{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T11:06:09Z","timestamp":1790766369665,"version":"4.1.0"},"reference-count":50,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2022,11,21]],"date-time":"2022-11-21T00:00:00Z","timestamp":1668988800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research and Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"publisher"}]},{"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>Background<\/jats:title><jats:p>Limited data exist on pregnant women living with HIV exposed to cabotegravir\u2009+\u2009rilpivirine (CAB\u2009+\u2009RPV). Outcomes in pregnant participants exposed to CAB\u2009+\u2009RPV, and pharmacokinetic washout data in those exposed to CAB\u2009+\u2009RPV long\u2010acting (LA) with live births, are presented.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Women exposed to one or more doses of CAB\u2009+\u2009RPV (oral\/LA) from ViiV Healthcare\u2010sponsored phase 2b\/3\/3b clinical trials and the compassionate use programme who became pregnant were included. Upon pregnancy in the trial programme, CAB\u2009+\u2009RPV was discontinued, an alternative antiretroviral regimen was initiated, and quarterly pharmacokinetic sampling for 52\u2009weeks post\u2010last injection was obtained. CAB\u2009+\u2009RPV continuation or alternative antiretroviral regimen initiation was decided by pregnant compassionate use programme participants and their treating physicians.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>As of 31 March 2021, 25 pregnancies following CAB\u2009+\u2009RPV exposure at conception were reported (five oral, 20 LA), including four who conceived during pharmacokinetic washout following treatment discontinuation. There were eight elective abortions, six miscarriages (five in first trimester), one ectopic pregnancy, and 10 live births (one oral, nine LA), including one infant born with congenital ptosis. Among participants exposed to CAB\u2009+\u2009RPV LA at conception with live births, plasma CAB and RPV washout concentrations during pregnancy were within the range of those observed in non\u2010pregnant women.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In this first analysis of pregnancy outcomes following CAB\u2009+\u2009RPV exposure at conception, 10 live births, including one with congenital anomaly, were reported. Plasma CAB and RPV washout concentrations during pregnancy were within the range of those in non\u2010pregnant women. Pregnancy surveillance within ViiV Healthcare\u2010sponsored clinical trials is ongoing, with dedicated pregnancy studies planned.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.13439","type":"journal-article","created":{"date-parts":[[2022,11,22]],"date-time":"2022-11-22T05:59:11Z","timestamp":1669096751000},"page":"568-579","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":46,"title":["Pregnancy outcomes and pharmacokinetics in pregnant women living with <scp>HIV<\/scp> exposed to long\u2010acting cabotegravir and rilpivirine in clinical trials"],"prefix":"10.1111","volume":"24","author":[{"given":"Parul","family":"Patel","sequence":"first","affiliation":[{"name":"ViiV Healthcare  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan L.","family":"Ford","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Baker","sequence":"additional","affiliation":[{"name":"ViiV Healthcare  Nyon Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Meyer","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  Brentford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louise","family":"Garside","sequence":"additional","affiliation":[{"name":"PHASTAR  Macclesfield UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald","family":"D'Amico","sequence":"additional","affiliation":[{"name":"ViiV Healthcare  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodica","family":"Van Solingen\u2010Ristea","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development  Beerse Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4516-8830","authenticated-orcid":false,"given":"Herta","family":"Crauwels","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development  Beerse Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph W.","family":"Polli","sequence":"additional","affiliation":[{"name":"ViiV Healthcare  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ciara","family":"Seal","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Itziar","family":"Yag\u00fce Mu\u00f1oz","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  Brentford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shanker","family":"Thiagarajah","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  Brentford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eileen","family":"Birmingham","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development  Titusville New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William R.","family":"Spreen","sequence":"additional","affiliation":[{"name":"ViiV Healthcare  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bryan","family":"Baugh","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development  Titusville New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean","family":"van Wyk","sequence":"additional","affiliation":[{"name":"ViiV Healthcare  Brentford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vani","family":"Vannappagari","sequence":"additional","affiliation":[{"name":"ViiV Healthcare  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,11,21]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"UNICEF.Reimagining a resilient HIV response for children adolescents and pregnant women living with HIV.http:\/\/www.childrenandaids.org\/sites\/default\/files\/2020-12\/2020%20World%20AIDS%20Day%20Report.pdf. 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