ICYMI: FDA Approves HIV Prevention Drug That Isn’t Safety Tested for All

By Ayana Byrd Oct 09, 2019

Since 2012, Truvada has been the only drug approved by the United States Food and Drug Administration (FDA) to prevent HIV infection. But on October 3, the government agency approved a second drug: Descovy. But the new drug is not approved for use by some of the people who are at high risk for infection.  

Descovy, manufactured by Gilead Sciences, excludes “individuals who have receptive vaginal sex,” writes the FDA in a statement. This means it is not deemed safe for cisgender women and many transgender men. Reports The New York Times:


Gilead tested Descovy in a multinational trial that included 5,313 men and 74 transgender women who have sex with men. There were no cisgender women or transgender men, and 84 percent of the participants were White.

Pending requirements from the FDA, Gilead, which also makes Truvada, has until December 2024 to complete a trial that includes cisgender women. Accordingly, it is planning a study of at least 1,500 high-risk women in southern Africa by the end of 2020.

Excluding cisgender women and other groups at risk of HIV infection “should be unacceptable in these days and times,” Dr. Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital, told The Times. The physician added that the drug may work differently in the vagina than it does in rectal tissues.

According to the Centers for Disease Control and Prevention (CDC), around one in four people living with HIV is a woman. Among all women, Black women are disproportionately more likely to receive a diagnosis; they are diagnosed at 15 times the rate of White women.

“[Gilead Sciences] did a terrible job of inclusion for a company that dominates the market,” Jeremiah Johnson, a project director at advocacy organization Treatment Action Group, told The Times.

Truvada, which is more commonly referred to as PrEP, is considered to be 90 percent effective at preventing HIV infection via sex, and more than 70 percent effective at blocking it from drug injections. Yet its high cost—up to $2,000 per month if not covered by health insurance—means that only a fraction of those who are eligible to take the prescription drug actually do. In response, on Monday, (October 7), California became the first state to allow pharmacies to dispense it over the counter without a doctor’s prescription.