{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T21:37:56Z","timestamp":1792618676695,"version":"4.5.0"},"reference-count":33,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T00:00:00Z","timestamp":1778803200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T00:00:00Z","timestamp":1778803200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","award":["CO\u2010EU\u2010276\u20104399"],"award-info":[{"award-number":["CO\u2010EU\u2010276\u20104399"]}],"id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001322","name":"South African Medical Research Council","doi-asserted-by":"publisher","award":["96737"],"award-info":[{"award-number":["96737"]}],"id":[{"id":"10.13039\/501100001322","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["HIV Medicine"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The effect of tenofovir disoproxil fumarate (TDF) when used as pre\u2010exposure prophylaxis (PrEP) on renal function in pregnant and postpartum women is understudied. An open\u2010label clinical trial (CAP016 study) was designed to examine the safety of TDF\u2010PrEP use during pregnancy and breastfeeding.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Women were randomized (1:1) to either initiate PrEP at enrolment in pregnancy (Immediate PrEP\u2010IP) or initiate PrEP (Deferred PrEP\u2010DP) at the time of breastfeeding cessation. We compared changes in creatinine clearance and frequency of adverse renal events in women randomized to initiate TDF\u2010PrEP in pregnancy versus women randomized to defer initiation of TDF\u2010PrEP to the time of breastfeeding cessation. Participants were recruited between 28 September 2017 and 3 December 2019. Serum creatinine was measured at baseline during pregnancy and at 6, 26, 54 and 74\u2009weeks postpartum. Creatinine clearance (CrCl) (mL\/min) was calculated using the Cockroft\u2013Gault equation. CrCl \u226590\u2009mL\/min was considered normal, CrCl 60\u201390\u2009mL\/min (moderate) and CrCl &lt;60\u2009mL\/min (abnormal). We used mixed\u2010effects linear regression models to test for differences in the change in CrCl between the IP and DP arms. The frequency of adverse renal events between the randomization arms was examined using \u03c7\n                      <jats:sup>2<\/jats:sup>\n                      \/Fisher's exact tests. The CAP016 parent study was registered on\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      under NCT03227731.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Mean difference in CrCl change from 6 to 74\u2009weeks between IP and DP arms was \u22120.67% (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.809). There was no correlation between randomization arm and change in CrCl over time (\u03b2\u20102.08;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.094). There were 16 (4%) moderate\/Grade 2 CrCl abnormalities during the postpartum period, which were comparable between randomization arms. BMI of &lt;18.5\u2009kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      was significantly associated with a moderate renal adverse event (OR 71.8; 95% CI 17.0\u2013302.8) (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.0001).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Tenofovir disoproxil fumarate, when given in combination with emtricitabine as pre\u2010exposure prophylaxis during pregnancy and lactation, appears not to have an effect on creatinine clearance and the frequency of adverse renal events in African women without HIV during the 74\u2009week postpartum period. More research is needed to support our findings.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/hiv.70258","type":"journal-article","created":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T04:20:22Z","timestamp":1778905222000},"page":"1333-1343","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Renal function in African women receiving tenofovir disoproxil fumarate as pre\u2010exposure prophylaxis for\n                    <scp>HIV<\/scp>\n                    during pregnancy and postpartum: A postpartum safety analysis in the\n                    <scp>CAP016<\/scp>\n                    randomized control trial"],"prefix":"10.1111","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6833-1963","authenticated-orcid":false,"given":"Gaysheen","family":"Kistan","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynaecology, School of Clinical Medicine University of KwaZulu Natal  Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tonya","family":"Esterhuizen","sequence":"additional","affiliation":[{"name":"Division of Epidemiology and Biostatistics, Department of Global Health Stellenbosch University  Tygerberg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megeshinee","family":"Naidoo","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":"Motshedisi","family":"Sebitloane","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, School of Clinical Medicine University of KwaZulu Natal  Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dhayendre","family":"Moodley","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, School of Clinical Medicine University of KwaZulu Natal  Durban South Africa"},{"name":"Centre for the Program of AIDS Research in South Africa (CAPRISA)  Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,5,15]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"U.S. Food and Drug Administration.Truvada for PrEP fact sheet: ensuring safe and proper use. Accessed December 10 2024.https:\/\/www.fda.gov\/files\/drugs\/published\/Truvada-for-PrEP-Fact-Sheet--Ensuring-Safe-and-Proper-Use.pdf"},{"key":"e_1_2_10_3_1","unstructured":"World Health Organisation.Guideline on when to start antiretroviral therapy and on pre\u2010exposure prophylaxis for HIV.2015. Accessed April 20 2019.https:\/\/www.who.int\/hiv\/pub\/guidelines\/earlyrelease-arv\/en\/"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000001313"},{"key":"e_1_2_10_5_1","unstructured":"WHO.Technical brief: preventing HIV during pregnancy and breastfeeding in the context of PrEP.2017. Accessed February 16 2020.https:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/255866\/WHO-HIV-2017"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000001850"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/jia2.25378"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(22)00369-1"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000001654"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bbrc.2010.02.080"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000003478"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(22)00080-8"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000004029"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.3389\/frph.2023.1240990"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000001475"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2014.6786"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000001566"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000000868"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12879\u2010022\u201007608\u20108"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000003829"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000003563"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/jia2.26379"},{"key":"e_1_2_10_23_1","unstructured":"US Department of Health and Human Services National Institutes of Health National Institute of Allergy and Infectious Diseases Division of AIDS.Table for grading the severity of adult and pediatric adverse events corrected version 2.1.2017. 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