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FOUR-WEEK ORAL ADMINISTRATION OF BALOXAVIR MARBOXIL AS AN ANTI-INFLUENZA VIRUS DRUG SHOWS NO TOXICITY IN CHICKENS.
- Source :
-
Journal of zoo and wildlife medicine : official publication of the American Association of Zoo Veterinarians [J Zoo Wildl Med] 2024 Jun; Vol. 55 (2), pp. 313-321. - Publication Year :
- 2024
-
Abstract
- High pathogenicity avian influenza is an acute zoonotic disease with high mortality in birds caused by a high pathogenicity avian influenza virus (HPAIV). Recently, HPAIV has rapidly spread worldwide and has killed many wild birds, including endangered species. Baloxavir marboxil (BXM), an anti-influenza agent used for humans, was reported to reduce mortality and virus secretion from HPAIV-infected chickens ( Gallus domesticus , order Galliformes) at a dosage of ≥2.5 mg/kg when administered simultaneously with viral challenge. Application of this treatment to endangered birds requires further information on potential avian-specific toxicity caused by repeated exposure to BXM over the long term. To obtain information of potential avian-specific toxicity, a 4-wk oral repeated-dose study of BXM was conducted in chickens ( n = 6 or 7 per group), which are commonly used as laboratory avian species. The study was conducted in reference to the human pharmaceutical guidelines for nonclinical repeated-dose drug toxicity studies to evaluate systemic toxicity and exposure. No adverse changes were observed in any organs examined, and dose proportional increases in systemic exposure to active pharmaceutical ingredients were noted from 12.5 to 62.5 mg/kg per day. BXM showed no toxicity to chickens at doses of up to 62.5 mg/kg per day, at which systemic exposure was approximately 71 times higher than systemic exposure at 2.5 mg/kg, the reported efficacious dosage amount, in HPAIV-infected chickens. These results also suggest that BXM could be considered safe for treating HPAIV-infected endangered birds due to its high safety margin compared with the efficacy dose. The data in this study could contribute to the preservation of endangered birds by using BXM as a means of protecting biodiversity.
- Subjects :
- Animals
Administration, Oral
Pyridines administration & dosage
Thiepins administration & dosage
Thiepins pharmacology
Male
Influenza in Birds drug therapy
Female
Oxazines
Hydroxybutyrates administration & dosage
Triazines administration & dosage
Chickens
Dibenzothiepins administration & dosage
Antiviral Agents administration & dosage
Antiviral Agents pharmacology
Morpholines administration & dosage
Morpholines pharmacology
Pyridones administration & dosage
Pyridones pharmacology
Subjects
Details
- Language :
- English
- ISSN :
- 1042-7260
- Volume :
- 55
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Journal of zoo and wildlife medicine : official publication of the American Association of Zoo Veterinarians
- Publication Type :
- Academic Journal
- Accession number :
- 38875188
- Full Text :
- https://doi.org/10.1638/2023-0103