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OpenTrials
Completed

NCT Number: NCT04048850

Zepatier in Patients with Substance Use

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.

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Key information

Conditions

Hepatitis C Acquired Immunodeficiency Syndrome Blood-Borne Infections Chemically-Induced Disorders Coinfection, HIV Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases HIV HIV Infections Hepatitis Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance Use Disorders Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Daily medication

Other names: Zepatier

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 7, 2019
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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