Bridging Active Heroin Users to Hepatitis C Treatment Using Buprenorphine - 1

Study Overview
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Brief Summary
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The purpose of this study is to see whether street-recruited heroin users can be successfully treated for hepatitis C after stabilizing them on buprenorphine.

Detailed Description
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This is a prospective pilot safety study based on the hypothesis that active, street-recruited heroin users can be successfully treated for hepatitis C after stabilization on buprenorphine. Eligible subjects will be actively using heroin and have hepatitis C viremia; screening will occur at street-based sites like syringe exchange programs. Those who are eligible will sign informed consent, and then be asked to attend 3 weekly educational sessions about hepatitis C and addiction as well as undergo an intake interview. After this, subjects will be inducted onto buprenorphine/naloxone combination therapy (Suboxone) and receive this medication for 12-24 weeks. Once reaching the 12-24 week study time point, subjects will have the option of a 12-week Suboxone taper, or instead of undergoing 6-12 months of hepatitis C treatment with pegylated interferon and ribavirin while being maintained on Suboxone. Once completing hepatitis C treatment, subjects will undergo a 24-week Suboxone taper, or be transitioned to outpatient Suboxone therapy by a medical provider.

Official Title
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HCV Treatment of IDUs After Buprenorphine Stabilization

Conditions
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Hepatitis C, Heroin Dependence

Intervention / Treatment
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* Drug: Buprenorphine/naloxone
* Drug: pegInterferon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active heroin or other illicit opioid use Active hepatitis C No medical or psychiatric contraindications Able to sign informed consent Exclusion Criteria: No opiate dependence Age <18 Unable or uninterested in attending weekly group sessions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pegInterferon<br>Open label, observational trial to determine the safety of HCV treatment in active IDUs stabilized on buprenorphine/naloxone | Drug: Buprenorphine/naloxone<br>* Human subjects HIV, HCV<br>Drug: pegInterferon<br>* intervention drug 1. buprenorphine/naloxone. street-recruited heroin users induced on bup/naloxone for period of 3-6 months, after which the second intervention is offered. intervention drug 2: pegInterferon/ribavirin. subjects interested in initiation treatment for HCV are offered pegInterferon, 180ug SQ/wk and ribavirin, 800-1200 mg daily for the standard duration of HCV treatment as dictated by genotype.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of medication |  |  | 
| Compliance |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heroin addiction