Gilead has expanded the scope of its 6 royalty-free voluntary licensing agreements for lenacapavir to include investigational once-yearly lenacapavir for HIV prevention as Pre-Exposure Prophylaxis (PrEP). The agreements cover 120 high-incidence countries (which are primarily low- and lower-middle-income) and will support manufacturing readiness, technology transfer and future supply planning while the phase 3 PURPOSE 365 trial is ongoing.

If approved, once-yearly lenacapavir could provide a full year of HIV prevention with a single annual dose, expanding prevention choice and helping address barriers that can limit PrEP uptake and persistence.

PURPOSE 365 is an ongoing phase 3 study evaluating the pharmacokinetics, safety and tolerability of investigational once-yearly intramuscular lenacapavir for HIV prevention.

Across the phase 3 PURPOSE 1 and PURPOSE 2 trials, twice-yearly lenacapavir demonstrated unprecedented efficacy for HIV prevention, delivering protection against HIV acquisition across diverse populations while showing superiority to a daily oral PrEP comparator.

Gilead is extending its global access model for twice-yearly lenacapavir for HIV prevention to enable broad and sustainable access to multiple generic long-acting HIV prevention options.

The expanded agreements represent one of the earliest HIV PrEP access planning efforts undertaken during phase 3 development and build on Gilead's 2 decades of experience developing global access pathways for HIV medicines, including unprecedented work for twice-yearly lenacapavir.

Johanna Mercier, Chief Commercial and Corporate Affairs Officer, Gilead Sciences, said, “Investigational once-yearly lenacapavir for HIV prevention has the potential to add a discreet, extended-duration prevention option that, if approved, could be especially important in high-incidence, resource-limited settings, where people often face significant barriers to accessing and staying on PrEP. By establishing voluntary licensing agreements this early in our development process, we are hoping to provide additional time to support manufacturing readiness, healthcare system preparation and community engagement. This supports our goal of helping to ensure that, if approved, the path from innovation to impact has the potential to be shorter, broader and more equitable.”

The expanded agreements have been signed between Gilead and the 6 voluntary licensing partners who are manufacturing twice-yearly lenacapavir for HIV prevention as PrEP: Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Eva Pharma for Pharmaceutical Industries S.A.E., Ferozsons Laboratories, Hetero and Mylan Laboratories, a subsidiary of Viatris.

These manufacturers were selected based on their demonstrated capabilities in producing complex, sterile injectable medicines and their long-standing experience as voluntary licensing partners with Gilead.