Nakijoba, Ritah, Nakayiwa Kawuma, Aida, Ojara, Francis Williams, Tabwenda, Jovia, Kyeyune, Jacqueline, Turyamureba, Christine, Peter Asiimwe, Simon, Magoola, Johnson, Castelnuovo, Barbara, Buzibye, Allan et al (show 1 more authors)
(2023)
Pharmacokinetics of drugs used to treat drug sensitive-tuberculosis in breastfeeding mother-infant pairs: An observational pharmacokinetic study.
Wellcome Open Research, 8.
p. 216.
Abstract
<h4>Background: </h4> Globally, more than half of women take medicines whilst breastfeeding. Data concerning the exposure of the breastfed infant to drugs and any related risks are sparce. Lactation studies are only rarely performed close to licensing for medicines anticipated to be widely used in women of childbearing age. Medicines taken by breastfeeding mothers on tuberculosis (TB) treatment can be transferred to the breastfed infant. Potential effects of anti-tuberculosis medicines on nursing infants are not well understood. Potential risks are the development of adverse drug effects in the breastfed infant and selection for resistance, whereas potential benefits might include exposure to potentially prophylactic concentrations of the drug. Pharmacokinetic studies are therefore necessary to understand this situation fully. <h4>Methods: </h4> This study will enroll 20 mothers receiving first-line anti-tuberculosis medicines, together with their breastfed infants, with the aim of characterizing the breastmilk transfer of the medicines from the mother to the infants. Samples of maternal blood, breastmilk and breastfeeding infant’s blood will be obtained at specific time points for bioanalysis of drug concentrations. Pharmacokinetic data will be analyzed using a population pharmacokinetic approach. Additionally, the study will assess the psychological status of breastfeeding women and the well-being of their infants. Maternal depression is linked to long-term negative consequences for the infant’s physiological regulation, poor growth-promoting setting for the infants, and inappropriate interactive conduct, characterized by low compassion, constrained range of emotional expression, and varying provision of the infant’s budding engagement. <h4>Conclusions: </h4> This study will provide the first systematic characterization of mother-to-infant transfer of first-line anti-tuberculosis medicines through breast milk. A mathematical pharmacokinetics model characterizing plasma-to-breastmilk transfer of rifampicin, isoniazid, ethambutol, and pyrazinamide will be developed and used to characterize infant exposure through breast milk. Our findings will contribute towards treatment optimization in breastfeeding and provide a framework to foster other lactation pharmacokinetic studies.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Vaccine Related, Prevention, Infant Mortality, Rare Diseases, Clinical Research, Infectious Diseases, Pediatric, Nutrition, Tuberculosis, Reproductive health and childbirth, 3 Good Health and Well Being |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 02 Oct 2023 09:06 |
| Last Modified: | 25 Apr 2024 19:48 |
| DOI: | 10.12688/wellcomeopenres.19113.1 |
| Open Access URL: | https://doi.org/10.12688/wellcomeopenres.19113.1 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3173263 |
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