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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

"CMV is the most common viral infection in transplant patients. It can 'lie in wait' leaving high risk patients more vulnerable to infection for longer than was previously thought, placing the new organ and patient at risk. We expect this Study to provide clinically important results about the benefits of 200-day prophylaxis with Valcyte that will translate into tangible improvements in patient care."

About the IMPACT (NT18435) Study

IMPACT (NT18435) study: This Study of Valcyte for the Prevention of CMV Disease in Kidney Allograft Recipients is a global, multi-center (65 centers in 13 countries), double-blind study that randomized 326 high-risk (donor CMV seropositive/recipient CMV seronegative) kidney allograft recipients to one of two treatment groups:

  • 100 days Valcyte (900 mg once daily) post-transplant followed by 100 days placebo
  • 200 days Valcyte (900 mg once daily) post-transplant

The primary endpoint of the study was the proportion of patients who developed CMV disease within the first 52 weeks (12 months) post-transplant. Secondary endpoints for the study include safety and tolerability, time to CMV disease, time to CMV infection, acute rejection and graft loss.

About Valcyte

Valcyte tablets are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Valcyte is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Valcyte is not indicated for use in liver transplant patients. The safety and efficacy of Valcyte for the prevention of CMV disease in other solid organ transplant patients such as lung transplant patients have not been established.

The clinical toxicity of Valcyte, which is metabolized to ganciclovir, includes granulocytopenia, anemia, and thrombocytopenia. In ani
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SOURCE Roche
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