Zepatier in Patients with Substance Use (NCT04048850) | Clinical Trial Compass
CompletedNot Applicable
Zepatier in Patients with Substance Use
United States25 participantsStarted 2019-09-20
Plain-language 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-naïve or peginterferon/ribavirin-experienced patients with HCV genotype 1a, without baseline NS5A resistance, 1b, or 4 and substance use in urban, multidisciplinary specialty clinics.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
SVR - PP
Timeframe: 12 weeks after the end of therapy (SVR-12)