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.
Contact:
Jeanne Antol Krull
305-243-4853