Gilead's Biannual HIV Shot Shows Zero Infections in Trial

Gilead Sciences' experimental HIV drug, lenacapavir, has shown exceptionally promising results in preventing HIV infections among women. This was demonstrated in the first-ever phase 3 HIV prevention trial to report zero infections. In this groundbreaking study, the twice-yearly injectable lenacapavir was compared to the daily oral medication Truvada, a current standard for HIV prevention.

In the PURPOSE 1 trial, over 2,100 women received lenacapavir. Astonishingly, none of these women contracted HIV, while the Truvada group reported 16 infections. The significance of these results led the trial's independent monitoring board to recommend halting the blinded phase and offering lenacapavir to all participants.

Gilead Sciences is now conducting another extensive trial, PURPOSE 2, which aims to deliver results by late 2024 or early 2025. This trial will evaluate the effectiveness of lenacapavir for PrEP (pre-exposure prophylaxis) in a more diverse population, including cisgender men who have sex with men, transgender individuals, and gender-nonbinary people across various countries.

Lenacapavir is engineered to be a long-acting alternative to daily HIV prevention medications, addressing the challenge of adherence to daily pills. If approved, lenacapavir could significantly improve HIV prevention efforts. Gilead's goal is to submit a regulatory filing for lenacapavir for PrEP based on the results from both PURPOSE 1 and PURPOSE 2 trials.

In the United States, the HIV National Strategic Plan emphasizes viral suppression as a key success indicator. The specific goal is for 86% of people living with HIV to be virally suppressed on antiretroviral treatment by 2030. The promising results from lenacapavir trials could be a crucial step toward achieving this objective.