N/A
N=198
Hepatitis C Treatment to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior
HCV · Buprenorphine · PreP
Bottom Line
View on ClinicalTrials.gov: NCT03221309 ↗Enrolled (actual)
198
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Hepatitis C Virus (HCV) Cure (Sustained Virologic Response) — 158 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Evaluate model of care for HCV-infected adults with on-going opioid misuse (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hepatitis C Virus (HCV) Cure (Sustained Virologic Response) |
158 | — |
| SECONDARY Uptake of HIV Pre-exposure Prophylaxis (PrEP) |
29 | — |
| SECONDARY Retention on HIV PrEP |
8 | — |
| SECONDARY Uptake of Buprenorphine |
61 | — |
| SECONDARY Retention in Buprenorphine Program |
41 | — |
Summary
This is an open label, non-randomized, observational pilot study to evaluate a model of care for treatment of hepatitis C in people with ongoing injection drug use. Participants will be treated with direct-acting antivirals (DAA) as per standard of care and will concomittantly be offered pre-exposure prophylaxis for HIV prevention and buprenorphine for treatment of opioid use disorder when clinically indicated.
Eligibility Criteria
Inclusion Criteria
- Age 18 years old
- Able and willing to sign informed consent
- Chronically infected with HCV, defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater).
- Willing to have samples stored for future use
- Ongoing injection drug use, defined as self-report of either:
- Phase 1 (first 100 enrolled participants) Injection non-prescription drug use within three months of screening visit or
- Phase 2 (enrolled participants 101-200) Use of non-prescription opioids within twelve months of screening visit
Exclusion Criteria
- Decompensated liver disease (Childs Pugh B or C)
- Unable to comply with research study visits
- Poor venous access not allowing screening laboratory collection
- Have any condition that the investigator considers a contraindication to study participation
- Pregnant or breastfeeding woman
Data sourced from ClinicalTrials.gov (NCT03221309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.