The drug, Lenacapavir, has shown exceptional promise in clinical trials, including research conducted in Houston.
In Harris County, new HIV cases are diagnosed at a significantly higher rate than the national average, according to the Centers for Disease Control and Prevention.
Dr. Gordon Crofoot, a Houston-based infectious disease expert who participated in the medical trials, said he believes FDA approval is likely. The timing is significant as the world celebrates Pride Month.
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Currently, the primary HIV prevention method is a once-daily pill known as PrEP (pre-exposure prophylaxis). While highly effective, PrEP remains underutilized, especially among communities most at risk.
That includes Black and Latino populations, women, and residents of southern states like Texas. Experts point to limited awareness, stigma, and access challenges as key obstacles.
Lenacapavir, if approved, would offer a discreet and convenient alternative. Early trial results have shown zero HIV infections among participants who received the medication every six months.
Still, its high cost could limit access to the populations it aims to help. Dr. Crofoot said.
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"This drug is being pushed to target the hardest groups to treat, which are often the underfinanced and underinsured groups. So, we have this huge barrier to this fabulous 100% effective therapy to prevent transmission and $40,000 right now to make that happen," Dr Crofoot said.
Dr. Crofoot added that several companies are already working on more affordable, generic versions of Lenacapavir, which could help expand access if and when the drug becomes available.
The FDA is expected to decide by June 19 at the latest.
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