ArticleBritish journal of clinical pharmacology2022
Bedaquiline exposure in pregnancy and breastfeeding in women with rifampicin-resistant tuberculosis.
Article in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.
- A systematic review on maternal-to-infant transfer of drugs through breast milk during the treatment of malaria, tuberculosis, and neglected tropical diseases.PLoS neglected tropical diseases · 2023Pooled it
- Assessing the Safety of Medications During Lactation: Lactation safety.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Successful treatment of pre-extensively drug-resistant tuberculous meningoencephalomyelitis in pregnancy with a bedaquiline and delamanid-based regimen: a case report.BMC infectious diseases · 2026Article
- Clinical study design and modeling approaches to study secretion of drugs in human milk.Frontiers in pediatrics · 2026Review
- Tuberculosis in Pregnant Women After COVID-19: Features of Prevention, Diagnosis, and Treatment (Narrative Review).Journal of clinical medicine · 2025Review
- An Update on the Clinical Management of HIV and Tuberculosis Co-Infection in Pregnancy: TB Preventative Therapy, Long-Acting ARVs, and Bedaquiline-Based Regimens.Current HIV/AIDS reports · 2025Review
- Tuberculosis disease among people with HIV: therapeutic advances.The lancet. HIV · 2025Review
- Clinical lactation studies. Acting on key recommendations over the last decade.npj women's health · 2025Review
- Population pharmacokinetic modeling of paired plasma-breast milk lamivudine data for estimation of infant exposure in breastfeeding mother-infant pairs.CPT: pharmacometrics & systems pharmacology · 2024Observational
- Development and validation of a liquid chromatography tandem mass spectrometry assay for the analysis of bedaquiline and M2 in breast milk.Journal of mass spectrometry and advances in the clinical lab · 2024Article
- Pharmacokinetics and Safety of Group A and B Anti-Tuberculosis Drugs Used in Treatment of Rifampicin-Resistant Tuberculosis during Pregnancy and Post-Partum: A Narrative Review.Pathogens (Basel, Switzerland) · 2023Review
- Updated considerations in the diagnosis and management of tuberculosis infection and disease: integrating the latest evidence-based strategies.Expert review of anti-infective therapy · 2023Review
- Best practices for the care of pregnant people living with TB.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023Review
- Infant Exposure to Antituberculosis Drugs via Breast Milk and Assessment of Potential Adverse Effects in Breastfed Infants: Critical Review of Data.Pharmaceutics · 2023Review
- Perinatal tuberculosis-An approach to an under-recognized diagnosis.Frontiers in public health · 2023Review
- Validation and application of a quantitative LC-MS/MS assay for the analysis of first-line anti-tuberculosis drugs, rifabutin and their metabolites in human breast milk.Journal of chromatography. B, Analytical technologies in the biomedical and life sciences · 2022Article
- Bedaquiline exposure in pregnancy and breastfeeding in women with rifampicin-resistant tuberculosis.British journal of clinical pharmacology · 2022Article
- Pulmonary nontuberculous mycobacterial infections among women with cystic fibrosis and non-cystic fibrosis bronchiectasis.Therapeutic advances in respiratory diseaseReview
Corrections and comments
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Authors and funding
9 authors at 3 institutions in 2 countries.
Funding
Abstract
aimsWe 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.
methodsWe 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 6 weeks postpartum. We obtained serial breast milk samples from breastfeeding mothers, and a single plasma sample taken from breastfed and nonbreastfed infants to assess bedaquiline exposure. We used liquid chromatography-tandem mass spectrometry to perform the breast milk and plasma bedaquiline assays, and population PK modelling to interpret the bedaquiline concentrations.
resultsWe recruited 13 women, 6 of whom completed the ante- and postpartum PK sampling. All participants were HIV-positive on antiretroviral therapy. We observed lower ante- and postpartum bedaquiline exposures than reported in nonpregnant controls. Bedaquiline concentrations in breast milk were higher than maternal plasma (milk to maternal plasma ratio: 14:1). A single random plasma bedaquiline and M2 concentration was available in 4 infants (median age: 6.5 wk): concentrations in the 1 breastfed infant were similar to maternal plasma concentrations; concentrations in the 3 nonbreastfed infants were detectable but lower than maternal plasma concentrations.
conclusionWe report low exposure of bedaquiline in pregnant women treated for rifampicin-resistant TB. Bedaquiline significantly accumulates in breast milk; breastfed infants receive mg/kg doses of bedaquiline equivalent to maternal doses.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.