{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T15:02:15Z","timestamp":1788447735885,"version":"build-2803163510"},"reference-count":32,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2024,11,11]],"date-time":"2024-11-11T00:00:00Z","timestamp":1731283200000},"content-version":"vor","delay-in-days":10,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Int AIDS Soc."],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Tenofovir disoproxil fumarate (TDF) is a common drug of choice for pre\u2010exposure prophylaxis (PrEP) or as a combination HIV treatment for pregnant women. In\u2010utero exposure to TDF was found to be associated with lower bone mineral content (BMC) in HIV\u2010exposed uninfected neonates. Data for infants born to women taking TDF\u2010PrEP are lacking. The CAP016 randomized control trial was conducted in South Africa between September 2017 and August 2021 and pregnant women either initiated TDF\/FTC PrEP in pregnancy (Immediate PrEP arm\u2010IP) or at cessation of breastfeeding (Deferred PrEP arm\u2010DP). In a secondary data analysis, we evaluated BMC in HIV\u2010unexposed infants in the CAP016 trial in the first 18 months of life in association with maternal TDF\u2010PrEP use during pregnancy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Infants born to women randomized to the IP arm or DP arm in the CAP016 clinical trial had BMC measurements of the whole body with head (WBH) and lumbar spine (LS) by dual energy X\u2010ray absorptiometry (DXA) at 6, 26, 50 and 74 weeks.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 481 infants born to women enrolled in the CAP016 clinical trial, 335 (69.6%) infants had a minimum of one DXA scan of the WBH and LS between 6 and 74 weeks of age (168 IP and 167 DP). Women in the IP arm received TDF\u2010FTC PreP for a median of 19 weeks between initiation in pregnancy and delivery. Using a mixed linear regression model and adjusted for gestational age, sex and ever\u2010breastfed, the mean difference (95% CI) for BMC of the WBH between IP and DP arms were \u22120.74 (\u22128.69 to 7.20), \u22121.26 (\u221210.75 to 8.23), \u22129.17 (\u221220.02 to 1.69) and 5.02 (\u22126.74 to 16.78) g at 6, 26, 50 and 74 weeks (<jats:italic>p<\/jats:italic> = 0.283). Mean differences in BMC of the LS were 0.07 (\u22120.10 to 0.23), 0.02 (\u22120.18 to 0.22), \u22120.14 (\u22120.36 to 0.09) and 0.14 (\u22120.11 to 0.38) g at 6, 26, 50 and 74 weeks, respectively (<jats:italic>p<\/jats:italic> = 0.329).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In a randomized controlled trial, there were no differences in BMC of the WBH and LS between infants exposed to in\u2010utero TDF\u2010FTC PrEP and unexposed infants in the first 18 months of life.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jia2.26379","type":"journal-article","created":{"date-parts":[[2024,11,12]],"date-time":"2024-11-12T03:38:57Z","timestamp":1731382737000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["In\u2010utero exposure to tenofovir\u2010containing pre\u2010exposure prophylaxis and bone mineral content in HIV\u2010unexposed infants in South Africa"],"prefix":"10.1002","volume":"27","author":[{"given":"Kerusha","family":"Reddy","sequence":"first","affiliation":[{"name":"Department of Paediatrics and Child Health School of Clinical Medicine University of KwaZulu Natal  Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimesh L.","family":"Naidoo","sequence":"additional","affiliation":[{"name":"Department of Paediatrics and Child Health School of Clinical Medicine University of KwaZulu Natal  Durban South Africa"},{"name":"King Edward VIII Hospital Durban South Africa  Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carl","family":"Lombard","sequence":"additional","affiliation":[{"name":"Biostatistics Unit South African Medical Research Council  Tygerberg South Africa"},{"name":"Division of Epidemiology and Biostatistics Department of Global Health University of Stellenbosch  Tygerberg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zukiswa","family":"Godlwana","sequence":"additional","affiliation":[{"name":"Centre for the Program of AIDS Research in South Africa (CAPRISA)  Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alicia C.","family":"Desmond","sequence":"additional","affiliation":[{"name":"Centre for the Program of AIDS Research in South Africa (CAPRISA)  Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Clark","sequence":"additional","affiliation":[{"name":"Gilead Sciences Inc  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James F.","family":"Rooney","sequence":"additional","affiliation":[{"name":"Gilead Sciences Inc  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Glenda","family":"Gray","sequence":"additional","affiliation":[{"name":"South African Medical Research Council  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1849-9631","authenticated-orcid":false,"given":"Dhayendre","family":"Moodley","sequence":"additional","affiliation":[{"name":"Centre for the Program of AIDS Research in South Africa (CAPRISA)  Durban South Africa"},{"name":"Department of Obstetrics and Gynaecology School of Clinical Medicine University of KwaZulu Natal  Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,11,11]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"IN DANGER: UNAIDS Global AIDS Update 2022.Geneva:Joint United Nations Programme on HIV\/AIDS;2022."},{"key":"e_1_2_12_3_1","unstructured":"WHO.Technical brief: Preventing HIV during pregnancy and breastfeeding in the context of pre\u2010exposure prophylaxis (PrEP).Geneva:World Health 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