Population Pharmacokinetics and Exposure-Response Relationships of Maribavir in Transplant Recipients With First Episode or Refractory Cytomegalovirus.

ABSTRACT: Maribavir's anti-cytomegalovirus (CMV) activity and favorable safety/tolerability profile is a welcomed addition to the CMV treatment armamentarium. To further characterize pharmacokinetic (PK) and exposure-response relationships of maribavir in transplant recipients with CMV, a population PK model was updated with data from the AURORA study, using non-linear mixed-effect modeling. Covariates were tested using a stepwise procedure. In exposure-response 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-compartment disposition model with first-order elimination, first-order absorption and an absorption lag-time. Exposure levels were similar irrespective of t

SUBMITTER: Sun K 

PROVIDER: S-EPMC12358310 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature