Education + Antiviral Therapy for Hepatitis C
What You Need to Know Before You Apply
What is the purpose of this trial?
The study hypothesis is that the test and treat model utilizing video-based patient education will have higher rates of hepatitis C virus (HCV) treatment initiation and treatment completion.
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 safety data exists for the treatment of Hepatitis C with Glecaprevir/Pibrentasvir?
Glecaprevir/Pibrentasvir is considered safe and efficacious for treating Hepatitis C across various genotypes and patient populations, including those with cirrhosis, HIV-1 coinfection, or renal impairment. Clinical trials have shown sustained virological response rates from 83% to 100%, with safety outcomes similar to other recommended treatments. It is well tolerated, with no dose adjustments needed for factors like age, body weight, or renal function, including in patients with severe renal impairment.12345
Is the drug Glecaprevir and Pibrentasvir a promising treatment for Hepatitis C?
What data supports the idea that Education + Antiviral Therapy for Hepatitis C is an effective treatment?
The available research shows that the combination of glecaprevir and pibrentasvir (GLE/PIB) is effective for treating hepatitis C. It is approved for treating all major types of hepatitis C in adults, and studies have shown it works well even for patients who have not responded to other treatments. Although some patients may need a different treatment if GLE/PIB doesn't work, the overall effectiveness of GLE/PIB is high, making it a strong option for many people with hepatitis C.346910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Education and Testing
Participants receive video-based or healthcare provider-delivered education and undergo HCV Viremia (RNA) testing
Treatment
Participants receive Glecaprevir/Pibrentasivir (G/P) treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Glecaprevir and Pibrentasvir is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
AbbVie
Industry Sponsor
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