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Model-based predictions of protective HIV pre-exposure prophylaxis adherence levels in cisgender women

Most human immunodeficiency virus (HIV) infections occur in cisgender women in resource-limited settings. In women, self-protection with emtricitabine/tenofovir disoproxil fumarate pre-exposure prophylaxis (FTC/TDF-PrEP) constitutes a major pillar of HIV prevention. However, clinical trials in women...

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Autores principales: Zhang, Lanxin, Iannuzzi, Sara, Chaturvedula, Ayyappa, Irungu, Elizabeth, Haberer, Jessica E., Hendrix, Craig W., von Kleist, Max
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group US 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10667095/
https://www.ncbi.nlm.nih.gov/pubmed/37957377
http://dx.doi.org/10.1038/s41591-023-02615-x
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author Zhang, Lanxin
Iannuzzi, Sara
Chaturvedula, Ayyappa
Irungu, Elizabeth
Haberer, Jessica E.
Hendrix, Craig W.
von Kleist, Max
author_facet Zhang, Lanxin
Iannuzzi, Sara
Chaturvedula, Ayyappa
Irungu, Elizabeth
Haberer, Jessica E.
Hendrix, Craig W.
von Kleist, Max
author_sort Zhang, Lanxin
collection PubMed
description Most human immunodeficiency virus (HIV) infections occur in cisgender women in resource-limited settings. In women, self-protection with emtricitabine/tenofovir disoproxil fumarate pre-exposure prophylaxis (FTC/TDF-PrEP) constitutes a major pillar of HIV prevention. However, clinical trials in women had inconsistent outcomes, sparking uncertainty about adherence requirements and reluctance in evaluating on-demand regimens. We analyzed data from published FTC/TDF-PrEP trials to establish efficacy ranges in cisgender women. In a ‘bottom-up’ approach, we modeled hypotheses in the context of risk-group-specific, adherence–efficacy profiles and challenged those hypotheses with clinical data. We found that different clinical outcomes were related to the proportion of women taking the product, allowing coherent interpretation of the data. Our analysis showed that 90% protection was achieved when women took some product. We found that hypotheses of putative male/female differences were either not impactful or statistically inconsistent with clinical data. We propose that differing clinical outcomes could arise from pill-taking behavior rather than biological factors driving specific adherence requirements in cisgender women.
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spelling pubmed-106670952023-11-13 Model-based predictions of protective HIV pre-exposure prophylaxis adherence levels in cisgender women Zhang, Lanxin Iannuzzi, Sara Chaturvedula, Ayyappa Irungu, Elizabeth Haberer, Jessica E. Hendrix, Craig W. von Kleist, Max Nat Med Article Most human immunodeficiency virus (HIV) infections occur in cisgender women in resource-limited settings. In women, self-protection with emtricitabine/tenofovir disoproxil fumarate pre-exposure prophylaxis (FTC/TDF-PrEP) constitutes a major pillar of HIV prevention. However, clinical trials in women had inconsistent outcomes, sparking uncertainty about adherence requirements and reluctance in evaluating on-demand regimens. We analyzed data from published FTC/TDF-PrEP trials to establish efficacy ranges in cisgender women. In a ‘bottom-up’ approach, we modeled hypotheses in the context of risk-group-specific, adherence–efficacy profiles and challenged those hypotheses with clinical data. We found that different clinical outcomes were related to the proportion of women taking the product, allowing coherent interpretation of the data. Our analysis showed that 90% protection was achieved when women took some product. We found that hypotheses of putative male/female differences were either not impactful or statistically inconsistent with clinical data. We propose that differing clinical outcomes could arise from pill-taking behavior rather than biological factors driving specific adherence requirements in cisgender women. Nature Publishing Group US 2023-11-13 2023 /pmc/articles/PMC10667095/ /pubmed/37957377 http://dx.doi.org/10.1038/s41591-023-02615-x Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
Zhang, Lanxin
Iannuzzi, Sara
Chaturvedula, Ayyappa
Irungu, Elizabeth
Haberer, Jessica E.
Hendrix, Craig W.
von Kleist, Max
Model-based predictions of protective HIV pre-exposure prophylaxis adherence levels in cisgender women
title Model-based predictions of protective HIV pre-exposure prophylaxis adherence levels in cisgender women
title_full Model-based predictions of protective HIV pre-exposure prophylaxis adherence levels in cisgender women
title_fullStr Model-based predictions of protective HIV pre-exposure prophylaxis adherence levels in cisgender women
title_full_unstemmed Model-based predictions of protective HIV pre-exposure prophylaxis adherence levels in cisgender women
title_short Model-based predictions of protective HIV pre-exposure prophylaxis adherence levels in cisgender women
title_sort model-based predictions of protective hiv pre-exposure prophylaxis adherence levels in cisgender women
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10667095/
https://www.ncbi.nlm.nih.gov/pubmed/37957377
http://dx.doi.org/10.1038/s41591-023-02615-x
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