Clinical trial NCT04048850: Zepatier in Patients with Substance Use
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Hiv
Coinfection, HIV
Substance Use Disorders
Keywords: HCV
HIV-HCV coinfection
DAA
Elbasvir/grazoprevir
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-08-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: SVR - PP
timeFrame: 12 weeks after the end of therapy (SVR-12)
Secondary outcomes:
measure: SVR - stratified
timeFrame: 12 weeks after the end of therapy (SVR-12)
measure: Drug-Drug interactions (DDIs)
timeFrame: From enrollment to treatment completion or termination, which ever comes first, for up to 36 weeks
measure: Adherence
timeFrame: During 12 weeks of treatment
measure: SVR - ITT
timeFrame: 12 weeks after the end of therapy (SVR-12)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago College of Pharmacy
name: Rodrigo Mauricio Burgos, PharmD
role: PRINCIPAL_INVESTIGATOR
References: