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Gilead Sciences partners with PEPFAR to enhance access to Lenacapavir for HIV prevention, aiming to support over 2 million people in resource-limited countries.
Pepfar will support deliveries of Lenacapavir for PrEP in high occurring, resource-limited countries.
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Gilead Sciences announced its partnership with the U.S. State Department and the United States President’s Emergency Plan for AIDS Relief (PEPFAR). The partnership assists Gilead in its expanded coordination efforts, advancing accesses to Lenacapavir for pre-exposure prophylaxis (PrEP) for upwards of 2 million people spanning three years in countries that support both organizations.
Daniel O’Day, chairman and chief executive officer of Gilead Sciences, touched on the support that Gilead will receive, saying, “The support of the U.S. State Department through PEPFAR will accelerate access to Lenacapavir and move us closer to ending the HIV epidemic. Lenacapavir is one of the most important scientific breakthroughs of our time and the result of nearly two decades of work by Gilead scientists. We are providing the medicine at no profit in this partnership so we can support the U.S. government in delivering life-saving programs where the need is most urgent.”1
Gilead’s access strategy enables broad, sustainable access to Lenacapavir for PrEP in low-and lower-middle-income countries. To achieve this, Gilead secured royalty-free agreements consisting of six generic manufactures covering 120 high-incident resource-limited countries, accounting for a large share of global HIV concerns.
The agreement grants the manufacturers the ability to seek out regulatory approvals for Lenacapavir for use in PrEP, along with providing ample access to meet demand, while generating competition resulting in lowered costs.Gilead anticipates by the end of 2025 to complete its regulatory submissions for Lenacapavir in 18 countries representing an estimated 70% of HIV burden covered by the voluntary license.
Product provided by Gilead will be offered at no profit until standard manufacturers are capable of supporting the full demand within the new countries, including leveraging its partnerships with PEPFAR and the Global fund to provide Lenacapavir for over two million patients. To provide support for patients in middle-income countries with a high burden of HIV and not covered by Gilead’s voluntary licensing program or the agreement with the Global Fund, Gilead is pursuing multiple strategies to improve access, including tiered pricing and public-private partnerships, while also working with payers establishing efficient pathways to access.1
Peter Sands, executive director of the Global Fund, touched on the partnership with Gilead and the focus on providing improved access to Lenacapavir, saying, “Accelerating access to innovations like Lenacapavir is imperative if we are to turn the tide against HIV. In a severely resource-constrained environment, we must ensure that breakthrough tools are deployed rapidly, affordably, and in the most impactful way possible. By targeting where Lenacapavir can have the greatest effect, and working with the U.S. and Gilead, we can help countries integrate it efficiently into their HIV prevention programs reducing new infections and enabling them to move more quickly along the pathway toward transition and self-reliance.”1
Gilead is focused on obtaining secure approvals in key-incidence, resource-limited countries as soon as possible, following the recent approval in the U.S., European Commission marketing authorization, and EU-medicines for all’s positive opinion. Gilead expects to advance its access strategy for Lenacapavir through the following methods.
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