Ten patients to undergo the transplant were treated with direct-acting antiviral Zepatier for 12 weeks post-op.
In September 2016, researchers at Penn Medicine reported on the results of a clinical trial in which kidneys from hepatitis C virus (HCV)-positive donors were transplanted into 10 patients on the kidney waiting list.
All 10 of the patients were cured of HCV following the transplants, and the trial was extended, with 10 more patients being enrolled in a similar trial at Johns Hopkins University. In April of this year, the researchers announced that an additional 10 kidney transplant recipients had been cured of HCV.
There are more than 97,000 patients in the United States waiting for kidney transplants.
“We estimate that as many as 1,000 additional kidney transplants could happen each year if transplant centers and organ procurement organizations aggressively pursued the use of every viable HCV-infected kidney from a deceased donor,” Peter Reese, MD, assistant professor of medicine and epidemiology at Penn and the chair of the ethics committee for the United Network of Organ Sharing (UNOS), said.
In the pilot study, the researchers recruited patients who were on dialysis due to the extensive damage to their kidneys. The participants were educated about the risks associated with the trial before beginning the process of enrollment. All of the participants had been on the waiting list for a transplant for a minimum of 18 months, and were between the 40 and 65 years old.
The average wait for study participants to receive a kidney was 58 days. Once the transplant was complete, the patients began a standard, 12-week course of elbasvir/grazoprevir (Zepatier). Zepatier is a direct acting antiviral (DAA) approved by the US Food and Drug Administration (FDA) to treat HCV genotypes 1 — the most common form of the virus in the US — and 4 in January 2016. It is often used to treat non-transplant patients, Reese said.
David S. Goldberg, MD, assistant professor of medicine and epidemiology in the Perelman School of Medicine at the University of Pennsylvania, and trial co-leader, presented early data from the study at the 2017 American Transplant Congress in Chicago. Simultaneously, the team published a letter describing the trial in the New England Journal of Medicine.
Reese said the team anticipated submitting results, "including outcomes for the second group of kidney transplant recipients, for publication in winter 2017.”
The next step for the researchers is two-fold: larger trials of kidney transplants and a trial for heart transplants. In the future trials of HCV-positive kidney transplants, the researchers may modify the inclusion criteria in order to increase the the number of participants, such as making consider to whether or not the patients should be required to already be on dialysis, Reese said.
Since the 2 trials for kidney transplants were successful, it only makes sense to find out if transplants of HCV-infected organs could work in other instances, as well.
“Partnering with our colleagues in heart failure, we have commenced an analogous trial of HCV-infected hearts for uninfected recipients,” Reese said.
They hope to eventually also investigate the possibility for those in need of lung transplants.
One of the challenges that must be overcome to reach the full potential of this research is the cost of the DAAs that cure the virus.
“We are working vigorously to develop new pathways to make these transplants happen — either via insurance company support and/or by applying for grants from drug companies,” Reese said.
Although the outcomes in the first trial are positive, with all 10 patients being cured of HCV, Reese suggests more work is needed.
“We need to build a scientific infrastructure and expertise to use these organs and confirm these preliminary outcomes from our group," Reese said. "Until that day comes, this work should not be considered standard of care.”
A press release regarding the study was made available.