By: Bunmi Yekini
In a major advancement for HIV prevention, Gilead Sciences announced impressive interim results from its PURPOSE 2 trial. The study of lenacapavir, a twice-yearly injectable PrEP, demonstrated a 96% reduction in HIV rates among cisgender men, transgender individuals, and nonbinary people who have sex with male partners. Among over 2,000 people in the trial who received lenacapavir, only two HIV infections were reported. These results align with the earlier PURPOSE 1 trial, which showed no new HIV infections among cisgender women in sub-Saharan Africa.
The findings are being celebrated by AVAC, a global HIV prevention advocacy organization. “This is the second impressive result for this new HIV prevention option, opening up more possibilities for choice for even more people to find an option that is right for them,” said Mitchell Warren, AVAC’s executive director. “But these data only matter if the field moves with speed, scale, and equity.”
Despite the promise of lenacapavir, concerns about access and pricing remain significant. Historically, Gilead’s PrEP products, such as Truvada, have been priced at over $23,000 annually, limiting access to white cisgender men in the US. Kenyon Farrow, AVAC’s communications director and PrEP user, highlighted the importance of ensuring broader access: “I am excited that people who want to use PrEP or who fear stigma or discrimination may soon have another option that could be easier to use and provide more discretion. It is imperative that we accelerate planning for rollout.”
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Gilead has committed to seeking regulatory approval by the end of 2024 and has pledged to make lenacapavir available in countries where it is needed most. However, advocates like Amy Killelea, Senior Policy Advisor at PrEP4All, warn that pricing will be a critical factor. “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,” Killelea said.
The call for equitable access is especially urgent as lenacapavir’s price for treatment currently stands at $42,250 annually. To prevent the same access barriers faced by other PrEP options, activists are pushing for public health pricing and faster regulatory action.
“There is no time to waste if we are to translate these exciting clinical trial results into actual public health impact,” Warren emphasized, adding that Gilead and regulatory agencies must act swiftly to ensure lenacapavir becomes an accessible HIV prevention option for all communities, not just the privileged few.
As trials continue, including PURPOSE 3 among cisgender women in the US and PURPOSE 4 among people who inject drugs, advocates hope the lessons learned from past PrEP rollouts will lead to better outcomes for lenacapavir’s introduction.