Transcript Treating Hepatitis C in Persons Actively Using Illicit Drugs

Hepatitis C Treatment Among CommunityRecruited 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
• 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
Epidemiology: Undercounted
► Incidence
►
Prevalence
Basic Science: Understudied
► Acute
HCV Infection
Treatment: Undertreated
► Clinical
Trials
►
Clinical Practice
Prevention: Underserved
Outreach
► Sterile Needle Access
►
► Counseling
and Testing
► 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
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
NIH Consensus Development Conference Statement
on Management of Hepatitis C: 2002
Final Statement released September 10, 2002
Treatment
1. Treatment decisions for active IDUs on a case-by-case basis
2. Active IDU in and of itself not a reason to exclude patients from
3.
4.
5.
6.
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
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
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 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 Drugs
Barriers to Care: Lack of available services
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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
Treatment of Hepatitis C in Persons Actively
Using Illicit Drugs
Research Gaps
Data are needed on:
•
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•
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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
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 Drugs
● Collaborative
Model
 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 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 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 Drugs
Program Design
Needs Assessment
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
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
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 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
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 Drugs
• HCV RNA-negative (ineligible)
30
8
• Enrolled
22
• Recruited (≥18 yo, heroin, cocaine, methamphetamine/30 days)
(N=22)
• Median age (IQR)
40 yrs (30-50 yrs)
• Male
• Ethnicity
64%
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 Drugs
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)
Center for the Study of Hepatitis C, Weill Medical College, Cornell University
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
 Median # days smoked crack
in past 30 days (N=8)
• Drank ≥ 5 drinks > 1x in past 30 days
36% (8)
10 (IQR, 4 – 19)
41% (9)
Center for the Study of Hepatitis C, Weill Medical College, Cornell University
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 Drugs
Liver Biopsy (N=22)
• Biopsy (study)
64% (14)
• Biopsy (< 3 years ago)
5%
(1)
• Acute HCV infection
9%
(2)
• Relocated
5%
(1)
18%
(4)
• Declined Biopsy
(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 Drugs
Liver Biopsy: Fibrosis Stage (N=15)
8
7
6
No. of
5
participants 4
3
2
1
0
Stage 0
Stage 1
Stage 2
Stage 3
Stage 4
Center for the Study of Hepatitis C, Weill Medical College, Cornell University
Treatment of Hepatitis C in Persons Actively
Using Illicit Drugs: Current Outcomes
Sample
N = 30
RNA Negative
n=8
RNA Positive
n = 22
Eligible for Treatment
n = 16
Decided Against
Treatment
n=7
Liver Biopsy
n = 15
Relocated n = 2
Incarcerated n = 1
Head Injury n = 1
In Evaluation n = 2
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 Drugs
Treatment (N=22)
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•
•
•
•
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
• Opted to defer
9 (56%)
7 (44%)
Center for the Study of Hepatitis C, Weill Medical College, Cornell University
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
4
N=8
# of Participants
Before Treatment
3
On Treatment
At Treatment
Initiation
2
1
0
0
Moderate
0
Severe
Moderate
Severe
Moderate
Severe
Depression Category (Beck Depression Inventory)
Center for the Study of Hepatitis C, Weill Medical College, Cornell University
Mean Depression Scores (BDI) Before and During
Treatment
30
28
Mean Depression Score (BDI)
27
24
21
(N=8)
22
Before
*
21 Treatment
During
Treatment *
Moderate
Depression
21
Baseline
18
19
17
15
At Start of
Treatment
12
9
6
3
0
* 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
Start Treatment
60
Off Peg/Riba
40
Severe
Depression
30
Moderate Depression
20
10
49
43
40
32
29
27
25
21
18
15
13
8
11
4
0
-2
-4
-6
0
-1
3
-1
6
0
-1
BDI Score
50
Weeks
Center for the Study of Hepatitis C, Weill Medical College, Cornell University
Treatment of Hepatitis C in Persons Actively
Using Illicit Drugs
Tolerability (N=8*)
 Side effects:
 fatigue (n=6)
 loss of appetite (n=5)
 difficulty sleeping (n=3)
 difficulty concentrating (n=3)







► nausea (n=2)
► depression (n=3)
► skin rash (n=3)
► hair loss (n=2)
Rx epoetin-alfa (anemia)
Rx filgrastim (neutropenia)
Rx anti-D (thrombocytopenia)
Rx psych meds before HCV treatment
Rx psych meds during HCV treatment
Dose reductions
Drug discontinuations
*Excludes one patient lost to follow-up after 1 week
** (N=9)
5
5
1
2
2
1
2
(63%)
(63%)
(13%)
(23%)**
(29%)
(13%)
(25%)
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 ***
 Oral ribavirin
 Epoetin-alfa, filgrastim injections
98% (92-100%)
93% (82-100%)
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
Interim Virologic Outcomes of Hepatitis C Treatment
in Persons Actively Using Drugs (N=9)
EVR
Participants (Age, Ethnicity, Gender)
RVR
19, L, F
G1, Acute
51, AA, F
G1
RVR
36, W, F
RVR
21, W, F
G2
G3
50, W, M
G1
45, AA, M
G1
Lost to f/u
G1
53, AA, M
4
ETR RNA (-)
EVR
EVR
ETR
EVR
ETR
EVR
ETR
SVR
RNA (-)
8
RNA (-)
EVR D/C RNA (-)
NR
EVR
12
Peg/riba
24-week follow-up
D/C RNA (+)
RNA (+)
G1
0
SVR
G3
35, L, M
33, L, M
ETR
RNA (-)
16
NR = No Virologic Response
RVR = Rapid Virologic Response
EVR = Early Virologic Response
ETR = End of Treatment Response
SVR = Sustained Virologic Response
20 24 28
Weeks
32
36 40
44
48
Center for the Study of Hepatitis C, Weill Medical College, Cornell University
Treatment of Hepatitis C in Persons Actively
Using Illicit Drugs
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
Center for the Study of Hepatitis C, Weill Medical College, Cornell University
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
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 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