2022
DOI: 10.1111/bcp.15380
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Bedaquiline exposure in pregnancy and breastfeeding in women with rifampicin‐resistant tuberculosis

Abstract: We aimed to explore the effect of pregnancy on bedaquiline pharmacokinetics (PK) and describe bedaquiline exposure in the breast milk of mothers treated for rifampicin-resistant tuberculosis (TB), where there are no human data available. Methods:We performed a longitudinal PK study in pregnant women treated for rifampicin-resistant TB to explore the effect of pregnancy on bedaquiline exposure.Pharmacokinetic sampling was performed at 4 time-points over 6 hours in the third trimester, and again at approximately… Show more

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Cited by 10 publications
(12 citation statements)
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“…In the 4 studies that enrolled infants, evaluation of infant blood drug concentrations was performed in 2 studies. In the study by Court and colleagues [ 30 ], limited infant plasma sampling was performed, based on 4 infants from the 13 mother–infant pairs. In the study by Gilder and colleagues [ 29 ], infant capillary blood concentrations were collected only for evaluation of the hematocrit.…”
Section: Methodsmentioning
confidence: 99%
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“…In the 4 studies that enrolled infants, evaluation of infant blood drug concentrations was performed in 2 studies. In the study by Court and colleagues [ 30 ], limited infant plasma sampling was performed, based on 4 infants from the 13 mother–infant pairs. In the study by Gilder and colleagues [ 29 ], infant capillary blood concentrations were collected only for evaluation of the hematocrit.…”
Section: Methodsmentioning
confidence: 99%
“…M:P ratios calculated from specific time points do not account for differences between plasma and breast milk concentration-time profiles, unlike those generated from AUCs, and might yield misleading findings. For studies that employed model-based compartmental analysis, the M:P ratio was calculated from model-derived breast milk and plasma AUCs [ 42 , 43 ] or by directly modeling the plasma-to-milk drug transfer kinetics [ 30 , 44 ].…”
Section: Methodsmentioning
confidence: 99%
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“…We used drug-free human breast milk donated by Milk Matters human milk bank, South Africa (HREC number 639/2019) for the preparation of STDs and QCs for method development and validation. For our exploration of isoniazid, acetyl isoniazid, ethambutol, and pyrazinamide in breast milk, we used breast milk samples from women (≥18 years old) on treatment for rifampicin-resistant (RR-) TB at King Dinuzulu-Hospital (KDH) in Durban, South Africa [17] . KDH is a specialist provincial rifampicin-resistant TB hospital where, until recently, all pregnant women with RR-TB in KwaZulu-Natal province were referred for care.…”
Section: Methodsmentioning
confidence: 99%
“…Regimen construction in pregnant people follows a similar approach as in non-pregnant people: selecting 4–5 drugs that are active against the person’s particular TB strain is desirable. Clinicians should prioritize the use of the WHO Group A medications (bedaquiline [BDQ], linezolid [LZD], and the third-generation FQs) 45 , 46 and the WHO Group B medications (clofazimine [CFZ] and cycloserine [CS}). 47 , 48 The novel nitroimidazole agent, pretomanid, has been associated with testicular toxicity in animal studies and the US Food and Drug Agency has mandated semen studies in humans prior to recommending the drug for broader use.…”
Section: Best Clinical Practice For Pregnant People With Tbmentioning
confidence: 99%