Trial Outcomes & Findings for Hepatitis C Treatment to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior (NCT NCT03221309)
NCT ID: NCT03221309
Last Updated: 2025-03-18
Results Overview
Undetectable HCV viral load 12 weeks after the end of treatment
Recruitment status
ACTIVE_NOT_RECRUITING
Target enrollment
198 participants
Primary outcome timeframe
24 weeks
Results posted on
2025-03-18
Participant Flow
Participant milestones
| Measure |
Adults Infected With HCV
Phase 1 (first 100 enrolled participants) HCV-infected adults with on-going injection drug use use with opioids with 3 months of screening
Phase 2 (enrolled participants 101-198) HCV-infected adults with on-going opioid misuse of non-prescription opioids within twelve months of screening
Evaluate model of care for HCV-infected adults with on-going opioid misuse: Participants will be treated with direct-acting antivirals per standard of care and will be concomittantly be offered PreP for HIV prevention and buprenorphine for treatment of opioid-use disorder when clinically indicated
|
|---|---|
|
Overall Study
STARTED
|
198
|
|
Overall Study
Phase 1
|
100
|
|
Overall Study
Phase 2
|
98
|
|
Overall Study
COMPLETED
|
160
|
|
Overall Study
NOT COMPLETED
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hepatitis C Treatment to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior
Baseline characteristics by cohort
| Measure |
Adults Infected With HCV
n=198 Participants
Phase 1 (first 100 enrolled participants) HCV-infected adults with on-going injection drug use use with opioids with 3 months of screening
Phase 2 (enrolled participants 101-200) HCV-infected adults with on-going opioid misuse of non-prescription opioids within twelve months of screening
Evaluate model of care for HCV-infected adults with on-going opioid misuse: Participants will be treated with direct-acting antivirals per standard of care and will be concomittantly be offered PreP for HIV prevention and buprenorphine for treatment of opioid-use disorder when clinically indicated
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
182 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
197 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
165 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
198 participants
n=5 Participants
|
|
Chronic HCV Infection
|
198 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksUndetectable HCV viral load 12 weeks after the end of treatment
Outcome measures
| Measure |
Adults Infected With Hepatitis C Virus (HCV)
n=198 Participants
Two Phases:
Phase 1 (first 100 enrolled participants) HCV-infected adults with on-going injection drug use use with opioids with 3 months of screening
Phase 2 (enrolled participants 101-198) HCV-infected adults with on-going opioid misuse of non-prescription opioids within twelve months of screening
Evaluate model of care for HCV-infected adults with on-going opioid misuse: Participants will be treated with direct-acting antivirals per standard of care and will be concomittantly be offered Pre-Exposure Prophylaxis (PrEP) for HIV prevention and buprenorphine for treatment of opioid-use disorder when clinically indicated
|
|---|---|
|
Hepatitis C Virus (HCV) Cure (Sustained Virologic Response)
|
158 Participants
|
SECONDARY outcome
Timeframe: 24 weeksNumber of participants who initiated PrEP between Day 0 and Week 24
Outcome measures
| Measure |
Adults Infected With Hepatitis C Virus (HCV)
n=185 Participants
Two Phases:
Phase 1 (first 100 enrolled participants) HCV-infected adults with on-going injection drug use use with opioids with 3 months of screening
Phase 2 (enrolled participants 101-198) HCV-infected adults with on-going opioid misuse of non-prescription opioids within twelve months of screening
Evaluate model of care for HCV-infected adults with on-going opioid misuse: Participants will be treated with direct-acting antivirals per standard of care and will be concomittantly be offered Pre-Exposure Prophylaxis (PrEP) for HIV prevention and buprenorphine for treatment of opioid-use disorder when clinically indicated
|
|---|---|
|
Uptake of HIV Pre-exposure Prophylaxis (PrEP)
|
29 Participants
|
SECONDARY outcome
Timeframe: 48 weeksNumber of participants who initiated PrEP between Day 0 and Week 24 and continued on PrEP through week 48
Outcome measures
| Measure |
Adults Infected With Hepatitis C Virus (HCV)
n=29 Participants
Two Phases:
Phase 1 (first 100 enrolled participants) HCV-infected adults with on-going injection drug use use with opioids with 3 months of screening
Phase 2 (enrolled participants 101-198) HCV-infected adults with on-going opioid misuse of non-prescription opioids within twelve months of screening
Evaluate model of care for HCV-infected adults with on-going opioid misuse: Participants will be treated with direct-acting antivirals per standard of care and will be concomittantly be offered Pre-Exposure Prophylaxis (PrEP) for HIV prevention and buprenorphine for treatment of opioid-use disorder when clinically indicated
|
|---|---|
|
Retention on HIV PrEP
|
8 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Patients not on MOUD at time of ANCHOR screening
Number of participants who initiated on-site co-located buprenorphine between Day 0 and Week 24
Outcome measures
| Measure |
Adults Infected With Hepatitis C Virus (HCV)
n=90 Participants
Two Phases:
Phase 1 (first 100 enrolled participants) HCV-infected adults with on-going injection drug use use with opioids with 3 months of screening
Phase 2 (enrolled participants 101-198) HCV-infected adults with on-going opioid misuse of non-prescription opioids within twelve months of screening
Evaluate model of care for HCV-infected adults with on-going opioid misuse: Participants will be treated with direct-acting antivirals per standard of care and will be concomittantly be offered Pre-Exposure Prophylaxis (PrEP) for HIV prevention and buprenorphine for treatment of opioid-use disorder when clinically indicated
|
|---|---|
|
Uptake of Buprenorphine
|
61 Participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Patients who initiated buprenorphine between Day 0 and Week 24
Number of participants who initiated buprenorphine between Day 0 and Week 24 and were retained in buprenorphine treatment at week 48
Outcome measures
| Measure |
Adults Infected With Hepatitis C Virus (HCV)
n=61 Participants
Two Phases:
Phase 1 (first 100 enrolled participants) HCV-infected adults with on-going injection drug use use with opioids with 3 months of screening
Phase 2 (enrolled participants 101-198) HCV-infected adults with on-going opioid misuse of non-prescription opioids within twelve months of screening
Evaluate model of care for HCV-infected adults with on-going opioid misuse: Participants will be treated with direct-acting antivirals per standard of care and will be concomittantly be offered Pre-Exposure Prophylaxis (PrEP) for HIV prevention and buprenorphine for treatment of opioid-use disorder when clinically indicated
|
|---|---|
|
Retention in Buprenorphine Program
|
41 Participants
|
Adverse Events
Adults Infected With HCV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 14 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Elana Rosenthal / Associate Professor
Institute of Human Virology, University of Maryland School of Medicine
Phone: 2403674157
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place