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Hepatitis C Treatment Among Community-Recruited Active Drug Users: Establishing a Collaborative, Multidisciplinary Mod

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

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Hepatitis C Treatment Among Community-Recruited Active Drug Users: Establishing a Collaborative, Multidisciplinary Mod

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  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 6th 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. 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 Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  6. 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? Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  7. Treatment of HIV and Hepatitis C in Persons Who Use Illicit Drugs Barriers to Care: Drug Users • Poverty • Homelessness • Addiction • Mental health • Negative experiences with health care system • Mistrust of authorities • Unpredictable follow-through Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  8. Treatment of HIV and Hepatitis C in Persons Who Use Illicit Drugs Barriers to Care: Physicians • Ignorance • Inexperience • Unrealistic expectations • Frustration • Negative attitudes • Moralizing, patient blaming Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  9. Treatment of HIV and Hepatitis Cin Persons Who Use Illicit Drugs Barriers to Care: Lack of available services • Comprehensive, continuing primary care • Subspecialty care: HIV, HCV • Mental health services • Substance use services • Housing • Social services • Integrated multidisciplinary models Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  10. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs Research Gaps 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 Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  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 • One million infected persons actively using illicit drugs in U.S. with no access to antiviral treatment for hepatitis C. Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  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 Interested 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 Program Design Needs Assessment • Other medical conditions • Mental health • Health insurance • Housing • Income • Substance use services • Social support • Additional supportive services Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  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. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs 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

  18. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs • 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% Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  19. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs Baseline Characteristics (N=22) MeanMedian (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) Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  20. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs: Substance Use 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) Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  21. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs 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) Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  22. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs 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) Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  23. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs Liver Biopsy: Fibrosis Stage (N=15) No. of participants Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  24. Treatment of Hepatitis C in Persons Actively Using Illicit Drugs: Current Outcomes Sample N = 30 RNA Negative n = 8 Liver Biopsy n = 15 RNA Positive n = 22 Relocated n = 2 Incarcerated n = 1 Head Injury n = 1 In Evaluation n = 2 Eligible for Treatment n = 16 Decided Against Treatment n = 7 Initiated HCV Treatment n = 9 Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  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 N=8 # of Participants Before Treatment On Treatment At Treatment Initiation 0 0 Moderate Moderate Severe Severe Moderate Severe Depression Category (Beck Depression Inventory) Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  28. Mean Depression Scores (BDI) Before and During Treatment 28 Moderate Depression (N=8) * * 19 *Multiple administrations per participant, approximately every 30 days Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  29. Before and On Peg/Riba Off Peg/Riba Depression Scores (BDI) Before, During and After Treatment (N=8) Start Treatment BDI Score Severe Depression Moderate Depression Weeks Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  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 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 Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  32. Interim Virologic Outcomes of Hepatitis C Treatment in Persons Actively Using Drugs (N=9) EVR RVR ETR SVR G1, Acute 19, L, F ETR EVR RNA (-) G1 51, AA, F SVR ETR RVR EVR 36, W, F G2 EVR ETR RVR RNA (-) 21, W, F G3 ETR EVR 35, L, M Participants (Age, Ethnicity, Gender) G3 RNA (-) D/C EVR RNA (-) Peg/riba 50, W, M G1 24-week follow-up NR D/C RNA (+) 45, AA, M G1 NR = No Virologic Response Lost to f/u RVR = Rapid Virologic Response RNA (+) 33, L, M G1 EVR = Early Virologic Response ETR = End of Treatment Response RNA (-) EVR 53, AA, M SVR = Sustained Virologic Response G1 0 4 8 12 16 20 24 28 32 36 40 44 48 Weeks Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  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 *Excludes one patient lost to follow-up after 2 weeks Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  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. 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. Center for the Study of Hepatitis C, Weill Medical College, Cornell University

  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

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