{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T22:25:56Z","timestamp":1791930356494,"version":"4.3.4"},"reference-count":28,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,12,17]],"date-time":"2025-12-17T00:00:00Z","timestamp":1765929600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,12,17]],"date-time":"2025-12-17T00:00:00Z","timestamp":1765929600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Bictegravir is an integrase strand transfer inhibitor available in fixed\u2010dose combination with emtricitabine and tenofovir alafenamide for HIV treatment. The objectives of this study were to develop a population pharmacokinetic model for bictegravir during pregnancy and postpartum, identify main drivers of between\u2010subject variability, and evaluate the role of adherence patterns in maintaining therapeutic exposure. Intensive bictegravir concentration\u2013time data were used from IMPAACT 2026, a pharmacokinetic study of selected antiretroviral drugs during pregnancy and postpartum. Five hundred and eight bictegravir plasma concentrations from 27 participants during the second and third trimesters of pregnancy and postpartum were utilized for model development. A one\u2010compartment structural model best described bictegravir PK. Pregnancy increased bictegravir apparent clearance (CL\/F) by 61% compared to postpartum, while Black\/African American race was associated with a 32% increase in apparent volume of distribution (Vd\/F). Plasma albumin concentrations were associated with a 43% decrease in CL\/F and body weight was associated with a 120% increase in Vd\/F over the range of observed values. Monte Carlo simulations predicted median (90% prediction interval) pre\u2010dose bictegravir concentrations of 920 ng\/mL (265\u20132081) during the third trimester and 3399 ng\/mL (1423\u20136391) postpartum, exceeding the protein\u2010adjusted 95% effective concentration (162 ng\/mL). Adherence simulations predicted a single missed dose at steady\u2010state during the third trimester results in 43.7% of virtual subjects with concentrations below pharmacodynamic target, while two consecutive missed doses result in 90.4% with concentrations below target. These results show that while standard bictegravir dosing is effective during pregnancy, consistent adherence is critical to maintain effective therapeutic exposures.<\/jats:p>","DOI":"10.1002\/jcph.70134","type":"journal-article","created":{"date-parts":[[2025,12,17]],"date-time":"2025-12-17T13:14:05Z","timestamp":1765977245000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Population Pharmacokinetics of Bictegravir During Pregnancy and Postpartum: Role of Adherence in Maintaining Therapeutic Exposure"],"prefix":"10.1002","volume":"66","author":[{"given":"Steven","family":"Sun","sequence":"first","affiliation":[{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences University of California San Diego  La Jolla CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mina","family":"Nikanjam","sequence":"additional","affiliation":[{"name":"Division of Hematology\u2010Oncology University of California San Diego  La Jolla CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Mirochnick","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Boston University Chobanian &amp; Avedisian School of Medicine  Boston MA USA"},{"name":"Boston Medical Center  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen M.","family":"Powis","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital  Boston MA USA"},{"name":"Harvard T.H. Chan School of Public Health  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahizechukwu C.","family":"Eke","sequence":"additional","affiliation":[{"name":"Division of Maternal\u2010Fetal Medicine Department of Gynecology and Obstetrics Johns Hopkins University School of Medicine  Baltimore MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice","family":"Stek","sequence":"additional","affiliation":[{"name":"Division of Maternal\u2010Fetal Medicine Department of Obstetrics and Gynecology University of Southern California School of Medicine  Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Priyanka","family":"Arora","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tim R.","family":"Cressey","sequence":"additional","affiliation":[{"name":"AMS\u2010PHPT Research Collaboration Faculty of Associated Medical Sciences Chiang Mai University  Chiang Mai Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristina M.","family":"Brooks","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences Skaggs School of Pharmacy and Pharmaceutical Sciences University of Colorado Anschutz Medical Campus  Aurora CO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edmund V.","family":"Capparelli","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences University of California San Diego  La Jolla CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeremiah D.","family":"Momper","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences University of California San Diego  La Jolla CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,12,17]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.5076"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciw791"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/INF.0000000000002290"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2022\u2010059604"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265\u2010018\u20101010\u20107"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.2217\/fvl\u20102019\u20100077"},{"key":"e_1_2_10_8_1","unstructured":"Gilead Sciences Inc.BIKTARVY (bictegravir emtricitabine and tenofovir alafenamide) [package insert]. U.S. Food and Drug Administration website. Published online October 8 2024. Accessed February 9 2025.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2024\/210251Orig1s020lbl.pdf"},{"key":"e_1_2_10_9_1","unstructured":"Lack of experience with antiretroviral drugs during pregnancy and prior to pregnancy (antiretroviral\u2010naive) | NIH.2025. 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