Rapid HCV Treatment Access for Persons Who Use Drugs

Not Applicable

Completed

• Conditions: Hepatitis C Virus Infection, Response to Therapy of
• Interventions: Other: Test and treat plus peer mentors; Other: Usual care

• Registration Number: NCT04677153
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-21
• Study Start: 2021-08-06
• Primary Completion: 2024-02-23
• Study Completion: 2024-09-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test and Treat plus Peer Mentors Intervention Arm	Test and treat plus peer mentors	Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support.
Standard of Care Referral Arm	Usual care	Participants referred to offsite (non-OTP) location for HCV treatment.

Primary Outcome Measures

Name	Time	Method
Participants Who Initiate HCV Therapy	Within 12 weeks of randomization	Proportion of participants who start HCV treatment in each arm.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

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