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The Journal of Clinical Pharma - 2024 - Young - Comparison of Anti‐Hepatitis A Antibody Pharmacokinetics in Healthy228.75 kB
Published VersionCC BY-NC-ND V4.0, Open Access
Journal article
Comparison of Anti-Hepatitis A Antibody Pharmacokinetics in Healthy Australian Subjects Receiving Standard or Weight-Based Dosing of Polyvalent Immunoglobulin
The Journal of Clinical Pharmacology, Vol.64(11), pp.1391-1396
2024
Abstract
This randomized controlled trial compared two dosing regimens of the polyvalent immunoglobulin available for hepatitis A post-exposure prophylaxis in Australia. Participants were randomized to receive either 270 IU (standard dose) or 3.375 IU/kg (dose by weight). Quantitative serial serum hepatitis A antibody concentrations were measured at baseline and then on days 1, 3, 7, 28, and 50. Fifteen participants completed the trial. Serum hepatitis A antibody concentrations were not different between the study groups at any time point. Pharmacokinetic parameters estimated from participant data were not different between the study groups. The hepatitis A antibody level of all participants exceeded 10 mIU/mL at day 50. While no difference between dosing regimens was found in this study, further research should examine dosing at the lower limit of current Australian recommendations before making policy decisions.This randomized controlled trial compared two dosing regimens of the polyvalent immunoglobulin available for hepatitis A post-exposure prophylaxis in Australia. Participants were randomized to receive either 270 IU (standard dose) or 3.375 IU/kg (dose by weight). Quantitative serial serum hepatitis A antibody concentrations were measured at baseline and then on days 1, 3, 7, 28, and 50. Fifteen participants completed the trial. Serum hepatitis A antibody concentrations were not different between the study groups at any time point. Pharmacokinetic parameters estimated from participant data were not different between the study groups. The hepatitis A antibody level of all participants exceeded 10 mIU/mL at day 50. While no difference between dosing regimens was found in this study, further research should examine dosing at the lower limit of current Australian recommendations before making policy decisions.
Details
- Title
- Comparison of Anti-Hepatitis A Antibody Pharmacokinetics in Healthy Australian Subjects Receiving Standard or Weight-Based Dosing of Polyvalent Immunoglobulin
- Authors
- Megan K Young (Corresponding Author) - Griffith UniversityShu-Kay Ng (Author) - Griffith UniversityHelen Faddy (Author) - University of the Sunshine Coast, Queensland, School of Health - BiomedicineGraeme R Nimmo (Author) - Griffith University
- Publication details
- The Journal of Clinical Pharmacology, Vol.64(11), pp.1391-1396
- Publisher
- Wiley-Blackwell Publishing, Inc.
- Date published
- 2024
- DOI
- 10.1002/jcph.2491
- ISSN
- 1552-4604
- Copyright note
- © 2024 The Author(s). The Journal of Clinical Pharmacology published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
- Data Availability
- The data are not publicly available due to their containing in-formation that could compromise the privacy of participantsgiven the small size of the study.
- Organisation Unit
- School of Health - Biomedicine
- Language
- English
- Record Identifier
- 991046698902621
- Output Type
- Journal article
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