{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,16]],"date-time":"2025-10-16T01:15:57Z","timestamp":1760577357543},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2015,5,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To investigate the effect of food on the steady-state pharmacokinetics of rilpivirine when administered as a fixed-dose combination tablet containing tenofovir disoproxil fumarate, emtricitabine plus rilpivirine (TDF\/FTC\/RPV) in HIV-1-infected Ugandan patients.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This was an open-label, three-period, longitudinal pharmacokinetic study with patients serving as their own controls. Fifteen consenting and virologically suppressed HIV-1-infected adults were switched from an efavirenz-based regimen to TDF\/FTC\/RPV for 56 days. Enrolled patients underwent 24 h blood sampling with TDF\/FTC\/RPV dosing in the fasted state (day 42), with a low-fat meal (11 g of fat\/353 kcal, day 49) and with a moderate-fat meal (19 g of fat\/589 kcal, day 56; reference). A viral load assessment was performed on day 56.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Rilpivirine AUC0\u201324 was significantly decreased by 16% (geometric mean ratio, 90% CI: 0.84, 0.73\u20130.96) during administration in the fasted state when compared with AUC0\u201324 during administration with a moderate-fat meal. Similarly, rilpivirine C24 was significantly decreased by 21% (0.79, 0.65\u20130.97) in the fasted state compared with a moderate-fat meal. Pharmacokinetic parameters were unchanged during administration with a low-fat meal, except for C24, which was significantly increased by 15% (1.15, 1.01\u20131.31) when compared with the moderate-fat meal. Rilpivirine Cmax was similar under the three meal conditions. Virological suppression was unchanged at the end of the study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>A food effect was observed for steady-state pharmacokinetic parameters of rilpivirine (AUC0\u201324 and C24) when TDF\/FTC\/RPV was administered in the fasted state compared with the moderate-fat meal. The TDF\/FTC\/RPV formulation can be administered with either a low-fat or moderate-fat meal.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jac\/dku575","type":"journal-article","created":{"date-parts":[[2015,2,5]],"date-time":"2015-02-05T01:59:33Z","timestamp":1423101573000},"page":"1482-1486","source":"Crossref","is-referenced-by-count":10,"title":["Steady-state pharmacokinetics of rilpivirine under different meal conditions in HIV-1-infected Ugandan adults"],"prefix":"10.1093","volume":"70","author":[{"given":"Mohammed","family":"Lamorde","sequence":"first","affiliation":[{"name":"1 \u00a0Infectious Diseases Institute, Makerere University, Kampala, Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen","family":"Walimbwa","sequence":"additional","affiliation":[{"name":"1 \u00a0Infectious Diseases Institute, Makerere University, Kampala, Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pauline","family":"Byakika-Kibwika","sequence":"additional","affiliation":[{"name":"2 \u00a0Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Katwere","sequence":"additional","affiliation":[{"name":"1 \u00a0Infectious Diseases Institute, Makerere University, Kampala, Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lillian","family":"Mukisa","sequence":"additional","affiliation":[{"name":"1 \u00a0Infectious Diseases Institute, Makerere University, Kampala, Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph B.","family":"Sempa","sequence":"additional","affiliation":[{"name":"1 \u00a0Infectious Diseases Institute, Makerere University, Kampala, Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Else","sequence":"additional","affiliation":[{"name":"3 \u00a0Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David J.","family":"Back","sequence":"additional","affiliation":[{"name":"3 \u00a0Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Saye H.","family":"Khoo","sequence":"additional","affiliation":[{"name":"3 \u00a0Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Concepta","family":"Merry","sequence":"additional","affiliation":[{"name":"4 \u00a0Department of Global Health, Northwestern University, Chicago, IL, USA"},{"name":"5 \u00a0Department of Pharmacology and Therapeutics, Trinity College Dublin, Dublin, Ireland"},{"name":"6 \u00a0GUIDE Clinic, St James's Hospital, Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2015,2,3]]},"reference":[{"key":"2022020121021966700_DKU575C1","author":"UNAIDS","year":"2014"},{"key":"2022020121021966700_DKU575C2","author":"FAO","year":"2013"},{"key":"2022020121021966700_DKU575C3","author":"WHO","year":"2013"},{"key":"2022020121021966700_DKU575C4","doi-asserted-by":"crossref","first-page":"250","DOI":"10.1093\/jac\/dks404","article-title":"Rilpivirine: a new non-nucleoside reverse transcriptase inhibitor","volume":"68","author":"Sharma","year":"2013","journal-title":"J Antimicrob Chemother"},{"key":"2022020121021966700_DKU575C5","volume-title":"Edurant\u2122 (Rilpivirine) Tablets, Full Prescribing Information, Issued May 2011","author":"Tibotec"},{"key":"2022020121021966700_DKU575C6","article-title":"Effect of food and multiple dose pharmacokinetics of TMC278 as an oral tablet formulation","author":"Hoetelmans"},{"key":"2022020121021966700_DKU575C7","doi-asserted-by":"crossref","first-page":"834","DOI":"10.1002\/jcph.107","article-title":"Impact of food and different meal types on the pharmacokinetics of rilpivirine","volume":"53","author":"Crauwels","year":"2013","journal-title":"J Clin Pharmacol"},{"key":"2022020121021966700_DKU575C8","volume-title":"Complera\u00ae (Emtricitabine\/Rilpivirine\/Tenofovir Disoproxil Fumarate) Tablets, Full Prescribing Information, Revised December 2013","author":"Gilead Sciences"},{"key":"2022020121021966700_DKU575C9","doi-asserted-by":"crossref","first-page":"378","DOI":"10.1002\/jcph.210","article-title":"Effect of food on rilpivirine\/emtricitabine\/tenofovir disoproxil fumarate, an antiretroviral single tablet regimen for the treatment of HIV infection","volume":"54","author":"Custodio","year":"2014","journal-title":"J Clin 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pharmacokinetics of tenofovir and emtricitabine plus efavirenz in Ugandan adults","volume":"2012","author":"Lamorde","year":"2012","journal-title":"AIDS Res Treat"},{"key":"2022020121021966700_DKU575C17","doi-asserted-by":"crossref","first-page":"1483","DOI":"10.1007\/s10461-010-9789-6","article-title":"Food insufficiency is a risk factor for suboptimal antiretroviral therapy adherence among HIV-infected adults in urban Peru","volume":"15","author":"Franke","year":"2010","journal-title":"AIDS Behav"},{"key":"2022020121021966700_DKU575C18","doi-asserted-by":"crossref","first-page":"146","DOI":"10.1080\/09540121.2010.498874","article-title":"Structural barriers to adherence to antiretroviral therapy in a resource-constrained setting: the perspectives of health care providers","volume":"23","author":"Coetzee","year":"2011","journal-title":"AIDS 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