Real-World Use of Maribavir vs. Valganciclovir in Solid Organ Transplant (SOT) Patients with or without Refractory Cytomegalovirus Disease

Document Type

Conference Proceeding

Publication Date

8-1-2025

Publication Title

Am J Transplant

Abstract

Purpose: Cytomegalovirus (CMV) infection is a major complication in solid organ transplant (SOT) recipients, impacting graft function and survival. The SOLSTICE trial demonstrated maribavir's (MBV) superiority to investigator-assigned therapy for CMV clearance by week 8, yet data on MBV use in SOT patients with non-refractory CMV remains limited, and the impact of MBV on calcineurin inhibitor (CNI)-based immunosuppression (IS) has not been well characterized. The purpose of this study was to assess the efficacy of MBV for viremia clearance in a variety of SOT recipients and the real-world impact of MBV on CNI levels. Methods: This was a retrospective, single-center study of SOT recipients treated with MBV or valganciclovir (VGC) between 2021 to 2024. The primary outcome was CMV viremia clearance by week 8. Secondary outcomes included impact of antiviral therapy on CNI trough levels, adjustments to IS during treatment, treatment-related adverse events, and therapy discontinuation. Results: 55 SOT patients were included (MBV: 25; VGC: 30) with a median age of 58 (kidney 34.5%, liver 29.1%, lung 23.6%, heart 5.5%, multivisceral 5.5%, simultaneous liver-kidney 1.9%). Baseline demographics were comparable between groups (table 1). Notably, patients in MBV group had a median of 15 days of prior VGC exposure before switching therapies. By week 8, CMV clearance was achieved in 48% of MBV-treated patients versus 40% of VGC-treated patients (p=0.551). Among patients receiving tacrolimus in MBV group, a notable increase in FK trough levels was observed. Median FK level before treatment was 6.9, which increased to 9.2 by day 7 (+39%). To counteract this, tacrolimus doses were reduced early in therapy, with median daily dose decreasing from 6 mg to 4 mg by day 7 (−25%) and remaining stable by day 14. VGC-treated patients experienced significant leukopenia (37%). Initial WBC counts were lower in the MBV group but remained stable throughout therapy. In contrast, VGC patients had a median 50% WBC reduction, necessitating granulocyte-colony stimulating factor use in 27% of cases, while no MBV patients required it (p=0.005). Conclusions: MBV demonstrated comparable efficacy to VGC in CMV clearance. It was associated with fewer hematologic complications but led to increased CNI levels, requiring dose adjustments. These findings support MBV as an alternative for CMV treatment in SOT recipients, particularly those at risk for VGC-induced leukopenia. Close monitoring of CNI levels is required, thus larger studies validating degree of interaction are warranted. [Formula presented] CITATION INFORMATION: Eshaya M., Franco-Palacios D., Jakupovic L., Patel A., Tong M., Poparad-Stezar A., Fitzmaurice M. Real-World Use of Maribavir vs. Valganciclovir in Solid Organ Transplant (SOT) Patients with or without Refractory Cytomegalovirus Disease AJT, Volume 25, Issue 8 Supplement 1 DISCLOSURES: M. Eshaya: None.

Volume

25

Issue

8

First Page

S590

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