Glecaprevir/Pibrentasvir for Hepatitis C

Not yet recruiting at 9 trial locations

Overseen By Katie McCarthy

Age: < 65

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Efavirenz, Etravirine, Cobicistat, others

Disqualifiers: Hepatitis B, Decompensated cirrhosis, 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 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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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

I am legally able to give my own consent for treatment.

HIV status determined based on protocol requirements

I am between 14 and 32 weeks pregnant.

Exclusion Criteria

I do not have acute hepatitis or severe liver damage not caused by hepatitis C.

I have been treated for hepatitis C before.

High risk of preterm delivery

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Pregnant participants take three GLE/PIB fixed-dose combination tablets orally once daily with food

8 weeks

Follow-up

Participants and their infants are monitored for safety and effectiveness after treatment

10 weeks postpartum

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?

Group I: GLE/PIB Experimental Treatment 1 Intervention

Pregnant participants will take three (3) GLE/PIB fixed-dose combination tablets orally once daily with food for eight weeks

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35891520/

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.

2. brieflands.com brieflands.com/journals/hepatmon/articles/110077

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 ...

3. 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 ...

4. 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.

5. nature.com nature.com/articles/s41598-021-03006-3

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

6. 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.

7. 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, ...

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

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 ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/liv.16180

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 ...