Rapid HCV Treatment Access for Persons Who Use Drugs

NCT ID: NCT04677153

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-06
• Study Completion Date: 2024-09-23

Brief Summary

This study is being done to compare two strategies to deliver HCV treatment to persons with hepatitis C virus (HCV) who also use drugs and are participating in an outpatient opioid treatment program (OTP). Participants will be randomized into one of two treatment groups:

1. Test and treat plus peer-mentors: This treatment group will be offered 8 weeks of glecaprevir/pibrentasvir (an FDA approved HCV treatment) within days of HCV diagnosis at the OTP. Participants in this group will receive treatment adherence support from a peer-mentor who is someone who has been cured of HCV infection.

2. Standard of care HCV treatment referral: This treatment group will be referred to an offsite HCV treatment location. This is the usual care for anyone who tests positive for HCV at the OTP who is not participating in this study.

Conditions

Hepatitis C Virus Infection, Response to Therapy of

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test and Treat plus Peer Mentors Intervention Arm

Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support.

Group Type: EXPERIMENTAL

Test and treat plus peer mentors

Intervention Type: OTHER

Rapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment.

Standard of Care Referral Arm

Participants referred to offsite (non-OTP) location for HCV treatment.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Participants are referred to another location for HCV treatment.

Interventions

Test and treat plus peer mentors

Rapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment.

Intervention Type: OTHER

Usual care

Participants are referred to another location for HCV treatment.

Intervention Type: OTHER

Other Intervention Names

On-site treatment with peer support HCV treatment implementation strategy; Standard of care referral HCV treatment implementation strategy

Eligibility Criteria

Inclusion Criteria

• Ability and willingness of participant to provide written informed consent
• Men and women age ≥18 to ≤70 years at study entry
• HCV antibody positive/detectable HCV RNA
• HCV treatment naïve (no prior treatment with an approved or investigational oral Direct-Acting Antivirals (DAA) therapy
• Negative pregnancy test at screening or at the day of treatment initiation (females of childbearing potential only)
• If co-infection with Human Immunodeficiency Virus (HIV) is documented, the subject must be anti-retroviral treatment (ART) naïve with CD4 T cell count >500 cells/mm3 OR on a stable ART regimen (containing only permissible ART - Raltegravir; dolutegravir; Rilpivirine; Elvitegravir/cobicistat; Tenofovir disoproxil fumarate; Tenofovir alafenamide; Emtricitabine; Lamivudine and/or Abacavir, bictegravir)

Exclusion Criteria

• Women who are pregnant or breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug
• Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation
• Current or history of decompensated liver disease (including but not limited to encephalopathy, variceal bleeding, or ascites) prior to study entry
• History of hepatocellular carcinoma (HCC)
• Any history of active Hepatitis B or positive HBsAg test
• Platelet count < 150,000/mm3
• HCV RNA undetectable
• History of clinically significant abnormalities or co-morbidities that make the subject an unsuitable candidate for this study, in the opinion of the investigator.
• Women of childbearing potential that are not practicing at least one specified method of birth control that is effective from Study Day 1 through at least 30 days after the last dose of study drug.
• Subject is currently taking any of the following prohibited medications: red yeast rice (monacolin K), St. John's Wort, carbamazepine, dabigatran, efavirenz, phenytoin, pentobarbital, phenobarbital, primidone, rifabutin, rifampin.
• Subject is not able or willing to safely discontinue the prohibited medications or supplements listed below at least 14 days prior to the first dose of GLE/PIB: some HMG-CoA reductase inhibitors, astemizole, cisapride, terfenadine, ethinyl estradiol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oluwaseun Falade-Nwulia, MBBS, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

University of Alabama

Birmingham, Alabama, United States

University of California, San Francisco

San Francisco, California, United States

Johns Hopkins University

Baltimore, Maryland, United States

University Health Network Toronto

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

IRB00265240

Identifier Type: -

Identifier Source: org_study_id