Gilead Lenacapavir diminished HIV infections by 96% within the trial

A pharmacist holds an ampoule of lenacapavir, the new injectable drug for HIV prevention.

Nardus Engelbrecht | AP

GileadThe twice-yearly HIV vaccination reduced HIV infections by 96 percent in a second large study, the company announced on Thursday.

The positive results of the Phase 3 study on Lenacapavir create the conditions for a likely approval of the drug for HIV prevention by the US health authority FDA.

“Now that we have a comprehensive dataset from multiple study populations, Gilead will urgently work with regulators, governments, public health and community partners to ensure that, if approved, we can supply lenacapavir twice-yearly for PrEP to everyone who wants or needs PrEP globally,” Gilead CEO Daniel O'Day said in a statement.

PrEP, or pre-exposure prophylaxis, is a medication used to prevent HIV infection, according to the Centers for Disease Control and Prevention.

Gilead shares rose more than 1 percent on Thursday.

The company said 99.9% of participants who received lenacapavir did not become infected with HIV. There were two cases among 2,180 people. The study included cisgender men, transgender men, transgender women, and gender nonbinary people who have sex with partners assigned male at birth.

There were nine cases of HIV in a group of more than 1,000 people who received Truvada, Gilead's older daily pill for prevention and treatment. The company said lenacapavir was 89 percent more effective than Truvada in the study.

Lenacapavir and Truvada were also “generally well tolerated” by patients, according to Gilead, and there were no new safety concerns. The drugmaker plans to present detailed data at an upcoming medical conference.

Gilead also said in June that lenacapavir was 100% effective in preventing HIV in another late-stage study of cisgender women. As of an interim analysis in September 2023, none of the approximately 2,000 women in the study who received the vaccine had become infected with HIV.

In a research note Thursday, Jefferies analyst Michael Yee said overall the data on lenacapavir were “solid and consistent across both studies and populations.”

The test results should lead to FDA approval and market launch by 2025, Yee said.

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