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.
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
Percentage (No.) of Patients Developing CMV Disease‡1,4
|Valcyte Tablets n=239||Ganciclovir Capsules
|6 months posttransplantation||12.1% (29)||15.2% (19)|
|12 months posttransplantation||17.2% (41)||18.4% (23)|
* 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.