Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap
| dc.contributor.author | Davey, Dvora L. Joseph | |
| dc.contributor.author | Bekker, Linda‑Gail | |
| dc.contributor.author | Bukusi, Elizabeth A. | |
| dc.contributor.author | Chi, Benjamin H. | |
| dc.contributor.author | Delany-Moretlwe, Sinead | |
| dc.contributor.author | Goga, Ameena Ebrahim | |
| dc.contributor.author | Lyerly, Anne Drapkin | |
| dc.contributor.author | Mgodi, Nyaradzo M. | |
| dc.contributor.author | Mugo, Nelly | |
| dc.contributor.author | Myer, Landon | |
| dc.contributor.author | Noguchi, Lisa M. | |
| dc.contributor.author | Stranix-Chibanda, Lynda | |
| dc.contributor.author | Slack, Catherine | |
| dc.contributor.author | Pintye, Jillian | |
| dc.date.accessioned | 2023-07-20T09:56:12Z | |
| dc.date.available | 2023-07-20T09:56:12Z | |
| dc.date.issued | 2022-03 | |
| dc.description.abstract | Pregnant and breastfeeding populations are at substantial risk of acquiring HIV in some settings, yet are underrepresented in clinical trials of new pre-exposure prophylaxis (PrEP) agents. Several PrEP formulations are in development (eg, vaginal rings, long-acting injectables, and other modalities). Pregnant and breastfeeding populations are typically excluded from initial clinical trials. We identified 14 PrEP trials of novel agents in non-pregnant or non-breastfeeding populations, and six phase 1–3 trials and open label extensions among pregnant and breastfeeding populations, that are currently ongoing or complete. A framework shift is needed to consider the ethical costs of excluding pregnant and breastfeeding populations at risk for HIV in PrEP clinical trials and promote inclusion to maximise the benefits from PrEP tools in the pipeline. Research on new PrEP agents should include pregnant and breastfeeding populations to avoid delays in reaching those who could benefit from PrEP after efficacy is established. | en_US |
| dc.description.department | Paediatrics and Child Health | en_US |
| dc.description.librarian | hj2023 | en_US |
| dc.description.uri | https://www.thelancet.com/journals/lanhiv/home | en_US |
| dc.identifier.citation | Davey, D.L.J., Bekker, L.G., Bukusi, E.A. et al. 2022, 'Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap', Lancet HIV, vol. 9, no. 3, pp. e214-e222, doi : 10.1016/S2352-3018(21)00280-0. | en_US |
| dc.identifier.issn | 2405-4704 (print) | |
| dc.identifier.issn | 2352-3018 (online) | |
| dc.identifier.other | 10.1016/S2352-3018(21)00280-0 | |
| dc.identifier.uri | http://hdl.handle.net/2263/91562 | |
| dc.language.iso | en | en_US |
| dc.publisher | Elsevier | en_US |
| dc.rights | © 2022 Elsevier Ltd. All rights reserved. Notice : this is the author’s version of a work that was accepted for publication in Lancet HIV. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. A definitive version was subsequently published in Lancet HIV, vol. 9, no. 3, pp. e214-e222, doi : 10.1016/S2352-3018(21)00280-0. | en_US |
| dc.subject | Human immunodeficiency virus (HIV) | en_US |
| dc.subject | Pre-exposure prophylaxis (PrEP) | en_US |
| dc.subject | Pregnant women | en_US |
| dc.subject | Breastfeeding | en_US |
| dc.subject | SDG-03: Good health and well-being | en_US |
| dc.title | Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap | en_US |
| dc.type | Postprint Article | en_US |