Gilead Sciences' innovative long-acting HIV-1 therapy, lenacapavir, has secured FDA approval for pre-exposure prophylaxis (PrEP) against HIV, pioneering as the first HIV prevention drug necessitating only two injections annually. This novel drug, a long-acting HIV capsid inhibitor without cross-resistance, gained approval on the strength of favorable outcomes from two Phase III clinical trials, PURPOSE 1 and PURPOSE 2, which demonstrated a markedly reduced HIV infection rate in the lenacapavir group versus the control group. Recognizing its groundbreaking potential, Science magazine named lenacapavir the "Breakthrough of the Year" for 2024.