{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T03:59:53Z","timestamp":1791518393431,"version":"4.3.4"},"reference-count":23,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2024,9,5]],"date-time":"2024-09-05T00:00:00Z","timestamp":1725494400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["HIV Medicine"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>We examined adverse event (AE) reports relating to cabotegravir\/rilpivirine (CAB\/RPV) in the US FDA Adverse Event Reporting System (FAERS), focusing on therapeutic failure (TF) and non\u2010therapeutic failure (NTF) outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>FAERS is a database of AE and medication error reports from post\u2010marketing surveillance. The study was granted exempt approval by the Binghamton University Institutional Review Board. We queried reports for CAB\/RPV in the FAERS system from 1 January 2021 to 31 March 2024. TFs were defined as involving any of the following terms: viral load increased, virological failure, pathogen resistance, blood HIV RNA increased, treatment failure, drug ineffective, viral mutation identified, viraemia, and therapy non\u2010responder. The top 20 most common AEs were also identified. Means, standard deviations, and percentages were used to characterize the sample.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The study cohort consisted of 2605 reports. The reported sex of the study cohort was 50% male (<jats:italic>n<\/jats:italic>\u2009=\u20091295), 19% female (<jats:italic>n<\/jats:italic>\u2009=\u2009505), and 31% unspecified (<jats:italic>n<\/jats:italic>\u2009=\u2009805), with a mean \u00b1 standard deviation (SD) age of 46.9 \u00b1\u200912.4\u2009years (<jats:italic>n<\/jats:italic>\u2009=\u2009378). The top three most reported AEs were TFs, product dose omissions, and injection site pain, with 377 (14.5%), 354 (13.6%), and 331 (12.7%) cases, respectively. The mean \u00b1 SD weight of people with a report of TF versus NTF was 101.8\u2009\u00b1\u200933.4\u2009kg and 87.7\u2009\u00b1\u200926.7\u2009kg, respectively (<jats:italic>p<\/jats:italic>\u2009=\u20090.0175).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Our findings suggest that healthcare professionals should have a heightened awareness of potential challenges with CAB\/RPV administration, including TFs and dose omissions in real\u2010world settings.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.13709","type":"journal-article","created":{"date-parts":[[2024,9,5]],"date-time":"2024-09-05T09:42:00Z","timestamp":1725529320000},"page":"173-178","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Therapeutic failure reported with <scp>HIV<\/scp> long\u2010acting injectables: An analysis of the <scp>FDA<\/scp> Adverse Event Reporting System from 2021 to 2024"],"prefix":"10.1111","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2061-108X","authenticated-orcid":false,"given":"Kenneth L.","family":"McCall","sequence":"first","affiliation":[{"name":"Department of Pharmacy Practice Binghamton University School of Pharmacy &amp; Pharmaceutical Sciences  Johnson City New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danielle L.","family":"Cabral","sequence":"additional","affiliation":[{"name":"Center for Young Adult, Adolescent, and Pediatric HIV, Northwell Health  Great Neck New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jamie F.","family":"Coghlan","sequence":"additional","affiliation":[{"name":"Doctor of Pharmacy Candidate Binghamton University School of Pharmacy &amp; Pharmaceutical Sciences  Johnson City New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashante M.","family":"Concepcion","sequence":"additional","affiliation":[{"name":"Doctor of Pharmacy Candidate Binghamton University School of Pharmacy &amp; Pharmaceutical Sciences  Johnson City New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristine E.","family":"Denimarck","sequence":"additional","affiliation":[{"name":"Doctor of Pharmacy Candidate Binghamton University School of Pharmacy &amp; Pharmaceutical Sciences  Johnson City New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shawn S.","family":"Shalumov","sequence":"additional","affiliation":[{"name":"Doctor of Pharmacy Candidate Binghamton University School of Pharmacy &amp; Pharmaceutical Sciences  Johnson City New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,9,5]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"HIV & AIDS trends and U.S.Statistics Overview [Internet]. 2023 [cited 2024 Jul 28].https:\/\/www.hiv.gov\/hiv-basics\/overview\/data-and-trends\/statistics"},{"key":"e_1_2_11_3_1","unstructured":"About HIV [Internet].Centers for Disease Control and Prevention. 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Available from:https:\/\/www.cdc.gov\/hiv\/risk\/art\/evidence\u2010of\u2010hiv\u2010treatment.html#:~:text=Adherence%20to%20daily%20treatment:%20Taking is%20confirmed%20to%20be%20undetectable"},{"key":"e_1_2_11_7_1","unstructured":"FDA News Release.FDA approves first extended\u2010release injectable drug regimen for adults living with HIV [Internet]. FDA.2021[cited 2024 Aug 2]. 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