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Article History

Received: 29 May 2025

Accepted: 13 October 2025

First Online: 12 November 2025

Declarations

:

: Jeremiah D. Momper is an Editorial Board member of Clinical Pharmacokinetics . Jeremiah D. Momper was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Renee Heffron serves as a consultant to Merck and Sharp & Dohme and has been a Principal Investigator for studies that received donated FTC/TDF medication from Gilead Sciences. Robert Bies serves as a consultant for Advanced Bioscience Laboratories. Craig W. Hendrix holds several patents and receives royalties related to PrEP topical microbicides, and is a founder of Prionde Biopharma, LLC, a PrEP microbicide company; all conflicts are managed by Johns Hopkins University and the HPTN. Dvora Joseph Davey receives research support from ViiV Healthcare, Merck, and Gilead Sciences. Kristina M. Brooks previously received consulting fees from ViiV Healthcare. Peter Anderson receives research contracts from Gilead Sciences, with payments made to his institution. Mark Mirochnick receives research support through his institution from ViiV Healthcare and Merck. Rachel K. Scott has participated in advisory boards and received investigator-sponsored research funding from ViiV Healthcare and Gilead Sciences, managed by her institution. Yifan Yu, Gustavo F. Doncel, Brookie M. Best, Mark A. Marzinke, Landon Myer, Connie Celum, and Jenell Coleman have no conflicts of interest that are directly relevant to the content of this article.

: This study is a secondary analysis of deidentified data from multiple previously published studies [ , , , , ]. The original studies were approved by their respective institutional review boards, and all data were deidentified prior to data sharing and this analysis. The University at Buffalo reviewed this study (institutional review board ID: STUDY00006180) and determined that as this research does not involve human subjects, institutional review board approval was not required.

: Not applicable.

: Not applicable.

: The data cannot be made publicly available because of the ethical restrictions in the study’s informed consent documents and in the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network’s approved human subjects protection plan; public availability may compromise participant confidentiality. However, data are available to all interested researchers upon request to the IMPAACT Statistical and Data Management Center’s data access committee (e-mail: sdac.data@fstrf.org) with the agreement of the IMPAACT Network.

: Not applicable.

: RKS acquired funding for the study. RKS, RB, and CWH contributed to the conceptualization of the study. RKS, RB, CWH, and JDM supervised the research. YY conducted the data analysis and drafted the original manuscript. KMB, GFD, BMB, MAM, MM, PA, LM, CC, RH, JC, DJD, CW, JDM, and RKS contributed to data curation. All authors reviewed and edited the manuscript.