The Latest Advancement in HIV Treatment Proves How Important It Is To Include Women in Clinical Trials Research
It's especially a big deal for those living in countries where the rate of HIV-infection is high and prevention through the use of pharmaceuticals is crucial. As the New York Times reported, many people struggle to have access to current pre-exposure prophylaxis, or PrEP, drugs. Even when they do have access, many still find it challenging to take the pill every day.
The news also highlights the importance of including more women in scientific studies focusing on HIV treatment and prevention; currently, women are underrepresented in this field of research. This is in large part due to the fact that HIV/AIDS prevention and research efforts primarily focus on gay men, says Jaimie Meyer, MD, an associate professor at Yale with a focus on infectious disease. "In many countries, including in the U.S., most new cases of HIV are in men who have sex with men," she says. "So a lot of the funding and attention around HIV prevention are focused in that population, unfortunately excluding women." Still, she underlines the importance of including women and transgender men and women in trials—especially considering that women accounted for about half of all new HIV infections in 2019.
There are other societal factors at play that can make it harder for women to participate in any kind of clinical trial, including HIV research. "Cisgender women frequently think first about others and last about themselves so their lives are full of other things and people that make it difficult to give their time and attention to a study," says infectious disease specialist Jill Blumenthal, MD, as for one reason for the gender gap in research. For example, cisgender women—who typically bear the most childrearing responsibility—may have to figure out childcare arrangements (and pay for them) in order to participate. "Cisgender women of child-bearing potential are also often required to take contraceptives while being part of a study, which may not be desirable to many cisgender women," she adds.
"If women are excluded from clinical trials that generate the data, regulatory authorities cannot approve the drug for them." — Jaimie Meyer, MD,
Both doctors say that being underrepresented in studies has held women back in terms of prevention and treatment options available. "Approvals for any form of drug for prevention or treatment are based on existing data. So if women are excluded from clinical trials that generate the data, regulatory authorities cannot approve the drug for them," Dr. Meyer says. "If we don’t know how well the drug works in women or if it is safe in women who are pregnant or who may become pregnant, the argument is that we can’t in good faith provide it to women on-label. In reality, it means there is often a delay in available options for women, which is totally unfair and contributes to health disparities."
Dr. Blumenthal says that until now, the only approved and available PrEP drug for cisgender women is Truvada, the aforementioned daily pill. A generic version of the drug became available in the U.S. last month. (Another pill exists, but it's only approved for men and transgender women.) "For cisgender women, [Truvada] has been shown to be up to 99 percent effective when taken as directed, but there is some concern that there is little forgiveness with missed doses," she says. She also says it has minimal side effects and is safe to take while pregnant or breastfeeding. But the drug isn't without its cons. Dr. Blumenthal says taking Truvada long-term can lead to bone loss. And she underlines the struggle of having to take it every day, which requires continued access to a physician who can prescribe it.
Both doctors say that the promise of an injectable drug that only needs to be administered six times a year eliminates some of the obstacles of access, but not entirely. "As with any new drug, affordability and insurance approval may limit its overall accessibility, particularly if a cheaper, oral option is available," Dr. Blumenthal says. (Cost of the injectable drug has not yet been released.) Additionally, she points out that it still requires regular access to a medical provider, pharmacy, and reliable transportation.
Still, the new treatment method excites them both. "It makes it even easier for women to get and stay protected from HIV, which is what we want—to lower the barriers to effective prevention and treatment as much as possible so that people who need it can get it," Dr. Meyer says. "The more safe and effective options we have for women the better- then we can empower them to make informed choices."
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