NCT04048850

Zepatier in Patients with Substance Use

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]	Daily medication

Timeline

• Start date: 2019-09-20
• Primary completion: 2022-06-01
• Completion: 2022-09-09
• First posted: 2019-08-07
• Last updated: 2025-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study