Women are underrepresented in clinical HIV research

A woman blowing soap bubbles.

A study led by Shuang Zhou, published this year (study not easily available, news of the study by Aidsmap is found here), found that cisgender women (those who identify with the gender defined at birth) are chronically underrepresented in clinical trials of HIV medicines (antiretrovirals). This is astonishing when it is known that globally more than half of people living with HIV are women.

Before a new HIV medicine can be approved for general use, a large number of people are recruited at the final trial stage to evaluate the safety and effectiveness of the new treatment compared to the previously available drug. According to Zhou et al., the low number of female participants in the studies affected the ability of the studies to detect gender differences in the safety and efficacy of drugs.

Modern HIV medicines are generally well tolerated and their side effects are minimal. However, the fact that women are not well enough represented in clinical HIV research leads to a lack of information about gender-based differences in the side effects of HIV medication. For example, some side effects have been reported more frequently in female patients, but there is no systematic study data on gender differences.

The low representation of women in clinical HIV trials is not a new issue

The finding that women are not sufficiently well represented in HIV research is not new and there are other similar research results. Pharmaceutical companies such as ViiV (GSK as majority owner), which studies antiretrovirals, have themselves acknowledged the existence of the problem and declared an increase in the representation of women in clinical trials. However, according to Zhou et al., women’s participation in HIV research has not improved over the past 10 years. This means that there is no information on how HIV treatment affects women and men differently.

The representation of women in clinical HIV research can be increased

Zhou et al. are calling on pharmaceutical companies to improve the recruitment of women for trials. According to Bakita Kasadha, editor of Aidsmap, it’s time for researchers not to consider cisgender men as the default people and to recognize that recruitment practices for drug trials planned by men favor men. In research, women should be comprehensively represented, as the underrepresentation of women in research leads to distorted information about the effectiveness and side effects of HIV medication in women. The representation of women in pharmaceutical research can be improved by practical means, such as taking into account the times of participation in the study and, for example, by providing childcare support to the woman participating in the study.