Education + Antiviral Therapy for Hepatitis C

No longer recruiting at 2 trial locations

Overseen By Jessica Siguencia

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Decompensated liver disease, Hepatocellular carcinoma, Hepatitis B, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether video-based education can help more people start and complete treatment for hepatitis C. Hepatitis C, a liver disease caused by the hepatitis C virus (HCV), is treated in this trial with two antiviral medications, Glecaprevir and Pibrentasvir. Participants will either watch educational videos or receive standard care education about HCV. The trial includes a blood test to check virus levels, but this test is solely for research purposes. This trial suits individuals who have tested positive for HCV antibodies and have not previously received treatment. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and the research aims to understand how it benefits more patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop your current medications.

What is the safety track record for Glecaprevir and Pibrentasvir?

Research has shown that the treatments in this trial, Glecaprevir and Pibrentasvir, have FDA approval for hepatitis C. They have been tested for safety and are generally well-tolerated, with most people experiencing only mild side effects, such as headaches or fatigue. Serious side effects are rare.

The Cepheid Point-of-Care (POC) HCV Viremia test used in this study also has FDA authorization. It quickly and safely checks for the hepatitis C virus. As a test, it does not cause the same side effects as medication.

Overall, both the treatments and the test in this trial have strong safety records, supported by past research and approvals. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it combines education with antiviral therapy to tackle Hepatitis C in a novel way. Traditionally, treatments for Hepatitis C involve direct-acting antivirals like Glecaprevir and Pibrentasvir, which are effective but rely heavily on healthcare providers for patient education. This trial introduces a video-based education component that empowers patients with knowledge about the disease, screening, and medication, making the treatment process more accessible. Additionally, the trial includes a Point of Care (POC) testing method using the Cepheid Xpert HCV Viral Load Fingerstick assay, which provides quick and convenient viral load testing without influencing treatment decisions. By integrating these elements, researchers hope to enhance patient engagement and streamline the monitoring process, potentially improving treatment adherence and outcomes.

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

Research shows that the combination of Glecaprevir and Pibrentasvir, which participants in this trial may receive, effectively treats hepatitis C. Studies have found that this treatment cures over 95% of people with the hepatitis C virus (HCV) when taken as directed. It reliably targets the virus and stops it from spreading.

Meanwhile, research has shown that the Cepheid Point of Care (POC) HCV Viremia test, another component of this trial, works extremely well, with a sensitivity of 100% and a specificity of 98.5%. This means it almost always correctly identifies the virus and rarely gives false positive results. The test provides results quickly, often within an hour, which can help speed up treatment decisions. ^{1 2 4 6 7}

Who Is on the Research Team?

Robert S Brown, MD, MPH

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for men and women aged 18 to 70 who have never been treated for Hepatitis C. They must be HCV antibody positive but cannot have had liver cancer, active Hepatitis B, undetectable HCV RNA, or severe liver disease like encephalopathy or ascites.

Inclusion Criteria

I am between 18 and 70 years old, or an emancipated minor aged 16 or over.

HCV antibody positive

I have never been treated for Hepatitis C.

Exclusion Criteria

I have a history of liver cancer.

HCV RNA undetectable

I have a history of active Hepatitis B or a positive HBsAg test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Education and Testing

Participants receive video-based or healthcare provider-delivered education and undergo HCV Viremia (RNA) testing

1 day

1 visit (in-person)

Treatment

Participants receive Glecaprevir/Pibrentasivir (G/P) treatment

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cepheid POC HCV Viremia (RNA) test
• Glecaprevir and Pibrentasvir
• HCV education from a health care provider

Trial Overview The study tests if a model combining a point-of-care HCV RNA test with video-based patient education improves the start and completion rates of Hepatitis C treatment using Glecaprevir and Pibrentasvir medications.

How Is the Trial Designed?

Group I: Point of Care (POC) HCV Viremia (RNA) testing Experimental Treatment 3 Interventions

All participants will have standardized laboratory assessments for HCV Viremia (RNA testing) as well as Cepheid POC HCV Viremia (RNA) test. The Cepheid Xpert HCV Viral Load (VL) Fingerstick assay is a test designed for the quantitation (amount) of Hepatitis C Virus (HCV) DNA in human whole blood. The HCV RNA result will be compared to standardized laboratory assessment for HCV Viremia. The Cepheid test is being conducted for research use only and will not be used for HCV diagnosis or treatment decisions.

