Rapid HCV Treatment Access for Persons Who Use Drugs (RAPID-HCV)

Rapid HCV Test and Treat to Increase HCV Treatment Uptake Among People Who Use Drugs

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C Virus Infection, Response to Therapy of
• Intervention / Treatment: Other: Test and treat plus peer mentors; Other: Usual care

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network Toronto
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test and Treat plus Peer Mentors Intervention Arm; Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support.	Other: 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.; Other Names: On-site treatment with peer support HCV treatment implementation strategy
Active Comparator: Standard of Care Referral Arm; Participants referred to offsite (non-OTP) location for HCV treatment.	Other: Usual care; Participants are referred to another location for HCV treatment.; Other Names: Standard of care referral HCV treatment implementation strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Who Initiate HCV Therapy	Participants who start HCV treatment in each arm.	Within 12 weeks of randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to HCV Treatment Initiation	Time to HCV Treatment Initiation in weeks.	From randomization to initiation of treatment, up to 24 weeks
HCV Treatment Completion	Participants who start HCV treatment and subsequently complete treatment (take more than 90% of prescribed treatment course).	At expected end of treatment date, up to 20 weeks
Sustained Virologic Response (SVR) Following Treatment by Intervention Group	Participants in each arm who achieved SVR, defined as HCV RNA <15 IU/mL between 10 and 36 weeks after completion of the HCV treatment regimen.	Post-treatment week 12

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: AbbVie
• Investigators: Principal Investigator: Oluwaseun Falade-Nwulia, MBBS, MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2021
• Primary Completion (Actual): February 23, 2024
• Study Completion (Actual): September 23, 2024

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Flaviviridae Infections; Hepatitis; Hepatitis C; Complex Mixtures; Tars; Coal Tar
• Other Study ID Numbers: IRB00265240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No