Clinical trial transplants hepatitis C-infected kidneys into non-infected patients

The first patient to receive a kidney transplant as part of a trial that matches kidneys from donors who had the Hepatitis C virus (HCV) with recipients without the virus has no evidence of HCV in her blood. Irma Hendricks of East Stroudsburg, PA received a kidney transplant in July 2016, and was treated with a full regimen of Zepatier—a recently-approved oral medication prescribed to eradicate HCV.

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 Medicine, 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.

“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,” said 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."

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.

The study is enrolling patients between 40 and 65 years of age, with a blood type A, B, or O, who do not have Hepatitis C and are receiving dialysis.

In this study, only donated kidneys that are infected with a certain strain of HCV are used. There are six genotypes of HCV that have been identified, but patients will only receive HCV genotype 1-infected kidneys, since the viral treatment used in this study has a 95% success rate in eradicating this type of HCV in the general population. Additional steps are taken to ensure that the kidneys study participants receive are high quality, with the best possible chance of successful transplant.All participants must undergo an informed consent process.

"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 Goldberg, who is also 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. At this very early point in the study, we are pleased with how our first patients have responded to transplantation and antiviral treatment."

Researchers intend to transplant and treat 10 patients in this pilot study. Patients who receive an HCV-infected kidney, who are then treated with an extended regimen of Zepatier, can be classified as HCV-free or "cured" if they have undetectable levels of the virus three months after completion of the oral medication. One risk of participating in this clinical trial, which is discussed during the informed consent process, is that patients who receive the HCV-positive kidney may become infected with the Hepatitis C, and may never be cleared of the virus despite the medication regimen.