Integrating Integrating Hepatitis C and Hepatitis C and
Drug Treatment in Drug Treatment in a a
Community-Based Community-Based SettingSetting
Diana L. Sylvestre, Diana L. Sylvestre, MDMD
O.A.S.I.S.O.A.S.I.S.Organization to Achieve Organization to Achieve Solutions in Substance-Solutions in Substance-
AbuseAbuse
Who we are:Who we are:
A nonprofit organization located in Oakland, CA
HIV
Mental IllnessDedicated to addressing addiction-
related medical conditions including:
STDs TBAnd especially:
Hepatitis C
““Treatment of patients…who are Treatment of patients…who are actively using illicit drugs should be actively using illicit drugs should be delayed until these habits are delayed until these habits are discontinued for at least 6 months.” discontinued for at least 6 months.” --NIH Consensus Statement on HCV, --NIH Consensus Statement on HCV, 19971997
The O.A.S.I.S. The O.A.S.I.S. Group ModelGroup Model
One Stop ShoppingOne Stop Shopping
Peer-based educationPeer-based education
SupportSupport
Contemporaneous medical Contemporaneous medical interventionintervention
RequirementsRequirements
• HonestyHonesty• Show up on timeShow up on time• RespectRespect
– PeersPeers– StaffStaff
O.A.S.I.S. HCV PatientsO.A.S.I.S. HCV Patients• >2,000 patients screened to date>2,000 patients screened to date• Mean age 46 (16-76)Mean age 46 (16-76)• 56% male56% male• Race:Race:
– 48% Caucasian48% Caucasian– 28% African American28% African American– 17% Latino17% Latino
Drug Use at EngagementDrug Use at Engagement
• At engagement:At engagement:– 35% are using heroin35% are using heroin– 22% currently using cocaine22% currently using cocaine– 13% currently using methamphetamines13% currently using methamphetamines– 36% are drinking alcohol36% are drinking alcohol
• 42% on MMT42% on MMT• 61% report a pre-existing psychiatric 61% report a pre-existing psychiatric
conditioncondition
StudiesStudies
• IFN/Ribavirin in methadone patientsIFN/Ribavirin in methadone patients• PEG-IFN/Riba in methadone patientsPEG-IFN/Riba in methadone patients• Neuropsychiatric monitoring during HCV Neuropsychiatric monitoring during HCV
treatment: building a better Becktreatment: building a better Beck• Buprenorphine to transition street-recruited Buprenorphine to transition street-recruited
heroin users to HCV treatmentheroin users to HCV treatment• Development of a video-based HCV Development of a video-based HCV
curriculum for in- and out- of treatment IDUscurriculum for in- and out- of treatment IDUs
HCV Treatment in Methadone HCV Treatment in Methadone PatientsPatients
• Multicenter study:Multicenter study:– Subsites: Subsites: Gourevitch/Litwin, Bronx, NYGourevitch/Litwin, Bronx, NY
A. Williams, Philadelphia, PAA. Williams, Philadelphia, PA
• IFN alfa-2b 3mu tiw, ribavirin 1000-1200 qdIFN alfa-2b 3mu tiw, ribavirin 1000-1200 qd• Standard monitoringStandard monitoring• Group encouragedGroup encouraged• Treatment criteriaTreatment criteria
– Interested MMT with active HCVInterested MMT with active HCV– Reliable attendanceReliable attendance
Study Subjects (n=76)Study Subjects (n=76)
• 50 yr50 yr
• 47 (62%) male 47 (62%) male
• 45 (59%) self-reported psychiatric 45 (59%) self-reported psychiatric illness illness
• 23 (30%) had been abstinent < 6mo23 (30%) had been abstinent < 6mo
Substance Use HistorySubstance Use History
• Median lifetime heroin use = Median lifetime heroin use = 20 yr20 yr (3-50) (3-50)• 27/65 (42%) history of regular cocaine use27/65 (42%) history of regular cocaine use
– Median 3 yrMedian 3 yr (1-30) (1-30)
• 27/65 (42%) history of regular methamphetamine 27/65 (42%) history of regular methamphetamine useuse– Median 5 yrMedian 5 yr (1-41) (1-41)
• 41/65 (63%) history of regular MJ use41/65 (63%) history of regular MJ use– Median 10 yrMedian 10 yr (1-46) (1-46)
