Patients in the BENEFIT-EXT study received extended criteria donor kidneys and a more intensive (MI) or less intensive (LI) belatacept immunosuppression regimen, or cyclosporine A (CsA). Patients who remained on assigned therapy through year 3 were eligible to enter a long-term extension (LTE) study. Three hundred four patients entered the LTE (n ¼ 104 MI; n ¼ 113 LI; n ¼ 87 CsA), and 260 continued treatment through year 5 (n ¼ 91 MI; n ¼ 100 LI; n ¼ 69 CsA). Twenty patients died during the LTE (n ¼ 5 MI; n ¼ 9 LI; n ¼ 6 CsA), and eight experienced graft loss (n ¼ 2 MI; n ¼ 1 LI; n ¼ 5 CsA). Three patients experienced an acute rejection episode (n ¼ 2 MI; n ¼ 1 LI). The incidence rate of serious adverse events, viral infections and fungal infections was similar across groups during the LTE. There were four cases of posttransplant lymphoproliferative disorder (PTLD) from the beginning of the LTE to year 5 (n ¼ 3 LI; n ¼ 1 CsA); two of three PTLD cases in the LI group were in patients who were seronegative for Epstein-Barr virus (EBV(À)) at transplantation. Mean AE SD calculated GFR at year 5 was 55.9 AE 17.5 (MI), 59.0 AE 29.1 (LI) and 44.6 AE 16.4 (CsA) mL/min/ 1.73 m 2 . Continued treatment with belatacept was associated with a consistent safety profile and sustained improvement in renal function versus CsA over time.

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Background Cytomegalovirus (CMV) disease is a serious infection after kidney transplantation. The risk factors and the impact of CMV disease in African-American (AA) kidney transplant patients have not been well characterized. Methods We performed a retrospective analysis on 448 AA patients transplanted between 1996 and 2005. A 3-month universal chemoprophylaxis with ganciclovir or valganciclovir was administered to CMV donor-positive/recipient-negative (D+/R−) patients and to those treated with anti-thymocyte globulin for rejection, but not routinely to patients with other D/R serostatus. Results A total of 31 AA patients (7%) developed clinical CMV disease. Compared to other D/R serostatus, the D+/R− group had the highest 3-year cumulative incidence of CMV disease (16.9% vs. 6.3% in D+/R+, 4.9% in D−/R+, and 2.4% in D−/R−). The D+/R− group had the worst 3-year death-censored graft survival by Kaplan-Meier methods (75% vs. 92% in D+/R+, 94% in D−/R+, and 96% in D−/R−, P=0.01). Multivariate analysis found that D+/R− serostatus (odds ratio [OR] 5.4, 95% confidence interval [CI] 0.6-48.2, P=0.003) and donor age > 60 years (OR 9.1, 95% CI 1.3-65, P=0.03) were independent risk factors for CMV disease. Conclusion The D+/R− group has the highest incidence of CMV disease and the worst 3-year renal graft survival, in spite of the 3-month universal prophylaxis. Prolonged chemoprophylaxis may be needed to prevent the late development of CMV disease and to improve graft survival in the high-risk group of AA kidney transplant recipients.