{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,6]],"date-time":"2025-12-06T04:58:35Z","timestamp":1764997115957},"reference-count":15,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2017,2,14]],"date-time":"2017-02-14T00:00:00Z","timestamp":1487030400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2017,7]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>This study aimed to investigate whether cabotegravir (CAB), an integrase inhibitor in development for treatment and prevention of human immunodeficiency virus\u20101, influences the pharmacokinetics (PK) of a levonorgestrel (LNG) and ethinyl oestradiol (EO)\u2013containing oral contraceptive (OC) in healthy women.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this open\u2010label, fixed\u2010sequence crossover study, healthy female subjects received LNG 0.15\u00a0mg\/EO 0.03\u00a0mg tablet once daily Days 1\u201310 alone and with oral CAB 30\u00a0mg once daily Days 11\u201321. At the end of each treatment period, subjects underwent predose sampling for concentrations of follicle\u2010stimulating hormone, luteinizing hormone, and progesterone and serial PK sampling for plasma LNG, EO, and CAB concentrations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Twenty women were enrolled, and 19 completed the study. One subject was withdrawn due to an adverse event unrelated to study medications. Geometric least squares mean ratios (90% confidence interval) of LNG\u00a0+\u00a0CAB <jats:italic>vs<\/jats:italic>. LNG alone for LNG area under the plasma concentration\u2013time curve over the dosing interval of duration \u03c4 and maximum observed plasma concentration were 1.12 (1.07\u20131.18) and 1.05 (0.96\u20131.15), respectively. Geometric least squares mean ratio (90% confidence interval) of EO\u00a0+\u00a0CAB <jats:italic>vs<\/jats:italic>. EO alone for EO area under the plasma concentration\u2013time curve over the dosing interval of duration \u03c4 and maximum observed plasma concentration were 1.02 (0.97\u20131.08) and 0.92 (0.83\u20131.03), respectively. Steady\u2010state CAB PK parameters were comparable to historical values. There was no apparent difference in mean luteinizing hormone, follicle\u2010stimulating hormone, and progesterone concentrations between periods. No clinically significant trends in laboratory values, vital signs, or electrocardiography values were observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Repeat doses of oral CAB had no significant effect on LNG\/EO PK or pharmacodynamics, which supports CAB coadministration with LNG\/EO OCs in clinical practice.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.13236","type":"journal-article","created":{"date-parts":[[2017,1,14]],"date-time":"2017-01-14T12:53:27Z","timestamp":1484398407000},"page":"1499-1505","source":"Crossref","is-referenced-by-count":20,"title":["Lack of effect of oral cabotegravir on the pharmacokinetics of a levonorgestrel\/ethinyl oestradiol\u2010containing oral contraceptive in healthy adult women"],"prefix":"10.1111","volume":"83","author":[{"given":"Christine","family":"Trezza","sequence":"first","affiliation":[{"name":"ViiV Healthcare  Research Triangle Park North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan L.","family":"Ford","sequence":"additional","affiliation":[{"name":"PAREXEL International  Research Triangle Park North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth","family":"Gould","sequence":"additional","affiliation":[{"name":"PAREXEL International  Research Triangle Park North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yu","family":"Lou","sequence":"additional","affiliation":[{"name":"PAREXEL International  Research Triangle Park North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chuyun","family":"Huang","sequence":"additional","affiliation":[{"name":"PAREXEL International  Research Triangle Park North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James M.","family":"Ritter","sequence":"additional","affiliation":[{"name":"Quintiles Drug Research Unit  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ann M.","family":"Buchanan","sequence":"additional","affiliation":[{"name":"ViiV Healthcare  Research Triangle Park North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William","family":"Spreen","sequence":"additional","affiliation":[{"name":"ViiV Healthcare  Research Triangle Park North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Parul","family":"Patel","sequence":"additional","affiliation":[{"name":"ViiV Healthcare  Research Triangle Park North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,2,14]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/nar\/gkv1037"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/bph.13354"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000000301"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000000365"},{"key":"e_1_2_10_6_1","unstructured":"Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV\u20101\u2010infected adults and adolescents. Department of Health and Human Services. Available athttp:\/\/www.aidsinfo.nih.gov\/ContentFiles\/AdultandAdolescentGL.pdf. (last accessed 28 March 2016 [HIV\u2010Infected Women; pg I20\u201326])."},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.3109\/00498254.2015.1060372"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.3109\/00498254.2015.1081993"},{"key":"e_1_2_10_9_1","unstructured":"Microgynon Summary of Product Characteristics. Available athttp:\/\/www.medicines.org.uk\/EMC\/medicine\/1827\/SPC\/Microgynon+30. 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