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Use of In vivo Imaging to Monitor the Progression of Experimental Mouse Cytomegalovirus Infection in Neonates
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Renal maturation and catch-up clearance of ganciclovir in a preterm neonate: Bayesian pharmacokinetic analysis using

Katsuya Kata1, Satomi Inomata2, Mitsuru Nishikawa1

  • 1Department of Pharmacy Practice and Sciences, School of Pharmacy and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama, 930-0194, Japan.

Journal of Pharmaceutical Health Care and Sciences
|October 22, 2025
PubMed

Insights

Optimizing ganciclovir (GCV) dosing for congenital cytomegalovirus (CMV) in preterm infants requires considering renal maturation alongside weight. This case study shows GCV clearance significantly increases with infant development, informing individualized dosing strategies.

Area of Science:

  • Neonatal pharmacology
  • Pediatric infectious diseases
  • Clinical pharmacokinetics

Background:

  • Congenital cytomegalovirus (CMV) infection poses significant risks to neonates, particularly preterm infants.
  • Ganciclovir (GCV) dosing in preterm infants is challenging due to immature renal function and evolving pharmacokinetics.
  • Limited pharmacokinetic data exist for extremely low birth weight infants receiving GCV or valganciclovir (VGCV).

Purpose of the Study:

  • To characterize the longitudinal changes in ganciclovir (GCV) clearance in a preterm infant with congenital CMV infection.
  • To utilize Bayesian modeling to understand GCV pharmacokinetics in a developing neonate.

Main Methods:

  • Administered GCV/VGCV over 15 weeks with therapeutic drug monitoring.
  • Estimated individual pharmacokinetic parameters using a published population pharmacokinetic (PPK) model and a postnatal age-based maturation function in NONMEM.
  • Measured serum creatinine (Scr) clearance at two time points via 24-h urine collection.

Main Results:

  • GCV clearance increased substantially from 0.048 to 0.273 L/hr/kg between postnatal days 30 and 93.
  • Valganciclovir (VGCV) bioavailability remained stable at approximately 52-55%.
  • Estimated GCV clearance correlated with measured Scr clearance, validating the pharmacokinetic model; accelerated elimination suggested tubular secretion, and late-phase clearance indicated potential renal function catch-up.

Conclusions:

  • Renal maturation is a critical factor, in addition to body weight, for adjusting GCV dosage in preterm infants.
  • Individualized dosing must align with the developmental physiology of preterm neonates for optimal congenital CMV infection treatment.
  • This case underscores the need for dynamic dosing adjustments based on infant development and renal function.
Abstract

Keywords:
DevelopmentalGanciclovirInfantsLow birth weightMaturationPPKPretermValganciclovir

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