Zepatier in Patients With Substance Use

June 28, 2022 updated by: Sarah Michienzi, University of Illinois at Chicago

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]
Daily medication
Other Names:
  • Zepatier

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks after the end of therapy (SVR-12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SVR - stratified
Time Frame: 12 weeks after the end of therapy (SVR-12)

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
12 weeks after the end of therapy (SVR-12)
Drug-Drug interactions (DDIs)
Time Frame: From enrollment to treatment completion or termination, which ever comes first, for up to 36 weeks
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
From enrollment to treatment completion or termination, which ever comes first, for up to 36 weeks
Adherence
Time Frame: During 12 weeks of treatment
Self-reported adherence to elbasvir/grazoprevir, reported as number of missed doses and % missed doses of total doses
During 12 weeks of treatment
SVR - ITT
Time Frame: 12 weeks after the end of therapy (SVR-12)
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)
12 weeks after the end of therapy (SVR-12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Sarah Michienzi, PharmD, University of Illinois at Chicago College of Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2019

Primary Completion (Actual)

June 1, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

August 5, 2019

First Posted (Actual)

August 7, 2019

Study Record Updates

Last Update Posted (Actual)

July 5, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0478

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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