
    • Methadone maintenance Rx 77% (17)
    • Ever tested HCV antibody negative 23% (5)
    • HCV antibody negative in last 12 mos. 9% (2)
    • HCV genotype 1 73% (16)
    • HCV Viral Load ≥ 800,000 IU/mL 68% (15)
  • 22. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs Center for the Study of Hepatitis C, Weill Medical College, Cornell University
    • Liver Biopsy (N=22)
    • Biopsy (study) 64% (14)
    • Biopsy (< 3 years ago) 5% (1)
    • Acute HCV infection 9% (2)
    • Relocated 5% (1)
    • Declined Biopsy 18% (4)
      • (3 of the 4 had genotype 2 HCV)
  • 23. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs Center for the Study of Hepatitis C, Weill Medical College, Cornell University Liver Biopsy: Fibrosis Stage (N=15) No. of participants
  • 24. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs: Current Outcomes Center for the Study of Hepatitis C, Weill Medical College, Cornell University Eligible for Treatment n = 16 Sample N = 30 RNA Negative n = 8 RNA Positive n = 22 Liver Biopsy n = 15 Decided Against Treatment n = 7 Initiated HCV Treatment n = 9 Relocated n = 2 Incarcerated n = 1 Head Injury n = 1 In Evaluation n = 2
  • 25. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs
    • Treatment (N=22)
    • Left NYC 2 (9%)
    • Incarcerated 1 (5%)
    • Head injury 1 (5%)
    • Currently undergoing evaluation 2 (9%)
    • Completed evaluation and available for f/u 16 (73%)
    • (N=16)
    • Initiated peginterferon/ribavirin 9 (56%)
    • Opted to defer 7 (44%)
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University
  • 26. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs
    • Participants’ self-reported reasons for deferring treatment* (N=7)
    • More urgent needs at present 5 (71%)
    • Homeless/unstable housing 4 (57%)
    • Concerned about medication side effects 2 (29%)
    • Concerned drug use would interfere w/adherence 2 (29%)
    • Mental health concerns 1 (14%)
    • Mild fibrosis (on biopsy) 1 (14%)
    • Perceived mild fibrosis (no biopsy) 1 (14%)
    • *Mean = 2.3 reasons per participant
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University
  • 27. Significant Depression Before and During Treatment By Peak Beck Depression Inventory (BDI) Scores Center for the Study of Hepatitis C, Weill Medical College, Cornell University Moderate Severe Before Treatment Severe Moderate At Treatment Initiation Severe Moderate On Treatment N=8 # of Participants Depression Category (Beck Depression Inventory) 0 0
  • 28. Center for the Study of Hepatitis C, Weill Medical College, Cornell University Mean Depression Scores (BDI) Before and During Treatment Moderate Depression 19 28 * * * Multiple administrations per participant, approximately every 30 days (N=8)
  • 29. Depression Scores (BDI) Before, During and After Treatment (N=8) Center for the Study of Hepatitis C, Weill Medical College, Cornell University BDI Score Weeks Moderate Depression Severe Depression Start Treatment Before and On Peg/Riba Off Peg/Riba
  • 30. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs
    • Tolerability (N=8*)
    • Side effects:
      • fatigue (n=6) ► nausea (n=2)
      • loss of appetite (n=5) ► depression (n=3)
      • difficulty sleeping (n=3) ► skin rash (n=3)
      • difficulty concentrating (n=3) ► hair loss (n=2)
    • Rx epoetin-alfa (anemia) 5 (63%)
    • Rx filgrastim (neutropenia) 5 (63%)
    • Rx anti-D (thrombocytopenia) 1 (13%)
    • Rx psych meds before HCV treatment 2 (23%)**
    • Rx psych meds during HCV treatment 2 (29%)
    • Dose reductions 1 (13%)
    • Drug discontinuations 2 (25%)
    *Excludes one patient lost to follow-up after 1 week ** (N=9)
  • 31. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs Center for the Study of Hepatitis C, Weill Medical College, Cornell University
    • Adherence (N=8*)
    • Methods: self-report (n=8), directly observed therapy (n=4)
    • Mean adherence** (range):
    • Interferon injections *** 98% (92-100%)
    • Oral ribavirin 93% (82-100%)
    • Epoetin-alfa, filgrastim injections 96% (79-100%)
    * Excludes one participant lost to follow-up after 2 weeks ** Percent of prescribed doses taken *** Percent of Interferon doses taken < 10 days from previous dose
  • 32. Center for the Study of Hepatitis C, Weill Medical College, Cornell University G1 G3 G1 G1 G1 G2 G1, Acute 0 8 16 20 24 28 32 21, W, F 35, L, M 50, W, M 45, AA, M 51, AA, F 36, W, F 19, L, F 33, L, M Participants (Age, Ethnicity, Gender) Weeks RVR = Rapid Virologic Response EVR = Early Virologic Response ETR = End of Treatment Response EVR EVR EVR RVR RVR RVR Interim Virologic Outcomes of Hepatitis C Treatment in Persons Actively Using Drugs (N=9) EVR 4 12 36 40 44 48 NR NR = No Virologic Response D/C D/C EVR RNA (-) RNA (-) RNA (-) RNA (+) RNA (+) ETR ETR G1 53, AA, M 24-week follow-up Peg/riba SVR SVR = Sustained Virologic Response Lost to f/ u ETR G3 EVR ETR ETR EVR SVR RNA (-) RNA (-)
  • 33.
    • Illicit Drug Use (N=8 * )
    • Stopped using heroin/cocaine 4 (50%)
    • Stopped using daily 1 (13%)
    • Stopped or reduced 5 (63%)
    Treatment of Hepatitis C in Persons Actively Using Illicit Drugs Center for the Study of Hepatitis C, Weill Medical College, Cornell University *Excludes one patient lost to follow-up after 2 weeks
  • 34. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs
    • Conclusions
    • A large proportion of active illicit drug users chose antiviral treatment despite considerable barriers and ongoing active drug use.
    • They have tolerated the medications well.
    • Responses to treatment have been favorable thus far.
    • Treating active drug users for hepatitis C appears to be feasible using a collaborative, multidisciplinary, integrated care model.
    • Treating active drug users for hepatitis C may serve as a bridge to healthier behaviors in other domains as well.
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University
  • 35. Center for the Study of Hepatitis C, Weill Medical College, Cornell University
      • NIH Consensus Development Conference Statement on Management of Hepatitis C : 2002
      • Final Statement released September 10, 2002
    • Collaboration
    • A comprehensive approach to collaboration among addiction professionals, primary care physicians, and hepatitis C specialists to deal with the complex societal, medical, and psychiatric issues of IDUs afflicted by the disease.
  • 36. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs
    • The Participants
    • Citiwide Harm Reduction (George Santana, Raffi Torruella, Nancy Estrada)
    • Lower East Side Harm Reduction Center (Andrea Lindstrom)
    • New York Harm Reduction Educators (Donald Davis, Vanilla)
    • Andrew H. Talal
    • Elizabeth V. Getter
    • Jessica R. Daniels
    • Marla A. Shu
    • NIH grants R01-DA09532, R01-DA16159 and M01-RR00047
    Center for the Study of Hepatitis C, Weill Medical College, Cornell University