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Purpose: The efficacy of cytomegalovirus immune globulin (CMVIG) prophylaxis in transplant recipients is poorly investigated and studies that demonstrated benefit were conducted before the current gold standard of ganciclovir (GCV) and valganciclovir (VGCV) were widely available. Consensus guidelines remain unclear whether addition of CMVIG improves outcomes when appropriate antivirals are given. The purpose of this study was to demonstrate that CMV prophylaxis with optimized antiviral therapy is noninferior to combination antiviral therapy plus CMVIG in liver and liver/kidney recipients.
Methods: A single center, retrospective analysis was conducted to assess outcomes of patients transplanted between 2/2008-9/2009. Patients were excluded if less than 18 years old, intestine transplants, or expired within 30 days of transplant. Pre protocol patients who were CMV seronegative (R-) received 3 months of antiviral prophylaxis plus CMVIG and seropositive recipients (R+) received 6 weeks of antiviral prophylaxis. Post protocol patients received 3 months of antiviral prophylaxis and no CMVIG with implementation of routine PCRs. Comparisons made using Fisher's exact test.
Results: Analysis included 104 patients (55 pre vs 49 post). Patient demographics, induction, and immunosuppression were similar in both groups. The post group had more high risk (D+/R-) patients (13% vs 28%, p= 0.065). There was no difference regarding intermediate (R+) or low risk (D-/R-) between groups. There was no significant difference in incidence of CMV disease (10.9% vs 12.2%, p=0.536). Of the 12 patients with proven CMV disease, more patients had received alemtuzumab for induction (23%, p=0.023) and 42% developed CMV after treatment of rejection (p=0.003). No difference was found between the agents used for treatment of rejection. One CMV-related mortality was identified in the pre protocol group.
Conclusion: No significant difference was found between pre and post protocol change in CMV-related outcomes. CMV prophylaxis with optimized antiviral therapy was found to be noninferior to combination CMVIG plus GCV/VGCV.