In clinical trials, this type of preventive drug, called pre-exposure prophylaxis (PrEP), can be 99% effective in stopping new HIV infections from sex.
In this double-blind, randomized study of 5,300 cisgender women in South Africa and Uganda, 2,134 got the injection and the others took one of two types of daily PrEP pills.
“It’s fantastic,” says Dr. Jason Zucker, an assistant professor of medicine and infectious disease expert at Columbia University Vagelos College of Physicians and Surgeons.
An ongoing PURPOSE 2 trial is analyzing lenacapavir’s efficacy among cisgender men, transgender men, transgender women and non-binary individuals who have sex with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States.
Since sharing lenacapavir’s early success, Gilead has announced that they intend to “deliver lenacapavir swiftly, sustainably and in sufficient volumes, if approved, to high-incidence, resource-limited countries.” Their access strategy includes developing a voluntary licensing program that would enable generic versions to be produced before the original patent expires.
When NPR asked Dr. Jared Baeten, Gilead’s vice president of HIV Clinical Development, about timeframes, he said that estimates will depend on "another trial, a regulatory review and approval."
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