Exposure-safety relationship for acyclovir in the treatment of neonatal herpes simplex virus disease.

dc.contributor.author

Ericson, Jessica E

dc.contributor.author

Benjamin, Daniel K

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Boakye-Agyeman, Felix

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Balevic, Stephen J

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Cotten, C Michael

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Adler-Shohet, Felice

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Laughon, Matthew

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Poindexter, Brenda

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Harper, Barrie

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Payne, Elizabeth H

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Kaneshige, Kim

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Smith, P Brian

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Best Pharmaceuticals for Children Act - Pediatric Trials Network

dc.date.accessioned

2022-10-04T14:23:22Z

dc.date.available

2022-10-04T14:23:22Z

dc.date.issued

2022-07

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2022-10-04T14:23:22Z

dc.description.abstract

Background

Neonatal herpes simplex virus (HSV) disease has been treated with high-dose (20 mg/kg/dose) acyclovir since 1991.

Aims

Determine the safety of acyclovir in infants with neonatal HSV treated with high-dose acyclovir; examine the association between acyclovir dose and exposure with adverse events (AEs).

Study design

We obtained demographic information and acyclovir dosing via medical records. Acyclovir exposure was calculated using an established pharmacokinetic model.

Subjects

Infants <120 days of age with neonatal HSV discharged from four academic children's hospitals.

Outcome measures

We identified clinical and laboratory adverse events (AEs).

Results and conclusions

We identified 49 infants with neonatal HSV treated with acyclovir; 42 infants had complete 21-day dosing information. Median mean daily dose was 59 mg/kg/day. Clinical AEs were common among all gestational and postnatal age groups. Rash was the most common clinical AE (37 %). Mild laboratory AEs occurred in 2-37 % of infants. The median maximum doses (mg/kg/day) were higher among infants with hypokalemia, elevated blood urea nitrogen, and thrombocytosis. For all other laboratory AEs, the median maximum doses for infants without events were higher or equal to the median maximum dose of infants with the AE. The odds of experiencing any clinical or laboratory AE did not differ by predicted acyclovir exposure for either area under the curve (AUC) or maximum concentration (Cmax) (odds ratio [OR] = 1.00 [0.98, 1.03] and OR = 1.01 [0.93, 1.12], respectively). Although AEs were common with high-dose acyclovir exposure, severe AEs were rare. Acyclovir exposure was not associated with AEs.
dc.identifier

S0378-3782(22)00079-2

dc.identifier.issn

0378-3782

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1872-6232

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https://hdl.handle.net/10161/26055

dc.language

eng

dc.publisher

Elsevier BV

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Early human development

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10.1016/j.earlhumdev.2022.105616

dc.subject

Best Pharmaceuticals for Children Act - Pediatric Trials Network

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Humans

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Simplexvirus

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Pregnancy Complications, Infectious

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Herpes Simplex

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Acyclovir

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Antiviral Agents

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Child

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Infant

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Infant, Newborn

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Female

dc.title

Exposure-safety relationship for acyclovir in the treatment of neonatal herpes simplex virus disease.

dc.type

Journal article

duke.contributor.orcid

Benjamin, Daniel K|0000-0002-0764-8585

duke.contributor.orcid

Balevic, Stephen J|0000-0002-4016-1680

pubs.begin-page

105616

pubs.organisational-group

Duke

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School of Medicine

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Clinical Science Departments

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Institutes and Centers

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Medicine

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Pediatrics

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Medicine, Rheumatology and Immunology

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Pediatrics, Infectious Diseases

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Pediatrics, Neonatology

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Pediatrics, Rheumatology

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Duke Clinical Research Institute

pubs.publication-status

Published

pubs.volume

170

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