Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant

Mass General Brigham

Status and phase

Terminated

Phase 4

Conditions

Respiratory Failure

Hepatitis C

Treatments

Drug: Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks

Study type

Interventional

Funder types

Other

Identifiers

NCT03625687

2018P001697

Details and patient eligibility

About

This is a proof of concept, single center study for the donation of HCV-positive lungs to HCV negative recipient patients, with preemptive, interventional treatment with 8 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

Full description

The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after lungs transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCVpositive donor lung to an HCV naïve recipient.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Met MGH transplant center criteria, listed for lung transplant
Able to sign informed consent

Exclusion criteria

Pregnant or nursing (lactating) women
HIV positivity
Any contra-indication to lung transplantation per center protocol
For study patients in whom Epclusa® therapy is being considered, exclusion criteria includes patients on the following p-glycoprotein inducers or moderate to potent CYP inducers that cannot stop therapy: carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort.
For study patients in whom MavyretTM therapy is being considered, exclusion criteria includes patients on the following medications who cannot stop therapy: carbamazepine, rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.