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ATC: New Data Reveal Ganciclovir (Valcyte/Cymevene) Reduces The Risk Of Cancer In Kidney Transplant Patients BASEL, SWITZERLAND – May 21, 2004 -- Data presented at the American Transplant Congress (ATC) annual meeting show that the gold standard CMV antiviral ganciclovir (Valcyte/Cymevene) has been proven to reduce the risk of cancer and organ rejection in kidney transplant patients. Ganciclovir, the active antiviral agent in Roche's Valcyte and Cymevene drugs, is used to prevent cytomegalovirus (CMV) disease, a potentially fatal infection that can occur after a transplant and lead to the loss of the transplanted organ and patient death. The new data showed that for every month of treatment with ganciclovir, the risk of developing cancer was lowered by 41% when compared to patients on another antiviral, acyclovir*.1 Furthermore, the risk of early organ rejection was reduced by 75% compared to patients taking no antiviral agents.2 These data suggest ganciclovir offers benefits beyond the prevention of CMV by lowering the risk of early rejection and extending patient life by reducing the risk of malignancy. "Collectively, data presented show that a lower risk of cancer and reduced early rejection are dual benefits of ganciclovir prophylaxis, which may help improve patient and graft survival," said Mark Pescovitz, Professor of Microbiology/Immunology, and Professor, Vice Chair for Research and Director of the division of Transplant Surgery in the Department of Surgery, Indiana University, USA. "Valcyte delivers the same active drug ingredients as oral ganciclovir, with up to 10 times greater bioavailability and simple once-daily dosing, offering patients an effective, easy and convenient treatment option. Therefore, these data also support the role of Valcyte in reducing the risk of early rejection and malignancy," he continued. Study data An analysis of patients with post-transplant lymphoproliferative disease (PTLD), cancer of the blood, showed that the cumulative length of ganciclovir treatment is significantly associated with a lower risk of developing PTLD, compared to those with no antiviral therapy. There was no such effect for patients on acyclovir.1 Further results from the multicentre case-control study showed that patients treated with gancicolovir, of which Valcyte (valganciclovir) is a prodrug, were at one quarter the risk of early rejection (<31 days) compared to patients taking no antivirals. The benefit was lower (less than half) for patients receiving acyclovir.2 Worldwide, around 50,000 organs are transplanted each year, of which 50-60% are kidney or kidney/pancreas transplants. Although acute graft rejection can occur at any time, the risk is highest during the first few months after surgery and has a significant impact on the development of chronic allograft failure and subsequent graft loss. In addition to organ rejection, there is also a long-term risk of complications, including infection and malignancy, all of which jeopardise graft function and patient survival. The risk of developing certain cancers increases several hundredfold in immunosuppressed organ allograft recipients and PTLD currently represents the second most common de novo post-transplant malignancy. About Valcyte Valcyte, a prodrug of Roche's anti-CMV treatment, Cymevene (Cytovene in the US), was developed in response to the need for a more convenient and patient-friendly oral form of ganciclovir. Valcyte is now the most widely prescribed anti-CMV medication in the world. Valcyte allows for greater blood levels of ganciclovir, delivering a 10-fold greater bioavailability than Cytovene. Valcyte also offers the benefit of once-daily dosing, giving immunocompromised patients who often take multiple medications enhanced convenience in treatment About CMV CMV is a member of the herpes family of viruses, which include the Epstein Barr Virus, the causative agent of most cases of PTLD. In individuals with healthy immune systems, after initial infection, CMV can exist in the body in a dormant state. However, among individuals with compromised immune systems, such as patients taking post-transplant immunosuppressants or those with HIV/AIDS, the virus can become active causing disease and organ damage. CMV disease occurs in up to 40% of organ transplant recipients and is responsible for a substantial number of deaths and graft failures in these patients. CMV disease may affect the transplanted organ directly but can also cause indirect, insidious damage to patients and/or grafts. SOURCE: Roche E-mail this page to a friend or colleague! To print, use this version