Open-Labeled Trial Of Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Lung Transplants From Hepatitis C-Positive Donors

Study Overview

There has only been a modest increase in the number of lung transplants each year, increasing from a yearly average of 2,400 between 2009 and 2011, to 2,800 in 2016. Despite this, more than 300 patients died or became too sick to transplant on the lung transplant waiting list in 2016. These numbers dont even account for the large population of patients in need of a lung transplant who are never waitlisted because of the scarcity of donor organs relative to the number in need. The opioid epidemic has led to a staggering increase in the number of young, otherwise healthy donors dying of a drug overdose, many of whom are infected with HCV. In 2016, there were 661 HCV-positive donors in the US, of whom 450 had active HCV infection (detectable HCV RNA) at the time of donation. Yet more than 99% of lungs from these donors were discarded.1 Due to the limited supply of donor organs, patients awaiting a lung transplant have to be exceedingly sick, and many times are hospitalized, and sometimes even require mechanical ventilator support, prior to transplantation. This has direct consequences on short-term post-transplant morbidity and mortality. Thus expanding the donor pool could allow for earlier transplantation, which would decrease waitlist mortality while potentially improving post-transplant outcomes. At the very least such a strategy would increase the number of patients who could receive a lifesaving lung transplant. We will perform a pilot trial to prove feasibility of knowingly using HCV-positive organs for HCV-negative recipients, by transplanting at least 10 HCV-negative subjects with lungs 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 lung transplant from an HCV-positive donor, develop HCV, and are then treated for their HCV with Zepatier.

  • Study Identifier: 829397

Recruitment Status

Open

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