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IMPACT Study Demonstrates That Longer Prophylactic Therapy With Valcyte(R) (Valganciclovir Hydrochloride Tablets) Increases Protection Against CMV - the Most Serious Viral Infection Affecting Transplant Patients
Date:2/13/2009

Doubling duration of Valcyte therapy provides significant benefit to patients compared to current standard of care for the prevention of CMV disease

NUTLEY, N.J., Feb. 13 /PRNewswire/ -- Roche announced today that a Phase III study investigating the efficacy and safety of extended preventative therapy ('prophylaxis') with Valcyte met its primary endpoint of reducing the number of kidney transplant patients who develop cytomegalovirus (CMV) disease within the first year post-transplant.

Valcyte is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk and is administered for up to 100 days post-transplant. The successful IMPACT (NT18435) study was designed to investigate whether extending therapy with Valcyte to 200 days post-transplant will further reduce the incidence of CMV disease in high risk kidney transplant patients.

Previous studies have shown that although Valcyte administered for up to 100 days provides high protection against CMV infection and disease throughout therapy duration, some patients may still develop CMV infection and disease after stopping therapy. Valcyte for 200 days further reduced the risk of CMV disease without increasing this risk after stopping therapy. The one-year efficacy and safety data from this investigational study will be presented at the 2009 American Transplant Congress Meeting in Boston, Mass. (May 30 - June 3).

"Valcyte is considered the standard care for the prevention of CMV infection in transplant patients, and the fact that this study has shown that even more kidney transplant patients can be protected from CMV disease by extending the course of treatment is compelling news for both physicians and patients," said Primary Investigator Dr. Atul Humar, Director, Transplant Infectious Diseases and Associate Professor, Department of Medicine, University of Alberta, Canada.
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SOURCE Roche
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