Gilead data lends insight into transforming HIV prevention landscape

New clinical trial findings show that twice-yearly lenacapavir for HIV pre-exposure prophylaxis (PrEP) had high efficacy and safety in a diverse group of participants.

This data provides the first in-depth insight into full results of Gilead Sciences pivotal Phase III PURPOSE 2 trial.

In the oral PrEP study group, adherence to the small molecule injectable HIV-1 capsid inhibitor and placebo injections was 91.0 percent with on-time injections at week 26, the results showed.

The investigators found a lower of HIV infections in individuals who were given lenacapavir. A total of 99.9 percent of the 2,179 participants did not acquire HIV in the group, according to Gilead.

Additionally, the results showed that compared to a once-per-daily dose of Truvada^® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg), a twice-yearly dose of lenacapavir was 89 percent more effective at reducing these infections in participants.

Gilead HIV Phase III trial – impact of the new findings

“A twice-yearly choice for HIV prevention, if approved, could be transformative as we work toward achieving the UNAIDS 2030 targets around the world,” commented PURPOSE 2 Principal Investigator Onyema Ogbuagu, MBBCh, FACP, FIDSA, Associate Professor of Medicine and Pharmacology at Yale School of Medicine and Director of the Yale Antivirals and Vaccines Research Program, US.

“Lenacapavir for PrEP could provide an important alternative to existing preventative medications that require more frequent dosing, and could help transform the HIV prevention landscape by addressing a range of unmet needs for individuals who need or want PrEP globally,” Ogbuagu added.

Lenacapavir for PrEP was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) in October.

This newly released data was presented at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow) and will be published in The New England Journal of Medicine.