The cytomegalovirus (CMV) donor-positive/recipient-positive (D+/R+) population represents the largest proportion of renal transplant recipients (RTR). Current practice guidelines on the prevention of CMV recommend antiviral prophylaxis in D+/R+ population including the use of valganciclovir (VGC) for 3-6 months. To our knowledge, this study is the first head-to-head analysis comparing the efficacy and safety CMV prophylaxis of VGC 450 mg/day vs. 900 mg/day for 3 months in the D+/R+ renal transplant population.
Methods: A multicenter, retrospective analysis evaluated 465 adult RTR between 01/2006 and 11/2011. Study participants either received VGC 450 mg/day (Group 1; n=398) or 900 mg/day (Group 2; n=67) x 3 months for CMV prophylaxis. All groups had VGC dose adjusted for renal function. All patients received rabbit antithymocyte globulin (r-ATG) or basiliximab induction. Initial maintenance immunosuppression included tacrolimus, mycophenolate, and corticosteroids. The primary endpoint was prevalence of CMV disease at 12 months. The rates of graft loss, patient survival, T-cell mediated rejection (TCMR), antibody mediated rejection (AMR), hematological adverse events, opportunistic infections (OI), and early discontinuation were also evaluated.
Results: Patient demographics were similar, with the exceptions of Group 1 utilizing more r-ATG for induction, and having more Asians, Hispanics, and Caucasians. Group 2 had a higher number of standard criteria donors (SCD).
|12 Month Efficacy Analysis||Group 1||Group 2||P-value|
|CMV disease||14 (3.5%)||2 (2.9%)||1.00|
|Graft Loss||20 (5.0%)||4 (6.0%)||0.77|
|Patient Survival||378 (95.0%)||64 (95.5%)||0.41|
|TCMR||41 (10.3%)||4 (6.0%)||0.37|
|AMR||8 (2.0%)||0 (0%)||0.61|
|OI||82 (20.6%)||14 (21%)||1.00|
There were no cases of CMV breakthrough or resistant CMV disease. The rates of leukopenia and thrombocytopenia were similar between both groups; however, there was more use of G-CSF (p=0.0003) in Group 2. Rates of early VGC DC and other adverse effects evaluated were also similar.
Conclusion: Both regimens provide similar efficacy in the prevention of CMV disease in the D+/R+ RTR population. The 450 mg/day regimen required less growth-factor support, and would also result in significant cost avoidance.
To cite this abstract in AMA style:Gabardi S, Cross R, DePiero K, Dick T, Ferguson K, Newkirk E, Park J, Tichy E, Ueda K, Weng R, Heldenbrand S. Multicenter Evaluation of Efficacy and Safety of Valganciclovir 450 mg/day vs. 900 mg/day for Prevention of Cytomegalovirus Disease in Donor and Recipient Positive (D+/R+) Renal Transplant Recipients [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/multicenter-evaluation-of-efficacy-and-safety-of-valganciclovir-450-mgday-vs-900-mgday-for-prevention-of-cytomegalovirus-disease-in-donor-and-recipient-positive-dr-renal-transplant-recipients/. Accessed August 14, 2020.
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