Cohort Study of Hepatitis C Virus Treatment with Zepatier (Elbasvir/Grazoprevir) in Genotype 1 or 4 HCV Treatment-Naïve or Peginterferon/Ribavirin-Experienced Patients with Substance Use in Urban, Multidisciplinary Specialty Clinics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- SVR - PP
Study Overview
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-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.
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 sobriety and staging restrictions were recently lifted. However, due to these previous stringent requirements for sobriety, many patients were not able to be treated for HCV. This created a data gap for real-world outcomes of HCV treatment in people who use substances. This study presents a unique opportunity to provide patients with hepatitis C treatment and obtain much needed data on the use of elbasvir/grazoprevir in patients with substance use and other underrepresented comorbidities. Additionally, this study will determine if our current standard of care for the treatment of HCV is effective for patients with substance use.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients living with HCV +/- HIV
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 treated with elbasvir/grazoprevir 50-100 mg fixed-dose-combination, 1 tablet by mouth daily, for 12 weeks.
Intervention: Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER] (Drug)
Outcomes
Primary Outcomes
SVR - PP
Time Frame: 12 weeks after the end of therapy (SVR-12)
Proportion of patients in the per-protocol (PP) population with sustained virologic response (SVR). PP: excludes non-treatment related discontinuations and patients lost to follow-up before SVR-12 laboratory test.
Secondary Outcomes
- Adherence(During 12 weeks of treatment)
- SVR - ITT(12 weeks after the end of therapy (SVR-12))
- Drug-Drug interactions (DDIs)(From enrollment to treatment completion or termination, which ever comes first, for up to 36 weeks)
- SVR - stratified(12 weeks after the end of therapy (SVR-12))
Investigators
Rodrigo Mauricio Burgos
Clinical Associate Professor
University of Illinois at Chicago