Population pharmacokinetics and dose rationale for aciclovir in term and pre‐term neonates with herpes

Aciclovir is considered the first‐line treatment against Herpes simplex virus (HSV) infections in new‐borns and infants. As renal excretion is the major route of elimination, in renally‐impaired patients, aciclovir doses are adjusted according to the degree of impairment. However, limited attention...

Full description

Saved in:
Bibliographic Details
Published in:Pharmacology research & perspectives 2024-06, Vol.12 (3), p.e1193-n/a
Main Authors: D'Agate, S, Ruiz Gabarre, D, Della Pasqua, O
Format: Article
Language:English
Subjects:
aciclovir
Acyclovir - administration & dosage
Acyclovir - pharmacokinetics
Age groups
Antiviral Agents - administration & dosage
Antiviral Agents - pharmacokinetics
Antiviral drugs
Chicken pox
Computer Simulation
Creatinine
Creatinine - blood
Cytomegalovirus
dose rationale
Dose-Response Relationship, Drug
Drug dosages
Epstein-Barr virus
Female
Gestational age
Herpes simplex
Herpes Simplex - drug therapy
Herpes viruses
Humans
Infant, Newborn
Infections
Male
Menstruation
Metabolic Clearance Rate
Models, Biological
neonates
Original
pediatric extrapolation
Pediatrics
pharmacokinetic modeling
Pharmacokinetics
Physiology
Citations: Items that this one cites
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Aciclovir is considered the first‐line treatment against Herpes simplex virus (HSV) infections in new‐borns and infants. As renal excretion is the major route of elimination, in renally‐impaired patients, aciclovir doses are adjusted according to the degree of impairment. However, limited attention has been given to the implications of immature renal function or dysfunction due to the viral disease itself. The aim of this investigation was to characterize the pharmacokinetics of aciclovir taking into account maturation and disease processes in the neonatal population. Pharmacokinetic data obtained from 2 previously published clinical trials (n = 28) were analyzed using a nonlinear mixed effects modeling approach. Post‐menstrual age (PMA) and creatinine clearance (CLCR) were assessed as descriptors of maturation and renal function. Simulation scenarios were also implemented to illustrate the use of pharmacokinetic data to extrapolate efficacy from adults. Aciclovir pharmacokinetics was described by a one‐compartment model with first‐order elimination. Body weight and diagnosis (systemic infection) were statistically significant covariates on the volume of distribution, whereas body weight, CLCR and PMA had a significant effect on clearance. Median clearance varied from 0.2 to 1.0 L/h in subjects with PMA
ISSN:2052-1707
2052-1707
DOI:10.1002/prp2.1193