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

• Status: Enrolling by invitation
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Antiviral Agents; Sofosbuvir; Sofosbuvir-velpatasvir drug combination

Criteria

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.