A pharmacist holds a bottle of Lenacavir, a new HIV preventive injectable drug.
Naders Engelbrecht | Associated Press
GileadPhotography twice a year Reduce HIV infection In a second large study, that number fell by 96%, the company said Thursday.
Positive data from a Phase 3 trial of lenacavir pave the way 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 more than 1% on Thursday.
The company said 99.9% of participants treated with lenacavir were HIV-free, including two cases of infection 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.
In a group of more than 1,000 people, nine people living with HIV were assigned to receive Truvada, Gilead’s older daily drug for prevention and treatment. drug. The company said lenacapavir was 89% more effective than Truvada in the study.
Gilead said Lenacapavir and Truvada were “generally well tolerated” by patients and that no new safety concerns arose. The drugmaker plans to present detailed data at an upcoming medical meeting.
Gilead also said in June that lenacapavir 100% effective Preventing HIV in another late-stage trial in cisgender women. As of an interim analysis in September, none of the roughly 2,000 women who received the shot in the study had contracted HIV.
Overall, the data on lenacavir was “robust and consistent across both studies and populations,” Jefferies analyst Michael Yee said in a research note Thursday. of”.
Yee said the trial results should lead to FDA approval and a market launch in 2025.
