A pharmacist holds a bottle of Lenacavir, a new injectable HIV preventive drug.
Naders Engelbrecht | Associated Press
GileadThe twice-yearly shot reduced HIV infection rates by 96% in a second large study, the company said Thursday.
Positive data from a Phase 3 trial of Lenacapavi set the stage for possible U.S. Food and Drug Administration approval for HIV prevention.
“Now that we have a comprehensive data set spanning multiple study populations, Gilead will urgently work with regulatory, government, public health and community partners to ensure that, if approved, we can make PrEP available to everyone who wants it around the world. PrEP may be required to take nakavir twice a year,” Gilead CEO Daniel O’Day said in a statement.
According to the Centers for Disease Control and Prevention, PrEP, or pre-exposure prophylaxis, is a medication used to prevent contracting HIV.
Gilead shares rose about 3% in pre-market trading Thursday.
The company said 99.9% of participants who received Lenacapavi were HIV-free, with two cases among 2,180 people. The trial includes cisgender men, trans men, trans women and non-binary people who have sex with a partner assigned male at birth.