Gilead Accelerates Global Access Strategy for Gilead Once-Yearly Lenacapavir in HIV Prevention Push

Gilead once-yearly lenacapavir global access planning has officially been accelerated by Gilead Sciences to expand access to long-acting HIV pre-exposure prophylaxis (PrEP) across high-burden countries. The biopharmaceutical company announced the expansion of its six existing royalty-free voluntary licensing agreements to incorporate the investigational once-yearly formulation of lenacapavir. This initiative covers 120 high-incidence, primarily low- and lower-middle-income countries (LLMICs), establishing manufacturing readiness, technology transfer, and supply logistics while late-stage clinical trials continue.

By extending its global access model during Phase 3 clinical development, Gilead aims to eliminate traditional multi-year delays between regulatory authorization and product availability in resource-constrained regions. The strategy enables generic manufacturing partners to prepare facilities and supply chains concurrently with clinical testing, ensuring a seamless transition following potential regulatory approvals.

The investigational once-yearly formulation builds upon Gilead’s existing twice-yearly lenacapavir regimen, which has already secured regulatory approval in multiple jurisdictions. By offering a single annual intramuscular injection, the therapy aims to significantly lower adherence barriers, mitigate social stigma associated with frequent dosing, and provide full-year coverage for vulnerable populations globally.

Phase 3 PURPOSE 365 Study and Generic Manufacturing Agreements

The clinical evaluation for the single annual dose is anchored by PURPOSE 365, an ongoing Phase 3 open-label study designed to evaluate the pharmacokinetics, safety, and tolerability of intramuscular lenacapavir for PrEP. The trial investigates whether a single annual dose can reliably sustain target drug concentrations over a 52-week dosing interval. PURPOSE 365 builds on data from the landmark PURPOSE 1 and PURPOSE 2 Phase 3 trials, where twice-yearly lenacapavir demonstrated unprecedented efficacy and statistical superiority over daily oral PrEP options.

Learn More

Roche Vabysmo PCV Study Shows Sustained Two-Year Results in Difficult-to-Treat nAMD Subtype

To execute generic production across 120 target nations, Gilead expanded voluntary licensing deals with six global manufacturers possessing specialized expertise in sterile injectable production. These key partners include Dr. Reddy’s Laboratories Limited, Emcure Pharmaceuticals Limited, Eva Pharma for Pharmaceutical Industries S.A.E., Ferozsons Laboratories Limited, Hetero, and Mylan Laboratories Limited (a subsidiary of Viatris). The agreements allow these manufacturers to prepare production facilities and initiate technology transfer ahead of regulatory approvals.

This proactive manufacturing coordination aims to rapidly meet demand upon regulatory greenlights, addressing historically severe disparities in long-acting drug availability between high-income nations and resource-limited regions.

Global Supply Expansion for Gilead Once-Yearly Lenacapavir

In tandem with voluntary licensing frameworks, Gilead expanded its no-profit supply commitments by 50 percent, increasing its target reach from 2 million to up to 3 million individuals through 2028. This direct supply allocation is supported through deepened collaborations with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis and Malaria. Twice-yearly lenacapavir is currently available across 10 countries in sub-Saharan Africa under this access model.

Beyond sub-Saharan Africa, Gilead established an agreement with the Pan American Health Organization (PAHO) to streamline distribution across Latin America and the Caribbean. Utilizing PAHO’s Regional Revolving Funds, the framework establishes a unified regional pathway to accelerate regulatory filings and country-level implementation.

The urgency behind these multi-tiered access efforts is underscored by global epidemiological data from UNAIDS. Official figures indicate that fewer than 4 million individuals utilized PrEP globally in 2024 falling short of the international benchmark of 21 million users. With an estimated 1.2 million new HIV acquisitions recorded globally in 2025, expanding long-acting options remains pivotal to achieving global HIV prevention targets.

Learn More

GSK Ris-Rez SCLC Data: Phase III Trial Cuts Risk of Death by 54% Versus Topotecan

Structured Clinical, Access, and Epidemiological Data

Generic Manufacturing Partners Matrix