Preliminary data from a new study has demonstrated that pre-emptive administration of pan-genotypic, direct-acting antiviral therapy prevents hepatitis C virus (HCV) infection in HCV-negative cardiac transplant patients receiving donor hearts infected with the virus.
Pre-emptive administration of pan-genotypic, direct-acting antiviral (DAA) therapy prevents hepatitis C virus (HCV) infection in HCV-negative cardiac transplant patients receiving donor hearts infected with the virus, according to preliminary data from a new study presented at The Liver Meeting, held by the American Association for the Study of Liver Diseases.
The study findings have important implications as cardiac transplants are limited in the United States due to an increasing lack of available donor hearts. The annual number of heart transplants have remained steady over the last 10 years despite heart failure cases steeply increasing. Limiting the donor pool further, a significant amount of donor hearts are discarded for being infected with HCV.
“In the United Network for Organ Sharing Region 1, almost a quarter of hearts meeting standard criteria for cardiac donation were discarded solely on HCV positivity in 2016,” Emily D. Bethea, MD, fellow, Liver Center and HI Division at Massachusetts General, and the study’s first author, said in a statement. “As the shortage of transplant viable organs persists, it is of paramount importance that all potentially transplantable organs are identified.”
During the study, 25 patients enrolled in a single center had their status on a cardiac transplantation waitlist updated to reflect their willingness to receive an HCV-positive donor heart. If a patient received an offer for an HIV nucleic-acid testing-positive donor heart, they were pre-emptively treated with glecaprevir-pibrentasvir.
Patients received their first dose of antiviral therapy prior to going to the operating room for transplant, and after surgery, they completed 8 weeks of treatment. To ensure adequate viral suppression and no detectable HCV virus in the blood, HCV viral load monitoring was performed during and after treatment.
Sixteen patients have since received an HCV-positive donor heart and each of these patients has achieved viral suppression with undetectable or nonquantifiable HCV RNA by the ninth day after their transplant.
There have been no reported drug-related side effects or interactions resulting in lapses or a stop in therapy, and there have been no treatment failures. Cardiac allograft and patient survival is 100% over more than 1700 days of follow-up.
“Our study demonstrates the success of preemptive DAA therapy in cardiac transplantation. We believe this novel approach can help to increase the donor pool, decrease heart transplant wait times, and improve health outcomes,” said Bethea.