Women are rarely included in HIV studies

Women are rarely included in HIV studies

Despite the fact that, according to data from the Joint United Nations Program on HIV and AIDS (UNAIDS), more than half of the people living with HIV worldwide are women and girls, this population is not sufficiently represented in the studies for the development of new drugs against this infection.

This was stated by a research team from the United States, in an article recently published in the medical journal AIDS. The work measured the participation of women with HIV in studies carried out in people who had not been treated, in order to test new drugs.

This underrepresentation of cisgender women makes it difficult to know if there are sex differences in the effectiveness and safety of treatments, said the researchers, who are with the US Food and Drug Administration (FDA).

Underrepresented population

The study, as reported by the Working Group on HIV Treatments (gTt-HIV), analyzed data from clinical trials that have been registered with the FDA since 2010. It should be remembered that all research involving US institutions and involving testing drugs in humans must be evaluated and approved by that health authority.

Thus, the scientists, led by Dr. Shuang Zhou, found that 18 studies had been carried out involving 13,000 people from the United States and other parts of the world; of these, only 15% were women.

If only American women are taken into account, they were only 11% of the research participants, and they were mostly of African descent (62%) or white (34%) ethnic origin. They were also, on average, older than the male participants, and their levels of immune cells (CD4 cells) were significantly lower, indicating a weakness in the body’s defense system.

Of the 18 studies registered, 15 did not have an adequate representation of women. They were only 11% of the participants, but they account for 19% of HIV cases in the United States. Looking at the data by ethnic origin, Afro-descendant women make up 11% of all people living with HIV in that country, but they only made up 7% of those who took part in the studies. White women, on the other hand, were correctly represented, as their 4% participation coincided with the 4% they occupy in the population with HIV.

Difference in results

The researchers’ concern is that, by not having a truly representative number of women, the new drugs may not be as effective or may be more toxic for women than for men.

For example, men were more likely to minimize the amount of HIV in their blood (undetectable viral load) within the first year of treatment than women.

Likewise, in the aspect of drug safety, hemoglobin levels (which, if very low, are a sign of anemia) remained stable in them, while they decreased in women.

In addition, the degree of inclusion of women in clinical trials did not change in the period reviewed, which indicates, the researchers consider, that there is a great need to include more cisgender women in future studies.

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