Trial Outcomes & Findings for Rapid HCV Treatment Access for Persons Who Use Drugs (NCT NCT04677153)
NCT ID: NCT04677153
Last Updated: 2026-04-13
Results Overview
Participants who start HCV treatment in each arm.
COMPLETED
NA
198 participants
Within 12 weeks of randomization
2026-04-13
Participant Flow
Participants were recruited at five community sites - four in the United States and one in Canada. All sites were Opioid Treatment Programs (OTPs). Participants were recruited through staff referrals, on-site table events manned by research staff, as well as recruitment flyers and self-referrals.
198 participants were screened and consented. 16 participants were ineligible for randomization (for 3 participants, they were unable to collect blood, 12 participants had undetectable HCV RNA, and 1 participant was excluded per investigator decision). The remaining 182 were randomized.
Participant milestones
| Measure |
Test and Treat Plus Peer Mentors Intervention Arm
Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support.
Test and treat plus peer mentors: Rapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment.
|
Standard of Care Referral Arm
Participants referred to offsite (non-OTP) location for HCV treatment.
Usual care: Participants are referred to another location for HCV treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
91
|
|
Overall Study
Participants Who Initiated HCV Therapy
|
66
|
56
|
|
Overall Study
COMPLETED
|
54
|
42
|
|
Overall Study
NOT COMPLETED
|
37
|
49
|
Reasons for withdrawal
| Measure |
Test and Treat Plus Peer Mentors Intervention Arm
Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support.
Test and treat plus peer mentors: Rapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment.
|
Standard of Care Referral Arm
Participants referred to offsite (non-OTP) location for HCV treatment.
Usual care: Participants are referred to another location for HCV treatment.
|
|---|---|---|
|
Overall Study
Not eligible for treatment initiation
|
25
|
33
|
|
Overall Study
Lost to Follow-up
|
9
|
11
|
|
Overall Study
Participants refused to complete study visits
|
3
|
0
|
|
Overall Study
Unable to come in for visits
|
0
|
2
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Excluded from analysis - randomization error
|
0
|
2
|
Baseline Characteristics
Rapid HCV Treatment Access for Persons Who Use Drugs
Baseline characteristics by cohort
| Measure |
Test and Treat Plus Peer Mentors Intervention Arm
n=66 Participants
Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support.
Test and treat plus peer mentors: Rapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment.
|
Standard of Care Referral Arm
n=56 Participants
Participants referred to offsite (non-OTP) location for HCV treatment.
Usual care: Participants are referred to another location for HCV treatment.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.3 Years
STANDARD_DEVIATION 11.5 • n=193 Participants
|
47.5 Years
STANDARD_DEVIATION 12.3 • n=193 Participants
|
48.0 Years
STANDARD_DEVIATION 11.8 • n=386 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=193 Participants
|
19 Participants
n=193 Participants
|
49 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=193 Participants
|
37 Participants
n=193 Participants
|
73 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
6 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=193 Participants
|
53 Participants
n=193 Participants
|
116 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=193 Participants
|
20 Participants
n=193 Participants
|
45 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=193 Participants
|
34 Participants
n=193 Participants
|
71 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Region of Enrollment
Canada
|
8 Participants
n=193 Participants
|
8 Participants
n=193 Participants
|
16 Participants
n=386 Participants
|
|
Region of Enrollment
United States
|
58 Participants
n=193 Participants
|
48 Participants
n=193 Participants
|
106 Participants
n=386 Participants
|
|
Injection drug use reported in the past 30 days
|
21 Participants
n=193 Participants
|
13 Participants
n=193 Participants
|
34 Participants
n=386 Participants
|
|
Positive urine drug screen results at baseline - Any drug
|
42 Participants
n=193 Participants
|
43 Participants
n=193 Participants
|
85 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: Within 12 weeks of randomizationPopulation: Participants who were eligible for treatment initiation based on protocol criteria, excluding two participants from the analysis due to randomization error. Analyses were conducted with a modified intention to treat of approach, which excluded randomized participants who were found on testing to have an undetectable HCV RNA, HBsAg positive or a platelet count \<150,000.
Participants who start HCV treatment in each arm.
Outcome measures
| Measure |
Test and Treat Plus Peer Mentors Intervention Arm
n=66 Participants
Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support.
Test and treat plus peer mentors: Rapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment.
|
Standard of Care Referral Arm
n=56 Participants
Participants referred to offsite (non-OTP) location for HCV treatment.
Usual care: Participants are referred to another location for HCV treatment.
|
|---|---|---|
|
Participants Who Initiate HCV Therapy
|
59 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: At expected end of treatment date, up to 20 weeksPopulation: Participants who initiated and completed HCV Therapy
Participants who start HCV treatment and subsequently complete treatment (take more than 90% of prescribed treatment course).
Outcome measures
| Measure |
Test and Treat Plus Peer Mentors Intervention Arm
n=59 Participants
Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support.
Test and treat plus peer mentors: Rapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment.
|
Standard of Care Referral Arm
n=12 Participants
Participants referred to offsite (non-OTP) location for HCV treatment.
Usual care: Participants are referred to another location for HCV treatment.
|
|---|---|---|
|
HCV Treatment Completion
|
42 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Post-treatment week 12Population: Participants who achieved SVR among participants who initiated HCV treatment within 12 weeks
Participants in each arm who achieved SVR, defined as HCV RNA \<15 IU/mL between 10 and 36 weeks after completion of the HCV treatment regimen.
Outcome measures
| Measure |
Test and Treat Plus Peer Mentors Intervention Arm
n=59 Participants
Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support.
Test and treat plus peer mentors: Rapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment.
|
Standard of Care Referral Arm
n=12 Participants
Participants referred to offsite (non-OTP) location for HCV treatment.
Usual care: Participants are referred to another location for HCV treatment.
|
|---|---|---|
|
Sustained Virologic Response (SVR) Following Treatment by Intervention Group
|
40 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From randomization to initiation of treatment, up to 24 weeksPopulation: Participants who were eligible for treatment initiation based on protocol criteria, excluding two participants from the analysis due to randomization error. Analyses were conducted with a modified intention to treat of approach, which excluded randomized participants who were found on testing to have an undetectable HCV RNA, HBsAg positive or a platelet count \<150,000.
Time to HCV Treatment Initiation in weeks.
Outcome measures
| Measure |
Test and Treat Plus Peer Mentors Intervention Arm
n=66 Participants
Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support.
Test and treat plus peer mentors: Rapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment.
|
Standard of Care Referral Arm
n=56 Participants
Participants referred to offsite (non-OTP) location for HCV treatment.
Usual care: Participants are referred to another location for HCV treatment.
|
|---|---|---|
|
Time to HCV Treatment Initiation
|
2.86 Weeks
Interval 1.71 to 5.86
|
24 Weeks
Interval 19.2 to 24.0
|
Adverse Events
Test and Treat Plus Peer Mentors Intervention Arm
Standard of Care Referral Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Oluwaseun Falade-Nwulia, MBBS, MPH
Johns Hopkins University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place