{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T09:01:43Z","timestamp":1777453303103,"version":"3.51.4"},"reference-count":25,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2025,6,1]],"date-time":"2025-06-01T00:00:00Z","timestamp":1748736000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,6,1]],"date-time":"2025-06-01T00:00:00Z","timestamp":1748736000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100004331","name":"Johnson & Johnson","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004331","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Antiviral Therapy"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The bioequivalence of the simplified protease-inhibitor-based HIV-1 antiretroviral regimen darunavir\/cobicistat (DRV\/COBI) 600\/90-mg fixed-dose combination (FDC) tablet dispersed in water was evaluated in healthy adults and swallowability in children living with HIV aged &gt;3\u00a0years and weighing \u226515 to &lt;25\u00a0kg, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In the bioequivalence study 32 healthy adult participants received either a single oral dose of the DRV\/COBI-600\/90-mg FDC tablet dispersed in water (test) or the separate formulations (DRV 100-mg\/mL at a dose of 600-mg and COBI 90-mg tablet: reference) separated by \u2265 7\u00a0days of washout. In a separate acceptability study children living with HIV-1, aged \u22653\u00a0years and weighing \u226515 to &lt;25\u00a0kg, received a single oral dose of the dispersed DRV\/COBI-600\/90-mg FDC tablet. Acceptability questionnaires were completed by observers, participants and caregivers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The bioequivalence study indicated that the geometric mean ratios for DRV maximum plasma concentration and area under the concentration\u2013time curve of the dispersed DRV\/COBI-600\/90-mg FDC tablet versus the separate formulations fell within the 80\u2013125% bioequivalence limits. In the acceptability study in children, per independent observers 83% (10\/12) of the children were able to swallow the dispersion completely and rated the dispersed FDC tablet as \u201cok\u201d to \u201cvery easy\u201d to swallow.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The DRV\/COBI 600\/90-mg FDC tablet dispersed in water was bioequivalent to coadministration of the separate formulations and was acceptable for long-term daily use in the intended pediatric population.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13596535251349336","type":"journal-article","created":{"date-parts":[[2025,6,25]],"date-time":"2025-06-25T03:09:22Z","timestamp":1750820962000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Pediatric darunavir\/cobicistat fixed-dose combination tablet for dispersion: Bioequivalence versus separate agents in healthy participants and acceptability in children living with human immunodeficiency virus-1"],"prefix":"10.1177","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0103-8225","authenticated-orcid":false,"given":"Sandy","family":"Van Hemelryck","sequence":"first","affiliation":[{"name":"Janssen Pharmaceutica NV"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erika","family":"Van Landuyt","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutica NV"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sofie","family":"Deleu","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutica NV"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lorant","family":"Leopold","sequence":"additional","affiliation":[{"name":"Johnson & Johnson"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jay","family":"Ariyawansa","sequence":"additional","affiliation":[{"name":"Johnson & Johnson"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martyn","family":"Palmer","sequence":"additional","affiliation":[{"name":"Johnson & Johnson"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Labourdette","sequence":"additional","affiliation":[{"name":"Janssen Cilag"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,6,16]]},"reference":[{"key":"e_1_3_5_2_2","volume-title":"HIV \u2013 number of people dying from HIV-related causes (who.int)","author":"Organization WH","year":"2022","unstructured":"Organization WH. 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