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Purpose: High prevalence of cytomegalovirus (CMV) disease in the first year after transplantation leaves a critical need for understanding patient risk factors and pharmacotherapy involved to better identify effective prevention strategies in renal transplant recipients (RTR). This study compared efficacy of 6 months of low-dose valganciclovir (VGC) prophylaxis with the addition of CMV hyperimmune globulin (IVIG) vs. VGC prophylaxis alone in prevention of CMV disease in high-risk CMV donor-positive/recipient-negative (D+/R-) RTR.
Methods: A single center, retrospective analysis evaluated 86 adult RTR, who were CMV D+/R-, transplanted between 1/1/2000 and 12/31/2010. Group 1 (n=30) received CMV IVIG (150 mg/kg x 1 dose; followed by 100 mg/kg on weeks 2, 4, 6 and 8; and 50 mg/kg on weeks 12 and 16 post transplant) plus VGC 450 mg/day (dose adjusted for renal function) for 6 months. Group 2 (n=56) received only VGC 450 mg/day (dose adjusted for renal function) for 6 months. Induction therapy included IL2-RA (n=27), rATG (n=56) or both (n=3) and all received initial maintenance immunosuppression with tacrolimus, mycophenolic acid and corticosteroids. The primary endpoint was development of CMV disease at one year. Crude prevalence was established with chi-square analysis; multivariable logistic regression was used to estimate odds ratios for binary outcomes.
Results: Patient demographics and transplant characteristics were comparable between the two groups. The overall incidence of CMV disease in both groups was 24.4% (n=21) with a larger percentage occurring in males versus females (26.8% vs. 20% respectively; p=0.485) and with VGC alone vs. VGC plus CMV IVIG (28.6% vs. 16.7% respectively; p=0.221, OR=2.093, CI=0.662-6.616).
Conclusion: In this small sample of RTR, the addition of CMV IVIG to low-dose VGC did not provide a significant benefit in the prevention of CMV disease in the first year post-renal transplant.