In October 2019, the FDA approval of the new HIV-prevention drug Descovy was met with great excitement by doctors, HIV researchers, and many people at risk of HIV infection. Descovy functions as a pre-exposure prophylaxis (PrEP), medicine taken to prevent HIV infection. The second ever drug approved for PrEP, in research trials, Descovy reduced kidney and bone health side effects.
Not everyone, however, applauded the approval of this drug. To many people’s disappointment, Descovy was not approved for use by people assigned female at birth (AFAB), including cisgender women, trans men, and AFAB folks of other genders. Descovy’s safety and efficacy trials excluded these groups of people. While many were disappointed, they were not surprised. Drug companies have left the AFAB community out of HIV-related clinical trials before. Most likely, this time will not be the last, a fact that leaves many wondering when medical research will match the reality of the HIV epidemic.
Historical assumptions that HIV/AIDS is a disease that mostly affects gay and bisexual men has shaped the way medical professionals and drug companies have responded. In the early 1980s, cisgender women were not diagnosed with AIDS because physicians considered it a man’s disease. Throughout the decade, despite rising cases in cisgender women, prevention research focused on male-centered approaches, and women were excluded from medical trials.
Today, while over half of people living with HIV worldwide are women, the assumption that men bear most of the burden of HIV remains prevalent in modern discourse, clinical trials, and prevention research. As of 2016, women made up only 11% of participants in clinical trials of potential HIV cures and only 19% of participants in antiretroviral trials. According to Dr. Eileen Scully, assistant professor of medicine at Johns Hopkins University, it is difficult to convince many scientists to take seriously the need to enroll women in clinical trials. “Some of the hard scientists dismiss this type of discussion as being more socially determined, or some sort of women’s liberation thing,” she explained.
Research, however, shows that the biological response to HIV differs between the male and female sexes. In fact, HIV progresses faster to AIDS in females, and they are more likely to have heart attacks and strokes. HIV treatment and prevention drugs need to work for people of all sexes and genders, which starts with researchers prioritizing the recruitment of women to clinical trials.
For AFAB trans folks, including trans men and gender nonbinary people, the problem is even more severe. Inaccurate assumptions that they only have sex with cisgender women and engage less frequently in behaviors that increase HIV risk have not only led AFAB trans folks to be underrepresented in HIV-related clinical trials, but have also led to extreme undersurveillance of HIV spread throughout these populations. The CDC’s annual HIV Surveillance Report publishes vast amounts of data about HIV diagnoses and deaths, yet did not include any data about transgender folks until 2019. Even in the more recent reports, the amount of data published about trans folks is slim compared to that of cisgender folks (particularly cisgender men).
Furthermore, the CDC’s section on HIV and Transgender People includes very little information about trans men and no acknowledgement of nonbinary people. “AFAB trans people are still not recognized enough by researchers and health care providers to investigate the specific risks to our community or to offer us medically appropriate and accessible care,” explains trans activist and HIV researcher Max Appenroth in the book No Data No More, which he co-authored. “If we aren’t being discriminated against or even attacked,” Appenroth continues, “I and my community live with missing knowledge on the side of doctors or a lack of information based on insufficient research.” It is therefore imperative that medical professionals dedicate greater time and attention to studying HIV among AFAB trans folks.
Assumptions that cisgender women and AFAB trans folks are not at risk of HIV have deadly consequences. It is these assumptions that allow pharmaceutical companies to underrepresent these groups in clinical trials or leave them out altogether. These assumptions also cause cis women and AFAB trans folks to often perceive themselves as not at risk of HIV. Compounded by the fact that many doctors are influenced by this same belief, this perception makes AFAB folks less likely to be interested in and prescribed PrEP. In fact, in 2018 only 7% of women and AFAB trans people in the U.S. who were considered at risk of HIV were prescribed PrEP. Women and AFAB trans folks are not getting the protection they need from HIV infection.
We need to change the status quo about HIV. It is essential for researchers to put in the effort to recruit a substantial number of women and AFAB trans people in clinical trials for all HIV-related drugs. It is similarly important to include women and AFAB trans folks in conversations about HIV. Surveillance reports of HIV cases must also collect more data about transgender people, especially AFAB trans people, whose HIV cases have been greatly understudied. If the global HIV epidemic is to ever end, we need HIV research that is free from the biases and injustices that have fueled the persistence of this deadly disease.
Charlotte Babbin is a student at Wesleyan University and intern for Our Bodies Ourselves Today. Set to launch in 2022, Our Bodies Ourselves Today is an online platform created by the Center for Women’s Health & Human Rights at Suffolk University in partnership with Our Bodies Ourselves that is dedicated to providing women, girls, and gender-diverse people with comprehensive health information.