Thursday, Gilead Sciences, Inc. (NASDAQ: GILD) revealed the results of an interim analysis from a second Phase 3 trial investigating the use of the company's twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir.
Lenacapavir reduced HIV infections by 96% compared to background HIV incidence (bHIV).
There were two incident cases among 2,180 participants, corresponding to 99.9% of participants not acquiring HIV infection in the lenacapavir group.
Twice-yearly lenacapavir also demonstrated superiority to once-daily Gilead's Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; F/TDF).
There were nine incident cases among 1,087 individuals in the Truvada group (incidence 0.93 per 100 person-years).
Twice-yearly lenacapavir was 89% more effective than once-daily Truvada (incidence rate ratio 0.11, p=0.00245).
At the interim analysis, the independent Data Monitoring Committee (DMC) confirmed that the PURPOSE 2 trial met its key efficacy endpoints of the superiority of twice-yearly lenacapavir to both bHIV (primary endpoint) and once-daily oral Truvada (secondary endpoint) for pre-exposure prophylaxis (PrEP).
Therefore, the DMC recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.
In the trial, lenacapavir and Truvada were generally well-tolerated, and no significant or new safety concerns were identified.
In June, the PURPOSE 1 trial, studying lenacapavir for PrEP among cisgender women in sub-Saharan Africa, was also unblinded early because it met its key efficacy endpoints.
There were 0 incident cases of HIV infection among women in the lenacapavir group (incidence 0.00 per 100 person-years).
The PURPOSE 1 and PURPOSE 2 trial data will support upcoming regulatory filings.
Gilead will begin a series of global regulatory filings by the end of 2024. This could support the initial launch of the first and only twice-yearly HIV prevention choice in 2025.
The results demonstrated the superiority of twice-yearly lenacapavir over bHIV (incidence 2.37 per 100 person-years), with 96% relative risk reduction.
Price Action: GILD stock is up 2.24% at $82.75 at the last check Thursday.