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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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slide1

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

persons who inject drugs the core of the hepatitis c epidemic
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

persons who inject drugs the invisible core of the hepatitis c epidemic
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

hepatitis c in persons using illicit drugs treatment policy united states 1997
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

slide5

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

slide6

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

treatment of hiv and hepatitis c in persons who use illicit drugs
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

treatment of hiv and hepatitis c in persons who use illicit drugs1
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

treatment of hiv and hepatitis c in persons who use illicit drugs2
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

slide10

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

treatment of hepatitis c in persons actively using illicit drugs
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

treatment of hepatitis c in persons actively using illicit drugs1
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

treatment of hepatitis c in persons actively using illicit drugs2
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

treatment of hepatitis c in persons actively using illicit drugs3
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

treatment of hepatitis c in persons actively using illicit drugs4
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

treatment of hepatitis c in persons actively using illicit drugs5
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

slide17

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

treatment of hepatitis c in persons actively using illicit drugs6
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

treatment of hepatitis c in persons actively using illicit drugs7
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

treatment of hepatitis c in persons actively using illicit drugs substance use
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

treatment of hepatitis c in persons actively using illicit drugs8
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

treatment of hepatitis c in persons actively using illicit drugs9
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

treatment of hepatitis c in persons actively using illicit drugs10
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

treatment of hepatitis c in persons actively using illicit drugs current outcomes
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

treatment of hepatitis c in persons actively using illicit drugs11
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

treatment of hepatitis c in persons actively using illicit drugs12
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

significant depression before and during treatment by peak beck depression inventory bdi scores
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

slide28

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

depression scores bdi before during and after treatment n 8

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

treatment of hepatitis c in persons actively using illicit drugs13
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)

treatment of hepatitis c in persons actively using illicit drugs14
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

slide32

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

treatment of hepatitis c in persons actively using illicit drugs15
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

treatment of hepatitis c in persons actively using illicit drugs16
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

slide35

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

treatment of hepatitis c in persons actively using illicit drugs17
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