{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T23:40:50Z","timestamp":1787701250157,"version":"build-2784847793"},"reference-count":13,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T00:00:00Z","timestamp":1765843200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T00:00:00Z","timestamp":1765843200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    We report individualized off\u2010label monthly use of a high dose of long\u2010acting intramuscular cabotegravir\/rilpivirine (CAB\/RPV\u2009=\u2009600\u2009mg\/900\u2009mg) co\u2010administered preconceptionally and throughout pregnancy with subcutaneous lenacapavir to a young woman with perinatally acquired HIV, multiple comorbidities, and class III obesity. Therapeutic drug monitoring for CAB and RPV was performed throughout the pregnancy and postpartum. At 7\u2009weeks gestation, the plasma CAB and RPV\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>troughs<\/jats:sub>\n                    were 16 (2.58\u2009mg\/L) and 9 (0.11\u2009mg\/L) times above the respective protein adjusted (PA)\u2010IC\n                    <jats:sub>90<\/jats:sub>\n                    . From 7 to 32\u2009weeks of gestation, plasma CAB and RPV\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>troughs<\/jats:sub>\n                    decreased to 1.28 and to 0.08\u2009mg\/L, respectively, but remained above PA\u2010IC\n                    <jats:sub>90<\/jats:sub>\n                    for both drugs. After receiving one monthly high\u2010dose CAB\/RPV injection after delivery at 7\u2009weeks postpartum, the plasma CAB and RPV\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>troughs<\/jats:sub>\n                    were 4.02 and 0.19\u2009mg\/L, 56% and 73% higher than at 7\u2009weeks of gestation. Despite a decrease in cabotegravir (50%) and rilpivirine (27%) concentrations between first and third trimesters, plasma exposures remained above therapeutic thresholds and viral load &lt;20 copies\/mL was maintained throughout pregnancy. Higher CAB and RPV exposures did not result in adverse maternal, pregnancy or infant safety outcomes. At 7\u2009weeks postpartum, CAB\/RPV was switched to standard bimonthly dosing. At 33\u2009weeks postpartum, the patient remained undetectable on standard CAB\/RPV bimonthly dose, although subsequent pregnancies might require long\u2010acting CAB\/RPV dosing adjustments. Our case of empiric use of high\u2010dose CAB\/RPV with monthly injections and therapeutic drug monitoring during pregnancy in a complex patient with class III obesity provides novel insights into pharmacokinetics of long\u2010acting CAB\/RPV.\n                  <\/jats:p>","DOI":"10.1002\/bcp.70424","type":"journal-article","created":{"date-parts":[[2025,12,17]],"date-time":"2025-12-17T01:19:28Z","timestamp":1765934368000},"page":"1232-1236","source":"Crossref","is-referenced-by-count":4,"title":["Off\u2010label dosing of long\u2010acting injectable cabotegravir and rilpivirine during pregnancy: A case study with therapeutic drug monitoring"],"prefix":"10.1002","volume":"92","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2246-4581","authenticated-orcid":false,"given":"Natella","family":"Rakhmanina","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases Children's National Hospital  Washington District of Columbia USA"},{"name":"Department of Pediatrics The George Washington University School of Medicine and Health Sciences  Washington District of Columbia USA"},{"name":"Technical Strategies and Innovation Elizabeth Glaser Pediatric AIDS Foundation  Washington District of Columbia USA"},{"name":"Center for Health Outcomes Research and Delivery Science Children's National Research Institute, Children's National Hospital  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Unternaher","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases Children's National Hospital  Washington District of Columbia USA"},{"name":"Great Ormond Street Institute of Child Health University College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tierra","family":"Williams","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases Children's National Hospital  Washington District of Columbia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin J.","family":"Ryan","sequence":"additional","affiliation":[{"name":"Department of Pediatrics University of Alabama at Birmingham  Birmingham Alabama USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kedria","family":"Walker","sequence":"additional","affiliation":[{"name":"Department of Pediatrics University of Alabama at Birmingham  Birmingham Alabama USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward P.","family":"Acosta","sequence":"additional","affiliation":[{"name":"Department of Pediatrics University of Alabama at Birmingham  Birmingham Alabama USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Van Den Anker","sequence":"additional","affiliation":[{"name":"Center for Health Outcomes Research and Delivery Science Children's National Research Institute, Children's National Hospital  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel K.","family":"Scott","sequence":"additional","affiliation":[{"name":"School of Medicine Georgetown University  Washington District of Columbia USA"},{"name":"Department of Women's and Children's Research MedStar Health Research Institute  Washington District of Columbia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,12,16]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11904-025-00745-0"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/hiv.13439"},{"key":"e_1_2_10_4_1","unstructured":"ShortWR ZimmermanM AzizM et alLong\u2010Acting Cabotegravir\/Rilpivirine in Pregnancy [CROI Abstract 1050]. Abstracts From the 2025 Conference on Retroviruses and Opportunistic Infections CROI 2025 Abstract eBook.2025;601."},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciae242"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofae125"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-021-01005-1"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.lanepe.2023.100793"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000002883"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14977"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.16006"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000002637"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000000968"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciae060"}],"container-title":["British Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bcp.70424","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/bcp.70424","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bcp.70424","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,5]],"date-time":"2026-04-05T23:41:45Z","timestamp":1775432505000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1002\/bcp.70424"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,16]]},"references-count":13,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,4]]}},"alternative-id":["10.1002\/bcp.70424"],"URL":"https:\/\/doi.org\/10.1002\/bcp.70424","archive":["Portico"],"relation":{},"ISSN":["0306-5251","1365-2125"],"issn-type":[{"value":"0306-5251","type":"print"},{"value":"1365-2125","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,16]]}}}