Rapid Hepatitis C Treatment Access for Drug Users

(RAPID-HCV Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods of delivering Hepatitis C treatment to individuals who use drugs and participate in an outpatient opioid treatment program. One group begins medication (glecaprevir/pibrentasvir) immediately after diagnosis and receives support from a peer who has overcome Hepatitis C. The other group follows the standard process of being referred to a different location for treatment. Suitable candidates for this trial have tested positive for Hepatitis C, are new to its treatment, and are not currently using certain HIV medications.

As an unphased trial, this study provides a unique opportunity to explore innovative methods of delivering Hepatitis C treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications or supplements at least 14 days before starting the trial, such as some cholesterol-lowering drugs, certain antihistamines, and birth control containing ethinyl estradiol. If you're taking any of the prohibited medications like red yeast rice, St. John's Wort, or certain seizure medications, you must be able to safely stop them before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the medication glecaprevir/pibrentasvir (GLE/PIB) is generally easy to take and effective for treating hepatitis C. Studies indicate it is safe and effective for many individuals. An 8-week course of GLE/PIB is often recommended and typically results in only minor side effects. Most people do not experience serious issues while using it.

The approach of testing and treating with peer mentors lacks extensive direct safety data. However, support from peers has been shown to help individuals stay on track with their treatment and feel more satisfied with their care, potentially leading to better outcomes. Overall, GLE/PIB is considered safe, and peer mentors may enhance the treatment experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new approach for treating Hepatitis C in drug users because it combines the medication glecaprevir/pibrentasvir with peer mentorship. This method is different from the usual care, which often involves referring patients to offsite clinics without additional support. The unique feature here is the integration of peer support, which can make treatment more accessible and potentially increase adherence to the medication. Glecaprevir/pibrentasvir is a highly effective antiviral treatment that can clear the virus in just eight weeks, offering a quicker resolution compared to some other options. This combination of rapid treatment and peer support could significantly improve outcomes for a challenging patient population.

What evidence suggests that this trial's treatments could be effective for hepatitis C?

Studies have shown that the combination of the drugs glecaprevir and pibrentasvir effectively treats hepatitis C. This 8-week treatment has been proven to cure the infection, prevent its spread, and reduce the risk of liver problems. It is generally safe and well-tolerated, even for individuals with existing liver issues. In this trial, one group of participants will receive this medication along with peer mentors—individuals who support and guide patients. Research indicates that peer mentors help more people start and complete their treatment. This approach led to all participants starting treatment, with most completing it successfully. These findings suggest that both the medication and the additional support effectively treat hepatitis C. ^{1 4 5 6 7}

Who Is on the Research Team?

Oluwaseun Falade-Nwulia, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38169058/

Real-World Safety and Effectiveness of an 8-Week ... Conclusion: An 8-week regimen of GLE/PIB is well tolerated and highly effective among US patients with HCV and cirrhosis receiving routine clinical care.

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/kjm2.12929

Real‐world efficacy and safety of universal 8‐week ... The study concluded that the 8-week regimen is highly effective, well-tolerated, and associated with significant renal function improvement in ...

3. smw.ch smw.ch/index.php/smw/article/download/2940/4841

Real-world effectiveness and safety of glecaprevir ... Successful treatment cures the HCV infection, avoids further transmission and significantly reduces HCV-related complications, liver transplantations or death.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03089944?term=Glecaprevir%20%2F%20Pibrentasvir&viewType=Table&rank=10

A Study of Glecaprevir (GLE)/​ Pibrentasvir (PIB) in ... A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 ...

5. jcpres.com jcpres.com/storage/upload/pdfs/1750332271-en.pdf

Effectiveness and Safety of Glecaprevir/Pibrentasvir ... The purpose of this research is to assess the safety and effectiveness of the glecaprevir/pibrentasvir (GLE/PIB) combination, which is effective ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03067129

NCT03067129 | A Study to Evaluate the Pharmacokinetics, ... This was a multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of glecaprevir (GLE) and pibrentasvir (PIB) treatment for 8, 12, ...

7. mjima.org mjima.org/articles/efficacy-and-safety-of-glecaprevirpibrentasvir-in-chronic-hepatitis-c-patients-real-world-data/mjima.galenos.2025.25430.12

Efficacy and Safety of Glecaprevir/Pibrentasvir in Chronic ... G/P demonstrates high effectiveness, good tolerability, and a favorable safety profile as a pan-genotypic therapeutic option for chronic HCV ...