Study Proves Longer Prophylactic Therapy With Valcyte Increases Protection Against CMV – Most Serious Viral Infection Affecting Transplant Patients

February 16, 2009 at 11:00 am Leave a comment

Roche announced today that a Phase III study investigating the efficacy and safety of extended preventative therapy (‘prophylaxis’) with Valcyte (oral valganciclovir) met its primary endpoint of reducing the number of kidney transplant patients who develop cytomegalovirus (CMV) disease within the first year post-transplant. (1)

Valcyte is currently licensed for the prevention of CMV disease in high-risk kidney, heart, and kidney-pancreas transplant patients and is administered for up to 100 days post-transplant. The successful NT18435 study was designed to investigate whether extending therapy with Valcyte to 200 days post-transplant will further reduce the incidence of CMV disease. 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. (2, 3) Valcyte for 200 days further reduced the risk for CMV without increasing this risk after stopping therapy. The efficacy and safety data will be presented at an upcoming major medical meeting.

“Valcyte is considered the gold-standard anti-CMV medication for transplant patients, and the fact that this study has shown improved protection from CMV by extending the course of prophylaxis 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, he continued, “CMV is the most common viral infection in transplant patients. It can ‘lie dormant’ 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 CMV

CMV belongs to the family of herpes viruses (4) 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. (5) 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). (6) CMV is the most important serious infection complicating solid organ transplantation. (7) 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. (8) If left untreated, the mortality rate can be as high as 90%. (9)

About the NT18435 Study

NT18435 is a multi-centre (65 centres in 13 countries), double-blind study that randomised 326 high-risk (donor positive/recipient negative) kidney allograft recipients to one of two treatment groups:

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

• 200 days valganciclovir (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.

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, as leader in this field, has developed innovative therapies that improve graft and post-transplant health: CellCept® (mycophenolate mofetil) is the cornerstone of low toxicity immunosuppressant therapies. CellCept, the largest selling branded immunosuppressive in North America, offers both physicians and patients the possibility of an effective long-term immunosuppressive regimen with low toxicity. Valcyte was developed for the prevention of cytomegalovirus (CMV), a dangerous viral infection associated with transplantation. Oral Valcyte has displaced oral and intravenous ganciclovir as the gold standard for the management of CMV in immunocompromised patients. In addition, Roche supports basic research in transplantation with its funding of the independent Roche Organ Transplantation Research Foundation (ROTRF), which directly supports innovative research projects attracting new researchers with novel scientific ideas to meet unmet medical needs in solid organ transplantation.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2008 sales by the Pharmaceuticals Division totalled 36.0 billion Swiss francs, and the Diagnostics Division posted sales of 9.7 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested nearly 9 billion Swiss francs in R&D in 2008. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at


1. Roche data on file

2. Paya C et al. Efficacy and Safety of Valganciclovir vs. Oral Ganciclovir for Prevention of Cytomegalovirus in Solid Organ Transplant Recipients. Am J Transplantation 2004; 4:611-620

3. Limaya AP et al. Impact of Cytomegalovirus in Organ Transplant Recipients in the Era of Antiviral Prophylaxis. Transplantation 2006; 81:1645-52

4. Centers for Disease Control and Prevention. Frequently Asked Questions About CMV. Accessed on 9 February 2009 at:

5. PatientPlus. Cytomegalovirus (CMV). Accessed on 10 February 2009 at:

6. Health Protection Agency North West. Cytomegalovirus Information Leaflet. Accessed on 9 February 2009 here.

7. Weir MR. Medical Management of Kidney Transplantation. 2005 Chapter 28: Cytomegalovirus in Renal Transplantation. Lippincott Williams and Wilkins

8. Medscape. Infection in the Transplant Recipient: CMV. Accessed on 9 February 2009 at:

9. Pescovitz MD. Prevention and Treatment of Cytomegalovirus Disease in Solid Organ Transplant Recipients: The Clinical and Economic Impact of Evolving Strategies. Am J Health-Syst Pharm 2003; 60(23):S3-S4




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