Clinical Trials

MainTitle

Zepatier in Patients With Substance Use

This study has been enrolling by invitation
Sponsor
University of Illinois at Chicago

Collaborator
Merck Sharp & Dohme Corp.

Information provided by (Responsible Party)
Sarah Michienzi, University of Illinois at Chicago

ClinicalTrials.gov Identifier
NCT04048850

First received: August 1, 2019
Last updated: September 24, 2019
Last Verified: September 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention
Hepatitis C
Hiv
Coinfection, HIV
Substance Use Disorders

Drug : Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Sarah Michienzi, University of Illinois at Chicago:

Primary Outcome Measures

  • 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 Outcome Measures:
  • 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
  • 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
  • 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
  • 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)

Estimated Enrollment: 50
Study Start Date: September 20, 2019
Estimated Study Completion Date: August 1, 2021
Estimated Primary Completion Date: August 1, 2020 (Final data collection date for primary outcome measure)

Arms Assigned 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.
Drug: Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]

Daily medication

Other Name: Zepatier

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
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.

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04048850

Locations

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

Sponsors and Collaborators

University of Illinois at Chicago
Merck Sharp & Dohme Corp.

Investigators

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

More Information

Additional Information:

University of Illinois at Chicago Hospital and Health Sciences System

Responsible Party: Sarah Michienzi, Clinical Assistant Professor, University of Illinois at Chicago  
ClinicalTrials.gov Identifier: NCT04048850   History of Changes  
Other Study ID Numbers: 2019-0478  
Study First Received: August 1, 2019  
Last Updated: September 24, 2019  
Individual Participant Data    
Plan to Share IPD: No  

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  

Keywords provided by Sarah Michienzi, University of Illinois at Chicago:

HCV
HIV-HCV coinfection
DAA
Elbasvir/grazoprevir

Additional relevant MeSH terms:
Coinfection
Hepatitis C
HIV Infections
Hepatitis
Substance-Related Disorders
MK-5172
Elbasvir-grazoprevir drug combination

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.