RANDOMIZED STUDY COMPARING ORAL GANCICLOVIR PLUS CYTOMEGALOVIRUS IMMUNE GLOBULIN (CMV IG) VERSUS ORAL GANCICLOVIR ALONE FOR PROPHYLAXIS OF CMV IN LIVER AND KIDNEY TRANSPLANT RECIPIENTS.

Abstract

482 Introduction: CMV infection occurs in 30%-50% of transplant patients and can increase morbidity, mortality, and cost post-transplant. Centers use CMV prophylaxis, however the most cost-effective regimen remains controversial. Objective: To compare the efficacy of CMV Ig plus oral ganciclovir (Group 1) versus oral ganciclovir alone (Group 2) for prophylaxis of CMV disease in liver and kidney transplant recipients. Methods: An open-label randomized study of patients undergoing liver or kidney transplantation. Oral ganciclovir was given as 1 g TID for 3 months and 150 mg/kg of CMV Ig was given within 48 hours after transplant and 2, 4, 6, 8, and 12 weeks post-transplant. Primary outcomes of the study included biopsy or culture proven CMV and severe CMV disease, CMV antigenemia, rejection, patient/graft survival, and adverse events. Data were analyzed using chi-square analysis and Kaplan-Meier analysis. Results: 78 patients enrolled to date; 3 month data on 55 patients in Table 1. None of the above differences were statistically significant. Only 1 study patient (1.8%) developed CMV with vomiting and CMV on gastric biopsy (Group 2, kidney, d+/r−). At 6 months, no additional patients (n=34) developed CMV. There were no serious adverse events related to drug in either group.TableConclusions: Manifestations of CMV were uncommon in our study population. Preliminary results from our study suggest that oral ganciclovir alone is effective for CMV prophylaxis after kidney and liver transplantation. This study was sponsored in part by Medimmune, Gaithersburg, MD.