PURPOSE Phase 3 preliminary study results - Injectable PrEP

[Jim Allen]

POZ.com:

https://www.poz.com/article/nih-statement-preliminary-efficacy-results-twiceyearly-lenacapavir-hiv-prevention-cisgender-women

&

https://www.poz.com/article/twiceyearly-lenacapavir-prep-prevents-hiv-women

The injectable antiretroviral drug lenacapavir was safe and 100% effective as long-acting HIV pre-exposure prophylaxis (PrEP) among cisgender women in a Phase 3 clinical trial, according to top-line findings released by Gilead Sciences, Inc., the study sponsor.  Lenacapavir is administered every six months, making it the most durable HIV prevention method to have shown efficacy in this population.

NIAID applauds the study sponsor, investigators, study staff, and—most importantly—the participants in South Africa and Uganda, for contributing to this scientific advance for cisgender women, a population for whom biomedical HIV prevention evidence has been limited to date. We look forward to the release of additional data from this pivotal study, as well as the outcomes of companion studies of lenacapavir in other populations, to inform regulatory decisions on this novel PrEP method.

This study was mentioned in passing whilst discussing the CAPELLA trial in 2021 https://forums.poz.com/index.php?topic=75017.msg

[Matts]

I read some articles that Lenacapavir injectables "maybe could end HIV" and so on...
Maybe if it will be available worldwide for a cheap price...
We will see what will happen int he future when phase III results will be available.

A statement from UNAIDS I wanted to post:
"GENEVA, 10 July 2024— UNAIDS has welcomed the release of Gilead Sciences’ trial results on the injectable long-acting HIV medicine Lenacapavir for HIV prevention. The result “provides hope of accelerating efforts to end AIDS”, UNAIDS says, “but only if Gilead ensures that all people who need it can have access to this game-changing medicine....

“The success of Gilead’s recent Lenacapavir trial is an exciting development. While we still await regulatory approvals, normative guidance and results from the other ongoing trials, this news offers hope that we can enable everyone who would benefit, including especially the most marginalised communities, to have access to the help they need. Enabling equitable global access to new technologies can help get the world on track to end AIDS as a public health threat by 2030,” said Winnie Byanyima, Executive Director of UNAIDS. "However, it is concerning that Gilead’s latest announcement seems to mention neither upper-middle income countries, where people cannot afford anything like Lenacapavir’s current $42,250 price tag, nor a commitment to work with the UN-backed Medicines Patent Pool. Without these safeguards, it cannot be assured that this game-changing medicine will reach all those who need"

https://www.unaids.org/en/resources/presscentre/pressreleaseandstatementarchive/2024/july/20240710_lenacapavir