Zepatier in Patients with Substance Use

NCT04048850 | Completed FDA Drug

• 1 other identifier: 2019-0478
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; Hiv; Coinfection, HIV; Substance Use Disorders

Keywords

HCV; HIV-HCV coinfection; DAA; Elbasvir/grazoprevir

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks after the end of therapy (SVR-12)

Secondary Outcomes (4)

• SVR - stratified

  12 weeks after the end of therapy (SVR-12)

• Drug-Drug interactions (DDIs)

  From enrollment to treatment completion or termination, which ever comes first, for up to 36 weeks

• Adherence

  During 12 weeks of treatment

• SVR - ITT

  12 weeks after the end of therapy (SVR-12)

Study Arms (1)

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]

Interventions

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

Daily medication

Also known as: Zepatier

Patients living with HCV +/- HIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Links

• University of Illinois at Chicago Hospital and Health Sciences System

MeSH Terms

Conditions

Hepatitis C; Acquired Immunodeficiency Syndrome; HIV Infections; Substance-Related Disorders

Interventions

elbasvir; grazoprevir; elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Rodrigo Mauricio Burgos, PharmD

  University of Illinois at Chicago College of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 7, 2019
• Study Start: September 20, 2019
• Primary Completion: June 1, 2022
• Study Completion: September 9, 2022
• Last Updated: January 28, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)