CMV infection occurred despite six months of valganciclovir prophylaxis.

Six months of valganciclovir prophylaxis following renal transplantation can delay, but not prevent, late-onset primary infection with cytomegalovirus (CMV), according to newly released data.

The finding is based on a study of 25 renal transplant recipients who were CMV-negative at the time of transplantation but who received a kidney from a CMV-positive donor. All received six months of oral valganciclovir prophylaxis after transplantation at a dosage of 900 mg once daily if their renal function was normal.

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The researchers, led by Ilkka Helanterä, MD, at Helsinki University Hospital in Finland, monitored for CMV DNA in patients’ blood using a polymerase chain reaction (PCR) assay. CMV infection developed in 12 patients (48%) a mean of 101 days after cessation of prophylaxis (range 26-330 days), according to a report in Nephrology Dialysis Transplantation (2008; published online ahead of print). This incidence of late-onset primary CMV infection is higher than previously reported, the investigators noted.

Of the 12 patients, 10 had symptoms, which included fever, GI and upper respiratory tract problems, and hepatopathy. Six of the 12 patients were treated with IV ganciclovir and five were treated with high-dose valganciclovir.

One patient had a mild infection that was treated by minimizing immunosuppression. Treatments were successful in all patients, with CMV undetectable by PCR. Three patients experienced an infection relapse a mean 31 days after the end of therapy. The relapses were treated with valganciclovir.

“These preliminary findings warrant further studies, and because of the high costs associated with valganciclovir, the prevention strategies for CMV need to be reconsidered,” the authors concluded.