Hepatitis C, Opiate Dependence
Conditions
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.
Interventions
PROCEDURESelf-Administered Therapy (SAT)
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited over a 3-year period (2007-2010) from a substance abuse treatment clinic in New Haven, CT. Those with evidence of infection with HCV were subsequently seen by a medical provider to evaluate for HCV treatment, and if found to be appropriate, were referred to the research assistant.
Pre-assignment details
Subjects were eligible for participation if they were prescribed methadone and were opioid negative in the past 30 days, age 18 years or older, underwent documented HIV testing, competent to provide informed consent, had stable mental health status, and met the following criteria for HCV treatment: detectable HCV RNA and genotype testing.
Participants by arm
| Arm | Count |
|---|---|
| Modified Directly Observed Therapy (mDOT) Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV. | 12 |
| Self-Administered Therapy (SAT) Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work. | 9 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Couldn't tolerate side-effects | 1 | 1 |
| Overall Study | Homeless--no refrigeration for meds | 0 | 1 |
| Overall Study | incarceration | 0 | 2 |
| Overall Study | Mental Health--Depression | 0 | 1 |
| Overall Study | Not comfortable with self-injecting | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Modified Directly Observed Therapy (mDOT) | Self-Administered Therapy (SAT) | Total |
|---|---|---|---|
| Age Continuous | 40 years | 43 years | 42 years |
| Region of Enrollment United States | 12 participants | 9 participants | 21 participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 9 |
| serious Total, serious adverse events | 0 / 12 | 0 / 9 |
Outcome results
Primary
Number of Participants With a Sustained Virologic Response (SVR)
SVR is defined as continued undetectable HCV viral load at 24 weeks
Time frame: 24 weeks (end of treatment)
Population: All subjects in mDOT arm and SAT arm who completed treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Directly Observed Therapy (mDOT) | Number of Participants With a Sustained Virologic Response (SVR) | 7 participants |
| Self-Administered Therapy (SAT) | Number of Participants With a Sustained Virologic Response (SVR) | 1 participants |