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

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 CWeill Medical College of Cornell University

6th National Harm Reduction ConferenceOakland, CA

November 9, 2006

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

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


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


Hepatitis C in Persons Using Illicit

Drugs:

Treatment Policy, United States,

1997NIH 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.”


NIH Consensus Development Conference Statement on Management of Hepatitis C:

2002

Final Statement released September 10, 2002

Treatment1. Treatment decisions for active IDUs on a case-by-case

basis2. Active IDU in and of itself not a reason to exclude

patients from antiviral therapy3. Active IDUs can be successfully treated for hepatitis C4. Methadone is not a contraindication to HCV treatment5. Treatment for drug and alcohol dependence should be

made available to all patients who want and need it6. Experts in HCV and substance abuse should collaborate


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?


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


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


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


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



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.



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



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



Program DesignInitial Meeting:

Provide education on:• HCV natural history • HCV medical evaluation• HCV treatment

Assess:• Motivational factors • Potential barriers to follow-through and

treatment



Program Design

Needs Assessment Other medical conditions Mental health Health insurance Housing Income Substance use services Social support Additional supportive services



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


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




• 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%



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)


Treatment of Hepatitis C in Persons Actively Using Illicit Drugs: Substance Use


• 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)




• 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)



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)



0

1

2

3

4

5

6

7

8

Stage 0 Stage 1 Stage 2 Stage 3 Stage 4

Liver Biopsy: Fibrosis Stage (N=15)

No. ofparticipants


Eligible for Treatment

n = 16

Treatment of Hepatitis C in Persons Actively Using Illicit Drugs: Current

OutcomesSampl

eN = 30

RNA Negative

n = 8

RNA Positiven = 22

Liver Biopsyn = 15

Decided Against

Treatmentn = 7

Initiated HCV

Treatmentn = 9

Relocated n = 2Incarcerated n = 1Head Injury n = 1In Evaluation n = 2



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%)



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


Significant Depression Before and During Treatment By Peak Beck Depression Inventory (BDI) Scores

0

1

2

3

4

Moderate Severe

Before Treatment

SevereModerate

At Treatment Initiation

SevereModerate

On Treatment

N=8

# o

f P

art

icip

an

ts

Depression Category (Beck Depression Inventory)

0 0


Mean Depression Scores (BDI) Before and During Treatment

Moderate Depression

19

28

21

2221

17

0

3

6

9

12

15

18

21

24

27

30

Mean Depression Score (BDI)

Before Treatment

Baseline

At Start of Treatment

During Treatment* *

* Multiple administrations per participant, approximately every 30 days

(N=8)


0

10

20

30

40

50

60

-16 -13 -10 -6 -4 -2 0 4 8 11 13 15 18 21 25 27 29 32 40 43 49

Depression Scores (BDI) Before, During and After Treatment (N=8)B

DI S

co

re

Weeks

Moderate Depression

Severe Depression

Before and OnPeg/Riba

Off Peg/Riba

Start Treatment


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)



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 injections96%

(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


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

Part

icip

an

ts (

Ag

e,

Eth

nic

ity,

Gen

der)

Weeks

RVR = Rapid Virologic ResponseEVR = Early Virologic ResponseETR = 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

NRNR = No Virologic Response

D/C

D/C

EVRRNA (-)

RNA (-)

RNA (-)

RNA (+)

RNA (+)

ETR

ETR

G153, AA, M

24-week follow-up

Peg/riba

SVR

SVR = Sustained Virologic Response

Lost to f/u

ETR

G3EVR ETR

ETR

EVR

SVR

RNA (-)

RNA (-)


Illicit Drug Use (N=8*)

Stopped using heroin/cocaine 4(50%)

Stopped using daily 1(13%)

Stopped or reduced 5(63%)


*Excludes one patient lost to follow-up after 2 weeks



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.


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.



The ParticipantsCitiwide 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. TalalElizabeth V. GetterJessica R. DanielsMarla A. Shu

NIH grants R01-DA09532, R01-DA16159 and M01-RR00047

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

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