Gilead's experimental twice-yearly medicine to prevent HIV was 100% effective in a late-stage trial, the company said Thursday.
Gilead needs to replicate the results in another Phase 3 trial before seeking FDA approval. The company expects to share more data later this year or early next year.None of the roughly 2,000 women in the trial who received Gilead's shot lenacapavir 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.
Before seeking FDA approval, Gilead will first need to replicate these results. The company expects to share data from an ongoing Phase 3 study of men who have sex with men later this year or early next year. "It's really important to have more options than daily pills because the orals aren't going to get us to the end of the epidemic," said, founding executive director of the nonprofit Prevention Access Campaign. "We need to make sure that people have options to fit with their lifestyles."the first injectable PrEP in 2021. That drug, Apretude, is given every other month, or six times a year, by a medical professional.
RBC Capital Markets analyst Brian Abrahams expects Gilead's shot will significantly increase the number of people interested in preventative HIV medicine. He estimates peak sales of nearly $2 billion. Gilead's newer PrEP pill Descovy recorded about $2 billion of revenue last year.
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