Title: Hepatitis C Treatment Among CommunityRecruited Active Drug Users: Establishing a Collaborative, Mult
1Hepatitis 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
2Persons 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
3Persons 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 200642(5)673-6
4Hepatitis 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.
5NIH 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
6Treatment 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?
7Treatment 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
8Treatment 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
9Treatment 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
10Treatment 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
11Treatment 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.
12Treatment 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
13Treatment 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
14Treatment 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
15Treatment 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
16Treatment 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
17Treatment 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
18Treatment 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
- (N22)
- 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
19Treatment of Hepatitis C in Persons Actively
Using Illicit Drugs
- Baseline Characteristics (N22)
-
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) -
20Treatment of Hepatitis C in Persons Actively
Using Illicit Drugs Substance Use
- Baseline Characteristics (N22)
- 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 (N17) 30
(IQR, 9 123) - Median injections in past 6 months (N19) 168
(IQR, 42 897) - Smoked crack in past 30 days 36 (8)
- Median days smoked crack
- in past 30 days (N8) 10 (IQR, 4 19)
- Drank 5 drinks gt 1x in past 30 days 41 (9)
21Treatment of Hepatitis C in Persons Actively
Using Illicit Drugs
- Baseline Characteristics (N22)
- 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) -
22Treatment of Hepatitis C in Persons Actively
Using Illicit Drugs
- Liver Biopsy (N22)
- Biopsy (study) 64 (14)
- Biopsy (lt 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)
23Treatment of Hepatitis C in Persons Actively
Using Illicit Drugs
Liver Biopsy Fibrosis Stage (N15)
No. of participants
24Treatment 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
25Treatment of Hepatitis C in Persons Actively
Using Illicit Drugs
- Treatment (N22)
- 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) - (N16)
- Initiated peginterferon/ribavirin 9 (56)
- Opted to defer 7 (44)
26Treatment of Hepatitis C in Persons Actively
Using Illicit Drugs
- Participants self-reported reasons for deferring
treatment (N7) - 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
27Significant Depression Before and During
Treatment By Peak Beck Depression Inventory
(BDI) Scores
N8
of Participants
Before Treatment
On Treatment
At Treatment Initiation
0
0
Moderate
Moderate
Severe
Severe
Severe
Moderate
Depression Category (Beck Depression Inventory)
28Mean Depression Scores (BDI) Before and During
Treatment
28
Moderate Depression
(N8)
19
Multiple administrations per participant,
approximately every 30 days
29Depression Scores (BDI) Before, During and After
Treatment (N8)
Start Treatment
BDI Score
Severe Depression
Moderate Depression
Weeks
30Treatment of Hepatitis C in Persons Actively
Using Illicit Drugs
- Tolerability (N8)
- Side effects
- fatigue (n6) ? nausea (n2)
- loss of appetite (n5) ? depression (n3)
- difficulty sleeping (n3) ? skin rash (n3)
- difficulty concentrating (n3) ? hair loss (n2)
- 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 (N9)
31Treatment of Hepatitis C in Persons Actively
Using Illicit Drugs
- Adherence (N8)
- Methods self-report (n8), directly observed
therapy (n4) - 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 lt 10
days from previous dose
32Interim Virologic Outcomes of Hepatitis C
Treatment in Persons Actively Using Drugs (N9)
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
21, W, F
RNA (-)
G3
ETR
EVR
35, L, M
Participants (Age, Ethnicity, Gender)
RNA (-)
G3
D/C
EVR
RNA (-)
Peg/riba
G1
50, W, M
24-week follow-up
NR
D/C
RNA ()
G1
45, AA, M
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
8
16
20
24
28
32
4
12
36
40
44
48
Weeks
33Treatment of Hepatitis C in Persons Actively
Using Illicit Drugs
- Illicit Drug Use (N8)
- 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
34Treatment 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.
35NIH 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.
36Treatment 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