A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-12

Study Completion Date

2020-09-01

Brief Summary

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Patients who are Hepatitis C Negative (HCV negative) and are on the waiting list for a lung transplant at NYULH who consent to participate in this study will receive a lung transplant from a deceased donor that is HCV positive. Patients will initiate treatment for HCV with the pan-genotypic agent, Mavyret, on the day of surgery and will complete the full 8-week treatment course. Patients will be monitored post-transplant for the development of viremia, and for the time course of clearance of viremia among those who develop viremia.

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Post Lung Transplant Patients

The lung transplantation will be performed per standard of care techniques,and all post-transplant management of the transplanted organ, including immunosuppression, will be carried out per standard of care.

Group Type EXPERIMENTAL

Mavyret

Intervention Type DRUG

Patients will be on 8 weeks of Mavyret

Interventions

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Mavyret

Patients will be on 8 weeks of Mavyret

Intervention Type DRUG

Other Intervention Names

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pibrentasvir glecaprevir

Eligibility Criteria

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Inclusion Criteria

Recipient criteria:

* Listed for an isolated lung transplant at NYU Langone Health
* Between 18-70 years of age
* Able to travel to the NYU Langone Health for routine post-transplant visits and study visits for a minimum of 6 months after transplantation
* No active illicit substance abuse
* Weight at least 40kg
* Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to the increased risk of birth defects and/or miscarriage
* Both men and women must agree to use at least one barrier method after transplant to prevent any secretion exchange
* Able and willing to provide informed consent

Donor criteria:

* Detectable HCV RNA by nucleic acid test (NAT) or positive anti-HCV antibody
* Donor lung meets standard NYU Langone Health clinical criteria for procurement

Exclusion Criteria

Recipient criteria:

* HIV positive
* HCV RNA positive or history of previously treated HCV
* Evidence of active hepatitis B infection or on active antiviral treatment for HBV
* Pregnant or nursing (lactating) women
* Use of strong CYP3A inducers
* Requires multi-organ transplant

Donor criteria:

* Confirmed HIV positive
* Confirmed HBV positive (positive hepatitis B surface antigen, and/or detectable Hepatitis B virus DNA)
* Known previously failed treatment for HCV
* Donor age \>60 years

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes