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Pharmacokinetic sampling was performed at 4 time\u2010points over 6 hours in the third trimester, and again at approximately 6\u2009weeks 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\u2013tandem mass spectrometry to perform the breast milk and plasma bedaquiline assays, and population PK modelling to interpret the bedaquiline concentrations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We recruited 13 women, 6 of whom completed the ante\u2010 and postpartum PK sampling. All participants were HIV\u2010positive on antiretroviral therapy. We observed lower ante\u2010 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\u00a0wk): 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>We report low exposure of bedaquiline in pregnant women treated for rifampicin\u2010resistant TB. Bedaquiline significantly accumulates in breast milk; breastfed infants receive mg\/kg doses of bedaquiline equivalent to maternal doses.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.15380","type":"journal-article","created":{"date-parts":[[2022,5,8]],"date-time":"2022-05-08T23:28:45Z","timestamp":1652052525000},"page":"3548-3558","source":"Crossref","is-referenced-by-count":21,"title":["Bedaquiline exposure in pregnancy and breastfeeding in women with rifampicin\u2010resistant tuberculosis"],"prefix":"10.1111","volume":"88","author":[{"given":"Richard","family":"Court","sequence":"first","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine University of Cape Town"},{"name":"Wellcome Centre for Infectious Diseases Research in Africa (CIDRI\u2010Africa), Institute of Infectious Disease and Molecular Medicine University of Cape Town  Cape Town"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kamunkhwala","family":"Gausi","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine University of Cape Town"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Buyisile","family":"Mkhize","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine University of Cape Town"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lubbe","family":"Wiesner","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine University of Cape Town"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catriona","family":"Waitt","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Therapeutics University of Liverpool  UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0982-6226","authenticated-orcid":false,"given":"Helen","family":"McIlleron","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine University of Cape Town"},{"name":"Wellcome Centre for Infectious Diseases Research in Africa (CIDRI\u2010Africa), Institute of Infectious Disease and Molecular Medicine University of Cape Town  Cape Town"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3080-6606","authenticated-orcid":false,"given":"Gary","family":"Maartens","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine University of Cape Town"},{"name":"Wellcome Centre for Infectious Diseases Research in Africa (CIDRI\u2010Africa), Institute of Infectious Disease and Molecular Medicine University of Cape Town  Cape Town"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7494-079X","authenticated-orcid":false,"given":"Paolo","family":"Denti","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine University of Cape Town"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marian","family":"Loveday","sequence":"additional","affiliation":[{"name":"HIV Prevention Research Unit, South African Medical Research Council KwaZulu\u2010Natal  South Africa"},{"name":"CAPRISA\u2010MRC HIV\u2010TB Pathogenesis and Treatment Research Unit University of KwaZulu\u2010Natal  South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,5,26]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002882"},{"key":"e_1_2_10_3_1","unstructured":"WHO.WHO Consolidated Guidelines on Tuberculosis Module 4: Treatment \u2010 Drug\u2010Resistant Tuberculosis Treatment [Internet].2021[cited 2021 Oct 12]. 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