PrEP4All Statement on Lenacapavir Generic Licensing: Leave No PrEP User Behind
For media inquiries, contact Michael Chancley, Communications and Mobilization Manager at michael@prep4all.org.
(New York, NY) On October 2nd, Gilead announced that it had signed royalty-free licensing agreements with six generic manufacturers to make and sell lenacapavir in what it has termed “120 high incidence, resource-limited countries.” PrEP4All applauds global HIV advocates for advancing this conversation and securing a commitment from Gilead before lenacapavir has received any regulatory approval for a PrEP indication. However, we are also concerned that Gilead has still not committed to making lenacapavir for PrEP affordable and accessible to the communities that could most benefit from access in the United States.
“This announcement speaks to the power of global advocates who have built a movement around access to long-acting injectable HIV prevention options,” states Jeremiah Johnson, PrEP4All Executive Director. “However, we cannot leave behind US based communities that have been shut out of PrEP access due to Gilead’s price gouging and manipulation of the entire domestic PrEP response. We still do not have commitments from the company for a public health price for lenacapavir in the US– currently priced at $42,250 per year for HIV treatment– that would allow for integration into federal or state initiatives to improve equitable PrEP scale up, including the National PrEP Program being championed by advocates, members of Congress, and the Biden administration. Advocates should feel energized and motivated to see this fight through; to make sure that no community is left behind in accessing comprehensive HIV prevention options, domestically or globally.”
For over a decade now, oral PrEP has largely benefited white cisgender men, while racial and gender disparities persist among disproportionately impacted communities, largely due to the expensive price tag, lack of programs to address the costs of labs and provider visits, and the broken U.S. healthcare system. Cabotegravir, another long-acting PrEP formulation approved in December 2021, has seen incredibly poor uptake with only around 1% of PrEP users on it due in large part to an untenable price of $23,000 per year and the complexity of US healthcare. Thus far, Gilead has provided no answers on how to avoid a similar fate for lenacapavir.
“Although affordable generic oral PrEP will remain an excellent option for many if not most PrEP users, long-acting injectables can be a game changer for communities traditionally left behind in PrEP access, particularly those who face challenges adhering to daily oral medications,” said Michael Chancley, PrEP4All Communications and Mobilization Manager and PrEP user. “Despite making up 39% of new diagnoses, Black people make up only 14% of PrEP users and if future modalities such as long-acting injectables don’t address the unnecessarily high cost of medication, as well as lab and provider coverage, we will be having the same discussions about racial disparities in uptake years from now. U.S. advocates must follow in the footsteps of global advocates and call on Gilead to make lenacapavir affordable and accessible to uninsured and underinsured individuals.”