Antivirals may prevent chronic HCV in recipients of infected donor kidneys

Last Updated: 2018-03-05

By Marilynn Larkin

NEW YORK (Reuters Health) - Pre- and post-transplant treatment with direct-acting antivirals is safe and may prevent chronic hepatitis C virus (HCV) infection in patients who receive a kidney from an HCV-positive donor, a small study suggests.

Dr. Niraj Desai of Johns Hopkins University School of Medicine in Baltimore, Maryland told Reuters Health, "The current discard rate of HCV-positive donor organs is quite high due to the small number of HCV-positive recipients on the transplant waiting lists."

"Based on this initial pilot study," he said by email, "transplanting kidneys from HCV-positive organ donors into HCV-negative recipients while giving direct acting anti-viral medications appears to be a safe and effective way to expand the organ donor pool."

Dr. Desai and colleagues assessed outcomes of 10 HCV-negative recipients (median age, 71; 20% women; 80% white) of 10 kidneys from HCV-positive donors (median age, 30; 50% women, 100% white). The median wait from study entry to transplant was one month.

All recipients received one dose of 100 mg grazoprevir (GZR) and 50 mg elbasvir (EBR) immediately before transplant.

Recipients of kidneys from donors with genotype 1 infection continued receiving GZR-EBR for 12 weeks after transplant. Those receiving organs from donors with genotype 2 or 3 infection had 400 mg sofosbuvir added to GZR-EBR, for 12 weeks of triple therapy.

As reported online March 5 in Annals of Internal Medicine, donor-to-recipient HCV transmission occurred in 100% of recipients, with two cases of elevated aminotransferase levels. However, all recipients achieved a sustained virologic response at 12 weeks, with no HCV RNA detected.

There were no treatment-related adverse events.

Dr. Desai said, "This study needs to be replicated in larger, multicenter trials to demonstrate safety and to provide sufficient data to convince insurance payers to cover the additional cost of the hepatitis C medication."

Dr. Nabil Dagher, Director of Abdominal Transplant Surgery at the NYU Langone Transplant Institute in New York City, told Reuters Health, "With the high rate of mortality on the waitlist for those patients with renal failure, novel and innovative approaches such as this are needed to expand the limited donor pool and decrease waiting time to transplantation."

"The tremendous advances in the treatment of HCV have made the use of HCV-infected organs safe and has the potential to save hundreds of lives yearly," he said by email. "A similar approach is now being adopted for the transplantation of other organs including livers, hearts and lungs."

"The major hurdle that must be overcome is the extremely high cost of these medications and the ability to pay for them," he noted. "This study was sponsored by a drug company and antiviral therapy was fully covered."

"If the use of HCV-positive organs is going to work on a large scale, insurance companies will have to adopt this approach as a standard of care and cover the cost of these medications after transplantation," he concluded. "I suspect it will quickly become clear that the cost benefit analysis will easily favor this approach."

The study was funded primarily by Merck Sharp and Dohme Corp. Dr. Desai and three coauthors receive fees from the company.

SOURCE: http://bit.ly/2I7uxY0

Ann Intern Med 2018.