Real-life experience with maribavir for the treatment of cytomegalovirus infection in solid organ transplant recipients.

INTRODUCTION

Infection due to cytomegalovirus (CMV) frequently complicates the course of solid organ transplantation (SOT). The use of currently available antivirals is often limited due to toxicity. Maribavir (MBV) has demonstrated efficacy in clearing CMV DNAemia, with a favorable safety profile in SOT recipients. Nevertheless, real-life experience outside the clinical trial setting is still scarce.

METHODS

A retrospective observational study was conducted including adult SOT recipients who experienced CMV infection and were treated with MBV at our institution between April 2023 and March 2025.

RESULTS

Nineteen episodes of CMV infection diagnosed in 16 SOT (mostly lung [57.9%] and heart [26.3%]) recipients were treated with MBV (median duration of 48 days [interquartile range: 18.5-63]), primarily as salvage therapy due to previous toxicity (36.8%) or refractoriness or resistance (31.6%). The initial dose had to be subsequently increased (to 800 or 1200mg BID) in 36.8% of episodes. Transient CMV DNAemia blips were common (21.1%) but not associated to treatment failure. Breakthrough DNAemia while on MBV occurred in 36.8% of episodes. Antiviral resistance testing was performed in four episodes, with one case (25.0%) of documented resistance to MBV and ganciclovir. Clinical response was achieved in 72.2% of episodes, and treatment failure occurred in 26.3%. Treatment-emergent adverse events were rare (10.5%). All-cause mortality was 21.1%, with no CMV-attributable deaths.

CONCLUSIONS

In the present real-life experience, MBV appears to be a viable and safe alternative as salvage therapy for CMV infection in SOT recipients, although cases of clinical failure and treatment-emergent resistance were observed.