#3374 Maribavir treatment in resistant/refractory cytomegalovirus infection among kidney transplant recipients: a real-world experience

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Abstract Background and Aims Cytomegalovirus (CMV) infection impacts 30%–80% of solid organ transplant (SOT) patients. The primary risk factor is the combination of a seropositive donor and a seronegative recipient (D+/R−), particularly when accompanied by the use of anti-lymphocyte antibodies. CMV infection causes both direct and indirect effects due to immunosuppression and the release of proinflammatory cytokines. This increases susceptibility to opportunistic infections, the risk of graft rejection, and cardiovascular complications. Managing refractory CMV in organ transplant recipients poses a significant therapeutic challenge today. Maribavir (MBV) selectively inhibits the viral kinase UL97, offering a different mechanism of action compared to conventional treatments such as ganciclovir and valganciclovir (GCV/ VGC). This positions MBV as an innovative and promising alternative for treating CMV. The primary objective of this study was to evaluate our clinical experience with Maribavir in refractory CMV infection, analyzing its safety profile, and clinical effectiveness to optimize clinical implementation. Method A single-center retrospective study evaluated renal transplant recipients treated with Maribavir (MBV) for refractory/resistant CMV infection at Hospital Virgen del Rocío (Seville) between January 2023–November 2024. Data collection included demographics, clinical history, immunosuppression regimens, and treatment outcomes from electronic records. CMV monitoring was performed using quantitative plasma PCR, with resistance testing at reference laboratories. Treatment success was defined as two consecutive negative PCR results one week apart. Recurrence was established as viral load reappearance or clinical signs within 4 weeks post-treatment. Patients showing decreasing DNAemia without complete clearance were considered partial responders. Results In this retrospective analysis, six patients (5 male, 1 female; age range 25–79 years) with refractory cytomegalovirus (CMV) were treated with Maribavir. Complete viral clearance was achieved in 5/6 patients (80%) within four weeks. One patient died from unrelated cardiovascular causes. Treatment demonstrated favorable safety profile with preserved renal function. One patient (16.7%) experienced dysgeusia; no neutropenia cases were reported. Pre-existing cytopenias improved during treatment. Tacrolimus dose adjustment was required in 50% of patients due to increased drug levels. Among evaluable patients (n = 5), early CMV recurrence rate was 60%. Of these, two patients responded to repeated maribavir course, and one to ganciclovir. Initial viral loads were <10,000 copies/mL in all cases (range: 200–7,200) (Table 1). Conclusion Maribavir shows high efficacy in treating refractory cytomegalovirus (CMV) infections, with significant benefits from its oral administration and low side effect profile. These factors support outpatient management and reduce the need for hospitalization. Our data showed superior efficacy rates compared to published literature, maintaining comparable recurrence rates. Post-treatment monitoring and genetic resistance testing remain crucial considerations. Future research should address optimal treatment duration, viral load thresholds for initiation, role in preemptive therapy, and potential antiviral combinations.

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