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Gilead announced that its twice-yearly injection lenacapavir worked with 100% efficacy at preventing HIV infections in a late-stage clinical trial.
The pharma giant’s stock rose over 9% to about $69 on Thursday following the company’s announcement.
“With zero infections and 100% efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections,” said Gilead chief medical officer Merdad Parsey in a press release.
The double-blind phase 3 trial involved over 5,300 cisgender women in South Africa and Uganda.
All 2,134 women who were given lenacapavir were found to not have been infected with HIV in an interim analysis of the study.
In comparison, there were 39 HIV cases in a group of 2,136 women who were given the antiviral pill Descovy. And there were 16 cases of infection in the group of 1,068 people that were given Truvada. Descovy and Truvada, both of which are produced by Gilead, are approved by the U.S. Food and Drug Administration to prevent HIV infections.
Gilead said it ended the trial early after an independent data monitoring committee recommended the company to offer lenacapavir to all study participants.
The company expects to announce results of a second trial of the drug, which is being tested on other populations including cisgender men who have sex with men, in late 2024 or early 2025.
Gilead plans to submit results from both trials for regulatory approval.
Lenacapavir is already FDA-approved when used in combination with other antivirals for people with multi-drug resistant HIV.
Gilead said in April that its sales rose 5% year over year to $6.7 billion in the first quarter of 2024.