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11.17.2015

Antiviral Therapy Shows Hope for Advanced Kidney Disease Patients with Hepatitis C Virus Infection

A University of Miami Miller School of Medicine researcher has played a principal role in an international phase III study, known as the C-SURFER trial, of the effect of direct-acting antiviral therapy for hepatitis C virus (HCV) infection in patients with chronic kidney disease stage 4 or 5. The therapy has shown positive results — a first for patients with advanced kidney disease.

HCV infection is more prevalent in these patients than in the general population. It has been shown to increase the relative risk of death in dialysis and kidney transplant patients and is associated with increased rates of kidney allograft failure, yet patients with hepatitis C and chronic kidney disease have had few treatment options.

David Roth, M.D., the William Way Professor of Nephrology and Medical Director of Kidney Transplantation at the Miami Transplant Institute, was first author of an article describing the research, “Grazoprevir plus elbasvir in treatment-naïve and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study,” recently published in The Lancet.

“This is the first prospective, randomized phase III trial of direct-acting antiviral [DAA] therapy in hepatitis C virus infected chronic kidney disease patients, including those on dialysis,” said Roth. “Prior studies of DAAs for HCV have always excluded patients with kidney disease. This trial was developed out of a recognized unmet medical need for this group of patients.”

The trial demonstrated that the drug combination grazoprevir plus elbasvir (given as a single pill once a day for 12 weeks) was safe and effective in patients with advanced kidney disease. The sustained viral response rates were equal to or exceeded that usually obtained in HCV studies in the general population without kidney disease.

“Importantly, these two drugs are not cleared by the kidneys and are not removed by dialysis,” said Roth. “The major FDA approved product to treat HCV has on its package insert a warning against its use in patients with less than approximately 30 percent of kidney function.”

The agents used in the current study have received “fast-track” designation by the FDA for review since they address a medical need in a population of patients who have had few alternatives for treatment. It is expected that approval will come later this year or in early 2016. The research, meanwhile, is ongoing.

The sponsor of the C-SURFER trial is currently organizing a similar study of HCV-infected post-kidney-transplant recipients, and we hope to be one of the centers in that trial,” said Roth.

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