Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap.

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.

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Déclaration de conflit d'intérêts

Declaration of interests DLJD received funding from the US National Institutes of Health (K01TW01187 from the Fogarty International Center and National Institute of Mental Health R01MH116771), an honorarium for a meeting on long-acting PrEP by ViiV, donations of the study drug (Truvada) from Gilead, and donations of the STI test kits from Cepheid. NM has an investigator initiated trial from Merck. ADL declared funding for the PHASES Project (grant number R01 AI108368-05; principal investigator) and The FAIRER Project (grant number R01 HG 011480), and is the chair and on the data safety monitoring board for TNF-alpha Blockade with Certolizumab to Prevent Pregnancy Complications in High-Risk Patients with APS, is a member and on the interim review panel for MTN/042-DELIVER, is a member and on the external advisory board for the Infectious Diseases Clinical Research Consortium, and is a member and on the data safety monitoring board for the MOMPOD Study. CS is on the NIAID drug safety monitoring board for several HIV vaccine trials and has received an honorarium, is on a Clover biopharmaceuticals drug safety monitoring board for a COVID-19 vaccine trial and has received an honorarium, and is a member of the Coalition to Advance and Support Prevention Research funded by USAID. LMN received funding to their institution (the Magee-Womens Research Institute) from the US National Institutes of Health and funding from USAID and PEPFAR through a cooperative agreement (7200AA19CA00003; Jhpiego, Johns Hopkins University, Baltimore, MD, USA). The Microbicide Trials Network is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, and UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the US National Institutes of Health. All other authors declare no competing interests.