{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:42:46Z","timestamp":1777380166868,"version":"3.51.4"},"reference-count":29,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2023,1,1]],"date-time":"2023-01-01T00:00:00Z","timestamp":1672531200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["AIDS Research and Human Retroviruses"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:p>\n                    Medication adherence can be challenging for persons with difficulty swallowing tablets. We investigated the bioequivalence of a dissolved tablet when compared with that of a whole tablet of the fixed-dose combination elvitegravir (EVG)\/cobicistat (COBI)\/emtricitabine (FTC)\/tenofovir (TFV) alafenamide fumarate (TAF). A within-subject fixed-order two-period open-label study was conducted in 12 HIV-negative research participants after obtaining informed consent. Participants took a single dose each of the whole tablet and dissolved tablet under direct observation, separated by a 14-day washout period. The dissolved tablet was prepared by adding one whole EVG\/COBI\/FTC\/TAF tablet to 120\u2009mL tap water and stirring. Both dosage types were taken with a standardized meal. Plasma samples were obtained for 72\u2009h postdose. Plasma EVG, FTC, TAF, and TFV were analyzed with liquid chromatographic-tandem mass spectrometric methods. Peak plasma concentration (C\n                    <jats:sub>max<\/jats:sub>\n                    ) and the area under the concentration-time curve extrapolated to infinity (AUC\n                    <jats:sub>0\u2212\u221e<\/jats:sub>\n                    ) were estimated using WinNonlin software (v.8.3). The primary outcome was bioequivalence consistent with FDA guidance using the 90% confidence interval or the geometric mean ratio. Of 12 participants, 7 were black (58%) and 5 were white (42%), 4 were women (33%), 8 were men (67%), and the mean age was 43.6 years (23\u201354). There were no complaints about taste with the dissolved tablet. Bioequivalence was established only for FTC. EVG C\n                    <jats:sub>max<\/jats:sub>\n                    and AUC\n                    <jats:sub>0\u2013\u221e<\/jats:sub>\n                    were higher by 18% and 12%, respectively, when taking the dissolved compared with the whole tablet. TAF AUC\n                    <jats:sub>0\u2013\u221e<\/jats:sub>\n                    and C\n                    <jats:sub>max<\/jats:sub>\n                    were both 8% lower, whereas TFV C\n                    <jats:sub>max<\/jats:sub>\n                    and AUC\n                    <jats:sub>0\u2013\u221e<\/jats:sub>\n                    were 8% and 5% lower, respectively, when taken after dissolution. EVG\/COBI\/FTC\/TAF dissolved rapidly in water and had no unpleasant taste. Increases in EVG and decreases in TAF and TFV concentrations were observed when taking dissolved EVG\/COBI\/FTC\/TAF. These changes were judged to be clinically insignificant. Dissolving EVG\/COBI\/FTC\/TAF in water may be suitable for those with pill swallowing challenges. The trial was registered on (\n                    <jats:uri xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/\/\/clinicaltrials.gov\">\/\/clinicaltrials.gov<\/jats:uri>\n                    NCT03717129).\n                  <\/jats:p>","DOI":"10.1089\/aid.2022.0085","type":"journal-article","created":{"date-parts":[[2022,10,27]],"date-time":"2022-10-27T13:43:26Z","timestamp":1666878206000},"page":"38-43","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["EVG\/COBI\/FTC\/TAF Bioequivalence Comparing Whole Tablets with Tablets Dissolved in Tap Water"],"prefix":"10.1177","volume":"39","author":[{"given":"Adriana","family":"Andrade","sequence":"first","affiliation":[{"name":"DAIDS, NIAID, NIH, Bethesda, Maryland, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edward J.","family":"Fuchs","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark A.","family":"Marzinke","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3544-1319","authenticated-orcid":false,"given":"Sandra","family":"Abdul Massih","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer","family":"Breakey","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sasha","family":"Beselman","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ian","family":"McNicholl","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc., Foster City, California, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Craig W.","family":"Hendrix","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2023,1,11]]},"reference":[{"key":"e_1_3_6_2_2","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2019.1643160"},{"key":"e_1_3_6_3_2","doi-asserted-by":"publisher","DOI":"10.1177\/1715163513500208"},{"key":"e_1_3_6_4_2","doi-asserted-by":"publisher","DOI":"10.2147\/PPA.S141762"},{"key":"e_1_3_6_5_2","doi-asserted-by":"publisher","DOI":"10.1258\/0956462021925117"},{"key":"e_1_3_6_6_2","doi-asserted-by":"publisher","DOI":"10.1089\/aid.2004.20.1053"},{"key":"e_1_3_6_7_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002183"},{"key":"e_1_3_6_8_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra050100"},{"key":"e_1_3_6_9_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0031591"},{"key":"e_1_3_6_10_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0250993"},{"key":"e_1_3_6_11_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciu046"},{"key":"e_1_3_6_12_2","doi-asserted-by":"publisher","DOI":"10.1086\/596482"},{"key":"e_1_3_6_13_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.g3318"},{"key":"e_1_3_6_14_2","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000002923"},{"issue":"4","key":"e_1_3_6_15_2","first-page":"242","article-title":"Single- versus multiple-tablet HIV regimens: Adherence and hospitalization risks","volume":"22","author":"Sutton SS","year":"2016","unstructured":"Sutton SS, , Hardin JW, , Bramley TJ, et al. Single- versus multiple-tablet HIV regimens: Adherence and hospitalization risks. Am J Manag Care, 2016; 22(4):242\u2013248.","journal-title":"Am J Manag Care"},{"key":"e_1_3_6_16_2","doi-asserted-by":"publisher","DOI":"10.1080\/08964289.2018.1534076"},{"key":"e_1_3_6_17_2","doi-asserted-by":"publisher","DOI":"10.1023\/A:1023063916026"},{"key":"e_1_3_6_18_2","doi-asserted-by":"publisher","DOI":"10.5588\/ijtld.18.0775"},{"key":"e_1_3_6_19_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dky191"},{"key":"e_1_3_6_20_2","doi-asserted-by":"publisher","DOI":"10.1093\/jpids\/pit077"},{"key":"e_1_3_6_21_2","unstructured":"Genvoya [Package Insert]. 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Guidance for Industry Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs-General Considerations Draft Guidance. https:\/\/www.fda.gov\/files\/drugs\/published\/Bioavailability-and-Bioequivalence-Studies-Submitted-in-NDAs-or-INDs-%E2%80%94-General-Considerations.pdf"},{"key":"e_1_3_6_26_2","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0b013e318157131c"},{"key":"e_1_3_6_27_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-016-0424-1"},{"key":"e_1_3_6_28_2","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000001744"},{"key":"e_1_3_6_29_2","unstructured":"National Center for Biotechnology Information. PubChem Compound Summary for CID 5277135 Elvitegravir; 2022. 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