Gilead hops straight to Phase III with once-yearly HIV PrEP shot

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New Once-Yearly Lenacapavir Formulation

  • Gilead has developed two experimental once-yearly intramuscular (IM) formulations of lenacapavir for HIV pre-exposure prophylaxis (PrEP)613.

  • These formulations were tested in a Phase 1 study with 40 healthy adult participants613.

  • Both formulations (one with 5% ethanol, one with 10% ethanol) demonstrated promising pharmacokinetic profiles, maintaining lenacapavir concentrations above the efficacy threshold for over 56 weeks613.

Phase 1 Results

  • The once-yearly formulations showed sustained plasma concentrations that surpassed the twice-yearly subcutaneous formulation previously tested613.

  • No severe adverse events were reported, indicating both formulations were well-tolerated613.

  • Pre-treatment with ice helped reduce injection site pain613.

Plans for Phase 3 Trial

  • Based on the positive Phase 1 results, Gilead plans to skip Phase 2 and move directly to initiating a Phase 3 trial later in 20251613.

  • The Phase 3 trial will determine which of the two formulations to pursue for further development613.

  • This accelerated development plan aims to potentially bring a once-yearly PrEP option to market more quickly1.

Potential Impact

  • If approved, a once-yearly injectable PrEP option could improve adherence and help more people stay on PrEP consistently613.

  • It may address challenges some individuals face with daily regimens or more frequent injectable options613.

  • Gilead hopes this could ultimately help reduce new HIV infections globally613.

The rapid progression to Phase 3 reflects Gilead's confidence in lenacapavir's potential as a long-acting HIV prevention option. However, further research is still needed to confirm its safety and efficacy as a once-yearly PrEP formulation.

Sources:

1. https://www.eatg.org/hiv-news/gilead-to-test-once-a-year-hiv-prevention-shot/

6. https://www.eatg.org/hiv-news/gileads-once-yearly-lenacapavir-formulations-show-sustained-efficacy-for-hiv-prep-in-phase-1-study/

13. https://www.contagionlive.com/view/gilead-s-once-yearly-lenacapavir-formulations-show-sustained-efficacy-for-hiv-prep-in-phase-1-study