Gilead twice-yearly HIV shot delivers zero infections in trial

Gilead Sciences' experimental HIV drug, lenacapavir, has shown wildly promising results in preventing infection among women in the first phase 3 HIV prevention trial ever to show zero infections.

The twice-yearly injection was compared to daily oral Truvada, a current standard for HIV prevention.

In the PURPOSE 1 trial, none of the over 2,100 women given lenacapavir contracted HIV, whereas 16 infections occurred in the Truvada group. These results were significant enough for the trial's independent monitoring board to recommend stopping the blinded phase and offering lenacapavir to all participants.

Gilead is conducting another large trial, PURPOSE 2, expected to deliver results in late 2024 or early 2025. This trial will assess the effectiveness of twice-yearly lenacapavir for PrEP in a broader group, including cisgender men who have sex with men, transgender individuals, and gender-nonbinary people across several countries.

Lenacapavir is designed to be a long-acting alternative to daily medications for HIV prevention. If approved, it could help address challenges with adherence to daily pills. The goal now is to submit a regulatory filing for lenacapavir for PrEP with results from both PURPOSE 1 and PURPOSE 2. 

In the U.S., the HIV National Strategic Plan uses viral suppression as the main indicator of success. Specifically, the U.S. goal is for 86% of people living with HIV to be virally suppressed on antiretroviral treatment by 2030.