Clinical Transplantation Trial Tests Use of Hepatitis C-Infected Kidney

Doctors have completed a transplant in the first operation of a clinical trial meant to test use of hepatitis C-infected kidneys as organ donations.

The Penn Medicine clinical trial uses kidneys from deceased donors who were infected with the hepatitis C virus, according to a news release from Perelman School of Medicine at the University of Pennsylvania. The first person in the trial received a kidney transplant in July and then underwent treatment with a regimen of Zepatier, one of the direct acting antiviral drugs approved recently to treat the virus.

The patient’s doctors announced earlier this month that the patient, a woman from East Stroudsburg, no longer has evidence of the virus in her blood. Without the operation, she could have been on an organ donation wait list for as long as five years while undergoing weekly dialysis, the release stated.

The clinical trial is designed to test the safety and efficacy of transplanting kidneys from hepatitis C-positive donors into patients who do not have the virus but are in end-stage renal disease and are on a kidney transplant wait list, the release stated. The trial is being conducted by David S. Goldberg, MD, and Peter Reese, MD, who are assistant professors of Medicine and Epidemiology at Penn.

The doctors noted in the release that currently people who are infected with hepatitis C can only donate organs to other people who also have the virus.

“More than 99,000 Americans are awaiting a kidney transplant,” Reese said in the release. “Yet despite very long waiting times for transplant, hundreds of otherwise good kidneys from deceased donors infected with hepatitis C are discarded each year.”

Hepatitis C virus (HCV) is a bloodborne disease that if left unchecked can seriously damage the liver over time. Part of the study involves treating transplant patients for the hepatitis C virus with Zepatier, which is among the new hepatitis C drug regimens that works faster and have higher cure rates than older, traditional treatments.

The clinical trial is enrolling patients, 40 to 65 years old, who do not have hepatitis C and are receiving chronic dialysis. A rigorous informed consent process includes a discussion on the risk of a participant becoming infected with HCV, which may never clear even after treatment with Zepatier, according to the release.

“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,” stated Reese. “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.”

Kidney transplants have historically been used to treat patients who are on dialysis as a result of kidney failure. However, thousands of patients who don’t have a relative or matching unrelated donors end up waiting for years for a suitable deceased donor, according to the release.

Only donated kidneys that are infected with genotype 1 HCV will be used in transplants performed in the trial, since the selected drug regimen has a 95% success rate in eradicating that strain of hepatitis C in the general population, according to the release. In addition, measures are in place to ensure that the donated kidneys used for the transplants are of good quality, the release stated.

“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,” Goldberg, who is also the medical director for Living Donor Liver Transplantation at Penn, stated in the release. “We realized that the amazing transformation of treatment options for hepatitis C should also transform how we think about organs with hepatitis C. At this very early point in the study, we are pleased with how our first patients have responded to transplantation and antiviral treatment.”