{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,6]],"date-time":"2025-12-06T05:04:40Z","timestamp":1764997480594,"version":"3.40.5"},"reference-count":13,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2022,11,13]],"date-time":"2022-11-13T00:00:00Z","timestamp":1668297600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010877","name":"ViiV Healthcare","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100010877","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["HIV Medicine"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>Fostemsavir, a prodrug of temsavir, is indicated for heavily treatment\u2010experienced adults with multidrug\u2010resistant HIV\u20101 infection, antiretroviral (ARV) intolerance, or safety considerations. Understanding drug\u2013drug interactions (DDIs) is important in individuals taking fostemsavir with hormonal contraceptives or menopausal or gender\u2010affirming hormonal therapies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Effect of temsavir (active moiety) on the pharmacokinetics of ethinyl estradiol (EE) and norethindrone (NET) was evaluated in an open\u2010label, single\u2010sequence, four\u2010cycle, four\u2010treatment study in 26 healthy female participants (study 206279, NCT02480881). Relevant ARV\u2013contraceptive interaction studies and guideline recommendations were reviewed; that information was then applied to other contraceptive methods and hormone\u2010based therapies to predict the impact of fostemsavir co\u2010administration.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Temsavir increased EE concentrations by 40% and had no effect on NET concentrations. Fostemsavir co\u2010administration with hormone therapy is not expected to impact hormone treatment efficacy. Fostemsavir did not impact progestin; therefore, progestin\u2010only and non\u2010hormonal contraceptives will not be impacted by fostemsavir. Recommendations for co\u2010administration of fostemsavir and hormonal contraceptives or menopausal or gender\u2010affirming hormone therapies are based upon known and predicted DDIs, ensuring adequate hormonal concentrations to maintain the target effect.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Applying the results of Study 206279 and other relevant ARV\u2013contraceptive studies, we recommend that when co\u2010administering fostemsavir with combined oral contraceptives (COCs) and other oestrogen\u2010based therapies, EE dose should not exceed 30\u2009\u03bcg or equivalent, and caution is advised in the case of individuals with risk factors for thromboembolic events. Other oestrogen\u2010based therapies may be co\u2010administered with fostemsavir, with monitoring of oestrogen concentrations and appropriate dose adjustments. No impact of fostemsavir on COC efficacy is expected.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.13442","type":"journal-article","created":{"date-parts":[[2022,11,14]],"date-time":"2022-11-14T01:18:46Z","timestamp":1668388726000},"page":"580-587","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Fostemsavir and ethinyl estradiol drug interaction: Clinical recommendations for co\u2010administration"],"prefix":"10.1111","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2616-6394","authenticated-orcid":false,"given":"Nneka","family":"Nwokolo","sequence":"first","affiliation":[{"name":"Global Medical, ViiV Healthcare  Brentford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elana","family":"Post","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, ViiV Healthcare  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A. Savannah","family":"Mageau","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, ViiV Healthcare  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rimi","family":"Shah","sequence":"additional","affiliation":[{"name":"Global Medical, ViiV Healthcare  Brentford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mindy","family":"Magee","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Modeling and Simulation, GSK  Upper Providence Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank","family":"Mannino","sequence":"additional","affiliation":[{"name":"Clinical Statistics, GSK  Upper Providence Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Ackerman","sequence":"additional","affiliation":[{"name":"Clinical Development ViiV Healthcare  Branford Connecticut USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Clark","sequence":"additional","affiliation":[{"name":"Global Medical, ViiV Healthcare  Brentford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katy","family":"Moore","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, ViiV Healthcare  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,11,13]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/prot.24726"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/jps.23476"},{"key":"e_1_2_10_4_1","unstructured":"KozalM AbergJ PialouxG et al.Phase 3 study of fostemsavir in heavily treatment\u2010experienced HIV\u20101\u2010infected participants: day 8 and week 24 primary efficacy and safety results (BRIGHTE study formerly 205888\/AI438\u2010047). Slides presented at: 16th European AIDS Conference; October 25\u201327 2017; Milan Italy."},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1810"},{"key":"e_1_2_10_6_1","unstructured":"Rukobia [prescribing information].Research TrianglePark NC: ViiV Healthcare;2022."},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2012.05.017"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200746020-00003"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.104.000182"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsbmb.2007.09.025"},{"key":"e_1_2_10_11_1","unstructured":"Loestrin [prescribing information]. Rockaway NJ: Warner Chilcott;2013."},{"key":"e_1_2_10_12_1","unstructured":"Panel on Antiretroviral Guidelines for Adults and Adolescents.Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services. Available at:https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/adult-and-adolescent-arv. Accessed September 28 2022."},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.111.040162"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.346"}],"container-title":["HIV Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hiv.13442","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/hiv.13442","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hiv.13442","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,20]],"date-time":"2023-08-20T19:50:39Z","timestamp":1692561039000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hiv.13442"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,11,13]]},"references-count":13,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2023,5]]}},"alternative-id":["10.1111\/hiv.13442"],"URL":"https:\/\/doi.org\/10.1111\/hiv.13442","archive":["Portico"],"relation":{},"ISSN":["1464-2662","1468-1293"],"issn-type":[{"type":"print","value":"1464-2662"},{"type":"electronic","value":"1468-1293"}],"subject":[],"published":{"date-parts":[[2022,11,13]]},"assertion":[{"value":"2022-10-19","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-10-20","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-11-13","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}