172 Everolimus Treatment Reduces the Need for Anti-CMV Prophylaxis in De Novo Heart Transplant Recipients

Purpose: Cytomegalovirus (CMV) is the most clinically relevant infectious agent in heart transplant (HT) recipients. Although antiviral agents used in a prophylaxis strategy seem superior to a pre-emptive approach to reduce CMV burden and its consequences, the impact of the additional anti-CMV effect of everolimus (EVE) on the benefit of antiviral prophylaxis is currently unexplored. In this study we analyzed the interaction of anti-CMV strategy and the use of EVE or mycophenolate (MMF) on the occurrence of CMV events in de novo HT recipients. Methods and Materials: Consecutive HT recipients surviving at least 6 months after surgery, treated with either EVE or MMF, and transplanted between 2005 and 2010 in two centers entered the study. Oral valganciclovir or i.v. ganciclovir were used for pre-emptive or prohylaxis strategy. CMV infection was regularly monitored with CMV DNA PCR and pp65 antigenemia in all patients. CMV disease/syndrome was the main outcome event. Results: 191 patients (11% D /R-) entered the study (44 on EVE and 147 on MMF). Overall, CMV infection (45% vs. 78%), need for CMV treatment (20% vs. 53%), CMV disease/syndrome (2% vs. 15%), and peak CMV burden (4 vs. 27 pp65cells/205) were significantly lower in EVE than in MMF treated recipients (all P 0.01). Prophylaxis resulted more effective in preventing all these outcomes than preemptive strategy in MMF patients (all P 0.03), but not in EVE treated patients. Of note, EVE patients followed with pre-emptive approach showed less CMV infection (48 vs 70%; P 0.05), and less CMV syndrome/disease (0 vs. 8%; P 0.05) than MMF patients receiving prophylaxis. Conclusions: EVE-based immunosuppression showed a clinically relevant impact on all acute CMV outcomes as compared with MMF. The benefit of anti-CMV prophylaxis is retained only in MMF treated patients and EVE seems to provide an overall advantage in reducing acute CMV events without the need of extensive treatment with antiviral drugs.