Effective Treatment of Hepatitis C in Substance Users

Not Applicable

Completed

Interventions: Procedure: Modified Directly Observed Therapy (mDOT)
Procedure: Self-Administered Therapy (SAT)

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Modified Directly Observed Therapy (mDOT)	Modified Directly Observed Therapy (mDOT)	Hepatitis C Virus (HCV) Treatment in Modified Directly Observed Therapy (mDOT) in Methadone Maintenance Treatment (MMT)
Self-Administered Therapy at Liver Specialty Clinic (SAT)	Self-Administered Therapy (SAT)	Hepatitis C virus (HCV) at a liver specialty clinic as self-administered therapy

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Sustained Virologic Response (SVR)	24 weeks (end of treatment)	SVR is defined as continued undetectable HCV viral load at 24 weeks

Secondary Outcome Measures