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Updated Statement on Access Planning in High-Incidence, Resource-Limited Countries for Lenacapavir for HIV Prevention
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Download the PDF here
Foster City, Calif., September 12, 2024 -Today, Gilead announced that the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated superiority to background HIV incidence (bHIV) and once-daily oral Truvada® for the investigational use of HIV prevention at an interim analysis of a second pivotal Phase 3 clinical trial.
Full press release pdf attached
Getting lenacapavir to high-incidence, resource-limited countries
Although lenacapavir for PrEP is not currently approved anywhere in the world, Gilead continues to move with urgency to develop a robust direct voluntary licensing program to expedite access to lenacapavir for PrEP once approved in high-incidence, resource-limited countries. We are actively working to finalize contracts and are pleased to share that they will cover not only lenacapavir for PrEP, but also lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) adults with multi-drug resistant HIV-1 infection.
Gilead is committed to making lenacapavir available in the countries where the need is greatest until voluntary licensing partners are able to supply high-quality, low-cost versions of lenacapavir.
Regulatory status of lenacapavir for HIV prevention and next steps
The data from the PURPOSE 1 and PURPOSE 2 trials will support upcoming regulatory filings so that twice-yearly lenacapavir for PrEP, if approved, can be authorized for multiple populations and communities around the world who are most in need of additional HIV prevention choices. Gilead is executing an access strategy that prioritizes speed and enables the most efficient paths for the regulatory approval of lenacapavir for PrEP in regions around the world, including prioritizing high-incidence, low-resource countries. Gilead will begin a series of global regulatory filings by the end of 2024.
We are exploring frameworks intended to facilitate faster access in target populations and countries such as the European Medicines Agency’s EU Medicines for All, and the World Health Organization’s collaborative review and prequalification procedures. EU Medicines for All provides opinion on medicines intended for use outside of the EU and can run in parallel with an EU centralized filing. We believe these frameworks could enable Gilead to secure approvals in key high-incidence, resource-limited countries as quickly as possible in relation to an EU approval.
Updates on regulatory filings for lenacapavir for PrEP will be shared as discussions with regulatory bodies progress.
Pricing yet to be determined for lenacapavir for HIV prevention
Lenacapavir for PrEP remains an investigational drug until approved by regulatory authorities. While Gilead awaits the regulatory filing of lenacapavir for PrEP, it is too early to state the price.
Gilead is committed to access pricing for high-incidence, resource-limited countries. The current price for the approved indication in the heavily treatment-experienced HIV population will not be our reference.
Extensive consultations with HIV community
Our access strategy for high-incidence, resource-limited countries reflects extensive consultations with HIV-affected communities worldwide as well as governments, advocates, multilateral organizations, individuals who need or want PrEP, and community partners. Through these discussions, four essential priorities have consistently emerged: delivering long-acting PrEP with speed, at sufficient volume to meet demand, at prices that enable widespread availability and in coordination with partners on the ground.
These priorities are guiding every step of our strategy planning. We are also applying learnings from our two decades of innovation and leadership in global access to medicines. In 2023 alone, more than 20 million HIV and hepatitis B treatments based on Gilead therapeutics were made available to people living in low- and lower-middle-income countries. In that same year, more than 11 million units of Gilead-branded medicines were delivered to nearly 250,000 individuals in these countries.
We thank the people and organizations who have provided counsel and guidance on our lenacapavir for PrEP access strategy. We look forward to sharing further updates as milestones are reached.
The use of lenacapavir for the prevention of HIV is investigational and is not approved anywhere globally. The safety and efficacy of lenacapavir for this use have not been established.
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