Gilead shares positive phase 3 results for twice-yearly HIV PrEP drug in women
24 Jun 2024
Clinical ResultPhase 3Drug ApprovalPhase 1
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Source: PMLiVE
Gilead Sciences’ twice-yearly injectable pre-exposure prophylaxis (PrEP) drug lenacapavir has demonstrated 100% efficacy in protecting women against human immunodeficiency virus (HIV), according to new late-stage results shared by the company.
The phase 3 PURPOSE 1 study randomised more than 5,300 women and adolescent girls aged 16 to 25 years across sites in South Africa and Uganda to receive lenacapavir or one of Gilead’s once-daily oral PrEP drugs, Descovy (emtricitabine/tenofovir alafenamide) and Truvada (emtricitabine/ tenofovir disoproxil fumarate).
There were zero incident cases of HIV infection among the 2,134 women in the lenacapavir group and 16 among 1,068 of those in the Truvada group, Gilead said, adding that twice-yearly lenacapavir was superior to background HIV incidence (bHIV).
The results also showed that HIV incidence in the Descovy group was numerically similar to that in the Truvada group and not statistically superior to bHIV, and lenacapavir was generally well tolerated with no significant or new safety concerns identified.
Based on these results, an independent data monitoring committee has recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.
Merdad Parsey, Gilead’s chief medical officer, said: “With zero infections and 100% efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections.
“We look forward to additional results from the ongoing PURPOSE clinical programme and continuing toward our goal of helping to end the HIV epidemic for everyone, everywhere.”
PrEP is highly effective for preventing HIV when taken as prescribed. However, there are challenges surrounding adherence to daily oral therapies, including stigma and treatment persistence.
Lenacapavir was approved by the US Food and Drug Administration in 2022 under the brand name Sunlenca for use alongside other antiretrovirals to treat heavily treatment-experienced adults with multi-drug-resistant HIV-1 infection.
It is hoped that lenacapavir for PrEP could help address treatment barriers and increase adherence, given its twice-yearly dosing schedule.
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