{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,4]],"date-time":"2026-07-04T23:09:40Z","timestamp":1783206580330,"version":"3.54.6"},"reference-count":42,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2025,5,6]],"date-time":"2025-05-06T00:00:00Z","timestamp":1746489600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Merck Sharp & Dohme LLC"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,11,14]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Islatravir, a nucleoside reverse transcriptase translocation inhibitor, exhibits high potency against human immunodeficiency virus type 1 (HIV-1), with a long intracellular half-life. The safety, tolerability, and pharmacokinetics of once-monthly oral islatravir were evaluated in adults at low risk of acquiring HIV-1.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this double-blind, placebo-controlled trial, participants were randomized 2:2:1 to receive 6 once-monthly doses of islatravir 60\u2005mg, islatravir 120\u2005mg, or placebo. Objectives included assessing safety, tolerability, and pharmacokinetic profiles of islatravir in plasma and its active metabolite, islatravir triphosphate (ISL-TP), in peripheral blood mononuclear cells (PBMCs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 242 participants (islatravir 60\u2005mg, n = 97; islatravir 120\u2005mg, n = 97; placebo, n = 48), most were aged \u226445 years (90.1%), female (67.4%), and White (52.9%). Proportions of participants experiencing \u22651 adverse event (AE) were similar in the islatravir (60\u2005mg: 68.0%; 120\u2005mg: 64.9%) and placebo (75.0%) arms. AEs were generally mild to moderate, with infection-related AEs comparable across arms. Lymphocyte count decreased in the islatravir arms, with mean percentage changes of \u221221.3% \u00b1 20.1% (60\u2005mg) and \u221235.6% \u00b1 22.8% (120\u2005mg) versus +4.4% \u00b1 25.9% (placebo) at week 24. Median intracellular PBMC ISL-TP concentrations remained above the prespecified pharmacokinetic threshold for HIV-1 prophylaxis (0.050\u2005pmol\/106 cells) through 4 weeks after the first dose and \u22658 weeks after the last dose.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Oral islatravir 60\u2005mg and 120\u2005mg once monthly demonstrated similar tolerability and AE profiles to placebo, except for dose-dependent decreases in total lymphocyte counts. A partial recovery in total lymphocyte counts was observed. In most participants, both islatravir doses achieved PBMC ISL-TP exposure levels projected to be effective for once-monthly oral HIV-1 preexposure prophylaxis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trials Registration<\/jats:title>\n                    <jats:p>NCT04003103.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/infdis\/jiaf222","type":"journal-article","created":{"date-parts":[[2025,5,6]],"date-time":"2025-05-06T07:55:08Z","timestamp":1746518108000},"page":"1050-1060","source":"Crossref","is-referenced-by-count":8,"title":["Safety, Tolerability, and Pharmacokinetics of Once-Monthly Oral Islatravir: A Phase 2a Study in Participants at Low Risk for Acquiring Human Immunodeficiency Virus Type 1"],"prefix":"10.1093","volume":"232","author":[{"given":"Sharon L","family":"Hillier","sequence":"first","affiliation":[{"name":"Department of Obstetrics, Gynecology and Reproductive Sciences, Magee-Womens Research Institute and Foundation , Pittsburgh, Pennsylvania ,","place":["USA"]},{"name":"Department of Medicine, University of Pittsburgh , Pittsburgh, Pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0755-4386","authenticated-orcid":false,"given":"Linda-Gail","family":"Bekker","sequence":"additional","affiliation":[{"name":"Department of Medicine, Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town , Cape Town ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2545-7037","authenticated-orcid":false,"given":"Sharon A","family":"Riddler","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Pittsburgh , Pittsburgh, Pennsylvania 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