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IMPACT Study Showed Longer Valcyte(R) (valganciclovir hydrochloride tablets) Treatment Demonstrated Better Protection Against Cytomegalovirus (CMV) Disease One Year Post-Transplant
Date:6/1/2009

CMV is the most serious viral infection affecting transplant patients

BOSTON, June 1 /PRNewswire/ -- New Phase III study results presented for the first time today at the ninth annual American Transplant Congress 2009 (ATC) demonstrate that doubling the duration of preventive therapy ('prophylaxis') with Valcyte (oral valganciclovir) significantly reduced the incidence of CMV disease by 56% in high-risk kidney transplant patients within the first year post-transplant.

CMV is a major cause of morbidity and mortality during the first six months following transplantation and is a key concern for transplant recipients and physicians. While 100-day Valcyte prophylaxis has been the standard for providing protection against CMV infection and disease, studies have shown that over 30% of patients can develop late onset CMV infection after treatment has ceased.

"While CMV is very common, it rarely causes significant disease in an otherwise healthy person. However, when the immune system is compromised -- as after solid organ transplantation -- CMV can cause serious illness with long-term complications for our most vulnerable patients," said IMPACT Investigator, Dr. Robert Gaston, Medical Director for Kidney and Pancreas Transplantation and Professor of Medicine, University of Alabama at Birmingham. "The IMPACT study gave us the opportunity to examine what has been suspected for some time -- that extending prophylaxis to coincide with the time period during which patients are the most immunosuppressed might lead to less CMV disease and better patient outcomes."

The IMproved Protection Against Cytomegalovirus in Transplant (IMPACT) study showed that 200-day Valcyte prophylaxis significantly reduced the proportion of patients with CMV disease within the first year post-transplant to 16%, compared to 37% with 100-day Valcyte prophylaxis (p<0.0001).
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SOURCE Roche Pharmaceuticals
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