Neil Inhaber, MD, FRCPC, Therapeutic Area Head of Global Medical, Rare Disease at Takeda, discusses data on maribavir in post-transplant cytomegalovirus (CMV) presented at the American Transplant Congress 2026.
Post-transplant CMV is one of the most common infections following a solid organ transplant (SOT), which can lead to risk of graft loss and death. CMV is a ubiquitous herpes virus that infects up to 60−100% of people in adulthood, and it is one of the main agents involved in infectious complications after transplantation. Similarly to other herpes viruses, CMV establishes a latent infection after initial infection. In the immunocompetent host, the initial infection is generally asymptomatic but may present as an unspecified febrile, flu-like or mononucleosis-like syndrome. In rare cases, the infection presents as a systemic syndrome, affecting many organs. Additionally, immunocompetent adults may present a clinical syndrome later in life due to reactivation of latent virus or due to new infection by another viral strain. The disease caused by post-transplant CMV (PT-CMV) occurs due to transmission from the transplanted organ, due to reactivation of latent infection, or after a primary infection in seronegative transplant patients.
Efficacy of Maribavir in Solid Organ Transplant Recipients with and without Neutropenia: A Post Hoc Analysis of Phase 2 Data
The goal of this analysis was to assess the safety and efficacy of maribavir, an anti-CMV agent with lower incidence of myelosuppression, in SOT recipients with and without baseline neutropenia. A post hoc analysis was conducted from a phase 2, dose-ranging study in 120 SOT and hematopoietic cell transplant recipients with refractory/resistant (RR) CMV infection (NCT01611974).
In total, the analysis included 73 SOT recipients who received 1 or more doses of maribavir. At baseline, 14 patients had neutropenia and 59 did not. Baseline characteristics and safety data were similar between SOT recipients with and without neutropenia. There was no significant difference in time to CMV clearance in those with or without neutropenia at baseline.
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Real World Effectiveness and Safety of Maribavir in Solid Organ Transplant (SOT) Recipients with Refractory/Resistant Cytomegalovirus or Intolerance to Anti-Cytomegalovirus Drugs: Interim Results from ARISE
The goal of this analysis was to assess maribavir use, effectiveness, and safety for the treatment of post-transplant CMV infection in routine practice.
ARISE is a retrospective cohort study evaluating maribavir use in adult transplant recipients with RR CMV or intolerance to anti-CMV agents in 10 European countries. Interim results were recently presented.
The analysis included 124 SOT recipients. Overall, 47 patients experienced 1 or more CMV episodes before the index episode (first maribavir-treated episode). In patients with available viral load (n=79), CMV clearance at maribavir discontinuation was achieved by 62% RR and 88% intolerant patients. During the index episode maribavir monotherapy was the first treatment agent in 28% patients and second in 53%. Median duration of maribavir treatment course was 57 and 56 days in RR and intolerant patients, respectively, with 60% of treatment course discontinuations due to CMV episode resolution. Maribavir was initiated at home in 71% RR patients and 44% intolerant patients. In patients whose index episode ended, Kaplan-Meier estimates of recurrence 56 or less days from maribavir discontinuation were 39% and 27% in the RR and intolerant groups. Most common adverse events included myelosuppression, nephrotoxicity, and taste disturbance.
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