A pharmacist holds a vial of lenacapavir, a new injectable drug to protect against HIV.
Nardus Engelbrecht | AP
Gilead‘s twice-yearly shot reduced HIV infections by 96% in the second major study, the company said Thursday.
Positive phase three trial data for lenacapavir pave the way for presumptive approval by the US Food and Drug Administration for HIV prevention.
“Now that we have a comprehensive data set across multiple study populations, Gilead will urgently work with regulatory, government, public health and community partners to ensure that, if approved, we can deliver twice-yearly lenacapavir for PrEP worldwide for everyone who wants it. or need PrEP,” said Gilead CEO Daniel O’Day.
According to the Centers for Disease Control and Prevention, PrEP, or pre-exposure prophylaxis, is a medication taken to prevent HIV infection.
Shares of Gilead rose nearly 3% in premarket trading Thursday.
The company said 99.9% of participants taking Lenacapavir were HIV-free, with two cases among 2,180 people. The trial included cisgender men, transgender men, transgender women, and non-binary people who were sexually active with their male-assigned partners at birth.
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