Open-Labeled Trial Of Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Heart Transplants From Hepatitis C-Positive Donors
Since 2006, there has been a 50% increase in the number of adults added to the heart transplant waitlist in the US. Yet the persistent organ donor shortage has led to only a 25% increase in the number of transplants, and a 25% increase in the number of patients removed from the heart transplant waitlist because of death or becoming too sick to transplant, reaching nearly 700 patients in 2015. It has been suggested that the donor supply could be increased by utilizing hearts from older donors or those with more medical co-morbidities, but the increased risk of graft failure prevents their broader use. Despite advances in ventricular assist devices (VADs), which can prolong patient survival and improve quality-of-life, they are not a panacea. Long-term survival is superior for patients receiving a heart transplant, and VADs are not an option for patients with several forms of end-stage heart disease (i.e., arrhythmia disorders). Thus there is a critical need to expand the pool of heart donors in order to save more lives from end-stage heart disease. We will perform a pilot trial to prove feasibility of knowingly using HCV-positive organs for HCV-negative recipients, by transplanting 10 HCV-negative subjects with hearts from HCV-positive donors, and then treating these subjects with Zepatier in the early post-transplant phase in order to cure their HCV. If any subjects clear HCV spontaneously within the first four weeks post-transplantation, and do not require treatment, subjects will be added until there have been 10 HCV-negative subjects who receive a heart transplant from an HCV-positive donor, develop HCV, and are then treated for their HCV with Zepatier.
- Study Identifier: 826708
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