Penn Medicine pioneers transplantation of kidneys with hepatitis C

Peter Reese, MD, MSCE and David Goldberg, MD, MSCE

Investigators at Penn Medicine in Philadelphia have pioneered a new approach to grow the pool of organs for transplantation. More than two-thirds of kidneys from deceased-donors with hepatitis C virus (HCV) are discarded in the United States, despite the fact that these lost organs could provide valuable transplants to 500–1,000 patients with end-stage renal disease each year.

In the past, HCV was hard to treat. However, novel antiviral treatments for HCV can now achieve cure rates over 95% with few side effects. As a result, Penn Medicine physicians launched the THINKER study: a clinical trial that involves transplanting kidneys from deceased donors with hepatitis C to recipients without HCV, then curing the recipients of the disease.

In June 2017, together with our collaborators, we published results from the first 10 transplant recipients in the New England Journal of Medicine.  We described a thorough, physician-led, three-step informed consent process to make sure that participants understood the potential risks and benefits of receiving a kidney from a donor with HCV. Participants were between the ages of 40 to 65 years and receiving chronic dialysis.

If not for the THINKER trial, participants expected to wait multiple years for a kidney transplant from a donor without HCV. The trial required extensive coordination between diverse specialists—surgeons, hepatologists, nephrologists, infectious disease specialists, transplant coordinators, molecular pathology and staff at the Gift of Life organ procurement organization. Ten recipients were given kidneys from donors with HCV, and all tested positive for HCV after the surgery. These patients were then treated with a standard 12-week course of antiviral treatment (one pill a day, in addition to the other post-transplant medications).

These pilot results were exciting: All ten recipients had good transplant function six months later, and all of them were cured of HCV. Since these results were published, the investigator team has expanded the trial and continues to perform kidney transplants using donors with HCV and will publish more extensive results this spring.

The number of available organs with HCV has been rising because of the opiate crisis. Given the success of the initial experience, Penn Medicine investigators have launched another trial (USHER) which involves using HCV-infected hearts to transplant uninfected patients with end-stage heart disease. The initial experience has been positive, with some patients already cured, but final results are pending.

Interest in this innovative work has been high. We get inquiries on a weekly basis from other programs eager to start their own programs to transplant organs infected with hepatitis C. While we are very excited to see this work adopted elsewhere, we also believe that the practice needs further study so that we can define the risks more precisely.

A key issue ahead is getting insurance companies to pay for antiviral medication, which is very expensive. The THINKER trial was sponsored by Merck.

Additional resources:

Watch a video about the THINKER trial.

American Kidney Fund “Be Hep C Smart” campaign

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About the Author

Peter Reese, MD, MSCE and David Goldberg, MD, MSCE

Dr. Peter Reese is an associate professor of medicine and Dr. David Goldberg is an assistant professor of medicine and epidemiology at Penn Medicine. Dr. Reese is a transplant nephrologist and epidemiologist who cares for patients at the Hospital of the University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center. Dr. Goldberg is a hepatologist and epidemiologist who directs Living Donor Liver Transplantation at the Hospital of the University of Pennsylvania.

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