Multicenter evaluation of efficacy and safety of lowâ dose versus highâ dose valganciclovir for prevention of cytomegalovirus disease in donor and recipient positive (D+/R+) renal transplant recipients

Abstract

BackgroundThe cytomegalovirus (CMV) donorâ positive/recipientâ positive (D+/R+) population is the largest proportion of renal transplant recipients (RTR). Guidelines for prevention of CMV in the intermediateâ risk D+/R+ population include prophylaxis with valganciclovir (VGCV) 900Â mg/day for 3Â months. This study is the first headâ toâ head analysis, to our knowledge, comparing the efficacy and safety CMV prophylaxis of VGCV 450 vs 900Â mg/day for 3Â months in D+/R+ RTR.MethodsA multicenter, retrospective analysis evaluated 478 adult RTR between January 2008 and October 2011. Study participants received VGCV 450Â mg/day (Group 1; n=398) or 900Â mg/day (Group 2; n=89)Ã 3Â months for CMV prophylaxis. All VGCV was adjusted for renal function. All groups included in this study received studyâ approved induction and maintenance immunosuppression regimens. The primary endpoint was incidence of CMV disease at 12Â months.ResultsThe rates of graft loss, patient survival, Tâ cell and/or antibodyâ mediated rejection, hematological adverse events, opportunistic infections, and early VGCV discontinuation were evaluated. Patient demographics were comparable, but had significant differences in ethnicity and donor type between the groups.ConclusionThe occurrence of CMV disease at 12Â months was similar between the groups (3.5% vs 3.4%; P=1.000). Logâ rank test found no statistically significant difference in the time to development of CMV between the 2 groups (P=.939).