An observational study in Hepatitis C, Hiv and Coinfection, HIV, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by University of Illinois at Chicago · Observational
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.
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.
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's enrollment of 25 is below the median of 244 across 567 observational studies indexed under Hepatitis C.
Browse Hepatitis C studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
The specific patient population to be studied is HCV monoinfected and HIV-HCV co-infected, HCV treatment-naïve or peginterferon/ribavirin-experienced patients of the UI Health Infectious Disease or Liver Clinic with HCV genotype 1a, without baseline NS5A resistance, 1b, or 4 and substance use treated with 12 weeks of elbasvir/grazoprevir therapy.
Exclusion Criteria:
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.
Drug: Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]
Daily medication
Also known as: Zepatier
SVR - PP
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.
Time frame: 12 weeks after the end of therapy (SVR-12)
SVR - stratified
PP SVR-12 stratified by pre-specified baseline characteristics: * HCV monoinfection * HIV-HCV co-infection * Cirrhosis * Positive baseline urine toxicology * Men who have sex with men (MSM) * Commercial sex work * Diagnosed concomitant psychiatric disorder(s) * Use of concomitant medication(s) * Specific substance(s) used
Time frame: 12 weeks after the end of therapy (SVR-12)
Drug-Drug interactions (DDIs)
Interventions to prevent or remedy known or suspected DDIs between elbasvir/grazoprevir and concomitant prescription or over-the-counter medications, supplements, and substance of use
Time frame: From enrollment to treatment completion or termination, which ever comes first, for up to 36 weeks
Adherence
Self-reported adherence to elbasvir/grazoprevir, reported as number of missed doses and % missed doses of total doses
Time frame: During 12 weeks of treatment
SVR - ITT
Proportion of patients in the intention-to-treat (ITT) population with SVR-12. ITT: all patients who received at least one dose of Zepatier (elbasvir/grazoprevir)
Time frame: 12 weeks after the end of therapy (SVR-12)
Plan to share: No
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Illinois at Chicago