First Clinical Trial Transplants Hepatitis C-Infected Kidneys

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Patients who need a kidney transplant may have new hope, through an innovative Penn Medicine clinical trial using kidneys from deceased donors who had the Hepatitis C virus (HCV). The first study participant received a kidney transplant in July 2016, and after being treated with a full regimen of Zepatier – a recently-approved oral medication prescribed to eradicate HCV – her doctors announced today that there is no evidence of the virus in her blood. Irma Hendricks of East Stroudsburg, PA, faced upwards of five years on the transplant waiting list with dialysis three days a week for many hours, before enrolling and receiving a kidney transplant as part of this trial. The research team says if the new approach works, for patients who do not have HCV, there is the potential to provide a chance at a lifesaving kidney transplant for hundreds more patients each year.

The clinical trial, known as THINKER, led by David S. Goldberg, MD, MSCE, and Peter Reese, MD, MSCE, both assistant professors of Medicine and Epidemiology at Penn, aims to determine the safety and efficacy of transplanting kidneys from Hepatitis C-positive donors into patients currently on the kidney transplant waitlist who do not have the Hepatitis C virus.

“There are more than 99,000 Americans are awaiting a kidney transplant,” said Reese, who is also an assistant professor of Medical Ethics and Health Policy at Penn and chair of the Ethics Committee for the United Network of Organ Sharing (UNOS). “Yet despite very long waiting times for transplant, hundreds of otherwise good kidneys from deceased donors infected with Hepatitis C are discarded each year. If we can demonstrate that it’s possible to eradicate HCV from patients who contract the virus from a transplant, this approach could open up access to an entirely new pool of donor organs that are currently being discarded. Ultimately, our hope is that this trial will show that it is possible, and will then afford far more patients who are on the waiting list an opportunity to receive a lifesaving transplant much sooner.”

Reese and Goldberg estimate that if this experimental course of transplantation and treatment proves effective in the long term, at least 500 more kidneys could become available for transplantation each year. Currently, individuals who have Hepatitis C are only eligible to donate organs to recipients who also have the virus. But in most cases, these HCV-infected organs would be discarded, and never used for transplantation.


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