Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Zepatier in Patients With Substance Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04048850
Recruitment Status : Enrolling by invitation
First Posted : August 7, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sarah Michienzi, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment
Hepatitis C Hiv Coinfection, HIV Substance Use Disorders Drug: Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
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
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


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 Name: Zepatier




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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

  4. 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)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048850


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Sarah Michienzi, PharmD University of Illinois at Chicago College of Pharmacy

Additional Information:
Layout table for additonal information
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
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Coinfection
Hepatitis C
HIV Infections
Hepatitis
Substance-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Chemically-Induced Disorders
Mental Disorders
Infection
Parasitic Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
MK-5172
Elbasvir-grazoprevir drug combination
Antiviral Agents
Anti-Infective Agents