VCU Health is involved in a clinical trial using Hepatitis C kidneys in patients

Doctors at the VCU Health Hume-Lee Transplant Center are conducting a clinical trial that’s taking kidney disease patients off the waiting list and giving them a new chance at life.

The trial involves transplantation of a deceased donor’s kidney infected with the Hepatitis C virus into a recipient who does not have Hepatitis C, and then curing the virus. Hepatitis C, or HCV, is caused primarily by sharing drug needles or is transferred through birth, and is curable. It is a form of viral hepatitis transmitted in infected blood. If left untreated, it can cause chronic liver disease and may lead to cirrhosis or liver cancer. Because HCV is a blood-borne disease, a patient’s kidney often also is infected.

Gaurav Gupta, M.D.
Gaurav Gupta, M.D.

As part of Hume-Lee’s trial protocol, patients receive oral direct acting antiviral medication on the day of and day after the kidney transplant. Sometimes their body is rid of HCV in 48 hours. If not, the patient receives a full 12-week course of treatment. Study results have shown that after successful treatment there is an extremely low chance of HCV reoccurrence in the recipient’s bloodstream.

Several hundred HCV infected donor kidneys are discarded every year. The safe and controlled use of these organs would allow many patients to return to a life without dialysis.

According to the United Network for Organ Sharing, more Virginians are in need of a kidney than any other organ. Nationally, more than 3,000 patients are added to the kidney waiting list each month, according to the National Kidney Foundation.

Because the kidney plays such a critical role in the body, including regulating blood pressure and filtering toxins, people with kidney disease deteriorate daily.

Such a medical breakthrough could not only change the course of one person’s life, but also transform the trajectory of organ donation, said Gaurav Gupta, M.D., transplant nephrologist at VCU Health’s Hume-Lee Transplant Center.

VCU is only one of three transplant centers across the U.S. conducting a trial like this.

“Offering this lifesaving treatment at VCU Health is groundbreaking and very exclusive right now. VCU is only one of three transplant centers across the U.S. conducting a trial like this and offering this to patients,” Gupta said “These are organs that would have otherwise been discarded, but the idea that there’s a way to utilize them and save the lives of patients who otherwise would have little chance of getting a kidney offer is incredible. We’re proud to be a part of this medical breakthrough.”

Gupta and colleagues received a $45,000 presidential grant from VCU and VCU Health System President Michael Rao, Ph.D. to conduct the trial. The University of Pennsylvania and John Hopkins Medicine are conducting similar trials. However, in their protocols, all patients receive a mandatory 12 weeks of anti-viral medications that can cost between $40,000 and $60,000 per patient and have side effects.

Selection criteria for the VCU trial targets those most in need. A swollen face and hands, bloody urine, yellowing eyes and dry and itchy skin are all signs of kidney disease.

Richard Sterling, M.D.
Richard Sterling, M.D.

“Hume-Lee’s transplant nephrologists hand select the appropriate recipients, essentially patients with a low chance of getting a kidney offer in time while they’re still healthy enough for transplant. The subjects are followed closely by our hepatologists specializing in HCV treatment,” said Richard Sterling, M.D., chief of hepatology for the Virginia Commonwealth University Health Division of Gastroenterology, Hepatology and Nutrition. “The protocol has been carefully designed and is overseen by three VCU independent transplant professionals and the institutional review board.”

So far, six VCU Health patients have successfully received a transplant through the trial, four of whom have not tested positive for HCV following their initial two doses of the drug. Two patients tested positive and were treated for 12 weeks with a genotype-specific drug and are now free of Hepatitis C. VCU’s trial differs in a few key ways from the protocols followed by the other two centers, Sterling said.

“We believe our novel approach is contributing to our favorable results. In our protocol, because we do not know the HCV strain or genotype at the time of transplant, each patient in the trial is given two doses of an HCV medication that covers all HCV genotypes immediately after transplant,” he said. “They’re then tested frequently for a period of time based on the known blood transmission rate of HCV. If a positive test result occurs, we treat with the drug that specifically targets their genotype. This allows us to follow a treatment regimen that is best for each patient, ensuring a patient isn’t unnecessarily over-treated with HCV medication, which carries an increased cost and potential risks.”

VCU Health has been approved to perform this procedure on additional patients.

The work done through this trial is restoring quality of life for kidney disease patients. The goal of the trial is to institute this offering as broad, commercial practice throughout the U.S., Sterling said.

“These results can demonstrate safety and efficacy of the full use of HCV positive kidneys in an advanced medical setting with an advanced liver program that can cure the virus,” he said. “VCU is also contributing to a cost analysis to demonstrate to [the federal] Centers for Medicare and Medicaid Services, and private insurers, that this is cost effective and the outcomes are good.”

 

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