WHO-recommended lenacapavir could offer a path toward an HIV-free world, but only if people can access it

Current medical HIV prevention options include oral pre-exposure prophylaxis (PrEP), the dapivirine vaginal ring, and cabotegravir (an injection every two months). Oral PrEP, requiring frequent pill-taking, can be difficult for people to adhere to, potentially leading to poor effectiveness. Lenacapavir, on the other hand—which requires only twice-yearly injections—has been proven to be 100 percent effective in preventing HIV infection among cisgender women and girls, and reduced HIV risk by 96 percent in a gender-diverse group including cis- and transgender men and non-binary individuals, making it at least 89 percent more effective than the daily oral version.

However, the current patent licensing agreement signed by Gilead includes restrictive conditions that hinder access to generic lenacapavir in countries excluded from the license. These conditions further restrict the scope of generic competition at the global level and limit broader access to more affordable generic options of this groundbreaking tool.

MSF is already supporting the rollout of long-acting cabotegravir (CAB-LA) for PrEP in Eswatini, Malawi, Mozambique, and Zimbabwe, and offers other forms of PrEP (oral and ring) and broader HIV prevention strategies in many regions, including in countries in Africa and Latin America. Expanding the range of available tools—like by including lenacapavir—is a key priority as individual choice and agency are central tenets of HIV prevention, ones by which MSF operates.
 

“If Gilead made lenacapavir more affordable for people in low- and middle-income countries (LMICs), there’s no question we and other partners would offer it,” Flores said.

While MSF welcomes a recent partnership agreement between Gilead and the Global Fund to Fight AIDS, TB and Malaria, the agreed pricing and supply needs to be transparent to facilitate negotiations for affordable sustainable access to this critical HIV prevention tool outside of the Global Fund agreement.

Recent studies have shown that with sufficient demand and additional competition, generic versions of lenacapavir could be produced at about $40 per year, which is comparable to current prices for oral PrEP. Gilead has not made price information for LMICs publicly available, but the price for PrEP in the US is $28,218 . Global health funding cuts, which are significantly impacting HIV prevention services for key populations and vulnerable communities, mean there are even fewer programs that will be able to afford lenacapavir.

“Gilead is paying lip service to equity and access while imposing restrictions on potential generic producers that will minimize scale-up of this game-changing drug while protecting and maximizing its profits,” said Dr. Tom Ellman, MSF SAMU director.” We call on the US pharmaceutical corporation to remove its licensing roadblocks to ensure that the drug reaches its full potential impact in reversing the HIV epidemic.”

While the Global Fund has a stated aim of reaching 2 million people with lenacapavir, this would represent only a fraction of the missed UNAIDS target of 21 million by 2025, and the organization is itself facing major funding shortfalls. Funding gaps, the removal of restrictive licensing conditions, and facilitating generic competition must all be addressed to ensure larger communities can be reached with lenacapavir. This would subsequently drive down the price of the drug and allow for much wider use.

“We call for governments and global health donors to commit further funding to enable and sustain procurement and distribution of lenacapavir for those most at risk of HIV through the development of affordable and sustainable generic markets,” Dr. Ellman said.