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Authors
Waalewijn, Hylke
Bevers, Lisanne A. H. https://orcid.org/0009-0004-3699-2993
Lewis, Linda L.
Louey, Margaret D.
Kawakatsu, Sonoko
Zheng, Yanan
Giaquinto, Carlo
Nardone, Alessandra
Burger, David M.
ter Heine, Rob
Colbers, Angela
Svensson, Elin M.
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Article History
Received: 5 January 2026
Accepted: 16 June 2026
First Online: 30 July 2026
Declarations
Funding: This work was produced by the UNIVERSAL project, which is part of the EDCTP2 Programme supported by the European Union (grant number RIA2019PD-2882-UNIVERSAL). The views and opinions expressed herein are those of the authors and do not necessarily reflect those of EDCTP.
Conflicts of Interest: Yanan Zheng and Sonoko Kawakatsu are employees of Gilead Sciences, Inc., and hold stock in the company. Hylke Waalewijn, Lisanne A.H. Bevers, Linda L. Lewis, Margaret D. Louey, Carlo Giaquinto, Alessandra Nardone, David M. Burger, Rob ter Heine, Angela Colbers, and Elin M. Svensson is an Editorial Board member of Clinical Pharmacokinetics, but was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions.
Ethics Approval: Not applicable.
Consent to Participate: Not applicable.
Consent for Publication: Not applicable.
Availability of Data and Material: The pharmacokinetic model for dolutegravir, adapted from ViiV Healthcare’s publication, is included in the ESM. For the TAF/TFV model, the situation is more complex. Through our collaboration, Gilead shared their TAF/TFV model, which has been submitted to the US FDA as part of their pediatric TAF development program but it has not yet been published. Because of proprietary reasons, Gilead has provided permission to only share the model details provided in this article. We further adapted the Gilead TAF/TFV model for our analyses. Data supporting the findings of this study are available from the corresponding author upon reasonable request, subject to applicable agreements and permissions.
Code Availability: The code used for simulations is available from the corresponding author upon reasonable request.
Authors’ Contributions: All authors contributed to the study conception and design. Simulations and data analysis were performed by HW and LB. All authors contributed to the drafting and revision of the manuscript and approved the final version.
