Global Fund to Acquire Breakthrough HIV Injectable Vaccine for Poor Countries

The Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund) has announced that it has signed an access agreement with Pharmaceutical Company Gilead Sciences to procure lenacapavir, a long-acting injectable for HIV prevention, for low- and middle-income countries (LMICs).

This development comes amidst global advocacy for equitable access and is the first time in history that an HIV prevention product will be introduced in LMICs at the same time as in high-income countries. Previously, while most of the studies confirming the efficacy of such products have been done in developing countries such as Uganda, these countries never get to access these products early on due to, among others, high prices.

Gilead Sciences has previously announced a US list price of $28,218 for the drug per person per year, which is quite unaffordable for many. 

Now, the new agreement between the Global Fund and the manufacturer of Lenacapavir follows the U.S. Food and Drug Administration’s approval of the drug in June and represents one of the most significant advances in HIV prevention in decades. As the first twice-yearly, long-acting injectable for pre-exposure prophylaxis (PrEP), lenacapavir expands the HIV prevention choice basket, offering a powerful new option for people who experience stigma, adherence challenges with existing PrEP tools, or other barriers in their daily lives.

Global Fund plans to reach two million people with the drug in the next three years. 

“For the first time, we have a tool that can fundamentally change the trajectory of the HIV epidemic — but only if we get it to the people who need it most. Our ambition is to reach 2 million people with long-acting PrEP. But we can only do that if the world steps up with the resources required. This is a pivotal moment — not just for the fight against AIDS, but for the fundamental principle that lifesaving innovations must reach those who need them most—whatever they are, and wherever they live”, said Peter Sands, Executive Director of the Global Fund, in a statement.

Under the agreement, countries supported by the Global Fund can access lenacapavir for PrEP, and early access will be prioritised based on HIV epidemiology, national prevention strategies, and available resources.

“Our ambition is to have the first shipment and delivery of the products reaching at least one African country by the end of 2025, to mark the beginning of a transformational shift in how HIV prevention is delivered to communities with the highest burden of new infections”, Sands said.

Countries, particularly those with high HIV incidence, mostly in sub-Saharan Africa, have expressed strong interest in introducing lenacapavir for PrEP early and at scale because of the high number of women and young girls getting newly infected with HIV.

Dr Aaron Motsoaledi, Minister of Health of South Africa and co-host of the Global Fund’s upcoming Eighth Replenishment, said lenacapavir offers young women, and everyone at risk, a discreet, long-acting option to stay HIV-free.

“For far too long, women and girls in our country have carried the greatest burden of this epidemic. But scientific breakthroughs must be backed by political will, community leadership, and sustained investment. We are determined to ensure no one is left behind.”

To help accelerate access, the Global Fund is leveraging private-sector donor funding to make the introduction and scale-up of lenacapavir more affordable for the countries and communities it supports.

One of the entities that has already expressed interest in offering financial support is the Children’s Investment Fund Foundation (CIFF) to ensure that the financial barriers to scaling this new tool are lowered as much as possible, supporting countries to act quickly.  

“CIFF remains committed to accelerating access to lifesaving innovations that will break the cycle of HIV infection,” said Kate Hampton, CEO of the Children’s Investment Fund Foundation (CIFF). “Our support of the Global Fund’s efforts to introduce lenacapavir is about ensuring that no one is left behind and communities who need it the most can access it. We are proud to stand alongside governments, communities, and the Global Fund to help turn this breakthrough into impact, especially for adolescent girls and young women, who continue to bear the brunt of this epidemic.”