Unitaid ready to invest immediately to support accelerated global access to lenacapavir

Geneva – Unitaid welcomes Gilead’s announcement that six generic manufacturers have been awarded voluntary licenses for the production of lenacapavir, a groundbreaking, twice-yearly injectable for HIV prevention and potentially for treatment in low- and middle-income countries. As part of Unitaid’s mission to support and accelerate the introduction of innovative tests, tools and treatments to address major global health challenges, Unitaid is prepared to invest immediately and collaborate to fast-track access to lenacapavir.

“Unitaid has a strong track record of getting new HIV medications to people in need faster than ever before, and we are ready to work with the generic manufacturers to help speed up the introduction of affordable lenacapavir for people at risk of HIV infection,” said Dr. Philippe Duneton, Unitaid’s Executive Director. “This is a potentially game-changing medication that could dramatically turn the tide against HIV infections, and we must ensure, without delay, global access to lenacapavir for all those who need it.”

As part of Unitaid’s ongoing investment to Wits RHI, in partnership with the Clinton Health Access Initiative (CHAI), to support market-shaping interventions for long-acting pre-exposure prophylaxis (PrEP), including lenacapavir, Unitaid will soon launch an Expression of Interest for generic lenacapavir licensees to indicate their interest in receiving support from the Unitaid-funded Project PrEP for the accelerated development, regulatory filing, commercialization, and cost-effective launch pricing for generic lenacapavir. Unitaid, Wits RHI, and CHAI, through decades of experience, are well positioned to provide technical, regulatory, market shaping, and implementation support to the generic manufacturers, thereby mitigating development and regulatory risks, accelerating approval timelines, and ensuring a strategy that enables a successful launch.  

Alongside key stakeholders, we are working to accelerate access and two critical objectives must guide our collective action now. First, we must enable immediate impact by ensuring a sufficient supply of product at the lowest possible price for all in need. Second, we must prepare and support the capacity to adopt it promptly, widely and effectively in order to drastically change the pattern of new infections

Unitaid enables equitable access through such work accelerating generic entry, alongside continued support to WHO, WHO Prequalification Program and the Medicines Patent Pool for broad, transparent and access-oriented licensing, and other intellectual property initiatives aiming at accelerating equitable access. In addition, Unitaid supports implementation science and demand generation with two pathfinder programs for long-acting HIV PrEP in Brazil (with Fiocruz) and in South Africa (via Wits RHI). This work will shorten the time for effective adoption of lenacapavir, once available.

These efforts, alongside those of communities, countries, and our partners to increase access to and smooth planning for the scale-up of this game-changing product, can be instrumental: with 3,500 new HIV infections per day, there is no time to lose.

An access strategy must be transparent, global, and equitable, prioritizing those in greatest need wherever they live. Countries and populations with high, growing, concentrated HIV epidemics – including countries that have led foundational work to make PrEP a reality, like Brazil – cannot be excluded from licensing agreements, and registration plans. This is essential for equity – and to ensure that lenacapavir reaches its full potential in helping eliminate HIV.

Furthermore, there is an urgent need to understand what pricing policies would be put forward by Gilead, and whether the same populations excluded today from the possibility of acquiring lower-cost generic products in the future, will also be left with unaffordable for-profit prices.

“We urge Gilead to expand its licensing framework to include all populations in need, clarify its plans for registration in all trial countries, and provide a clear timeline for when lenacapavir will be accessible in the countries it promises to serve,” said Dr. Duneton. “Together, we can turn this innovation into a reality for the millions of people whose lives depend on it.”