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Gilead Sciences has expanded six royalty-free voluntary licensing agreements for lenacapavir to include its investigational once-yearly formulation for HIV pre-exposure prophylaxis (PrEP).  

The expanded agreements cover 120 high-incidence countries, primarily low- and lower-middle-income markets, and will support manufacturing readiness, technology transfer and future supply planning while Gilead conducts the Phase 3 PURPOSE 365 trial.

The move could have important implications for HIV prevention in Africa, where long-acting PrEP options may help address some of the barriers associated with daily oral medication and frequent healthcare visits.

Potential for once-yearly HIV prevention

PURPOSE 365 is evaluating the pharmacokinetics, safety and tolerability of investigational once-yearly intramuscular lenacapavir for HIV prevention. The Phase 3 study is designed to determine whether a single injection can maintain drug concentrations associated with HIV prevention throughout a 52-week dosing interval.

If successful and approved by regulators, once-yearly lenacapavir could provide a full year of HIV prevention with a single annual dose.

The approach could expand prevention choices for people who face challenges with daily medication, stigma, privacy concerns or frequent healthcare interactions. However, once-yearly lenacapavir remains investigational and has not been approved by any regulatory authority, and its safety and efficacy for this use have not yet been established.

Gilead Chief Commercial & Corporate Affairs Officer Johanna Mercier said establishing voluntary licensing agreements during Phase 3 development could give manufacturers, healthcare systems and communities more time to prepare for potential introduction.

The six licensing partners are Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Eva Pharma, Ferozsons Laboratories, Hetero and Mylan Laboratories, a subsidiary of Viatris. The companies were selected based on their experience manufacturing complex sterile injectable medicines and their existing voluntary licensing relationships with Gilead.

Addressing gaps in PrEP access

The announcement comes amid continued gaps in global HIV prevention coverage.

Gilead cited an estimated 1.2 million new HIV infections globally in 2025, while fewer than 4 million people were using PrEP globally in 2024. This remains well below the global target of more than 21 million people.

Expanding the range of PrEP options is therefore becoming increasingly important. Different dosing schedules may help address barriers including stigma, healthcare access, privacy and the challenges of maintaining daily medication routines.

For people who find daily PrEP difficult to maintain, a long-acting option could offer greater flexibility. A once-yearly product could potentially reduce the frequency of healthcare visits even further, although its eventual public-health impact will depend on clinical results, regulatory approval, affordability, healthcare infrastructure and community acceptance.

These issues are particularly relevant to Africa, which continues to carry a substantial share of the global HIV burden.

Building a sustainable supply network

Gilead's licensing expansion builds on its broader strategy to establish sustainable access pathways for long-acting lenacapavir.

The company has expanded commitments through partnerships with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund, increasing the planned reach of its no-profit supply programme from 2 million people to up to 3 million people through 2028.

According to Gilead, twice-yearly lenacapavir for HIV prevention is now available in 10 countries across sub-Saharan Africa. Licensed manufacturers, governments and implementation partners are also preparing for future generic availability.

The strategy is intended to create multiple sources of long-acting HIV prevention medicines and support broader, more sustainable access.

Earlier in September, Gilead also announced an agreement with the Pan American Health Organization (PAHO) to accelerate access to twice-yearly lenacapavir for HIV prevention across Latin America and the Caribbean through PAHO's Regional Revolving Funds.

From twice-yearly to once-yearly prevention

Lenacapavir has attracted significant attention because of its long-acting profile and its ability to act at multiple stages of the HIV lifecycle.

In the Phase 3 PURPOSE 1 and PURPOSE 2 trials, twice-yearly lenacapavir demonstrated high efficacy in preventing HIV acquisition and was superior to a daily oral PrEP comparator.

PURPOSE 365 is now exploring whether the dosing interval can be extended to an entire year.

Researchers are assessing whether drug concentrations following a single intramuscular dose remain at levels associated with HIV prevention for 52 weeks, while also monitoring safety and tolerability.

If successful, a once-yearly formulation could simplify prevention delivery by reducing administration to one healthcare visit annually. Nevertheless, clinical evidence will need to establish its efficacy and safety before regulatory authorities can consider approval.

What it could mean for Africa

For African health systems, the potential value of once-yearly PrEP extends beyond the medicine itself.

A longer-acting prevention option could reduce the frequency of medication refills and healthcare visits while providing an alternative for people who struggle with daily oral PrEP. Implementation would nevertheless require reliable supply chains, trained healthcare workers, injection capacity, pharmacovigilance systems and sustainable financing.

The early licensing agreements could help address supply readiness by allowing manufacturers to prepare for production and technology transfer ahead of potential approval.

Ultimately, the availability of multiple long-acting PrEP options could give HIV prevention programmes greater flexibility. Whether this translates into significantly higher PrEP uptake will depend on factors including price, regulatory approval, procurement, availability and integration into national HIV programmes.

For now, once-yearly lenacapavir remains investigational. PURPOSE 365 will provide critical evidence on whether a single annual injection can deliver sustained HIV prevention while meeting safety and tolerability requirements.

If successful and approved, early manufacturing preparation and voluntary licensing could help shorten the gap between regulatory approval and availability in countries with the greatest unmet need—potentially adding a new, longer-acting tool to Africa's HIV prevention arsenal.

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