The long-anticipated approval of lenacapavir as a once every six-month injectable option for PrEP is a welcome development in the fight to end HIV as an epidemic. It is also a testament to the value and power of American taxpayer investment in the research at the National Institutes of Health that set the stage for this groundbreaking advancement. However, the path to access is more perilous than ever for the communities in greatest need of PrEP, and it is far from clear that innovation will triumph over the expensive price Gilead has set for lenacapavir coupled with active efforts by the Trump administration and Congressional Republicans to dismantle HIV prevention and healthcare systems in America. 

Ahead of the expected approval, PrEP4All’s Senior Policy Consultant Amy Killelea and Executive Director Jeremiah Johnson published an article in Health Affairs outlining the perfect storm advocates now face as they seek to secure equitable access to lenacapavir. “As public and private coverage options for people who could benefit from PrEP are dramatically reduced at the same time as public health safety net programs are cut, access points for lenacapavir, and most other forms of PrEP, will be effectively cut off. Gilead’s charitable assistance programs cannot alone ensure that PrEP is available and accessible to the people who need it most.” 

PrEP4All will continue our leading efforts as part of the Save HIV Funding campaign to protect the systems that will be essential for the successful launch of lenacapavir in the US. We also hold steadfast in our pursuit of a National PrEP Program with the potential to address the most common barriers to access for the 2.2 million Americans who could most benefit from PrEP. And we call on Gilead to, for once, commit explicitly to a US pricing strategy that will actually lead to more equitable access, particularly for a growing number of un- and underinsured Americans. We anticipate several well-choreographed statements from the company regarding its commitment to ending HIV as an epidemic and equity, but that will be largely meaningless without a public health pricing strategy to back it up. 

“The stakes couldn’t be higher for communities of color that have yet to significantly benefit from PrEP,” states Michael Chancley, PrEP4All’s Communications and Mobilization Director, “Lenacapavir shows real innovation for cisgender women and other communities facing unique barriers to adhering to a daily pill, but I fear that we may see the same challenges in access that we saw with Apretude which, despite being the first long-acting PrEP available in the US, continues to make up only 2% of PrEP scripts.” 

Save HIV Funding Campaign Manager Maxx Boykin calls for concerted action by all stakeholders involved. “The FDA’s approval of lenacapavir for HIV prevention has the potential to be a pivotal moment for the broader fight to end HIV. It’s a reminder that prevention must be a national priority, backed by serious investment and political will. Ending the epidemic requires equal focus on prevention and treatment, delivered through equitable, community-driven systems. This moment calls for bold public funding, strong private sector leadership, and a shared commitment to making HIV prevention accessible, affordable, and a cornerstone of our national response.”