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Two million people to get new injectable HIV prevention drug

HIV scientists and activists hope that young people may find that having to make this “prevention decision” only twice a year may reduce unpredictability and barriers. PHOTO/COURTESY/SHUTTERSTOCK 

What you need to know:

  • Sir Chris Hohn, CIFF’s Founder and Chair said, “We must urgently break the cycle of HIV transmission and get back on track to achieve the 2030 goals.

At least 2 million people with elevated HIV infection risks, including those in Uganda, could access a new drug injected twice a year to prevent HIV infection under a new arrangement announced by donors.

“The Global Fund and the United States President’s Emergency Plan for AIDS Relief (PEPFAR) are aiming to secure sustainable arrangements for countries to access this new, potentially game-changing HIV prevention innovation – backed by a significant commitment from Children’s Investment Fund Foundation (CIFF), and with support from Bill & Melinda Gates Foundation (BMGF) – that would enable access to lenacapavir for at least 2 million people over three years in countries supported by PEPFAR and the Global Fund,” reads the PEPFAR statement.

This publication got the PEPFAR statement from the US Mission in Uganda on Monday. Uganda, according to government statistics, is registering around 38,000 new infections despite the deployment of different interventions such as condoms and oral drugs for HIV prevention.  

Lenacapvir was tested in Uganda and South Africa, and results showed that all the study participants with elevated HIV infection risks were protected from infection. In the statement, the donors indicated that the coordinated effort “will rapidly provide affordable and equitable access to twice-yearly injectable lenacapavir for HIV pre-exposure prophylaxis (PrEP) contingent upon regulatory approval from the U.S. Food and Drug Administration, relevant national pharmaceutical regulators, and a recommendation from the World Health Organization (WHO).”

The Global Fund and PEPFAR are some of the leading funders of Uganda’s health system with most of the support for the HIV fight including Anti-retroviral drugs purchased by them. According to PEPFAR, lenacapavir, which is made by Gilead Sciences, is already approved in multiple countries to treat adults with multidrug-resistant HIV in combination with other antiretroviral drugs. 

In October 2024, Gilead announced that it had signed non-exclusive, royalty-free voluntary licensing with six pharmaceutical companies to manufacture and supply high-quality, low-cost versions of lenacapavir for HIV prevention for 120 primarily low- and lower-middle-income countries.
“At the Global Fund, we are incredibly excited by the promise of lenacapavir and its potential to help us achieve a further significant reduction in new infections among individuals at high risk of acquiring HIV,” Peter Sands, the Executive Director of the Global Fund said in the statement.

“As part of this coordinated effort, the Global Fund, PEPFAR, CIFF, and BMGF will work with Gilead and the voluntary licensing manufacturers to accelerate affordable and equitable access, so that more people can benefit from this powerful innovation from day one,” he added.

Ambassador Dr John Nkengasong, the U.S. Global AIDS Coordinator and Senior Bureau Official for Global Health Security and Diplomacy at the U.S. Department of State said: “We cannot reach a sustainable HIV response without rapidly reducing the 1.3 million new HIV infections that occur worldwide every year.”
“Lenacapavir offers a potentially tremendous opportunity to transform the impact of HIV programs to ensure adolescent girls and young women, key populations, and others who could benefit have access to highly effective HIV prevention, testing and treatment services and to end HIV/AIDS as a public health threat by 2030," he added. 

Sir Chris Hohn, CIFF’s Founder and Chair said, “We must urgently break the cycle of HIV transmission and get back on track to achieve the 2030 goals.  Testing and prevention are vital, where innovations like lenacapavir can profoundly impact the lives of millions.  It will be a travesty if the communities who need it most don’t have access.  That is why this collaboration is so essential to ensure that lenacapavir is available as soon as possible for those who need it the most.”

“Implementation of affordable lenacapavir at scale, alongside other HIV prevention interventions, has the potential to catalyze improved sustainability of the HIV response, with countries and communities having choices and access to quality-assured and lower-cost HIV treatment and prevention tools to sustain over the long-term, owing to HIV infections averted,” said Hui Yang, Head of Supply Operations at the Global Fund.
The Global Fund and PEPFAR will work closely with CIFF and BMGF to support countries and communities to implement national and sub-national HIV long-acting injectable PrEP programs, alongside WHO, Unitaid, UNAIDS, and others.

“Far too many people at high risk of HIV infection lack access to lifesaving treatments,” said Trevor Mundel, President of Global Health at BMGF.  “Our mission is to work alongside communities and partners to change that by ensuring access to game-changing products like lenacapavir that can protect individuals from HIV infection and help to end the disease.”

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