Trial Outcomes & Findings for Effective Treatment of Hepatitis C in Substance Users (NCT NCT00633243)
NCT ID: NCT00633243
Last Updated: 2013-01-03
Results Overview
SVR is defined as continued undetectable HCV viral load at 24 weeks
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
24 weeks (end of treatment)
Results posted on
2013-01-03
Participant Flow
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.
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.
Participant milestones
| Measure |
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 weight-based ribavirin (RBV) dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. Pegylated interferon alfa-2a(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.
|
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 pegylated interferon alfa-a (PEG) and weight-based ribavirin (RBV). Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
|
Overall Study
COMPLETED
|
11
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
7
|
Reasons for withdrawal
| Measure |
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 weight-based ribavirin (RBV) dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. Pegylated interferon alfa-2a(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.
|
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 pegylated interferon alfa-a (PEG) and weight-based ribavirin (RBV). Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
incarceration
|
0
|
2
|
|
Overall Study
Homeless--no refrigeration for meds
|
0
|
1
|
|
Overall Study
Not comfortable with self-injecting
|
0
|
1
|
|
Overall Study
Mental Health--Depression
|
0
|
1
|
|
Overall Study
Couldn't tolerate side-effects
|
1
|
1
|
Baseline Characteristics
Effective Treatment of Hepatitis C in Substance Users
Baseline characteristics by cohort
| Measure |
Modified Directly Observed Therapy (mDOT)
n=12 Participants
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.
|
Self-Administered Therapy (SAT)
n=9 Participants
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.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
40 years
n=5 Participants
|
43 years
n=7 Participants
|
42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks (end of treatment)Population: All subjects in mDOT arm and SAT arm who completed treatment.
SVR is defined as continued undetectable HCV viral load at 24 weeks
Outcome measures
| Measure |
Modified Directly Observed Therapy (mDOT)
n=12 Participants
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.
|
Self-Administered Therapy (SAT)
n=4 Participants
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.
|
|---|---|---|
|
Number of Participants With a Sustained Virologic Response (SVR)
|
7 participants
|
1 participants
|
Adverse Events
Modified Directly Observed Therapy (mDOT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self-Administered Therapy (SAT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place