Group II: HCV Education Active Control 2 Interventions

The intervention of HCV education will be performed at the addiction care setting for video- based patient education. Health care provide delivered patient education is the standard of care referral approach. HCV Education will include HCV disease overview, HCV screening, taking Glecaprevir/Pibrentasivir (G/P), and post study drug assessment and management. Participants may be randomized to either the video-based patient education or the HCV delivered patient education.

Glecaprevir and Pibrentasvir is already approved in United States, European Union for the following indications:

Approved in United States as Mavyret for:

• Chronic hepatitis C virus (HCV) genotypes 1–6 infection in patients without cirrhosis or with compensated cirrhosis
• HCV genotype 1 infection in patients who have previously been treated with a regimen containing either an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both

Approved in European Union as Maviret for:

• Chronic hepatitis C virus (HCV) infection in adults and adolescents aged 12 years and older

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

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

Published Research Related to This Trial

Glecaprevir/pibrentasvir is a safe and effective treatment for hepatitis C virus (HCV) genotypes 1 to 6, showing sustained virological response rates between 83% and 100% across various patient populations, including those with cirrhosis and HIV-1 coinfection.

This medication is FDA-approved for an 8-week treatment regimen and has safety outcomes comparable to other recommended HCV treatments, making it a valuable option as HCV infection rates remain high.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glecaprevir/Pibrentasvir: The First 8-Week, Pangenotypic HCV Treatment Regimen for Patients 12 Years of Age and Older. Huff, J., Andersen, R.[2021]

Glecaprevir/pibrentasvir is a fixed-dose combination tablet approved for treating all major genotypes (1-6) of chronic hepatitis C virus (HCV) infection in adults, demonstrating broad efficacy across different HCV strains.

The treatment has been approved by both the EMA and the US FDA for patients with chronic HCV, including those with compensated cirrhosis and specific prior treatment histories, highlighting its safety and effectiveness in diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glecaprevir/Pibrentasvir: First Global Approval. Lamb, YN.[2022]

In a study of 21 patients with severe renal impairment receiving GLE/PIB treatment for chronic hepatitis C, the sustained virologic response (SVR12) rate was 100%, indicating the treatment was highly effective.

The treatment was well-tolerated with no significant adverse events reported, demonstrating that GLE/PIB is a safe option for HCV-infected patients with severe renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus infection and severe renal impairment. Yap, DYH., Liu, KSH., Hsu, YC., et al.[2021]

In a study of 30 patients with hepatitis C who previously failed direct-acting antiviral therapies, 93.3% achieved a sustained virologic response (SVR12) after 12 weeks of treatment with glecaprevir and pibrentasvir, demonstrating high efficacy.

While the treatment was effective across different liver fibrosis stages, two patients with genotype 1b experienced relapse, indicating that certain drug resistance-associated variants may reduce treatment effectiveness for specific genotypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world efficacy of glecaprevir plus pibrentasvir for chronic hepatitis C patient with previous direct-acting antiviral therapy failures. Osawa, M., Imamura, M., Teraoka, Y., et al.[2021]

Glecaprevir/pibrentasvir (GLE/PIB) is an effective all-oral treatment for chronic hepatitis C virus (HCV) infection, showing good pharmacokinetics in a study of 332 Japanese patients from two phase 3 trials.

The treatment was well tolerated, with no need for dose adjustments based on factors like age, body weight, or renal function, although higher drug exposures were noted in patients with cirrhosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics of Glecaprevir/Pibrentasvir in HCV-infected Japanese Subjects in Phase 3 CERTAIN-1 and CERTAIN-2 Trials. Suleiman, AA., Lin, CW., Liu, W., et al.[2021]

In a study involving 1208 patients with hepatitis C virus (HCV) genotype 1 or 3, treatment with glecaprevir and pibrentasvir for 8 or 12 weeks resulted in very high rates of sustained virologic response, reaching 99.1% for 8 weeks and 99.7% for 12 weeks in genotype 1 patients.

The treatment was also effective for genotype 3 patients, achieving a 95% sustained virologic response rate after both 12 weeks and 8 weeks of treatment, with minimal adverse events leading to discontinuation (less than 1%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection. Zeuzem, S., Foster, GR., Wang, S., et al.[2022]

In a study of 271 Japanese patients with chronic hepatitis C virus (HCV) infections, glecaprevir and pibrentasvir (GLE/PIB) achieved a sustained virological response (SVR12) rate of 99.4% for initial treatment and 97.7% for re-treatment, demonstrating high efficacy in real-world settings.

