Everolimus May Reduce CMV Risk

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DENVER—Use of everolimus (EVR) rather than mycophenolic acid (MPA) in renal transplant recipients may significant decrease the risk for cytomegalovirus events, according to a study.

“These findings are clinically relevant because CMV is one of the most common viral pathogen following kidney transplantation,” said lead investigator Fuad Shihab, MD, Professor of Medicine at the University of Utah in Salt Lake City, where he is Medical Director of the Kidney and Pancreas Transplantation Progress. “CMV disease is a risk factor for allograft rejection, for mortality and for interstitial fibrosis and tubular atrophy, which is a leading cause of chronic allograft injury.”

Kidney transplant recipients typically require prolonged antiviral prophylaxis therapies that increase the economic burden in post-transplant care, Dr. Shihab said. “Use of EVR with cyclosporine has been shown to decrease the incidence of CMV, which may mean a cost-savings benefit of EVR versus MPA,” he said.

Dr. Shihab and his colleagues analyzed CMV data from 2004 new kidney transplant recipients from three EVR studies (Study A included 833 patients, Study B included 588 patients, and study C included 583 patients). All three trials analyzed the differences between EVR dosing groups and MPA control groups.  In all three studies, EVR groups received either 1.5 or 3 mg a day with either standard or reduced dose cyclosporine based on individual study designs. The control groups in all three studies received MPA with standard dose of cyclosporine. Steroids were given as per the study site's practice.

Recipients in all three groups were similar in age, cause of end-stage renal disease, HLA mismatches, and donor age and type. The mean age of the patients was 45 years. Approximately 17% in all three groups were CMV seronegative and received kidneys from a CME seropositive donor, and 52% of the recipients in each group had received CMV prophylaxis.

The researchers analyzed the time to the first CMV event (infection/syndrome, viremia, or disease) between two treatment groups. The mean time to the first CMV event was 194 days for EVR 1.5 mg, 190 days for EVR 3.0 mg, and 124 days for MPA. In adjusted analyses, MPA recipients had a twofold increased likelihood of a CMV event compared with EVR-treated patients. In transplant recipients who did not receive prophylaxis, MPA treatment was associated with a 2.7 times increased risk.

“The hope is that if you have a regimen that could potentially decrease the incidence of CMV it would be beneficial and help lower morbidity and mortality,” Dr. Shihab told Renal & Urology News. “More rejection episodes always mean more hospitalization.  So it you have a regimen that could decrease the incidence of CMV then there would be a benefit.”

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