{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,12]],"date-time":"2025-08-12T21:36:56Z","timestamp":1755034616054},"reference-count":48,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2019,11,21]],"date-time":"2019-11-21T00:00:00Z","timestamp":1574294400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"European Union under the Sixth Framework Programme","award":["LSHP-CT-2006\u2013037570"],"award-info":[{"award-number":["LSHP-CT-2006\u2013037570"]}]},{"name":"Gilead Sciences, Janssen Pharmaceuticals, and Merck Laboratories and The French National Institute for Health and Medical Research"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,3,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>NEAT001\/ANRS143 demonstrated non-inferiority of once-daily darunavir\/ritonavir (800\/100\u2009mg)\u2009+\u2009twice-daily raltegravir (400\u2009mg) versus darunavir\/ritonavir\u2009+\u2009tenofovir disoproxil fumarate\/emtricitabine (245\/200\u2009mg once daily) in treatment-naive patients. We investigated the population pharmacokinetics of darunavir, ritonavir, tenofovir and emtricitabine and relationships with demographics, genetic polymorphisms and virological failure.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Non-linear mixed-effects models (NONMEM v. 7.3) were applied to determine pharmacokinetic parameters and assess demographic covariates and relationships with SNPs (SLCO3A1, SLCO1B1, NR1I2, NR1I3, CYP3A5*3, CYP3A4*22, ABCC2, ABCC10, ABCG2 and SCL47A1). The relationship between model-predicted darunavir AUC0\u201324 and C24 with time to virological failure was evaluated by Cox regression.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of 805 enrolled, 716, 720, 347 and 361 were included in the darunavir, ritonavir, tenofovir and emtricitabine models, respectively (11% female, 83% Caucasian). No significant effect of patient demographics or SNPs was observed for darunavir or tenofovir apparent oral clearance (CL\/F); coadministration of raltegravir did not influence darunavir or ritonavir CL\/F. Ritonavir CL\/F decreased by 23% in NR1I2 63396C&amp;gt;T carriers and emtricitabine CL\/F was linearly associated with creatinine clearance (P&amp;lt;0.001). No significant relationship was demonstrated between darunavir AUC0\u201324 or C24 and time to virological failure [HR (95% CI): 2.28 (0.53\u20139.80), P=0.269; and 1.82 (0.61\u20135.41), P=0.279, respectively].<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Darunavir concentrations were unaltered in the presence of raltegravir and not associated with virological failure. Polymorphisms investigated had little impact on study-drug pharmacokinetics. Darunavir\/ritonavir\u2009+\u2009raltegravir may be an appropriate option for patients experiencing NRTI-associated toxicity.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jac\/dkz479","type":"journal-article","created":{"date-parts":[[2019,11,4]],"date-time":"2019-11-04T20:14:09Z","timestamp":1572898449000},"page":"628-639","source":"Crossref","is-referenced-by-count":8,"title":["Population pharmacokinetics and pharmacogenetics of ritonavir-boosted darunavir in the presence of raltegravir or tenofovir disoproxil fumarate\/emtricitabine in HIV-infected adults and the relationship with virological response: a sub-study of the NEAT001\/ANRS143 randomized trial"],"prefix":"10.1093","volume":"75","author":[{"given":"Laura","family":"Dickinson","sequence":"first","affiliation":[{"name":"Department of Molecular & Clinical Pharmacology, University of Liverpool, Liverpool, 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