{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T18:05:19Z","timestamp":1778177119116,"version":"3.51.4"},"reference-count":32,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2026,1,27]],"date-time":"2026-01-27T00:00:00Z","timestamp":1769472000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,1,27]],"date-time":"2026-01-27T00:00:00Z","timestamp":1769472000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Broadly neutralizing antibodies (BNAb) are capable of neutralizing multiple HIV\u20101 strains through the targeting of conserved epitopes. This study's objective was to quantify the pharmacokinetic (PK) parameters describing the distribution and elimination of the BNAb VRC07\u2010523\u2010LS in people with HIV (PWH), and to identify the influence of viral load on VRC07\u2010523\u2010LS elimination. The PK of VRC07\u2010523\u2010LS was assessed in participants with and without HIV after intravenous or subcutaneous administration. A Bayesian strategy was utilized to estimate VRC07\u2010523\u2010LS PK parameters, leveraging a previously published study in adults without HIV. The effects of static viral loads on VRC07\u2010523\u2010LS exposure and time to a target trough serum concentration of 1\u2009mg\/L was then evaluated using clinical trial simulations. VRC07\u2010523\u2010LS serum concentrations were described by a two\u2010compartment model with first order absorption from the subcutaneous site. Typical clearance was estimated as 99.3\u2009mL\/day, which increased to a maximum of 6.46\u2010fold higher with viremia. Clinical trial simulations without viremia showed that a 700\u20132100\u2009mg dose of VRC07\u2010523\u2010LS is expected to remain above the IC\n                    <jats:sub>50<\/jats:sub>\n                    of 0.055\u2009mg\/L beyond 52\u2009weeks. With a viral load of 30,000 copies\/mL, a\u00a02100\u2009mg dose of VRC07\u2010523\u2010LS is expected to result in 90% of participants having a concentration below 1\u2009mg\/L by 18.6\u2009weeks, a decrease of 42\u2009weeks compared to aviremic patients. Mechanistic modeling offers the ability to identify HIV viral load effects on BNAb PK and can improve BNAb dosing, especially with consideration of acute versus maintenance treatment.\n                  <\/jats:p>","DOI":"10.1111\/cts.70488","type":"journal-article","created":{"date-parts":[[2026,1,27]],"date-time":"2026-01-27T15:47:08Z","timestamp":1769528828000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Enhanced Clearance of\n                    <scp>HIV<\/scp>\n                    \u20101 Broadly Neutralizing Antibody\n                    <scp>VRC07<\/scp>\n                    \u2010523\u2010\n                    <scp>LS<\/scp>\n                    During Viremia: Influences on Trial Design and Analysis"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0212-2787","authenticated-orcid":false,"given":"Nicholas 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