Adult Solid Organ Transplant (SOT)

Efficacy in Select Adult Patients

In high-risk adult kidney transplantation, the risk of CMV disease doesn’t stop at 100 days...
Take CMV disease prevention further with 200 days of Valcyte

In high-risk adult kidney transplantation...
Significant reduction in incidence of CMV disease with 200 days vs 100 days of Valcyte

• The primary efficacy endpoint was the proportion of D+/R- patients who developed protocol-defined CMV disease (CMV syndrome or tissue-invasive CMV) within the first 52 weeks
  • Patients with either CMV viral syndrome or tissue-invasive CMV were considered to have CMV disease. CMV syndrome was defined as evidence of CMV viremia accompanied by at least one of the following: fever (≥38°C), severe malaise, leukopenia, atypical lymphocytosis, thrombocytopenia, or elevation of hepatic transaminases¹
• Significant reduction in the incidence of CMV disease at month 12
  • 37% (60/163) of patients in the 100-day group vs 17% (26/155) in the 200-day group (P<.0001)^1,2
• Similar results were observed at month 24
  • 39% (63/163) of patients in the 100-day group developed CMV disease vs 21% (33/155) in the 200-day group (P<.001)^1,3

Patients with either CMV viral syndrome or tissue-invasive CMV were considered to have CMV disease. Patients found to have CMV disease after a blood sample was taken were treated in accordance with local practice.

Tissue-invasive CMV was defined as evidence of localized CMV infection in a biopsy or other appropriate specimen. Definitions of CMV disease were consistent with current AST guidelines for use in clinical trials.²

Study design: 12-month, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of up to 100 days of Valcyte vs up to 200 days of Valcyte for the prevention of CMV in high-risk adult kidney allograft recipients.

Learn more

Valcyte tablets effectively prevent CMV disease* in high-risk adult kidney, heart, or kidney-pancreas transplant patients

Valcyte received FDA approval based on the pivotal PV16000 clinical trial described below.

• Randomized, prospective, double-blind, double-dummy, multicenter, noninferiority study evaluating 372 heart, liver, kidney, and kidney-pancreas allograft recipients at high risk (D+/R-)† for CMV disease¹
• Primary objective was to compare the efficacy and safety of valganciclovir
  (900 mg once daily) with that of oral ganciclovir (1000 mg three times daily) in preventing CMV disease¹
• CMV prophylaxis therapy was started within 10 days of transplantation and continued through day 100¹
• Endpoint evaluation occurred 6 and 12 months posttransplantation for development of CMV disease²

* CMV syndrome was defined as evidence of CMV viremia accompanied with fever ≥38°C on 2 or more occasions separated by at least 24 hours within a 7-day period and one or more of the following: malaise, leukopenia, atypical lymphocytosis, thrombocytopenia, or elevation of hepatic transaminases.

^† D+/R- = donor CMV seropositive/recipient CMV seronegative.

^‡ In the phase 3 pivotal trial, the proportion of patients who developed CMV disease, including CMV syndrome and/or tissue-invasive disease during the first 6 months posttransplant, was similar between the Valcyte arm (12.1%; n=239) and the oral ganciclovir arm (15.2%; n=125). Mortality at 6 months was 3.7% (9/244) in the Valcyte group and 1.6% (2/126) in the oral ganciclovir group.

References:

1.

Valcyte^® [package insert]. South San Francisco, CA: Genentech USA, Inc.; 2010.

2.

Humar A, Lebranchu Y, Vincenti F, et al. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010;10:1228-1237.

3.

Humar A, Lebranchu Y, Vincenti F, et al. Long term results of the IMPACT study: 200 vs 100 days of valganciclovir prophylaxis in kidney recipients. Presented at: American Transplant Congress; May 4, 2010; San Diego, CA.

4.

Paya 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 Transplant. 2004;4:611-620.