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