Study finds once-daily Valcyte prevents serious viral infection after kidney transplant

May 18, 2004

MIAMI, Fla. and BOSTON - May 18, 2003 - Research conducted in the Division of Transplantation at the University of Miami School of Medicine has found that at least three months of therapy with a single daily dose of the antiviral medication Valcyte (valganciclovir HCl tablets) safely and effectively prevents cytomegalovirus (CMV), a common infection in kidney transplant patients taking highly potent immunosuppressive therapy. The results were presented today at the American Transplant Congress in Boston.

"CMV disease is one of the most serious infections that can occur after a transplant because it can lead to loss of the transplanted organ and even death," said Gaetano Ciancio, M.D., lead author of the study and professor of surgery and urology, Division of Kidney, Kidney/Pancreas Transplant at the University of Miami School of Medicine. "Transplant patients are often taking a number of medications, so giving them a more simplified therapy to prevent this dangerous condition is ideal."

CMV, which is present in a latent form in as many as 80 percent of the population, can activate and trigger a variety of gastrointestinal (GI) conditions and opportunistic infections, such as pneumonia or hepatitis, in transplant patients with suppressed immune systems.

Valcyte is an oral prodrug, or improved formulation, of Cytovene (ganciclovir), which has been widely used to prevent CMV for the past 15 years. This study compared treatment with the two medications and found that both are equally effective at preventing CMV in transplant patients. The difference is that Valcyte requires a comparatively smaller once-daily dose, while patients must take a larger dose of Cytovene three times daily.

"Valcyte has superior bioavailability to Cytovene in the body, which ultimately translates into fewer daily doses for patients," said Dr. Ciancio. "These findings represent yet another step forward in the improvement of care and quality of life for transplant recipients."

In addition to opportunistic infections and GI conditions, CMV has been associated with acute and chronic rejection of transplanted organs, as well as atherosclerosis in heart transplant patients. Studies have shown that CMV may be correlated with an increased risk of death after a transplant.

The study evaluated 150 kidney transplant patients in a randomized, single-center, prospective trial. Patients were equally divided into three arms receiving different post-transplant immunosuppression regimens. Oral Cytovene 1,000 mg three times daily was used in 92 patients. The remaining 58 patients received a single daily oral dose of 900 mg of Valcyte. Patients were observed for the development of any CMV-like illness during follow-up.
Editor's Note: study investigator is available for interviews.

Ketchum UK

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