HCV-positive kidneys transplanted into first patients in clinical trial

Researchers at the Hospital of the University of Pennsylvania, in Philadelphia, PA, reported on the first patient to receive a kidney transplant from a deceased donor infected with hepatitis C virus (HCV).

After the July 2016 transplant procedure, the patient was treated with a full regimen of Zepatier™ (Merck & Co, Inc.), a recently-approved, fixed-combination (elbasvir/grazoprevir) oral antiviral used to treat chronic HCV.

On September 13, 2016, Penn physicians announced there was no evidence of HCV in the transplant recipient’s blood.

This patient is the first in a clinical trial of 10 HCV-negative subjects with end-stage renal disease who will receive a kidney transplant from an HCV-positive donor. If this trial proves successful, it may mean an additional 500 (or more) kidneys would be available for transplantation each year, researchers estimated.

“There are more than 99,000 Americans awaiting a kidney transplant,” said Peter Reese, MD, MSCE, one of the trial’s leaders and an Assistant Professor of Medicine at Penn. “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,” added Dr. Reese, who is also Chair of the Ethics Committee for the United Network of Organ Sharing (UNOS). “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.”

The clinical trial, begun in May 2016, is enrolling patients between 40 and 65 years of age who do not have hepatitis C, are on chronic dialysis, and have no living kidney donor available.

Study investigators are using only donor kidneys infected with genotype 1 HCV because the viral treatment used in this study eradicates this HCV genotype in about 95% of cases. After transplantation, patients will receive at least 12 weeks of antiviral treatment. Investigators are taking additional steps to ensure that the donor kidneys are high quality, with the best possible chance of successful transplant.

“While these kidney quality criteria may be more selective than our usual approach to choosing organs, we are aiming to evaluate safety and efficacy in only the most viable organs in this initial pilot phase of the clinical trial,” said co-leader of the trial David S. Goldberg, MD, MSCE, Assistant Professor of Medicine and the Medical Director for Living Donor Liver Transplantation at Penn.

“We realized that the amazing transformation of treatment options for hepatitis C should also transform how we think about organs with hepatitis C,” Dr. Goldberg explained. “At this very early point in the study, we are pleased with how our first patients have responded to transplantation and antiviral treatment.”

This study is supported by Merck Sharp & Dohme Corp.