Status:
COMPLETED
Zepatier in Patients with Substance Use
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C
Hiv
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this study is to assess hepatitis C virus (HCV) treatment with Zepatier (elbasvir/grazoprevir) in HCV monoinfected and human immunodeficiency virus (HIV)-HCV co-infected, HCV treatment-naï...
Detailed Description
Previously, people who use substances and those without liver fibrosis or cirrhosis were excluded from receiving direct-acting antiviral (DAA) treatment due to Illinois Medicaid restrictions. These so...
Eligibility Criteria
Inclusion
- Adults (at least 18 years of age or older)
- Chronic HCV (HCV antibody positive with detectable HCV-RNA)
- HCV genotypes 1a, without the presence of baseline NS5A resistance (specifically, polymorphisms at amino acid positions 28, 30, 31, or 93), 1b, or 4
- HCV treatment-naïve or peginterferon/ribavirin-experienced
- Managed by the UI Health Infectious Diseases Clinic or Liver Clinic
- Recent or current substance use (per self-report or electronic medical record (EMR) data within 90 days of the screening visit, with or without positive baseline urine toxicology), inclusive of one or more of the following: Opiate substitution therapy; Prescription medication misuse (including: opiates, sedatives, tranquilizers, hypnotics, and psychostimulants); Illicit substances; Injection drug use; Alcohol
Exclusion
- Incarcerated
- Pregnant or breastfeeding
- Decompensated liver disease (Child-Pugh B or C)
- Albumin below 3 g/dL
- Platelet count below 75,000
- Unwilling to commit to treatment and/or monitoring
- Poor venous access inhibiting laboratory collection
- Any condition considered by the investigators to be a contraindication to study participation
- Hepatitis B virus (HBV) surface antigen (HBsAg) positive
Key Trial Info
Start Date :
September 20 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 9 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04048850
Start Date
September 20 2019
End Date
September 9 2022
Last Update
January 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612