Multinational Retrospective Chart Review of Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization in Solid Organ Transplant Recipients With Refractory/Resistant Cytomegalovirus Infection or Intolerance to Anti-Cytomegalovirus Therapy

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BACKGROUND: Real-world data on burden of refractory/resistant cytomegalovirus infection or intolerance to anti-cytomegalovirus (CMV) therapies (RRI CMV) among solid organ transplant (SOT) recipients are lacking. METHODS: Data from SOT recipients with RRI CMV aged ≥18 years were retrospectively collected from 13 centers (Europe, the United States) between 2014 and 2021. Anti-CMV treatment patterns, clinical outcomes, and hospitalization data were analyzed descriptively. RESULTS: Of 218 patients enrolled, 93.6% developed RRI CMV during their first CMV episode post-SOT. Valganciclovir was the most commonly used anti-CMV therapy for primary prophylaxis (97.1%), secondary prophylaxis (80.0%), and first-line treatment (90.1%). Most patients with data (59.6% [127/213]) received ≥2 anti-CMV therapies for treatment. Overall, 90.4% of patients experienced dose changes/treatment discontinuations during RRI CMV episodes. From RRI diagnosis, 50.0% of nephrotoxicity events occurred in patients receiving foscarnet and 61.3% of myelosuppression events in those receiving valganciclovir. CMV viremia cleared in 78.9% of patients during the first RRI CMV episode, and recurrent CMV episodes occurred in 21.6%. Graft loss occurred after the RRI CMV date in 8.4% (18/218) of patients. Overall mortality was 19.7%. Significantly more patients with RR CMV had CMV-related hospitalizations following SOT than those with intolerance to anti-CMV agents (58.2% vs 13.2%; P < .001). CONCLUSION: In this multinational real-world study of SOT recipients with RRI CMV infection, 21.1% did not achieve viremia clearance and 21.6% experienced recurrence, and a notable portion had unfavorable outcomes, such as adverse events, mortality, and hospitalizations. Results suggest that therapies that achieve and maintain CMV clearance without treatment-limiting toxicities are needed.

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