A Single-center Pilot Study Evaluating a Preemptive Short Course of Glecaprevir/Pibrentasvir in Hepatitis C Positive to Negative Kidney Transplantation

NCT ID: NCT04682509

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-20
• Study Completion Date: 2024-02-28

Brief Summary

The purpose of this research study is to evaluate the feasibility of a 2 week course of glecaprevir/pibrentasvir (Mavyret) starting immediately prior to transplantation to treat hepatitis C virus (HCV) in kidney transplant recipients who receive a kidney from a donor with HCV.

Detailed Description

This is a prospective, open-label, single-center, pilot study. The patient population will include 20 patients who are on the kidney transplant waitlist at NYU Langone Health, are hepatitis C virus (HCV) negative, are willing to accept an organ from an HCV positive donor, and consent to participate in this trial. Study subjects will receive a kidney transplant from a deceased donor who tested positive for HCV as confirmed by nucleic acid amplification testing (NAT) per standard of care. All study subjects will receive a two week course of preemptive therapy with glecaprevir/pibrentasvir (Mavyret®), starting on postoperative day (POD) 0 prior to the transplant. If HCV RNA is undetectable after 2 weeks of therapy, Mavyret will be discontinued and study subjects will be followed with an intensive HCV monitoring protocol. If HCV RNA is detectable after 2 weeks of therapy, Mavyret will be continued to complete a full course of 8 weeks per standard of care. All patients will undergo close monitoring and surveillance for HCV viremia post-transplant to ensure that sustained virologic response (SVR) is achieved.

Conditions

ESRD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Study group

All study subjects will receive glecaprevir/pibrentasvir (Mavyret®) 300/120 mg orally x 14 days, starting on POD 0 prior to transplantation of the HCV positive kidney. If HCV RNA is detectable after 2 weeks of therapy, Mavyret® will be continued to complete a full course of 8 weeks per standard of care. Safety monitoring and frequent surveillance for HCV viremia will occur for all subjects throughout the duration of the study. The kidney transplantation procedure and routine post-transplant management will be performed per standard of care.

Group Type: EXPERIMENTAL

Glecaprevir/pibrentasvir

Intervention Type: DRUG

Manufacturer is AbbVie, Inc., North Chicago, IL Mavyret® is commercially available and FDA approved for the treatment of HCV genotype 1, 2, 3, 4, 5, or 6 infection in patients without cirrhosis or with compensated cirrhosis and also for the treatment of adult patients with HCV genotype 1 infection who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor. An immediate release bilayer oral tablet containing a fixed-dose combination of 100 mg of glecaprevir and 40 mg of pibrentasvir. The daily dose of glecaprevir/pibrentasvir used will be the standard FDA approved dose: 3 tablets taken once daily (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg).

Interventions

Glecaprevir/pibrentasvir

Manufacturer is AbbVie, Inc., North Chicago, IL Mavyret® is commercially available and FDA approved for the treatment of HCV genotype 1, 2, 3, 4, 5, or 6 infection in patients without cirrhosis or with compensated cirrhosis and also for the treatment of adult patients with HCV genotype 1 infection who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor. An immediate release bilayer oral tablet containing a fixed-dose combination of 100 mg of glecaprevir and 40 mg of pibrentasvir. The daily dose of glecaprevir/pibrentasvir used will be the standard FDA approved dose: 3 tablets taken once daily (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg).

Intervention Type: DRUG

Other Intervention Names

Mavyret

Eligibility Criteria

Inclusion Criteria

• At least 18 years of age
• Listed for kidney transplantation at NYU Langone Health and willing to accept HCV positive donor organs
• Able to complete routine post-transplant visits and study visits for a minimum of 1 year after transplantation
• Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Stategy (REMS) after transplant due to increased risk of birth defects and/or miscarriage
• Both men and women must agree to use at least one barrier method of contraception after transplant to prevent any secretion exchange
• Able and willing to provide informed consent
• Receive an organ offer for a kidney from a deceased donor that:
• Is HCV NAT positive
• Meets all standard criteria for organ acceptability at NYU Langone Transplant Institute

Exclusion Criteria

• HCV RNA positive or history of previously treated HCV
• Evidence of active hepatitis B infection or on active antiviral treatment of HBV
• HIV positivity
• Pregnant or nursing (lactacting) women
• Current use of atazanavir or rifampin
• Known hypersensitivity to glecaprevir and/or pibrentasvir
• Current or history of decompensated liver disease
• Recipients of dual organs (i.e. simultaneous liver and kidney transplant, simultaneous kidney and pancreas transplant, or simultaneous heart and kidney transplant)
• Receive an organ offer for a kidney from a deceased donor that is:
• Confirmed HIV positive
• Confirmed HBV positive (positive hepatitis B surface antigen, and/or detectable hepatitis B virus DNA)
• Known to have previously failed DAA therapy for treatment for HCV
• HCV antibody positive, but NAT negative

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bonnie Lonze, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

20-01386

Identifier Type: -

Identifier Source: org_study_id