Scholarlink

Background <p>Congenital cytomegalovirus (CMV) infection is a major cause of neonatal morbidity. However, optimizing ganciclovir (GCV) dosing in preterm infants is complicated by immature renal function and developmental pharmacokinetics. Population pharmacokinetic (PPK) parameters for GCV and valganciclovir (VGCV) have been reported, but data remain limited for extremely low birth weight infants. We aimed to characterize longitudinal changes in GCV clearance in a preterm infant with congenital CMV infection using Bayesian modeling.</p> Methods <p>GCV/VGCV were administered over a 15-week period, with concurrent therapeutic drug monitoring. Individual parameters were estimated using a previously published PPK model and a postnatal age-based maturation function in NONMEM. Scr clearance was measured at two time points using the 24-h urine collection method.</p> Results <p>GCV clearance increased from 0.048 to 0.273 L/hr/kg from postnatal day 30 to day 93, whereas VGCV bioavailability remained stable (~ 52–55%). Scr clearance values matched estimated GCV clearance, supporting the validity of the model. The maturation function indicated that tubular secretion likely contributes to accelerated drug elimination. Late-phase GCV clearance exceeded typical glomerular filtration rate, indicating possible catch-up in renal function.</p> Conclusion <p>Renal maturation should be considered in addition to body weight when adjusting GCV dosing in preterm infants. This case highlights the importance of aligning individualized dosing strategies with the developmental physiology of preterm neonates.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Renal maturation and catch-up clearance of ganciclovir in a preterm neonate: Bayesian pharmacokinetic analysis using a population model

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年10月21日

查看全文
  • Katsuya Kata,
  • Satomi Inomata,
  • Mitsuru Nishikawa,
  • Haruka Ide,
  • Kentaro Nakamura,
  • Taketoshi Yoshida,
  • Masato Taguchi

摘要

Background

Congenital cytomegalovirus (CMV) infection is a major cause of neonatal morbidity. However, optimizing ganciclovir (GCV) dosing in preterm infants is complicated by immature renal function and developmental pharmacokinetics. Population pharmacokinetic (PPK) parameters for GCV and valganciclovir (VGCV) have been reported, but data remain limited for extremely low birth weight infants. We aimed to characterize longitudinal changes in GCV clearance in a preterm infant with congenital CMV infection using Bayesian modeling.

Methods

GCV/VGCV were administered over a 15-week period, with concurrent therapeutic drug monitoring. Individual parameters were estimated using a previously published PPK model and a postnatal age-based maturation function in NONMEM. Scr clearance was measured at two time points using the 24-h urine collection method.

Results

GCV clearance increased from 0.048 to 0.273 L/hr/kg from postnatal day 30 to day 93, whereas VGCV bioavailability remained stable (~ 52–55%). Scr clearance values matched estimated GCV clearance, supporting the validity of the model. The maturation function indicated that tubular secretion likely contributes to accelerated drug elimination. Late-phase GCV clearance exceeded typical glomerular filtration rate, indicating possible catch-up in renal function.

Conclusion

Renal maturation should be considered in addition to body weight when adjusting GCV dosing in preterm infants. This case highlights the importance of aligning individualized dosing strategies with the developmental physiology of preterm neonates.