Harvoni safe, effective in kidney transplant patients with HCV

BARCELONA — Harvoni treatment led to sustained virologic response without significant side effects in post-kidney transplant patients, a presenter said at the International Liver Congress.

“Approximately 10% of the Western population with a kidney graft are chronically infected with hepatitis C, an infection that carries important burden in terms of poor outcomes as far as graft survival is concerned,” Massimo Colombo, MD, from the Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, said during his presentation. “Ledipasvir/sofosbuvir fixed-combination therapy was generally safe and well-tolerated in kidney transplant recipients with hepatitis C infection and no clinically meaningful reductions in renal function were observed.”

This phase 2, open-label study looked at post-transplant patients with or without cirrhosis randomized to receive Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) for either 12 weeks (n = 57) or 24 weeks (n = 57). The two groups were well-matched at baseline.

Colombo noted that while inclusion criteria required patients to be more than 6 months post-transplant, the median time from transplant was 10 years out in the 12-week cohort and 12 years out in the 24-week cohort.

“This is an advantage; … here, we are dealing in a population with a stable kidney graft,” he said.

Overall, 100% of the 12-week cohort achieved SVR12 and, due to loss to follow-up, 96% of those in the 24-week cohort achieved SVR12. Broken down by genotype, the same percentages persisted in genotype 1 due to the two patients lost to follow-up while 100% of those with genotype 4 achieved SVR12.

“This treatment led to rapid suppression of viremia,” Colombo said.

NS5A resistance-associated variants were present in 19% of patients and 100% of those patients achieved SVR, he said.

Adverse events were mostly mild to moderate and only three serious adverse events were traced back to treatment. There were no episodes of rejection reported through the duration of the study, Colombo said.

“Ledipasvir/sofosbuvir therapy for 12 weeks resulted in 100% sustained virologic rate in HCV-infected kidney transplant recipients with or without cirrhosis,” Colombo concluded. “There was no virologic failure in either the 12- or 24-week treatment arm.” – by Katrina Altersitz