• 44/69 (64%) history of heavy alcohol use44/69 (64%) history of heavy alcohol use– Median 12 yrMedian 12 yr (1-43) (1-43)
Substance Use BehaviorsSubstance Use Behaviors
• 15 (20%) drank EtOH during treatment15 (20%) drank EtOH during treatment
• 27 (36%) used heroin, cocaine, or 27 (36%) used heroin, cocaine, or methamphetamine during treatmentmethamphetamine during treatment
• 45 (61%) used any illicit drug during 45 (61%) used any illicit drug during treatmenttreatment
• 33 (45%) increased methadone dose by 33 (45%) increased methadone dose by median of 15 mg (0-180)median of 15 mg (0-180)
Overall Impact of Barriers on Overall Impact of Barriers on Virologic Outcomes Virologic Outcomes
24
15
4955
28
40
0
10
20
30
40
50
60
Dropouts ETR SVR
All MMT (n=76)
No Negatives (n=20)
p=0.035
Duration of Abstinence vs HCV Duration of Abstinence vs HCV Treatment OutcomesTreatment Outcomes
2830
22
0
5
10
15
20
25
30
SVR %
All MMT >6mo Abstinence <6mo Abstinence
n=76n=53
n=23
p=0.18
Drug Use vs HCV Treatment Drug Use vs HCV Treatment OutcomesOutcomes
35
21
0
0
10
20
30
40
50
SVR %
None Occasional Regular
n=19
n=49n=8
p=0.09
Impact of MJ Use on HCV Impact of MJ Use on HCV Treatment (p=0.006)Treatment (p=0.006)
28
16
52
0
10
20
30
40
50
60
SVR%
All MMT No MJ MJ
n=74n=51
n=23
The Impact of Preexisting The Impact of Preexisting Psychiatric DiseasePsychiatric Disease
28
35
22
0
5
10
15
20
25
30
35
SVR %
All MMT No Psych Psych
n=45
n=31n=76
p=0.01
Drug Use vs. AdherenceDrug Use vs. Adherence
73 73 75
25
0
20
40
60
80
100
Adherence %
None Rare Intermittent Regular
Factors Contributing to Factors Contributing to AdherenceAdherence
VariableVariable P valueP value
Antidepressant useAntidepressant use 0.010.01
Length of SobrietyLength of Sobriety 0.040.04
Use of MarijuanaUse of Marijuana 0.060.06
Psychiatric diseasePsychiatric disease 0.080.08
Drug useDrug use 0.260.26
Study 2Study 2
PEG-IFN/Riba in Methadone-PEG-IFN/Riba in Methadone-maintained patientsmaintained patients
PEG Preliminary Outcomes PEG Preliminary Outcomes (n=30)(n=30)
83
50
10
0
10
20
30
40
50
60
70
80
90
100
ETR SVR Disc
% p
atie
nts
Caution:Caution:Site-based differences Site-based differences
in outcomesin outcomes
Study 3Study 3
Bridging Active Heroin Bridging Active Heroin Users to HCV Users to HCV
Treatment with Treatment with BuprenorphineBuprenorphine
Study DesignStudy Design350 Street-recruited
Heroin Users
Hepatitis C Testing
Active: 12-24 weeks Suboxone
Inactive: Ineligible
HCV Treatment
Not Interested in HCV Treatment: 12 wk detox
24 week Suboxone taper
RelevanceRelevanceAll Screened: n=299All Screened: n=299
0
10
20
30
40
50
60
70
80
90
100
Eligible (74%) Show Up Start Bupe
% P
ati
en
ts
Engagement By Engagement By Race/EthnicityRace/Ethnicity
0
10
20
30
40
50
All Screened(n=352)
Start Bupe(n=117)
Stable Wk 12(n=50)
Start HCV(n=24)
% P
atie
nts
Cauc
Afr-Am
Latino
Other
Preliminary Treatment Preliminary Treatment Retention (n=92)Retention (n=92)
0
10
20
30
40
50
60
70
80
90
0 1 2 3 4 5 6 7 8 9 10 11 12
Weeks on Buprenorphine
Nu
mb
er o
f P
atie
nts
Self-reported Drug UseSelf-reported Drug Use
0
1
2
3
4
5
6
7
Mea
n D
ays/
Wk
Use
d
Heroin
Cocaine
Alcohol
Self-reported Drug UseSelf-reported Drug Use
0102030405060708090
100B
asel
ine
Wk2
Wk4
Wk6
Wk8
Wk1
0
Wk1
2
Wk1
4
Wk1
6
Wk1
8
Wk2
0
Wk2
2
Wk2
4
% P
atie
nts Heroin
Cocaine
Alcohol
Urine ToxicologyUrine Toxicology
0
20
40
60
80
100
BASELINE WK4 WK8 WK12
HEROIN-HCV
HEROIN-ALL
COCAINE-HCV
COCAINE-ALL
Study 4: Study 4: Neuropsychiatric Neuropsychiatric
Monitoring During Monitoring During HCV TreatmentHCV Treatment
Pilot Study DesignPilot Study Design
• 40 patient, double-blind 40 patient, double-blind • Patients randomized to:Patients randomized to:
– PegIFN alfa-2a plus ribaPegIFN alfa-2a plus riba– PegIFN alfa-2b plus riba PegIFN alfa-2b plus riba
• Tools: BDI, POMS, HADS, SF-36, MMSE Tools: BDI, POMS, HADS, SF-36, MMSE qmo.qmo.
