POTENTIAL NEW PrEP EXPOSES GAPS IN DATA FOR WOMEN — Among all the CAR-T commotion you may have missed it: An FDA panel on Wednesday recommended Gilead’s Descovy to block HIV transmission in men and transgender women, a step toward another PrEP finally coming to market (the sole medicine right now being Gilead’s Truvada). One potential snag — the advisory committee narrowly voted not to recommend the medicine, which is already approved to treat HIV, for women who are not transgender, also referred to as cisgender women.
Why? Simply put, there isn’t enough specific data on women. Though Descovy is very similar to Truvada, its key ingredient, tenofovir, is delivered a slightly different way, translating to different side effects. But even Truvada doesn’t have much historical data for non-transgender women, making comparisons between the two very difficult. Enrolling enough women (thousands) to glean that data for both drugs could take years.
Members of the Antimicrobial Drugs Advisory Committee were not pleased. One panelist who ultimately voted no on recommending it for women said it wasn’t just “bad science” to lack the data but also “an issue of research equity.”
“I don’t think anyone was thrilled with their vote yes or no on cisgender women,” Mitchell Warren, executive director of Global Advocacy for HIV Prevention, told POLITICO. Warren, who spoke at the hearing, pushed for FDA and Gilead to “be creative” with requirements to collect real-world data on women rather than limiting Descovy’s approval out of the gate. Read more via Politico