Clinical Trial Pioneers Transplantation of Hepatitis C-Infected Kidneys

An ongoing clinical trial has shown that the use of a recently approved hepatitis C virus (HCV) medication could make it possible to transplant HCV-infected kidneys into non-infected patients. The trial conducted by Penn Medicine aims to determine the safety and efficacy of this new approach, which could make hundreds more kidneys available for transplant per year.

Under current regulations, organs from deceased donors with HCV can only be transplanted into other HCV-positive recipients, resulting in the majority of these organs being discarded. The researchers in this study estimate that if the trial is successful and HCV-infected kidneys are allowed to be used, then more than 500 additional patients a year could receive a desperately needed kidney.

The first participant in the study, who had been on the transplant waiting list for more than 5 years, received an infected kidney in July 2016. After a full course of the new HCV-eradicating medication Zepatier, her blood shows no evidence of the virus, inspiring hope for many patients in need of a transplant.

In the initial stage of the trial, researchers will give the transplant and treatment regimen to 10 patients. The kidneys used for these transplants are held to higher standards of quality and must only be infected with HCV genotype 1, the strain that is most successfully cured by this medication.

“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,” explained David S. Goldberg, MD, MSCE, one of the researchers leading the trial.

Participants in this study must undergo a thorough informed consent process to ensure they understand that they are at risk of contracting HCV if the medication fails. As these patients have been undergoing chronic dialysis for months or even years with little hope of finding a donor, many of them are willing to take that chance.

In a study published in The American Journal of Managed Care’s HCV special issue, researchers had anticipated that new HCV treatments could alleviate some of the need for transplants by preventing liver failure in patients with the virus, thus eliminating the infected person’s need for a transplanted organ. This clinical trial shows that effective treatment with new medications not only makes patients with HCV less likely to be organ recipients, but it actually allows them the possibility of becoming donors after their death.