IMPACT Study Demonstrates That Longer Prophylactic Therapy With Valcyte (Valganciclovir Hydrochloride Tablets) Increases Protection Against CMV - the Most Serious Viral Infection Affecting Transplant Patients

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/ --<!-- cpurl -->Roche<!-- /cpurl --> announced today that a Phase III study investigating the efficacy and safety of extended preventative therapy ('prophylaxis') with <!-- ppurl -->Valcyte<!-- /ppurl --> 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. "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 animal studies, ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis.
 

Valcyte tablets should not be administered if the absolute neutrophil count is less than 500 cells/micro liter, the platelet count is less than 25,000/micro liter, or the hemoglobin is less than 8 g/dL. Severe leucopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone morrow depression, and aplastic anemia have been observed in patients treated with Valcyte tablets (and ganciclovir). Other adverse events reported with frequency of greater or equal to 5% included diarrhea, tremors, graft rejection, nausea, headache, insomnia, hypertension, vomiting, and fever.
 

In liver transplant patients, there was a significantly higher incidence of tissue-invasive CMV disease in the Valcyte-treated group compared with oral ganciclovir group.
 

Strict adherence to dosage recommendations is essential to avoid overdose. Dose modifications are required for patients with renal impairment.
 

Prescribing information for Valcyte is available at www.rocheusa.com/products/valcyte or www.rochetransplant.com.
 

About CMV
 

CMV belongs to the family of herpes viruses and, as such, is very common among the general population. It is estimated that 50-80% of all adults have been infected with the CMV virus. In the majority of cases the virus lies dormant in the body throughout life, but can be reactivated at times when the immune system is weakened (e.g., transplant patients, AIDS patients and premature infants). CMV is the most important serious infection complicating solid organ transplantation. Transplant patients may already be infected with CMV prior to transplantation or receive a donor organ infected with CMV.
 

CMV infection usually develops during the first few months after transplantation and may cause complications in the lungs, kidneys, nervous system, stomach, liver, brain, and eyes. If left untreated, the mortality rate can be as high as 90%.
 

About Roche
 

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years in the U.S., Roche has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. For additional information about the U.S. pharmaceuticals business, visit our website http://www.rocheusa.com/. Product and treatment information for U.S. healthcare professionals is available at www.RocheExchange.com.
 

All trademarks used or mentioned in this release are protected by law.
 

Source: Roche

CONTACT: Christopher Vancheri, of Roche, Office +1-973-562-2203, Cell
+1-973-262-1175, Christopher.Vancheri@roche.com
 

Web Site: http://www.rocheusa.com/
 

Posted: February 2009

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