A randomized trial of ganciclovir versus ganciclovir plus immune globulin for prophylaxis against Epstein-Barr virus related posttransplant lymphoproliferative disorder

Background. Transplant recipients who are Epstein-Barr virus (EBV)-seronegative and receive organs from seropositive donors (EBV D+/R-) are at increased risk for posttransplant lymphoproliferative disorder (PTLD) and may benefit from antiviral prophylaxis. We performed a multi-center trial assessing two different antiviral regimens and their effect on EBV replication. Methods. EBV D+/R- solid organ transplant recipients were randomized to receive either ganciclovir and placebo or ganciclovir and immunoglobulin (IG) for 3 months. Following this, patients were unblinded and IG patients received additional IG therapy until 6 months. EBV viral loads were done at least monthly. Results. Thirty-four patients (25 pediatric, 9 adult) completed the protocol (16 placebo; 18 IG). The incidence of a detectable viral load within the first year posttransplant was 13/16 (81.3%) in the ganciclovir arm vs. 13/18 (72.2%) in the ganciclovir and IG arm (P=0.8). Time to first detectable viral load, and time to high-level viral load were not significantly different. By repeated measures ANOVA analysis, and by estimation of viral load AUC, no significant effect of randomization group was observed on EBV viral loads. PTLD developed in 3 (8.8%) patients (all in IG arm; P=0.23). Conclusions. No significant difference in EBV viral load suppression was observed when ganciclovir was compared with ganciclovir and IG in high-risk EBV D+/R- patients.