Inclusion of women in HIV research and clinical trials

Inclusion of women is critical in the evolving landscape of clinical and translational HIV research.We will herein interchangeably use the terms "females" and "women" when referring to individuals born with a uterus, although we fully acknowledge that not all women are assigned female sex at birth.Globally, of the approximately 38 million people estimated to live with HIV, over half (54%) are female (1).Women have historically been underrepresented in clinical trials (2); often excluded from clinical trials due to pregnancy or lactation status, or even childbearing potential, with participation considered only if contraception requirements are met (3).Prior analyses of clinical trials in the field of immunology demonstrated among the lowest female participant representation relative to their burden of disability-adjusted life years experienced (4).The US Food and Drug Administration (FDA) publishes annual drug trial "snapshots" of demographic data for new molecular entities and original biologics, in an effort to enhance transparency, and these suggest that the representation of women in clinical trials has increased in recent years (5).In the field of HIV research, women remain underrepresented in HIV treatment, HIV vaccine, and HIV cure studies (6, 7); a discrepancy that is heightened for women of color.Notably, in a 2020 study, Black women were underrepresented by 35% relative to HIV prevalence rates in phase 3 randomized clinical trials of three modern antiretrovirals (6).Such underrepresentation of women limits the ability to assess differences related to sex, including with respect to treatment efficacy and potential adverse effects.In this issue, an observational study by Zhou et al (8) investigates involvement of treatment naïve US women in clinical trials of HIV treatment, specifically focusing on phase 3 clinical trials submitted to the FDA between 2008 and 2019.They report the participation to prevalence ratio (PPR), where a PPR between 0.8 and 1.2 reflects similar representation of females in the trial and the disease population, as well sex differences in both efficacy and safety outcomes (8).Overall, across 18 phase 3 clinical trials for HIV treatment, 15% of participants were female.Within the United States 11% of phase 3 clinical trial participants were female, corresponding to a PPR of 0.58, and consistent with underrepresentation (8).Moreover, of new HIV diagnoses in the United States 20% were in women in 2020 (2% identified as transgender women), again highlighting how the enrollment of women in clinical trials for treatment-naïve individuals falls short of representing national epidemiological trends (9).

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