Gilead’s twice-yearly shot to prevent HIV succeeds in late-stage trial

Gilead's experimental twice-yearly medicine to prevent HIV was 100% effective in a late-stage trial, the company said Thursday.

None of the roughly 2,000 women in the trial who received the lenacapavir shot had contracted HIV by an interim analysis, prompting the independent data monitoring committee to recommend Gilead unblind the Phase 3 trial and offer the treatment to everyone in the study. Other participants had received standard daily pills.

The results bring Gilead one step closer to introducing a new form of pre-exposure prophylaxis, or PrEP, and broadening its HIV business. Shares of the company rose about 7% onThursday. 

"What the world needs is people to have more PrEP options so they can make the choice of the option that's going to work best for them," said Jared Baeten, Gilead's vice president of clinical development for HIV. 

Before seeking approval from the Food and Drug Administration, Gilead will first need to replicate these results. The company expects to share data later this year or early next year from an ongoing Phase 3 study of men who have sex with men.If those results are positive, the company could bring lenacapavir for PrEP to market as soon as late 2025.

More than a decade ago, Gilead's Truvada became the first approved PrEP for people without HIV who are at high risk of acquiring it. Daily pills dominate the market, but drugmakers are now focusing on developing longer-acting shots.

PrEP slashes the risk of getting HIV from sex by 99%, and from injected drug use by 74% when taken correctly. Yet only a little more than one-third of people in the U.S. who could benefit from PrEP take it, according to data from the Centers for Disease Control and Prevention.

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