Effective Treatment of Hepatitis C in Substance Users

Study Overview
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Brief Summary
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We hypothesize that integrating Hepatitis C into methadone and buprenorphine treatment will improve Hepatitis C outcomes as well as drug treatment outcomes in patients who are addicted to opiates. We will test this hypothesis by randomly assigning patients to receive integrated or separated care. The first group will receive Hepatitis C treatment and substance abuse treatment contemporaneously at the South Central Rehabilitation Center (SCRC). They will take both methadone or buprenorphine and Hepatitis C medications under the daily (methadone) or weekly (buprenorphine) observation of a health care provider. The second group will receive substance abuse treatment at SCRC, and go to another facility to receive Hepatitis C treatment services. These participants will take their medications on their own (without observation). We will look at outcomes such as Hepatitis C viral loads, adherence to medications, and drug treatment outcomes such as receipt of buprenorphine and methadone and urine toxicology testing.

Official Title
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Effective Treatment of Hepatitis C in Substance Users

Conditions
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Hepatitis C, Opiate Dependence

Intervention / Treatment
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* Procedure: Modified Directly Observed Therapy (mDOT)
* Procedure: Self-Administered Therapy (SAT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with a DSM IV diagnosis of opioid dependence who are currently enrolled in methadone or buprenorphine maintenance at South Central Rehabilitation Center in good standing (opiate free urine with positive methadone or buprenorphine, respectively) for at least 30 days. Hepatitis C infection as evidenced by a positive HCV antibody and a detectable HCV RNA. Exclusion Criteria: Suicidal or homicidal ideation Psychiatric condition that is not stable Pregnancy (RBV is a Class C drug during pregnancy) Pending court case or warrant which would interrupt treatment Decompensated cirrhosis (Child's Class B or C) or presence of hepatocellular carcinoma HIV+ with CD4<200 or CD4>200 and VL>5,000 copies/mL Platelet count < 75,000 /mL Hemoglobin < 10 mg/dL Absolute neutrophil count <1500 cells/mL

Ages Eligible for Study
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Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Directly Observed Therapy (mDOT)<br>Hepatitis C Virus (HCV) Treatment in Modified Directly Observed Therapy (mDOT) in Methadone Maintenance Treatment (MMT) | Procedure: Modified Directly Observed Therapy (mDOT)<br> <br> |
| Active Comparator: Self-Administered Therapy at Liver Specialty Clinic (SAT)<br>Hepatitis C virus (HCV) at a liver specialty clinic as self-administered therapy | Procedure: Self-Administered Therapy (SAT)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Sustained Virologic Response (SVR) | SVR is defined as continued undetectable HCV viral load at 24 weeks | 24 weeks (end of treatment) |