Cytomegalovirus (CMV) in renal transplant recipients (RTR) is associated with a high degree of morbidity. Current practice guidelines recommend CMV prophylaxis for 3-6 months with valganciclovir (VGC) in the intermediate risk (D-/R+) based on expert opinion only. This analysis aims to study the safety and efficacy of CMV prophylaxis with VGC 450mg daily vs. 900mg daily for three months in D-/R+ RTR.
Methods: A multicenter, retrospective analysis was performed with 261 adult RTR between 01/2008 and 10/2011. Patients in Group 1 received VGC 450mg daily (n=227) and patients in Group 2 received 900mg daily (n=34). All patients received rabbit antithymocyte globulin (r-ATG) or basiliximab induction therapy. Post-transplant maintenance immunosuppression included tacrolimus (TAC), mycophenolate (MPA) with or without corticosteroids. Prevalence of CMV at 12 months was the primary endpoint. Evaluation of biopsy proven acute refection (BPAR), antibody-mediated rejection (AMR), graft loss, patient survival, opportunistic infections (OI), adverse drug reactions (ADR) and early discontinuation were also analyzed.
Results: Baseline demographics of the groups were comparable, with the exception of Group 1 having a higher mean age (p=0.03). In terms of immunosuppression, r-ATG induction was used more frequently in Group 1 (p<0.01) and Group 2 patients had higher mean TAC levels at month 9 (p=0.04) and higher mean MPA doses at months 6, 9, and 12 (p<0.01).
|12 Month Efficacy Analysis||Group 1||Group 2||P-value|
|CMV disease||6 (2.6%)||2 (5.9%)||0.280|
|BPAR||23 (10.1%)||4 (11.8%)||0.763|
|AMR||8 (3.5%)||0 (0%)||0.602|
|Graft Loss||4 (1.8%)||0 (0%)||1.00|
|Patient Survival||225 (99.1%)||34 (100%)||1.00|
|OI||31 (13.7%)||6 (17.6%)||0.597|
Overall, there were no cases of breakthrough or resistant CMV disease. A safety analysis revealed more G-CSF (p<0.01) use in Group 2 along with higher rates of VCG dose reductions due to ADR (AE; p=0.04).
Conclusion: No significant difference in CMV disease prevalence was noted between the two treatment groups. High-dose VGC was associated with increased use of G-CSF and higher rates of ADR requiring dose reductions. The use of VCG 450mg daily for CMV prophylaxis in D-/R+ RTR is efficacious and results in fewer ADR and dose reductions and is associated with a 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. Prevention of Cytomegalovirus with Valganciclovir 450mg Daily vs. 900mg Daily in Intermediate Risk Renal Transplant Recipients (D-/R+); a Multicenter Safety and Efficacy Evaluation [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/prevention-of-cytomegalovirus-with-valganciclovir-450mg-daily-vs-900mg-daily-in-intermediate-risk-renal-transplant-recipients-d-r-a-multicenter-safety-and-efficacy-evaluation/. Accessed October 28, 2020.
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