Independent Data Monitoring Committee Recommended That Gilead Stop the Blinded Phase of the PURPOSE 1 Trial at Interim Analysis and Offer Open-Label Lenacapavir to All Participants.
Gilead Sciences Canada announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100 per cent efficacy for the investigational use of HIV prevention in cisgender women.
HIV remains an epidemic in Canada, with six Canadians dying on average every week of HIV-related illnesses and 35 more diagnosed with HIV each week.i While currently available oral HIV prevention options can reduce the risk of acquiring sexually transmitted HIV by more than 90 per cent when taken as prescribed,ii barriers remain including low awareness of transmission behaviours and prevention, recurring medication use, stigma and discrimination.ii
PURPOSE 1 met its key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV). Based on these results, the independent Data Monitoring Committee (DMC) recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.
„With early data showing zero infections and 100 per cent efficacy, twice-yearly lenacapavir has potential as a new option to prevent HIV transmission,“ said Wendy Arnott, Executive Director of Medical Affairs, Gilead Sciences Canada. „We remain focused on our goal of ending the HIV epidemic globally and here in Canada. We look forward to seeing further results from the PURPOSE clinical program.“
These are the first data generated from Gilead’s landmark PURPOSE program, which is the most comprehensive and diverse HIV prevention trial program ever conducted. The PURPOSE program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity.
– First Phase 3 HIV Prevention Trial to Show Zero Infections –
– Independent Data Monitoring Committee Recommended That Gilead Stop the Blinded Phase of the PURPOSE 1 Trial at Interim Analysis and Offer Open-Label Lenacapavir to All Participants –
MISSISSAUGA, ON, June 26, 2024 /CNW/ – Gilead Sciences Canada announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100 per cent efficacy for the investigational use of HIV prevention in cisgender women.
HIV remains an epidemic in Canada, with six Canadians dying on average every week of HIV-related illnesses and 35 more diagnosed with HIV each week.i While currently available oral HIV prevention options can reduce the risk of acquiring sexually transmitted HIV by more than 90 per cent when taken as prescribed,ii barriers remain including low awareness of transmission behaviours and prevention, recurring medication use, stigma and discrimination.iii
PURPOSE 1 met its key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV). Based on these results, the independent Data Monitoring Committee (DMC) recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.
„With early data showing zero infections and 100 per cent efficacy, twice-yearly lenacapavir has potential as a new option to prevent HIV transmission,“ said Wendy Arnott, Executive Director of Medical Affairs, Gilead Sciences Canada. „We remain focused on our goal of ending the HIV epidemic globally and here in Canada. We look forward to seeing further results from the PURPOSE clinical program.“
These are the first data generated from Gilead’s landmark PURPOSE program, which is the most comprehensive and diverse HIV prevention trial program ever conducted. The PURPOSE program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity.
Topline PURPOSE 1 data
PURPOSE 1, a Phase 3, double-blind, randomized study, is evaluating the safety and efficacy of twice-yearly, subcutaneous lenacapavir for pre-exposure prophylaxis (PrEP) and once-daily oral Descovy® (emtricitabine 200mg and tenofovir alafenamide 25mg; F/TAF) in more than 5,300 cisgender women and adolescent girls aged 16-25 across 25 sites in South Africa and three sites in Uganda. The drugs are being tested in parallel, with one group receiving twice-yearly lenacapavir and one group taking once-daily oral Descovy. Additionally, a third group was assigned once-daily oral Truvada. Study participants were randomized in a 2:2:1 ratio to lenacapavir, Descovy and Truvada, respectively. Because effective PrEP options already exist, there is broad consensus in the PrEP field that a placebo group would be unethical; thus, the trial used bHIV as the primary comparator and Truvada as a secondary comparator.
There were 0 incident cases of HIV infection among 2,134 women in the lenacapavir group (incidence 0.00 per 100 person-years). There were 16 incident cases among 1,068 women in the Truvada group (incidence 1.69 per 100 person-years). The results demonstrated superiority of twice-yearly lenacapavir over bHIV (primary endpoint, incidence 2.41 per 100 person-years) and superiority of twice-yearly lenacapavir over once-daily Truvada (secondary endpoint), with p<0.0001 for both endpoints. In the trial, lenacapavir was generally well-tolerated and no significant or new safety concerns were identified.
HIV incidence in the Descovy group was numerically similar (39 incident cases among 2,136 women, incidence 2.02 per 100 person-years) to that in the Truvada group and was not statistically superior to bHIV. Previous clinical trials among cisgender women have commonly found challenges with adherence to daily oral pills for PrEP, and adherence analyses for Descovy and Truvada from PURPOSE 1 are ongoing. In the trial, both Descovy and Truvada were generally well-tolerated and no new safety concerns were identified. More detailed data from PURPOSE 1 will be presented at a future conference.
The use of lenacapavir and the use of Descovy for the prevention of HIV in cisgender women are investigational and have not been determined to be safe or efficacious and are not approved anywhere globally.
