{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T08:02:01Z","timestamp":1778659321391,"version":"3.51.4"},"reference-count":25,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2024,4,1]],"date-time":"2024-04-01T00:00:00Z","timestamp":1711929600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research and Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Antiviral Therapy"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Darunavir\/cobicistat\/emtricitabine\/tenofovir alafenamide (D\/C\/F\/TAF) fixed-dose combination (FDC) was developed as a once-daily, complete antiretroviral (ARV) regimen therapy to address the need for simplified protease inhibitor-based ARV regimens. This study assessed the swallowability and acceptability for long-term use of scored placebo tablets matching the D\/C\/F\/TAF FDC tablets in children living with HIV-1.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This study (NCT04006704) was a Phase 1, open-label, randomized, single-dose, 2-period, 2-sequence crossover study in children living with HIV-1, aged \u22656 to &lt;12\u00a0years and weighing \u226525 to &lt;40\u00a0kg, on a stable ARV regimen for \u22653\u00a0months. Participants were asked to swallow whole (size, 21 \u00d7 11 \u00d7 7\u00a0mm) and split matching placebo D\/C\/F\/TAF tablets. Swallowability of the matching placebo D\/C\/F\/TAF tablets (primary endpoint) was assessed by observers. Acceptability of taking matching placebo D\/C\/F\/TAF tablets and current ARVs was evaluated by participants using a 3-point questionnaire. Participants rated the acceptability for long-term daily use of the placebo D\/C\/F\/TAF tablets, and observers assessed how easily caregivers could split a scored tablet by hand, using 3-point questionnaires.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among the 24 participants who enrolled and completed the study, 95.8% (23\/24) were able to swallow the whole and split matching placebo D\/C\/F\/TAF tablets after 1 or 2 attempts. Most participants (&gt;70%) rated the acceptability of tablets for long-term daily use as acceptable or good to take. Breaking the tablets was considered easy or OK by 79.2% (19\/24) of caregivers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Scored D\/C\/F\/TAF FDC tablets are swallowable \u2013 with whole favoured over split \u2013 and considered at least acceptable for long-term daily intake in children living with HIV-1 aged \u22656 to &lt;12\u00a0years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov Identifier: NCT04006704.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13596535241248282","type":"journal-article","created":{"date-parts":[[2024,5,10]],"date-time":"2024-05-10T01:51:49Z","timestamp":1715305909000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["Assessment of swallowability and acceptability of scored darunavir\/cobicistat\/emtricitabine\/tenofovir alafenamide (D\/C\/F\/TAF) fixed-dose combination (FDC) tablets in HIV-1\u2013infected children aged \u22656 to &lt;12 years, using matching placebo tablets: A randomized study"],"prefix":"10.1177","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0103-8225","authenticated-orcid":false,"given":"Sandy","family":"Van Hemelryck","sequence":"first","affiliation":[{"name":"Janssen Pharmaceuticals NV, Beerse, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erika","family":"Van Landuyt","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceuticals NV, Beerse, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veerle","family":"Hufkens","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceuticals NV, Beerse, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simon","family":"Vanveggel","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceuticals NV, Beerse, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2024,5,9]]},"reference":[{"key":"bibr1-13596535241248282","first-page":"242","volume":"22","author":"Sutton SS","year":"2016","journal-title":"Am J Manag Care"},{"key":"bibr2-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1186\/s12981-018-0204-0"},{"key":"bibr3-13596535241248282","doi-asserted-by":"publisher","DOI":"10.18553\/jmcp.2019.25.1.088"},{"key":"bibr4-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1080\/13696998.2021.1995868"},{"key":"bibr5-13596535241248282","doi-asserted-by":"publisher","DOI":"10.5863\/1551-6776-26.8.783"},{"key":"bibr6-13596535241248282","unstructured":"Department of Health and Human Services (DHHS). Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/hiv-clinical-guidelines-adult-and-adolescent-arv\/ 2022, accessed 19 August 2022."},{"key":"bibr7-13596535241248282","volume-title":"EACS guidelines version 11.1","author":"European AIDS Clinical Society","year":"2022"},{"key":"bibr8-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000001817"},{"key":"bibr9-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000002463"},{"key":"bibr10-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(17)30031-0"},{"key":"bibr11-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1016\/j.antiviral.2019.104543"},{"key":"bibr12-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.628"},{"key":"bibr13-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1293"},{"key":"bibr14-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.632"},{"key":"bibr15-13596535241248282","volume-title":"SYMTUZA\u2122 (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide)","author":"European Medicines Agency (EMA)","year":"2022"},{"key":"bibr16-13596535241248282","volume-title":"SYMTUZA\u00ae (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide)","author":"SYMTUZA\u00ae","year":"2021"},{"key":"bibr17-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1111\/jphp.12610"},{"key":"bibr18-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2018.01.038"},{"key":"bibr19-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1177\/20499361231159993"},{"key":"bibr20-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1179\/1465328111Y.0000000025"},{"key":"bibr21-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0220408"},{"key":"bibr22-13596535241248282","doi-asserted-by":"publisher","DOI":"10.3851\/IMP3054"},{"key":"bibr23-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2011-1740"},{"key":"bibr24-13596535241248282","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2019-036508"},{"key":"bibr25-13596535241248282","unstructured":"CinicalInfo. Appendix A, Table 2. Antiretroviral fixed-dose combination tablets and Co-packaged formulations: minimum body weights and considerations for use in children and adolescents. (accessed August 4, 2023) https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/appendix-a-table-2-antiretroviral-fixed-dose-combination-tablets-and-copackaged-formulations."}],"container-title":["Antiviral Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13596535241248282","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/13596535241248282","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13596535241248282","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:53:14Z","timestamp":1777380794000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/13596535241248282"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4]]},"references-count":25,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,4]]}},"alternative-id":["10.1177\/13596535241248282"],"URL":"https:\/\/doi.org\/10.1177\/13596535241248282","relation":{},"ISSN":["1359-6535","2040-2058"],"issn-type":[{"value":"1359-6535","type":"print"},{"value":"2040-2058","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4]]},"article-number":"13596535241248282"}}