# Presentation: 082759

## Integrating Hepatitis C and Drug Treatment in a Community-Based Setting

**Diana L. Sylvestre, MD**
**O.A.S.I.S.**
**Organization to Achieve Solutions in Substance-Abuse**

## Who we are:

##   Hepatitis C

**A nonprofit organization located in Oakland, CA**

**HIV**

-   Mental Illness

**Dedicated to addressing addiction-related medical conditions including:**

** ****STDs**

** ****TB**

**And especially:**

**  ****Hepatitis C**

## “Treatment of patients...who are actively using illicit drugs should be delayed until these habits are discontinued for at least 6 months.”  --NIH Consensus Statement on HCV, 1997

## Slide 5

## The O.A.S.I.S. Group Model

## One Stop Shopping

**One Stop Shopping**

## Peer-based education

## Support

## Contemporaneous medical intervention

## Requirements

- Honesty
- Show up on time
- Respect
- Peers
- Staff

## O.A.S.I.S. HCV Patients

**>2,000 patients screened to date**
**Mean age 46 (16-76)**
**56% male**
**Race:**
**48% Caucasian**
**28% African American**
**17% Latino**

## Drug Use at Engagement

**At engagement:**
**35% are using heroin**
**22% currently using cocaine**
**13% currently using methamphetamines**
**36% are drinking alcohol**
**42% on MMT**
**61% report a pre-existing psychiatric condition**

## Studies

**IFN/Ribavirin in methadone patients**
**PEG-IFN/Riba in methadone patients**
**Neuropsychiatric monitoring during HCV treatment: building a better Beck**
**Buprenorphine to transition street-recruited heroin users to HCV treatment**
** ****Development of a video-based HCV curriculum for in- and out- of treatment IDUs**

## HCV Treatment in Methadone Patients

**Multicenter study:**
**Subsites: ****Gourevitch/Litwin, Bronx, NY**
**                  ****A. Williams, Philadelphia, PA**
**IFN alfa-2b 3mu tiw, ribavirin 1000-1200 qd**
**Standard monitoring**
**Group encouraged**
**Treatment criteria**
**Interested MMT with active HCV**
**Reliable attendance**

## Study Subjects (n=76)

**50 yr**
**47 (62%) male **
**45 (59%) self-reported psychiatric illness **
**23 (30%) had been abstinent < 6mo**

## Substance Use History

**Median lifetime heroin use = ****20 yr**** (3-50)**
**27/65 (42%) history of regular cocaine use**
**Median 3 yr**** (1-30)**
**27/65 (42%) history of regular methamphetamine use**
**Median 5 yr**** (1-41)**
**41/65 (63%) history of regular MJ use**
**Median 10 yr**** (1-46)**
**44/69 (64%) history of heavy alcohol use**
**Median 12 yr**** (1-43)**

## Substance Use Behaviors

**15 (20%) drank EtOH during treatment**
**27 (36%) used heroin, cocaine, or methamphetamine during treatment**
**45 (61%) used any illicit drug during treatment**
**33 (45%) increased methadone dose by median of 15 mg (0-180)**

## Overall Impact of Barriers on Virologic Outcomes  

- p=0.035

## Duration of Abstinence vs HCV Treatment Outcomes

**n=76**

**n=53**

**n=23**

**p=0.18**

## Drug Use vs HCV Treatment Outcomes

- n=19

- n=49

- n=8

**p=0.09**

## Impact of MJ Use on HCV Treatment (p=0.006)

**n=74**

**n=51**

**n=23**

## Slide 23

## The Impact of Preexisting Psychiatric Disease

**n=45**

**n=31**

**n=76**

**p=0.01**

## Drug Use vs. Adherence

## Factors Contributing to Adherence

| Variable | P value |
| --- | --- |
| Antidepressant use | 0.01 |
| Length of Sobriety | 0.04 |
| Use of Marijuana | 0.06 |
| Psychiatric disease | 0.08 |
| Drug use | 0.26 |

## Study 2

- PEG-IFN/Riba in Methadone-maintained patients

## PEG Preliminary Outcomes (n=30)

## Caution:Site-based differences in outcomes

## Study 3

**Bridging Active Heroin Users to HCV Treatment with Buprenorphine**

## Study Design

## RelevanceAll Screened: n=299

## Engagement By Race/Ethnicity

## Preliminary Treatment Retention (n=92)

## Self-reported Drug Use

## Self-reported Drug Use

## Urine Toxicology

## Study 4: Neuropsychiatric Monitoring During HCV Treatment

## Pilot Study Design

- 40 patient, double-blind
- Patients randomized to:
- PegIFN alfa-2a plus riba
- PegIFN alfa-2b plus riba
- Tools: BDI, POMS, HADS, SF-36, MMSE qmo.
- Main goal: to look for individual measures that might be predictive of useful outcomes
- Secondary goal: to assess whether true differences exist btw the 2 interferons

## The Data Looks Fine

- Sylvestre D, unpublished data

## BDI vs Reported Symptoms

**Treatment Week**

**Psychiatric Symptoms Reported:**
**Depressed**
**Irritable**
**Anxious**
**None**

## BDI vs Discontinuation

**Completed Treatment**
**       ****vs**
**Dropouts**

**Treatment Week**

## Study 5:  A Video-based HCV Curriculum for IDUs

## Aims

- Improve knowledge
- Improved attitudes toward change
- Improve motivations toward healthy behaviors
- Short and long term
- In- and out-of-treatment drug users

## Current O.A.S.I.S. HCV Curriculum

- 4 short peer-based videos
- Companion workbook
- Positive, educational, upbeat

## Study Design

- Year 1: Curriculum development
- 2 cohorts
- In-treatment drug users on methadone maintenance
- Out of treatment drug users at syringe exchange
- Single session vs multi-session
- Standard-of-care comparator
- KAM test: before and after

## “HCV therapy has been successful even when the patients have not abstained from continued drug or alcohol use... Thus, it is recommended that treatment of active injection drug use be considered on a case-by-case basis, and that active injection drug use in and of itself not be used to exclude such patients from antiviral therapy.”  --NIH Consensus Statement on HCV, 2002

## Slide 48

## Additional Comments

**Highly efficient**
**Not all that hard**
**Multidisciplinary medical training**
**ID**
**Addiction**
**Psychiatry**
**BEHAVIOR**

## Acknowledgements

**Deborah Greene, MD**
**Chris McNeil**
**Many patient volunteers**
**Larry Galindo**
**Tim Maginnis**
**Gerard Wallace**

**Barry Clements, PA-C**
**Alice Asher**
**Laphyne Barrett**
**Beth Klem**
**Lisa Hartfield**
**EBCRP**
**TCHC**
**HEPPAC**