{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T14:59:03Z","timestamp":1788274743632,"version":"build-2803163510"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2025,6,3]],"date-time":"2025-06-03T00:00:00Z","timestamp":1748908800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001713","name":"European and Developing Countries Clinical Trials Partnership","doi-asserted-by":"publisher","award":["RIA2017S"],"award-info":[{"award-number":["RIA2017S"]}],"id":[{"id":"10.13039\/501100001713","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001322","name":"South African Medical Research Council","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001322","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100016962","name":"South African Department of Science and Innovation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016962","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Department of National Health"},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100030692","name":"Intramural Research Program","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100030692","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100015199","name":"Halozyme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015199","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>In the development of broadly neutralizing monoclonal antibodies (bNAb) for HIV prevention, there is a need for simpler dosing strategies. This study assessed whether fixed dosing achieves comparable systemic bNAb concentrations to weight-based dosing across a range of weights.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The CAPRISA 012B trial was a first-in-human, Phase 1 dose-escalation study conducted in young, HIV-negative women (median age 25\u2005years; IQR: 22\u201329) in South Africa, evaluating the subcutaneous administration of CAP256V2LS alone and in combination with VRC07-523LS. Weight-based dosing between 5 and 20\u2005mg\/kg was assessed. A fixed 1200\u2005mg dose of CAP256V2LS and VRC07-523LS, administered alone or in combination, was evaluated in women weighing from 59.5\u2005kg to 93.2\u2005kg, with a median weight of 78.3\u2005kg (IQR: 67.2\u201381.5). A population pharmacokinetic model was developed to describe and predict the concentration\u2013time profiles of CAP256V2LS in participants. Model-based simulations then extended this analysis across a broader hypothetical weight range (34.2\u2013119\u2005kg).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Model-based simulations revealed comparable exposure between the 1200\u2005mg fixed-dose and the 20\u2005mg\/kg weight-based dosing regimens. Inter-individual variability in bioavailability and clearance was 0.212 and 0.019, respectively, and was consistent across both fixed-dose and weight-based dosing, regardless of the route of administration. Weight-based dosing of CAP256V2LS led to a mean wastage of 265.8\u2005mg for the 5\u2005mg\/kg dose, 433.4\u2005mg for the 10\u2005mg\/kg dose, and 324.2\u2005mg for the 20\u2005mg\/kg dose.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>For women weighing 60\u201393\u2005kg, a fixed-dose of 1200\u2005mg of CAP256V2LS produced similar adverse events and pharmacokinetic profiles as weight-based dosing. The fixed dose reduced variability in the plasma concentrations and product wastage compared with weight-based dosing.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jac\/dkaf181","type":"journal-article","created":{"date-parts":[[2025,5,23]],"date-time":"2025-05-23T09:41:38Z","timestamp":1747993298000},"page":"2135-2144","source":"Crossref","is-referenced-by-count":3,"title":["Population pharmacokinetics of weight-based compared with fixed dosing of CAP256V2LS, a broadly neutralizing antibody for HIV prevention in women"],"prefix":"10.1093","volume":"80","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-1449-160X","authenticated-orcid":false,"given":"Sharana","family":"Mahomed","sequence":"first","affiliation":[{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal , Durban ,","place":["South Africa"]},{"name":"Department of Medical Microbiology, University of Kwazulu-Natal , Durban ,","place":["South 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