{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T18:46:07Z","timestamp":1781289967726,"version":"3.54.1"},"reference-count":28,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,7,4]],"date-time":"2025-07-04T00:00:00Z","timestamp":1751587200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["CPT Pharmacom &amp; Syst Pharma"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>Maribavir's anti\u2010cytomegalovirus (CMV) activity and favorable safety\/tolerability profile is a welcomed addition to the CMV treatment armamentarium. To further characterize pharmacokinetic (PK) and exposure\u2013response relationships of maribavir in transplant recipients with CMV, a population PK model was updated with data from the AURORA study, using non\u2010linear mixed\u2010effect modeling. Covariates were tested using a stepwise procedure. In exposure\u2013response analyses, relationships between maribavir exposure metrics and the primary and key secondary response endpoints and safety data from AURORA were characterized. The final model was a two\u2010compartment disposition model with first\u2010order elimination, first\u2010order absorption and an absorption lag\u2010time. Exposure levels were similar irrespective of transplant type and in patients with refractory CMV infection versus those receiving first\u2010line maribavir. Concomitant administration of proton\u2010pump inhibitors resulted in reduced maribavir exposure that was not clinically significant. There was no apparent relationship between maribavir exposure and the primary or key secondary endpoints of the AURORA study. Steady\u2010state maribavir exposures were not significantly associated with any adverse events other than nausea and vomiting. In conclusion, maribavir's efficacy, safety, and favorable tolerability profile in transplant recipients with first CMV infection after transplant or refractory CMV infection is supported by PK exposure metrics. Higher maribavir steady\u2010state concentrations were not associated with greater efficacy or a higher frequency of adverse events other than nausea and vomiting.<\/jats:p>","DOI":"10.1002\/psp4.70054","type":"journal-article","created":{"date-parts":[[2025,7,4]],"date-time":"2025-07-04T12:39:36Z","timestamp":1751632776000},"page":"1346-1358","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Population Pharmacokinetics and Exposure\u2013Response Relationships of Maribavir in Transplant Recipients With First Episode or Refractory Cytomegalovirus"],"prefix":"10.1002","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-3580-6365","authenticated-orcid":false,"given":"Kefeng","family":"Sun","sequence":"first","affiliation":[{"name":"Takeda Development Center Americas, Inc.  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Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-6392-8633","authenticated-orcid":false,"given":"Yaming","family":"Hang","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9268-6844","authenticated-orcid":false,"given":"Indranil","family":"Bhattacharya","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  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