Hepatitis CNCT04048850
Zepatier in Patients with Substance Use
An observational study of Hepatitis C and Hiv, run by University of Illinois Chicago at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Hiv, Coinfection, HIV
- What is being tested?
- Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]
- Type of treatment
- Pill or oral medicine
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2019to 9 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
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
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.
Read the 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
- Being tested
- Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]
- Keywords
- HCV, HIV-HCV coinfection, DAA, Elbasvir/grazoprevir
- Medical subject headings
- Hepatitis C, Acquired Immunodeficiency Syndrome, HIV Infections, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]Drug
Also called Zepatier
Daily medication
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after the end of therapy (SVR-12)
Secondary outcomes (4)
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
Measured: 12 weeks after the end of therapy (SVR-12)
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
Measured: From enrollment to treatment completion or termination, which ever comes first, for up to 36 weeks
Adherence
Self-reported adherence to elbasvir/grazoprevir, reported as number of missed doses and % missed doses of total doses
Measured: During 12 weeks of treatment
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)
Measured: 12 weeks after the end of therapy (SVR-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start20 Sep 2019
- Primary completion1 Jun 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Rodrigo Mauricio Burgos, University of Illinois Chicago
- Investigators
- Rodrigo Mauricio Burgos, PharmD, Principal investigator, University of Illinois at Chicago College of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048850
- Sponsor's protocol ID
- 2019-0478
- Status last verified
- Feb 2024
- First submitted
- 1 Aug 2019
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04048850
- Acronym / sponsor ID
- 2019-0478
- Conditions
- Hepatitis C, Hiv, Coinfection, HIV, Substance Use Disorders
- Keywords
- HCV, HIV-HCV coinfection, DAA, Elbasvir/grazoprevir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients living with HCV +/- HIV | – | Drug: Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Incarcerated
- Pregnant or breastfeeding
- Decompensated liver disease (Child-Pugh B or C)
- Albumin below 3 g/dL
- Platelet count below 75,000
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]Also: ZepatierDaily medication | Drug | Patients living with HCV +/- HIV |
Primary outcome
SVR - PP
Time frame: 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.
4 secondary outcomes
SVR - stratified
Time frame: 12 weeks after the end of therapy (SVR-12)
Drug-Drug interactions (DDIs)
Time frame: From enrollment to treatment completion or termination, which ever comes first, for up to 36 weeks
Adherence
Time frame: During 12 weeks of treatment
SVR - ITT
Time frame: 12 weeks after the end of therapy (SVR-12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- University of Illinois at Chicago Hospital and Health Sciences SystemLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Mauricio Burgos, PharmD principal investigator
University of Illinois at Chicago College of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Hiv, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR - PP (time frame: 12 weeks after the end of therapy (SVR-12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.