In‐utero exposure to tenofovir‐containing pre‐exposure prophylaxis and bone mineral content in HIV‐unexposed infants in South Africa
ABSTRACT Introduction Tenofovir disoproxil fumarate (TDF) is a common drug of choice for pre‐exposure prophylaxis (PrEP) or as a combination HIV treatment for pregnant women. In‐utero exposure to TDF was found to be associated with lower bone mineral content (BMC) in HIV‐exposed uninfected neonates....
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Wiley
2024-11-01
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| Series: | Journal of the International AIDS Society |
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| Online Access: | https://doi.org/10.1002/jia2.26379 |
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| author | Kerusha Reddy Kimesh L. Naidoo Carl Lombard Zukiswa Godlwana Alicia C. Desmond Richard Clark James F. Rooney Glenda Gray Dhayendre Moodley |
| author_facet | Kerusha Reddy Kimesh L. Naidoo Carl Lombard Zukiswa Godlwana Alicia C. Desmond Richard Clark James F. Rooney Glenda Gray Dhayendre Moodley |
| author_sort | Kerusha Reddy |
| collection | DOAJ |
| description | ABSTRACT Introduction Tenofovir disoproxil fumarate (TDF) is a common drug of choice for pre‐exposure prophylaxis (PrEP) or as a combination HIV treatment for pregnant women. In‐utero exposure to TDF was found to be associated with lower bone mineral content (BMC) in HIV‐exposed uninfected neonates. Data for infants born to women taking TDF‐PrEP 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‐IP) or at cessation of breastfeeding (Deferred PrEP arm‐DP). In a secondary data analysis, we evaluated BMC in HIV‐unexposed infants in the CAP016 trial in the first 18 months of life in association with maternal TDF‐PrEP use during pregnancy. Methods 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‐ray absorptiometry (DXA) at 6, 26, 50 and 74 weeks. Results 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‐FTC 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‐breastfed, the mean difference (95% CI) for BMC of the WBH between IP and DP arms were −0.74 (−8.69 to 7.20), −1.26 (−10.75 to 8.23), −9.17 (−20.02 to 1.69) and 5.02 (−6.74 to 16.78) g at 6, 26, 50 and 74 weeks (p = 0.283). Mean differences in BMC of the LS were 0.07 (−0.10 to 0.23), 0.02 (−0.18 to 0.22), −0.14 (−0.36 to 0.09) and 0.14 (−0.11 to 0.38) g at 6, 26, 50 and 74 weeks, respectively (p = 0.329). Conclusions In a randomized controlled trial, there were no differences in BMC of the WBH and LS between infants exposed to in‐utero TDF‐FTC PrEP and unexposed infants in the first 18 months of life. |
| format | Article |
| id | doaj-art-b81ac07b94a54a948d2a5552e30e90fa |
| institution | OA Journals |
| issn | 1758-2652 |
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| publishDate | 2024-11-01 |
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| spelling | doaj-art-b81ac07b94a54a948d2a5552e30e90fa2025-08-20T01:53:25ZengWileyJournal of the International AIDS Society1758-26522024-11-012711n/an/a10.1002/jia2.26379In‐utero exposure to tenofovir‐containing pre‐exposure prophylaxis and bone mineral content in HIV‐unexposed infants in South AfricaKerusha Reddy0Kimesh L. Naidoo1Carl Lombard2Zukiswa Godlwana3Alicia C. Desmond4Richard Clark5James F. Rooney6Glenda Gray7Dhayendre Moodley8Department of Paediatrics and Child Health School of Clinical Medicine University of KwaZulu Natal Durban South AfricaDepartment of Paediatrics and Child Health School of Clinical Medicine University of KwaZulu Natal Durban South AfricaBiostatistics Unit South African Medical Research Council Tygerberg South AfricaCentre for the Program of AIDS Research in South Africa (CAPRISA) Durban South AfricaCentre for the Program of AIDS Research in South Africa (CAPRISA) Durban South AfricaGilead Sciences Inc Foster City California USAGilead Sciences Inc Foster City California USASouth African Medical Research Council Cape Town South AfricaCentre for the Program of AIDS Research in South Africa (CAPRISA) Durban South AfricaABSTRACT Introduction Tenofovir disoproxil fumarate (TDF) is a common drug of choice for pre‐exposure prophylaxis (PrEP) or as a combination HIV treatment for pregnant women. In‐utero exposure to TDF was found to be associated with lower bone mineral content (BMC) in HIV‐exposed uninfected neonates. Data for infants born to women taking TDF‐PrEP 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‐IP) or at cessation of breastfeeding (Deferred PrEP arm‐DP). In a secondary data analysis, we evaluated BMC in HIV‐unexposed infants in the CAP016 trial in the first 18 months of life in association with maternal TDF‐PrEP use during pregnancy. Methods 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‐ray absorptiometry (DXA) at 6, 26, 50 and 74 weeks. Results 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‐FTC 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‐breastfed, the mean difference (95% CI) for BMC of the WBH between IP and DP arms were −0.74 (−8.69 to 7.20), −1.26 (−10.75 to 8.23), −9.17 (−20.02 to 1.69) and 5.02 (−6.74 to 16.78) g at 6, 26, 50 and 74 weeks (p = 0.283). Mean differences in BMC of the LS were 0.07 (−0.10 to 0.23), 0.02 (−0.18 to 0.22), −0.14 (−0.36 to 0.09) and 0.14 (−0.11 to 0.38) g at 6, 26, 50 and 74 weeks, respectively (p = 0.329). Conclusions In a randomized controlled trial, there were no differences in BMC of the WBH and LS between infants exposed to in‐utero TDF‐FTC PrEP and unexposed infants in the first 18 months of life.https://doi.org/10.1002/jia2.26379tenofovir disoproxil fumaratepre‐exposure prophylaxisin‐utero exposurebone mineral contentbreastfeedinginfants |
| spellingShingle | Kerusha Reddy Kimesh L. Naidoo Carl Lombard Zukiswa Godlwana Alicia C. Desmond Richard Clark James F. Rooney Glenda Gray Dhayendre Moodley In‐utero exposure to tenofovir‐containing pre‐exposure prophylaxis and bone mineral content in HIV‐unexposed infants in South Africa Journal of the International AIDS Society tenofovir disoproxil fumarate pre‐exposure prophylaxis in‐utero exposure bone mineral content breastfeeding infants |
| title | In‐utero exposure to tenofovir‐containing pre‐exposure prophylaxis and bone mineral content in HIV‐unexposed infants in South Africa |
| title_full | In‐utero exposure to tenofovir‐containing pre‐exposure prophylaxis and bone mineral content in HIV‐unexposed infants in South Africa |
| title_fullStr | In‐utero exposure to tenofovir‐containing pre‐exposure prophylaxis and bone mineral content in HIV‐unexposed infants in South Africa |
| title_full_unstemmed | In‐utero exposure to tenofovir‐containing pre‐exposure prophylaxis and bone mineral content in HIV‐unexposed infants in South Africa |
| title_short | In‐utero exposure to tenofovir‐containing pre‐exposure prophylaxis and bone mineral content in HIV‐unexposed infants in South Africa |
| title_sort | in utero exposure to tenofovir containing pre exposure prophylaxis and bone mineral content in hiv unexposed infants in south africa |
| topic | tenofovir disoproxil fumarate pre‐exposure prophylaxis in‐utero exposure bone mineral content breastfeeding infants |
| url | https://doi.org/10.1002/jia2.26379 |
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