Glecaprevir/Pibrentasvir for Hepatitis C
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for pregnant women with hepatitis C, a liver infection. The goal is to assess the safety and effectiveness of the antiviral medication glecaprevir/pibrentasvir for these women and their babies. Participants will take the medicine for eight weeks during pregnancy. Women with hepatitis C who are between 14 to 32 weeks pregnant may be suitable candidates, especially if they have not received prior treatment for hepatitis C. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works and measure its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking medical advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have taken any prohibited medications within 14 days before starting the trial. It's best to discuss your current medications with the study team to see if they are allowed.
Is there any evidence suggesting that glecaprevir/pibrentasvir is likely to be safe for humans?
Research has shown that the medication glecaprevir/pibrentasvir is generally safe and well-tolerated for people with hepatitis C. Earlier studies found no serious side effects. About 20.6% of patients experienced minor side effects, but these did not require stopping or pausing the treatment. No severe negative reactions were reported in these studies. This suggests that the treatment is safe for most patients and effectively treats hepatitis C.12345
Why do researchers think this study treatment might be promising for hepatitis C?
Glecaprevir/pibrentasvir is unique because it combines two antiviral agents that work together to target and inhibit essential proteins needed for the Hepatitis C virus to replicate. Unlike some existing treatments that might require longer treatment durations, this combination is designed to be effective in as little as eight weeks. Researchers are excited because this offers a potentially shorter and more convenient treatment course, which is particularly appealing for pregnant participants who may face additional health considerations.
What evidence suggests that glecaprevir/pibrentasvir might be an effective treatment for hepatitis C?
Research shows that the medication combination glecaprevir/pibrentasvir (GLE/PIB) effectively treats hepatitis C. Studies have found that an 8-week course of this treatment can cure the infection and prevent its spread. Patients generally tolerate the treatment well, and it significantly reduces the risk of liver damage and other hepatitis C-related complications. Evidence from various patient groups supports its safety and success in eliminating the virus. This treatment is a strong option for managing chronic hepatitis C.36789
Are You a Good Fit for This Trial?
This trial is for pregnant women aged 16-45 with hepatitis C, at 14-32 weeks gestation. It's open to those with or without HIV but requires a suppressed HIV viral load if positive. Participants must not have liver complications unrelated to hepatitis C, previous HCV treatment, high preterm delivery risk, or other conditions that could affect the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Pregnant participants take three GLE/PIB fixed-dose combination tablets orally once daily with food
Follow-up
Participants and their infants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Glecaprevir/pibrentasvir
Trial Overview
The study is examining Glecaprevir/Pibrentasvir (GLE/PIB) given during pregnancy to treat hepatitis C. It's a single-arm trial focusing on how the drug behaves in the body (pharmacokinetics) and its safety for both mother and infant until 10 weeks after birth.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Pregnant participants will take three (3) GLE/PIB fixed-dose combination tablets orally once daily with food for eight weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Citations
Updated Data from the German Hepatitis C-Registry (DHC-R)
GLE/PIB was highly effective and well tolerated in this real-world study of patient groups key to HCV elimination.
Real-world Effectiveness of Glecaprevir/Pibrentasvir (GLE ...
This study demonstrated that initial and re-treatment with GLE/PIB were effective and safe in a German cohort with chronic HCV infection in real ...
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 ...
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.
Nationwide registry of glecaprevir plus pibrentasvir in the ...
The study evaluated the real-world treatment outcomes of Glecaprevir/pibrentasvir (GLE/PIB) including effectiveness, safety and healthcare resource utilization
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.
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, ...
Effectiveness and Safety of Glecaprevir/Pibrentasvir ...
Conclusion: The GLE/PIB combination is an effective and safe treatment option in the treatment of HCV infection. Due to the high EVR rates, more ...
Effectiveness and Safety of Glecaprevir/Pibrentasvir in ...
These results suggest that therapy with GLE/PIB for 8 weeks in children and adolescents with HCV infection is effective and safe, independently ...
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