• Main goal: to look for individual measures Main goal: to look for individual measures that might be predictive of useful outcomesthat might be predictive of useful outcomes
• Secondary goal: to assess whether true Secondary goal: to assess whether true differences exist btw the 2 interferonsdifferences exist btw the 2 interferons
The Data Looks FineThe Data Looks Fine
BSLN
50403020100
WK
4
40
30
20
10
0
Rsq = 0.8226
thru origin
Sylvestre D, unpublished data
BDI vs Reported BDI vs Reported SymptomsSymptoms
0
10
20
30
40
50
60
0 5 10 15 20 25 30 35 40 45 50
Treatment Week
Psychiatric Symptoms Reported:
Depressed
Irritable
Anxious
None
BDI vs DiscontinuationBDI vs Discontinuation
0
10
20
30
40
50
60
0 5 10 15 20 25 30
Completed Treatment
vs
Dropouts
Treatment Week
Study 5: A Video-Study 5: A Video-based HCV based HCV
Curriculum for IDUsCurriculum for IDUs
AimsAims
• Improve knowledgeImprove knowledge• Improved attitudes toward changeImproved attitudes toward change• Improve motivations toward healthy Improve motivations toward healthy
behaviorsbehaviors• Short and long termShort and long term• In- and out-of-treatment drug usersIn- and out-of-treatment drug users
Current O.A.S.I.S. HCV Current O.A.S.I.S. HCV CurriculumCurriculum
• 4 short peer-based videos4 short peer-based videos• Companion workbookCompanion workbook• Positive, educational, upbeatPositive, educational, upbeat
Study DesignStudy Design
• Year 1: Curriculum developmentYear 1: Curriculum development• 2 cohorts2 cohorts
– In-treatment drug users on methadone In-treatment drug users on methadone maintenancemaintenance
– Out of treatment drug users at syringe Out of treatment drug users at syringe exchangeexchange
• Single session vs multi-sessionSingle session vs multi-session• Standard-of-care comparatorStandard-of-care comparator• KAM test: before and afterKAM test: before and after
““HCV therapy has been successful even HCV therapy has been successful even when the patients have not abstained when the patients have not abstained from continued drug or alcohol use... from continued drug or alcohol use... Thus, it is recommended that treatment Thus, it is recommended that treatment of active injection drug use be of active injection drug use be considered on a case-by-case basis, and considered on a case-by-case basis, and that active injection drug use in and of that active injection drug use in and of itself not be used to exclude such itself not be used to exclude such patients from antiviral therapy.” --NIH patients from antiviral therapy.” --NIH Consensus Statement on HCV, 2002Consensus Statement on HCV, 2002
Additional CommentsAdditional Comments
• Highly efficientHighly efficient• Not all that hardNot all that hard
– Multidisciplinary medical trainingMultidisciplinary medical training• IDID• AddictionAddiction• PsychiatryPsychiatry• BEHAVIORBEHAVIOR
AcknowledgementsAcknowledgements
• Deborah Greene, Deborah Greene, MDMD
• Chris McNeilChris McNeil• Many patient Many patient
volunteersvolunteers– Larry GalindoLarry Galindo– Tim MaginnisTim Maginnis– Gerard WallaceGerard Wallace
• Barry Clements, Barry Clements, PA-CPA-C
• Alice AsherAlice Asher• Laphyne BarrettLaphyne Barrett• Beth KlemBeth Klem• Lisa HartfieldLisa Hartfield• EBCRPEBCRP• TCHCTCHC• HEPPACHEPPAC
Top Related