Zepatier in Patients With Substance Use

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04048850

Collaborator

Merck Sharp & Dohme LLC (Industry)

Enrollment

Location

39.4

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Actual Enrollment :

25 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 :

Sep 20, 2019

Actual Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	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 Names: Zepatier

Arm

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 Names:

Zepatier

Outcome Measures

Primary Outcome Measures

SVR - PP [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

SVR - stratified [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
Drug-Drug interactions (DDIs) [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
Adherence [During 12 weeks of treatment]
Self-reported adherence to elbasvir/grazoprevir, reported as number of missed doses and % missed doses of total doses
SVR - ITT [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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