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

Phase 4TerminatedNCT03625687

Massachusetts General Hospital19 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Respiratory Failure Hepatitis C

Interventions

Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeksDRUG

8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Undetectable Blood HCV RNA Level

Negative HCV RNA by blood testing at 12 weeks after the last dose of treatment.

Time frame: 12 weeks post last dose of treatment with DAA

Secondary Outcomes

Number of Participants With Treatment Emergent Adverse Events

Safety and tolerability of DAA therapy in the lung transplant recipient monitored by quantifying the number of treatment related adverese events per patient and evaluation clinically significant out of range lab results as compared to baseline/pretreatment values per patient

Time frame: 8 weeks

Tolerability (Based on Number of Adverse Events and Clinically Significant Laboratory Values)

Tolerability of commercially available DAA therapy in the lung transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant laboratory results

Time frame: 8 weeks

Data from ClinicalTrials.gov

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