Efficacy 

Valcyte effectively prevents CMV disease in kidney, heart and kidney-pancreas transplant patients at high risk. Valcyte received approval based on the pivotal clinical trial described below:

• Randomized, prospective, double-blind, double-dummy, multicenter, non-inferiority study evaluated 364 heart, liver, kidney, and kidney-pancreas allograft recipients at high risk (D+/R-)* for CMV³
• Primary objective was to compare the efficacy and safety of valganciclovir (900 mg QD) versus that of oral ganciclovir (1000 mg tid) in preventing CMV disease³
• CMV prophylaxis therapy was started within 10 days of transplant and continued through day 100
• Endpoint evaluation occurred 6 and 12 months posttransplantation for development of CMV disease
  *D=/R-=donor CMV seropositive/recipient CMV seronegative

Percentage (No.) of Patients Developing CMV Disease^*3

	Valcyte Tablets n=239	Ganciclovir Capsules n=125
6 months posttransplantation	12.1% (29)	15.2% (19)
12 months posttransplantation	17.2% (41)	18.4% (23)

Valcyte is not indicated for use in liver transplant patients.⁴

  Safety Information

 

References:

³Paya C, Humar A, Dominguez E, et al. Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am J Transpl. 2004;4:611-620.

⁴Valcyte® [product information]. Nutley, NJ: Roche Laboratories Inc.; January 2006.