When Gilead Sciences announced in June the unprecedented results of a phase 3 HIV prevention clinical trial, it made headlines. Lenacapavir, which is injected once every six months, had a 100% success rate protecting cisgender women from HIV in the PURPOSE 1 study. For the first time in a prevention study, not a single new HIV diagnosis was reported among the 2,134 women who received lenacapavir. Now, as more studies are underway, advocates are urging Gilead to make lenacapavir more accessible by cutting its price.
At the AIDS 2024 international conference in July, UNAIDS executive director Winnie Byanyima was among the voices calling for lenacapavir to be licensed in low- and middle-income countries through the Medicines Patent Pool, a UN-backed organization that helps development of and access to life-saving medications in those countries.
Marketed under the brand name Sunlenca, lenacapavir is used in combination with other antiretrovirals as an HIV treatment. It has not been FDA approved for HIV prevention, known as PrEP. Sunlenca’s list price is $42,250 a year. In comparison, Gilead also manufactures Descovy, the leading brand name oral PrEP medication, which lists for $26,000 a year. Apretude, the brand name of cabotegravir, sold as another long-acting PrEP drug injected every two or three months and made by rival ViiV, lists for $23,000.
‘We have been down this road before... more than a decade after the first approval for PrEP in the United States, we still see significant disparities in getting PrEP to communities of color and cisgender women in the U.S.’
—PREP4ALL
“The list price sets the ceiling from which the complex set of drug distribution players in the U.S. negotiate a lower price,” says PrEP4All in a commentary released on Aug. 26. “Start high and even with discounts, we’ll end high. For a drug with such public health significance as PrEP, the high list price also hamstrings the ability of state and local public health departments that perennially struggle with anemic budgets—some of whom qualify for discounts and some of whom do not—to purchase the drug and get it out to uninsured, low-income, and vulnerable populations.”
Written by PrEP4All executive director Jeremiah Johnson and consultant Amy Killelea, the commentary appeared in the online journal Health Affairs. PrEP4All is an advocacy organization promoting the development of a national PrEP program and wider access to PrEP medications.
“We have been down this road before,” the commentary says. “It was not so long ago that the very same drug manufacturer released similarly jaw dropping clinical trial results first for Truvada and then Descovy, the first two medications approved for the prevention of HIV; it led to widespread speculation of the end of HIV as an epidemic. And yet, more than a decade after the first approval for PrEP in the United States, we still see significant disparities in getting PrEP to communities of color and cisgender women in the U.S.”
The commentary adds, “...there is still always the potential for an alternative future here. We can envision a scenario in which Gilead—perhaps facing significant pressure from the U.S. advocacy community and the U.S. government—commits to working with existing public health programs and, eventually, a national PrEP program to set a public health price point for lenacapavir to ensure a simple, transparent, and intuitive pathway for uninsured populations. This would be a new, bold approach—not a repeat of past charitable and donation programs that fail to provide an integrated approach to PrEP delivery. Instead, it would be a true, significantly lower price point that empowers public programs and health departments to come up with simple and comprehensive financing and delivery mechanisms that are highly accessible for end users. Only then will we stop repeating the same pattern in which the bang of a big scientific breakthrough is followed by the whimper of inaccessibility.”
Several other PURPOSE clinical trials are underway or are being planned that will look at how well lenacapavir works in specific groups of people including men who have sex with men, trans men and people who inject drugs. Results of at least one of these PURPOSE studies are expected by early next year, if not sooner, before the drug is submitted for FDA approval.
Read the complete commentary on Health Affairs here.
This article includes reporting from associate editor Enid Vázquez