{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T02:37:28Z","timestamp":1779244648105,"version":"3.51.4"},"reference-count":17,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2022,8,9]],"date-time":"2022-08-09T00:00:00Z","timestamp":1660003200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/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":[[2023,2]]},"abstract":"Abstract<\/jats:title>Objectives<\/jats:title>Physicians could request compassionate use of oral and long\u2010acting (LA) cabotegravir + rilpivirine for people living with HIV\u20101 under a single\u2010patient request programme supported by ViiV Healthcare and Janssen. Outcomes are reported.<\/jats:p><\/jats:sec>Methods<\/jats:title>Eligibility criteria included need for parenteral therapy, no primary resistance mutations to cabotegravir or rilpivirine, and established retention in care. Demographic, efficacy, and safety data were obtained from standardized programme applications and quarterly clinical updates. Individuals received a loading dose of LA cabotegravir 600 mg + rilpivirine 900 mg, followed by LA maintenance doses of 400 mg\/600 mg every 4\u2009weeks; some received lead\u2010in oral cabotegravir and rilpivirine.<\/jats:p><\/jats:sec>Results<\/jats:title>Through July 2020, 35 people living with HIV\u20101 had data available. The most frequent reason for compassionate use request was chronic non\u2010adherence due to psychological conditions (n\u00a0=\u00a015). Of 35 people living with HIV\u20101, 28 had detectable viremia (median viral load 60\u2009300 copies\/mL) and seven were virologically suppressed at programme entry; 16\/28 and 6\/7 achieved or maintained virological suppression at data cutoff, respectively. Seven people living with HIV\u20101 discontinued for incomplete virological response, six with detectable viremia at initiation; six and four had new reverse transcriptase and integrase mutations at discontinuation, respectively. Six non\u2010fatal serious adverse events were reported, two considered possibly treatment related. Four deaths were reported; none were treatment related. One individual reported two pregnancies and continued LA dosing.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>Most people living with HIV\u20101 had advanced disease and achieved (16\/28) or maintained (6\/7) virological suppression with LA therapy. Cabotegravir LA\u2009+\u2009rilpivirine LA as compassionate use provided a valuable treatment option for individuals with adherence issues with oral therapy and advanced disease.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.13370","type":"journal-article","created":{"date-parts":[[2022,8,10]],"date-time":"2022-08-10T02:24:26Z","timestamp":1660098266000},"page":"202-211","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":44,"title":["Compassionate use of long\u2010acting<\/scp> cabotegravir plus rilpivirine for people living with HIV<\/scp>\u20101 in need of parenteral antiretroviral therapy"],"prefix":"10.1111","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0828-0222","authenticated-orcid":false,"given":"Ronald","family":"D'Amico","sequence":"first","affiliation":[{"name":"ViiV Healthcare Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Santiago","family":"Cenoz Gomis","sequence":"additional","affiliation":[{"name":"ViiV Healthcare Madrid Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Riya","family":"Moodley","sequence":"additional","affiliation":[{"name":"ViiV Healthcare Brentford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rodica","family":"Van Solingen\u2010Ristea","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutica Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bryan","family":"Baugh","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutica Raritan New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erika","family":"Van Landuyt","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutica Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veerle","family":"Van Eygen","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutica Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sherene","family":"Min","sequence":"additional","affiliation":[{"name":"ViiV Healthcare Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy","family":"Cutrell","sequence":"additional","affiliation":[{"name":"ViiV Healthcare Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8278-8564","authenticated-orcid":false,"given":"Caroline","family":"Foster","sequence":"additional","affiliation":[{"name":"Imperial College NHS Healthcare Trust London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1254-9853","authenticated-orcid":false,"given":"Daniella","family":"Chilton","sequence":"additional","affiliation":[{"name":"Guys and St Thomas NHS Healthcare Trust London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sabine D.","family":"Allard","sequence":"additional","affiliation":[{"name":"HIV Reference Center Universitair Ziekenhuis Brussel Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annemiek","family":"Ruiter","sequence":"additional","affiliation":[{"name":"ViiV Healthcare Brentford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,8,9]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1909512"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1904398"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32666-0"},{"key":"e_1_2_8_5_1","unstructured":"Cabenuva [prescribing information]. Research Triangle Park NC: ViiV Healthcare; 2022."},{"key":"e_1_2_8_6_1","article-title":"ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long\u2010acting regimen for HIV treatment","volume":"21","author":"ViiV Healthcare","year":"2021","journal-title":"ViiV Healthcare, January"},{"key":"e_1_2_8_7_1","volume-title":"Vocabria [Summary of Product Characteristics]","year":"2022"},{"key":"e_1_2_8_8_1","unstructured":"Rekambys [summary of product characteristics]. Beerse Belgium: Janssen Pharmaceutica NV;2022."},{"key":"e_1_2_8_9_1","article-title":"ViiV Healthcare announces the marketing authorisation of the first complete long\u2010acting injectable HIV treatment in Europe","volume":"21","author":"ViiV Healthcare","year":"2020","journal-title":"ViiV Healthcare, December"},{"key":"e_1_2_8_10_1","volume-title":"Cabenuva [product monograph]","year":"2021"},{"key":"e_1_2_8_11_1","article-title":"ViiV Healthcare announces first global regulatory approval of Cabenuva; the first complete, long\u2010acting, regimen for the treatment of HIV","volume":"20","author":"ViiV Healthcare","year":"2020","journal-title":"ViiV Healthcare, March"},{"key":"e_1_2_8_12_1","volume-title":"Cabenuva [Product Information]","year":"2021"},{"key":"e_1_2_8_13_1","unstructured":"US Food and Drug Administration.Expanded access to investigational drugs for treatment use\u2014questions and answers: guidance for industry. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evalution and Research (CBER) October 2017. Available at:https:\/\/www.fda.gov\/media\/85675\/download. Accessed August 14 2020."},{"key":"e_1_2_8_14_1","unstructured":"European Medicines Agency. Guideline on compassionate use of medicinal products pursuant to Article 83 of Regulation (EC) no. 726\/2004. European Medicines Agency July 19 2007. Available at:ema.europa.eu\/docs\/en_GB\/document_library\/Regulatory_and_procedural_guideline\/2009\/10\/WC500004075.pdf. Accessed August 14 2020."},{"key":"e_1_2_8_15_1","first-page":"111","article-title":"2019 update of the drug resistance mutations in HIV\u20101","volume":"27","author":"Wensing AM","year":"2019","journal-title":"Top Antivir Med"},{"key":"e_1_2_8_16_1","first-page":"1","article-title":"Revised surveillance case definition for HIV infection\u2014United States","volume":"63","author":"Centers for Disease Control and Prevention (CDC)","year":"2014","journal-title":"MMWR Recomm Rep"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)31917-7"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.4103\/2229-3485.173779"}],"container-title":["HIV Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hiv.13370","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/hiv.13370","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hiv.13370","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,18]],"date-time":"2023-08-18T21:15:56Z","timestamp":1692393356000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hiv.13370"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8,9]]},"references-count":17,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2023,2]]}},"alternative-id":["10.1111\/hiv.13370"],"URL":"https:\/\/doi.org\/10.1111\/hiv.13370","archive":["Portico"],"relation":{},"ISSN":["1464-2662","1468-1293"],"issn-type":[{"value":"1464-2662","type":"print"},{"value":"1468-1293","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,8,9]]},"assertion":[{"value":"2022-03-18","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-07-12","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-08-09","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}