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We report on the safety and CAB\u2010LA pharmacokinetics in pregnant women during the blinded period of HPTN 084.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Participants were randomized 1:1 to either active cabotegravir (CAB) plus tenofovir disoproxil fumarate\/emtricitabine (TDF\/FTC) placebo or active TDF\/FTC plus CAB placebo. Pregnancy testing was performed at each visit; participants with a positive test had study product withheld and were offered open\u2010label TDF\/FTC. Pregnancies were confirmed on two tests at least 4 weeks apart. All participants with a positive pregnancy test prior to November 5, 2020 are included in this analysis. Pregnancy incidence, maternal adverse event (AE) incidence, pregnancy outcomes (including composite outcome of spontaneous abortion &lt;20 weeks, intrauterine foetal death or stillbirth \u226520 weeks, premature birth &lt;37 weeks, or small for gestational age) were assessed. The apparent terminal phase half\u2010life (t<jats:sub>1\/2app<\/jats:sub>) of CAB\u2010LA in pregnant women in HPTN 084 was compared to non\u2010pregnant women from the phase 2a HPTN 077 trial. Multivariable models assessed associations with t<jats:sub>1\/2app.<\/jats:sub><\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Fifty\u2010seven pregnancies (30 CAB\u2010LA, 27 TDF\/FTC) were confirmed over 3845 person\u2010years [py] (incidence 1.5\/100 py, 95% CI 1.1\u22121.9). CAB\u2010LA group participants had a median 342 days (IQR 192, 497) of CAB\u2010LA exposure prior to pregnancy detection. Grade 2 or higher maternal AE incidence did not differ by study arm (CAB 157, 95% CI 91\u2212271 per 100 py vs. TDF\/FTC 217, 95% CI 124\u2013380 per 100 py; <jats:italic>p<\/jats:italic> = 0.256). Most pregnancies (81%) resulted in live births (25 CAB\u2010LA, 22 TDF\/FTC). Composite poor pregnancy outcomes did not differ significantly by group (CAB 6\/30 vs. TDF\/FTC 4\/27; <jats:italic>p<\/jats:italic> = 0.476). No congenital anomalies were observed. The CAB t<jats:sub>1\/2app<\/jats:sub> geometric mean was 52.8 days (95% CI 40.7\u221268.4) in pregnant women compared to 60.3 days (95% CI 47.7\u221276.3; <jats:italic>p<\/jats:italic> = 0.66) in non\u2010pregnant women; neither pregnancy nor body mass index were significantly associated with t<jats:sub>1\/2app<\/jats:sub>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>CAB\u2010LA concentrations post\u2010cessation of injections were generally well tolerated in pregnant women. The t<jats:sub>1\/2app<\/jats:sub> was comparable between pregnant and non\u2010pregnant women. Ongoing studies will examine the safety and pharmacology of CAB\u2010LA in women who choose to continue CAB\u2010LA through pregnancy and lactation.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jia2.26401","type":"journal-article","created":{"date-parts":[[2025,1,3]],"date-time":"2025-01-03T05:14:04Z","timestamp":1735881244000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Evaluation of long\u2010acting cabotegravir safety and pharmacokinetics in pregnant women in eastern and southern Africa: a secondary analysis of HPTN 084"],"prefix":"10.1002","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0376-1019","authenticated-orcid":false,"given":"Sinead","family":"Delany\u2010Moretlwe","sequence":"first","affiliation":[{"name":"Wits RHI University of the Witwatersrand  Johannesburg South 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