# Use of Maribavir in Adult Patients With Post-Transplant Refractory Cytomegalovirus Infection in the Real-Life Setting

## TL;DR

This study examines the real-world effectiveness of maribavir in treating refractory CMV infections in transplant patients, finding a 53.2% clearance rate and lower resistance compared to clinical trials.

## Contribution

The study provides real-world evidence on maribavir's effectiveness and resistance patterns in a larger cohort of transplant patients.

## Key findings

- Maribavir achieved a 53.2% CMV viremia clearance rate in real-world transplant patients.
- Resistance to maribavir emerged in 13.9% of patients, lower than in clinical trials.
- Extending treatment beyond 8 weeks showed potential benefits for CMV clearance.

## Abstract

Maribavir is indicated for the treatment of refractory cytomegalovirus (CMV) infection/disease in patients who have undergone a solid organ transplant (SOT) or hematopoietic cell transplant (HCT). Only limited data on its use in real-world settings have been published from retrospective series. This retrospective study describes the real-world effectiveness of maribavir in 79 transplant patients with refractory CMV infection (67 SOT and 12 HCT) treated under a compassionate use program in France between October 2021 and April 2023. Maribavir was administered for <8 weeks, 8 weeks, and >8 weeks in 17, 32, and 30 patients, respectively. The response rate, defined as viremia clearance, was 53.2%, with a median time to first CMV clearance of 59 days. CMV clearance was observed in patients beyond 8 weeks of treatment. De novo maribavir resistance mutations were observed in 13.9% of patients, and CMV recurrence occurred in 45.2% of patients. Presence of CMV disease at baseline was associated with a lower likelihood of maribavir response. Compared to the pivotal SOLSTICE trial, real-world maribavir use demonstrated comparable effectiveness and a lower emergence of maribavir resistance. Moreover, outcomes of patients with a longer treatment duration suggested potential benefits of extending maribavir therapy beyond the recommended 8 weeks.

Infographic summarizes maribavir use in adult transplant patients with refractory cytomegalovirus infection, showing a median treatment duration of fifty-nine days. Pie chart details initiation groups: solid organ transplant eighty-four point eight percent, hematopoietic cell transplant fifteen point two percent. At treatment end, fifty-three point two percent clearance and thirteen point nine percent emergent maribavir resistance are noted. Key messages include real-world effectiveness, less frequent resistance, and clearance after eight weeks.