The treatment was found to be safe, with only 3.0% of patients experiencing serious adverse events, and all patients who discontinued due to adverse events still achieved SVR12, indicating that GLE/PIB is a viable option for managing HCV infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial- and re-treatment effectiveness of glecaprevir and pibrentasvir for Japanese patients with chronic hepatitis C virus-genotype 1/2/3 infections. Sezaki, H., Suzuki, F., Hosaka, T., et al.[2021]

In a study of 423 patients with hepatitis C, glecaprevir + pibrentasvir therapy achieved a high sustained virologic response (SVR12) rate of 89% for 8-week treatment and 93% for 12-week treatment, demonstrating its efficacy especially in HCV genotype 1 and 2 patients.

The therapy was generally safe, but caution is advised for elderly patients and those who may drop out, as severe adverse effects were noted in some older individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intention-to-treat assessment of glecaprevir + pibrentasvir combination therapy for patients with chronic hepatitis C in the real world. Tamori, A., Inoue, K., Kagawa, T., et al.[2020]

Glecaprevir/pibrentasvir (GLE/PIB) therapy demonstrated a high sustained virological response (SVR12) rate of 98.1% in a study of 326 patients with chronic hepatitis C genotype 2, indicating its efficacy as a treatment.

However, patients with a high baseline viral load (≥107 IU/ml) showed a significantly lower SVR12 rate (90.6%) compared to those with lower viral loads, suggesting that high viral load may predict treatment failure in non-cirrhotic patients receiving 8 weeks of GLE/PIB therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High viral load predicts virologic failure in chronic genotype 2 hepatitis C virus-infected patients receiving glecaprevir/pibrentasvir therapy. Chen, WM., Wei, KL., Tung, SY., et al.[2021]

In a study involving three non-cirrhotic patients who previously failed treatment with the GLE/PIB regimen, retreatment with sofosbuvir/velpatasvir plus ribavirin (SOF/VEL+RBV) for 24 weeks resulted in all patients achieving a sustained viral response (SVR) at 24 weeks post-treatment.

This indicates that SOF/VEL+RBV is an effective option for retreating HCV infections after the failure of the GLE/PIB therapy, highlighting its potential as a second-line treatment for patients who do not respond to initial therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sofosbuvir/Velpatasvir Plus Ribavirin Combination Therapy for Patients with Hepatitis C Virus Genotype 1a, 2a, or 3b after Glecaprevir/Pibrentasvir Therapy Failed. Nonomura, A., Tamori, A., Hai, H., et al.[2021]

Citations

1. cepheid.com cepheid.com/en-US/tests/blood-virology-womens-health-sexual-health/xpert-hcv-info.html

Xpert® HCV Info Cepheid's CLIA waived Xpert® HCV test, authorized by the FDA, allows complete hepatitis C RNA testing at the point-of-care. The test runs on the Xpert® ...

2. cepheid.com cepheid.com/en-US/tests/blood-virology-womens-health-sexual-health/xpert-hcv.html

Xpert HCV The Xpert HCV test utilizes an automated in vitro reverse transcription polymerase chain reaction (RT-PCR) to qualitatively detect hepatitis C virus (HCV) RNA.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7379744/

Field evaluation of GeneXpert® (Cepheid) HCV performance ... Our study findings demonstrate the excellent performance, in terms of sensitivity (100%) and specificity (98.5%), of the Xpert platform compared to the Roche ...

4. nvhr.org nvhr.org/from-fingerstick-to-cure/

From Fingerstick to Cure: Factors to Consider Around ... It detects HCV RNA in adults aged 22 years and older via fingerstick, providing positive results in as little as 41 minutes, with negative ...

5. fda.gov fda.gov/news-events/press-announcements/fda-permits-marketing-first-point-care-hepatitis-c-rna-test

FDA Permits Marketing of First Point-of-Care Hepatitis C ... Rather than requiring a sample to be sent to a central lab for testing, the test detects HCV RNA and delivers results in about an hour using a ...

6. cepheid.com cepheid.com/en-NZ/tests/blood-virology-womens-health-sexual-health/xpert-hcv-vl-fingerstick.html

Xpert® HCV VL Fingerstick The Xpert® HCV VL Fingerstick test is intended to be used as an aid in the initial diagnosis in individuals at high risk of HCV infection or in anti-HCV ...

7. academic.oup.com academic.oup.com/jid/article/229/Supplement_3/S342/7332131

Molecular Point-of-Care Testing for Hepatitis C The only POC tests for HCV detection currently available are on near-POC platforms (Table 1). The Cepheid GeneXpert system with Mycobacterium ...