For media inquiries, contact Michael Chancley, Communications and Mobilization Manager at michael@prep4all.org. 

Today, Gilead Sciences announced early interim results from its PURPOSE 2 trial demonstrating that among men who have sex with men, transgender, and nonbinary individuals lenacapavir– administered as a once every six-month injectable PrEP– resulted in an HIV rate that was 96% lower compared with expected background levels of new HIV infections and 89% lower compared with oral TDF/FTC. Following on the early results of PURPOSE 1 in cisgender women in sub-Saharan Africa, which showed no new HIV infections in the lenacapavir arm, the company is prepared to seek regulatory approval in hopes of coming to market in 2025. 

For over a decade in the US, expensive Gilead PrEP products have largely only served white cisgender men. Due in large part to the $23,000 annual price tag and the complexities of America’s broken healthcare system, ViiV’s long-acting injectable has shown incredibly poor uptake since FDA approval in December 2021, with utilization by less than 1% of overall PrEP users in the US. It is reasonable to assume that without a dramatic shift in approaches to price, financing, and delivery, lenacapavir will become yet another promising HIV prevention intervention that fails to benefit the communities being left behind in national efforts to end HIV as an epidemic. 

Just last month, PrEP4All Senior Policy Advisor Amy Killelea and Executive Director Jeremiah Johnson published a piece in Health Affairs calling for the establishment of a National PrEP Program and a pathway to public health pricing for lenacapavir in order to ensure widespread access. A National PrEP Program “would provide the infrastructure necessary for the government to work meaningfully with Gilead to come up with an access strategy for lenacapavir at a price point that would work for a public health response. Should that come to pass, the US could really see the potential of this innovation for communities other than cisgender White men.” This infrastructure will be particularly necessary should Gilead pursue its usual pricing strategy based on what the company believes the market can bear, as “insurers will be absolutely disincentivized to encourage new PrEP users to access lenacapavir, particularly with affordable daily oral generic options at less than $20 per month.”

At present, the most the company seems to concede in terms of pricing is that the current price of lenacapavir for treatment will not be the reference point for PrEP. But at $42,250 a year, the price would need to drop dramatically to avoid the access nightmares of brand name Truvada, Descovy, and Apretude. 

No status quo approach will result in anything close to equitable access to lenacapavir as PrEP. This is a moment for advocates and policy makers to forcefully get behind the movement for a National PrEP Program and support a pathway to reasonable public health pricing for lenacapavir.