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.
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.3 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.4
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 recipients5 and PTLD currently represents the second most common de novo post-transplant malignancy6.
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
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.
Roche in transplantation
Roche is strongly committed to improving the long-term outcomes of transplantation and enhancing the quality of life of transplant recipients. Roche has developed innovative therapies that improve graft and post-transplant health: CellCept is the cornerstone of low toxicity immunosuppressant therapies. CellCept is the largest selling branded immunosuppressive in North America, offering both physicians and patients the possibility of an effective long term immunosuppressive regimen with low toxicity, Zenapax prevents the acute rejection of the newly transplanted organ, and Valcyte was developed for the prevention of cytomegalovirus, a dangerous viral infection associated with transplantation. In addition, Roche supports basic research in transplantation with its funding of the independent Roche Organ Transplantation Research Fund (ROTRF), which directly supports innovative research projects attracting new researchers with innovative and novel scientific ideas to meet unmet medical needs in solid organ transplantation.
Headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche employs roughly 65,000 people in 150 countries. The Group has alliances and R&D agreements with numerous partners, including majority ownership interests in Genentech and Chugai.
Roche in transplantation:
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1.Pescovitz MD, Funch DP, Schneider G, et al. Antiviral use and its association with post-transplant lymphoproliferative disorder (PTLD) in renal transplant patients. 2004. Data presented at the fifth joint American transplant meeting, ATC 2004, Boston, MA, USA, 17 May 2004.
2.Funch DP, Pescovitz MD, Schneider G, et al. The impact of antiviral prophylaxis on allograft rejection in renal transplant patients. 2004. Data presented at the fifth joint American transplant meeting, ATC 2004, Boston, MA, USA, 16 May 2004.
3.Transplant Procurement Management http://www.tpm.org/registry/reg_mondo.htm
4.Danovitch GM. Immunosuppressive medications for renal transplantation: A multiple choice question. Kidney Int. 2001;59:388-402.
5. Penn I. Post-transplant malignancy: the role of immunosuppression. Drug Saf. 2000;23(2):101-13.
6.Trofe J, Buell JF, First MR, et al. The role of immunosuppression in lymphoma. Recent Results Cancer Res. 2002;159:55-66.