HIV Preventative Drug Not Tested on Nor Approved for Female Patients

Dec 2, 2019 | Female Patients, HIV, Inclusivity, PrEP

HIV Preventative Drug Not Tested On nor Approved for Female Patients

According to the website for the HIV preventative drug, Descovy, it has not been tested for females who engage in sex vaginally. This means that more than half the population of the world has been excluded from the clinical trials that could have helped prevent HIV in a high at-risk population. 

As Assistant Commissioner for the Bureau of HIV/AIDS Prevention and Control for the NYC Health Department, Oni Blackstock, MD, MHS, oversees and supervises all programmatic and administrative activities for the Bureau of HIV/AIDS. She is also a primary care physician, HIV specialist and researcher.

According to an article by Blackstock, Gilead Sciences, which manufactures Truvada, sought Food and Drug Administration approval to market Descovy, its anti-HIV therapy, as a PrEP regimen. According to the company, it would have required too many resources to enroll a sufficient number of cisgender women into a trial and closely monitor their adherence to the daily pill regimen. The company presented the FDA with data only from a clinical trial involving men who have sex with men, and men who had sex with transgender women.

So, when the FDA approved Descovy for PrEP last month, it did not approve it for those “at risk from receptive vaginal sex,” but only for men who have sex with men and transgender women. Members of the FDA advisory committee, however, had cited significant concerns that cisgender women were not included in studies presented for the drug’s licensing.

According to

  • In 2018, there were an estimated 18.8 million women living with HIV (aged 15 and older), constituting 52% of all adults living with HIV.
  • In 2018, more than 46% of the estimated 1.6 million new HIV infections in adults globally were among women.
  • In 2018, new infections among young women (aged 15-24 years) were 555 higher than among men in the same age group.

PrEP is a breakthrough HIV strategy that, when taken as a daily pill, is more than 90% effective at preventing sexually acquired HIV. The first drug for PrEP, Truvada, has become an essential tool for bringing us closer to ending the HIV epidemic in the U.S. and around the world. So, why was the female population been excluded from the clinical trial for Descovy, and why would the FDA not require that this high risk population be included in the trial?

Blackstock says “Gilead’s decision to exclude cisgender women from its clinical trials for Descovy appears nothing short of profit-driven” as the use of PrEP among men who have sex with men in the U.S. has skyrocketed by approximately 500% since 2014, while its use among cisgender women has essentially flatlined.

Source: STAT


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