Geneva – Unitaid welcomes the remarkable news that lenacapavir has achieved a 96% reduction in HIV acquisition in the PURPOSE 2 trial. This trial, which included cisgender and transgender men, transgender women, and gender non-binary individuals who have sex with partners assigned male at birth, holds great potential for transforming the trajectory of the HIV epidemic in populations where new infections are on the rise.

These findings build on the results of the PURPOSE 1 trial announced earlier this year, which demonstrated 100% efficacy of lenacapavir in preventing HIV infections among cisgender women and adolescent girls—groups that also continue to experience disproportionately high rates of new infections in many countries.

We are at a pivotal moment in the fight against HIV. With lenacapavir’s high efficacy and the convenience of only two injections per year, it represents a groundbreaking advancement in HIV prevention. It is now crucial to ensure prompt and equitable access to lenacapavir for all populations and countries in need. This is essential to keeping progress on track toward the Sustainable Development Goal of ending the AIDS epidemic by 2030. Immediate action is required to accelerate the product’s uptake where it is needed most.

Unitaid commends Gilead for including populations at highest risk of HIV acquisition in the clinical trials and for ensuring geographical diversity in the studies. This strategic approach can expedite access and impact for those most at risk. However, without affordable and sufficient supply, the full potential of this innovation will either go unrealized or face significant delays.

Gilead’s commitment to collaborate with stakeholders and countries to ensure accelerated access to lenacapavir is encouraging. However, the access plan communicated yesterday lacks critical detail and presents challenges that have historically delayed access to other lifesaving products, including in licencing and pricing.

Unitaid continues to support implementation science for long-acting HIV prevention products in South Africa and Brazil, alongside key efforts on market shaping and generic development, and support to WHO, WHO Prequalification Program, the Medicines Patent Pool, and other intellectual property initiatives aimed at accelerating equitable access.

Lenacapavir presents a new opportunity in the fight against HIV, offering a solution for prevention in a field where decades of research have yet to deliver an effective vaccine. Beyond prevention, it also holds promise for long-acting HIV treatment, pending further evidence on suitable combination therapies.

Communities and countries most affected by HIV, including but not limited to those whose participation made these breakthroughs possible, must be placed at the center of the access strategy for this revolutionary product. Together, we can fast-track every step of lenacapavir’s journey to those who need it most, making this a historic moment in the fight against HIV.

We remain committed to working with Gilead, generic manufacturers, countries, and partners to expedite the pathway to an affordable product.

• Read our previous statement: Unitaid calls for accelerated global access to long-acting HIV prevention drug lenacapavir after positive trial results

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About Unitaid

Unitaid saves lives by making new health products available and affordable for people in low- and middle-income countries. Unitaid works with partners to identify innovative treatments, tests and tools; helps tackle the market barriers that are holding them back; and gets them to the people who need them most—fast. Since it was created in 2006, Unitaid has unlocked access to more than 100 groundbreaking health products to help address the world’s greatest health challenges, including HIV, TB and malaria; women’s and children’s health; and pandemic prevention, preparedness and response. Every year, these products benefit more than 300 million people. Unitaid is a hosted partnership of the World Health Organization.

Media contacts

Kyle Wilkinson, Communications Officer, Unitaid

Mobile: +41 79 445 17 45
Email: wilkinsonk@unitaid.who.int