Early Results of Innovative Trial Point Toward Greater Kidney Supply for Patients Awaiting Transplants

Kiran Shelat (shown with wife and daughter) used to be one of the more than 97,000 patients in the U.S. who are waiting for kidney transplants—often for five years or more. Then he became part of a groundbreaking clinical trial that seeks to substantially increase the supply of transplant kidneys by using some of the many donated but previously discarded organs infected with the hepatitis C virus (HCV), then destroying the disease in the recipient.

In this first phase of the Transplanting Hepatitis C Kidneys into Negative Kidney Recipients (THINKER) study, 10 patients on the kidney transplant waitlist who did not have the virus, and who opted in to receive these otherwise unused organs, received transplant kidneys from donors with HCV. Participants were between 40 and 65 years old and had been waiting for a transplant for less than a year and a half. After transplant, all of the recipients tested positive for the disease and were then treated with the standard 12-week course of elbasvir/grazoprevir (commonly known as Zepatier), a recently approved, highly effective oral medication.

All 10 patients were cured of the virus. "Our pilot data demonstrate that we can cure the contracted virus following transplantation in this patient population. If future studies are successful, this may be a viable option for patients who may otherwise never see a transplant,” said David Goldberg, MD, MSCE, who is co-leading the study with Peter Reese, MD, MSCE. “For so long, HCV had a very negative stigma associated with it, especially among physicians," commented Dr. Reese. "Going into the study, we knew it was possible that some or all of the patients would contract HCV, and that they could have the disease for the rest of their lives if we were unsuccessful. But for these patients, getting off of dialysis and getting back to their normal lives was very much worth the risk.”

Following these early positive results, the research team has been granted an extension of their study, which will allow them to proceed with an additional 10 kidney transplant patients. The team also is designing a new clinical trial that will study this same approach in heart-transplant recipients; and in future they hope to examine its efficacy in liver and lung transplants. They note the need for longer and larger trials, in a broader population, to continue evaluating the effectiveness of this approach to transplantation.