In a recent pilot trial, patients who were previously hepatitis C-negative had detectable HCV RNA after transplantation with HCV-infected kidneys. All patients in the trial achieved sustained virologic response with Zepatier.
“Waiting times for kidney transplants exceed 3 to 5 years in many parts of the United States. Yet more than 500 high-quality kidneys from deceased donors with hepatitis C virus (HCV) infection are discarded annually,” David S. Goldberg, MD, MSCE, an assistant professor of Medicine and Epidemiology in the Perelman School of Medicine at the University of Pennsylvania, and colleagues wrote. “Direct-acting antiviral agents, which are associated with high HCV cure rates and manageable side effects, have created the potential to substantially increase the number of kidney transplants by making HCV-infected kidneys available to HCV-negative candidates on the waiting list.”
The trial comprised 10 patients who were undergoing dialysis and had long anticipated waiting times for a kidney transplant. Median patient age was 59 years (range, 51-63 years), half were men and two patients were black. Median time from eligibility on the waiting list for HCV-infected kidneys to transplantation was 58 days (range, 53-100 days). Median Kidney Donor Profile Index score was 42% (range 32-48).
Patients had detectable HCV RNA at day 3 after transplantation. Nine patients had genotype 1a and the other patient had genotype 1. All participants were treated with Zepatier (elbasvir-grazoprevir, Merck) and achieved SVR at 12 weeks.
Adverse events included delayed graft function in one patient, transiently elevated aminotransferase levels in two patients, and a transient new class I donor-specific antibody level developed in one patient. One patient who had immunoglobulin A nephropathy before transplantation developed proteinuria; focal segmental glomerulosclerosis was later detected with biopsy following SVR.
“For so long, HCV was a virus with a very negative stigma associated with it, especially among physicians. So it was interesting to see that patients were quick to jump at the chance to get this transplant, despite the possibility that they could get hepatitis C permanently,” Peter Reese, MD, MSCE, chair of the Ethics Committee for the United Network of Organ Sharing (UNOS), said in a press release. “Going into the study, we knew it was a possibility 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.” – by Talitha Bennett
Disclosures: Goldberg reports grants from Merck and the Biesecker Pediatric Liver Center at the Children’s Hospital of Philadelphia. Please see the full study for the other researchers’ relevant financial disclosures.