Rapid Hepatitis C Treatment Access for Drug Users

(RAPID-HCV Trial)

Recruiting at 4 trial locations

Overseen By Mark Sulkowski, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Red yeast rice, St. John's Wort

Disqualifiers: Pregnancy, Decompensated liver disease, HCC, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

124 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Oluwaseun Falade-Nwulia, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Adults aged 18-70 with Hepatitis C who use drugs and are in an opioid treatment program can join. They must be new to HCV treatment, may have HIV if treated or with high CD4 counts, and not pregnant or breastfeeding. Those with severe liver disease, other hepatitis types, low platelets, or taking certain medications cannot participate.

Inclusion Criteria

I have never been treated for hepatitis C.

Negative pregnancy test at screening or at the day of treatment initiation (females of childbearing potential only)

I have HIV and am either not on ART with a CD4 count over 500, or on a stable ART regimen.

Exclusion Criteria

Any history of active Hepatitis B or positive HBsAg test

I have a history of liver cancer.

Women who are pregnant or breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 weeks of glecaprevir/pibrentasvir with peer-mentor support or are referred to an offsite HCV treatment location

8 weeks

Follow-up

Participants are monitored for sustained virologic response and treatment completion

12-36 weeks

Treatment Details

Interventions

• Glecaprevir/pibrentasvir
• Test and treat plus peer mentors
• Usual care

Trial Overview The trial compares immediate HCV treatment using glecaprevir/pibrentasvir plus support from a peer mentor versus the usual care of being referred to an offsite clinic for those diagnosed at the opioid treatment program.

Participant Groups

Group I: Test and Treat plus Peer Mentors Intervention Arm Experimental Treatment 1 Intervention

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

Group II: Standard of Care Referral Arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois