Zepatier in Patients With Substance Use

Hiv Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04048850
• Other study ID #: 2019-0478
• Status: Active, not recruiting
• Start date: September 20, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: December 31, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coinfection
• Coinfection, HIV
• Hepatitis
• Hepatitis C
• Hiv
• HIV Infections
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Drug:
• Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]
Daily medication

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	SVR - stratified	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	12 weeks after the end of therapy (SVR-12)
Secondary	Drug-Drug interactions (DDIs)	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	From enrollment to treatment completion or termination, which ever comes first, for up to 36 weeks
Secondary	Adherence	Self-reported adherence to elbasvir/grazoprevir, reported as number of missed doses and % missed doses of total doses	During 12 weeks of treatment
Secondary	SVR - ITT	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)	12 weeks after the end of therapy (SVR-12)

External Links

•   University of Illinois at Chicago Hospital and Health Sciences System