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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). No significant difference was detected in overall safety and tolerability, demonstrating that extended treatment poses no additional risk to patients.

"As transplant physicians, we go to significant lengths to safeguard the health of the organ and patient post-transplant. We already recognize the terrible damage that CMV can cause to graft and patient," said Primary Investigator, Dr. Atul Humar, Director, Transplant Infectious Diseases and Associate Professor, Department of Medicine, University of Alberta, Canada. "Today's results show that continuing to treat with Valcyte for longer can help make a difference."

About the IMPACT Study

This Valcyte study for the prevention of CMV disease in kidney allograft recipients was a global, multi-center (65 centers in 13 countries including the United States), 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 included safety and tolerability, time to CMV disease, time to CMV infection, acute rejection, and graft loss.

The results demonstrated that 200-day Valcyte therapy prevented CMV disease in 84% of patients and significantly reduced the incidence of CMV disease by 56%, compared to the current standard of care (100-day Valcyte therapy) (p<0.0001). In addition, the IMPACT study showed that extending Valcyte prophylaxis up to 200 days significantly reduced CMV viremia (the spread of the CMV virus into the bloodstream and a known risk factor for developing CMV disease) from 51% with 100-day Valcyte prophylaxis to 37% with 200-day Valcyte prophylaxis (p=0.0149).

The most common adverse events occurring in both groups were leukopenia, diarrhea, and peripheral edema. Four deaths, unrelated to treatment with Valcyte, occurred in the 100-day treatment group and took place in France, Belgium and Romania. They were attributed to hemorrhage (one), sepsis (one) or septic shock (two).

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 and AIDS patients). 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, liver, and gastrointestinal tract. If left untreated, the mortality rate can be as high as 90%.

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 leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow depression, and aplastic anemia have been observed in patients treated with Valcyte tablets (and ganciclovir). Other adverse events reported with frequency of greater than 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 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.


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SOURCE Roche Pharmaceuticals
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