{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T09:51:53Z","timestamp":1791971513352,"version":"4.3.4"},"reference-count":34,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T00:00:00Z","timestamp":1788393600000},"content-version":"vor","delay-in-days":2,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100000071","name":"National Institute of Child Health and Human Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000071","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Cisgender women face an increased risk of HIV acquisition during pregnancy and postpartum. Oral pre\u2010exposure prophylaxis (PrEP) with emtricitabine and tenofovir disoproxil fumarate (F\/TDF) is recommended in pregnancy despite limited published pharmacokinetic (PK) and efficacy data during pregnancy. Altered PK during pregnancy may reduce prophylactic efficacy and necessitate higher adherence. Tenofovir alafenamide (TAF) is a newer tenofovir prodrug with higher tenofovir diphosphate (TFV\u2010DP) exposure in peripheral blood mononuclear cells (PBMCs), but the prophylactic efficacy of F\/TAF across different reproductive stages in women is understudied. We adapted a multiscale modeling framework to predict the prophylactic efficacy of F\/TDF and F\/TAF across varying adherence levels and during the second trimester, third trimester, and 6\u201312 weeks postpartum. Clinical trial simulations were conducted utilizing PBMC TFV\u2010DP and emtricitabine triphosphate concentrations as surrogate markers for F\/TAF and F\/TDF efficacy. For both F\/TDF and F\/TAF, prophylactic efficacy was lowest during the second trimester, increased in the third trimester (but remained below nonpregnant levels), and was highest postpartum. At high adherence levels of five or more pills per week, predicted effectiveness remained high across pregnancy and postpartum and effectiveness exceeded 97% for both regimens, with maximum decreases in the second trimester of only 0.9 percent point for F\/TDF and 0.3 percent point for F\/TAF. These findings suggest that adherence is the primary determinant of PrEP effectiveness during pregnancy and postpartum, while pregnancy\u2010related PK changes have a limited impact on efficacy.<\/jats:p>","DOI":"10.1002\/jcph.70278","type":"journal-article","created":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T07:09:10Z","timestamp":1788419350000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Predicting Oral HIV Pre\u2010Exposure Prophylaxis Efficacy in Cisgender Women Across Pregnancy and Postpartum"],"prefix":"10.1002","volume":"66","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-7897-9906","authenticated-orcid":false,"given":"Yifan","family":"Yu","sequence":"first","affiliation":[{"name":"School of Pharmacy and Pharmaceutical Sciences University at Buffalo  Buffalo NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3832-8699","authenticated-orcid":false,"given":"Kristina M.","family":"Brooks","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences University of Colorado\u2010Anschutz Medical Campus  Aurora CO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gustavo F.","family":"Doncel","sequence":"additional","affiliation":[{"name":"CONRAD Eastern Virginia Medical School Old Dominion University  Norfolk VA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8569-2293","authenticated-orcid":false,"given":"Brookie M.","family":"Best","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences University of California San Diego  La Jolla CA USA"},{"name":"Pediatrics Department University of California San Diego School of Medicine\u2010Rady Children's Hospital San Diego San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1670-8786","authenticated-orcid":false,"given":"Mark A.","family":"Marzinke","sequence":"additional","affiliation":[{"name":"School of Medicine Johns Hopkins University  Baltimore MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Mirochnick","sequence":"additional","affiliation":[{"name":"Chobanian &amp; Avedisian School of Medicine Boston University Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1200-8494","authenticated-orcid":false,"given":"Peter L.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences University of Colorado\u2010Anschutz Medical Campus  Aurora CO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8106-7658","authenticated-orcid":false,"given":"Landon","family":"Myer","sequence":"additional","affiliation":[{"name":"Division of Epidemiology and Biostatistics School of Public Health University of Cape Town  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8813-3419","authenticated-orcid":false,"given":"Connie","family":"Celum","sequence":"additional","affiliation":[{"name":"Departments of Global Health Medicine &amp; Epidemiology miology University of Washington Seattle WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6039-0352","authenticated-orcid":false,"given":"Renee","family":"Heffron","sequence":"additional","affiliation":[{"name":"Department of Medicine University of Alabama at Birmingham  Birmingham AL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jenell","family":"Coleman","sequence":"additional","affiliation":[{"name":"School of Medicine Johns Hopkins University  Baltimore MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6290-9293","authenticated-orcid":false,"given":"Dvora L. 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