Press release: Full efficacy and safety results for Gilead investigational twice-yearly lenacapavir for HIV prevention presented at AIDS 2024

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PURPOSE 1 data showed zero infections and 100% efficacy and superiority of lenacapavir to background HIV incidence and daily Truvada® for PrEP.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced full efficacy and safety results from its pivotal, Phase 3 PURPOSE 1 trial. Detailed data from the trial’s interim analysis announced in June showed that lenacapavir, the company’s twice-yearly injectable HIV-1 capsid inhibitor, demonstrated zero infections, 100% efficacy and superiority to background HIV incidence for the investigational use of HIV prevention in cisgender women (women assigned female at birth). Lenacapavir also demonstrated superior prevention of HIV infections when compared with once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF).

The new data provide details on the efficacy, safety and tolerability of twice-yearly lenacapavir injections; drug adherence among trial participants, including poor levels of adherence to daily oral pre-exposure prophylaxis (PrEP) and high levels of adherence to lenacapavir; and demographic and behavioral characteristics of trial participants, including pregnant women and adolescents.

The data are being presented at a special late-breaking session at the 25th International AIDS Conference (AIDS 2024) in Munich, Germany and were published today in The New England Journal of Medicine.

Read the full press release here.

 

SEE ALSO:

Updated statement on global access planning for lenacapavir for HIV prevention

 

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