In a landmark move for public health, the US Food and Drug Administration (FDA) has approved a new HIV prevention drug that could revolutionise the fight against the virus worldwide. Known commercially as Yeztugo (lenacapavir or LEN), the injectable medication only needs to be administered twice a year and has been shown to reduce the risk of HIV transmission by 96%.
Health advocates have hailed the drug as a breakthrough, describing it as one of the most significant steps forward in HIV prevention in over four decades. Clinical trials found the drug overwhelmingly effective, and experts believe it could drastically reduce transmission rates, especially as it provides an easier alternative to daily PrEP (pre-exposure prophylaxis) pills.
One of the principal researchers involved in the trials highlighted that, “Because adherence to oral products can be challenging for some people, twice-yearly injectable lenacapavir for PrEP has the potential to be one of the most impactful interventions we could have to drive down new infections.”
However, despite its promise, global access remains a concern. Currently priced at more than $3,000 per month for HIV treatment, there are urgent calls for the drug to be made widely available at a much lower cost, around $100 or less. Advocates have urged Gilead Sciences, the pharmaceutical company behind the drug, to permit generic versions and prioritise affordability and accessibility.
Global health organisations are also pushing for the drug to be rapidly integrated into national health programs, particularly in low- and middle-income countries, where HIV remains a major public health issue. They are calling on governments and funders, including major players like the Gates Foundation, to act swiftly and help supply the medication to at least two million people by 2027.
The approval comes at a time when access to HIV prevention and treatment is under threat due to funding cuts and policy shifts. Recent budget decisions in the US have slashed grants supporting HIV research and programmes serving at-risk communities, including Black, Latino, and LGBTQ+ populations.
Advocates warn that ending the HIV epidemic will require more than just new science. “No one donor, national government, or manufacturer can realise this ambition alone,” a campaign leader said. “This is the moment to act. We must ensure this innovation reaches all people, regardless of who they are or where they live.”
Globally, HIV prevention has seen significant progress. New infections have dropped from 3.3 million in 1995 to 1.3 million in 2023, largely thanks to the rise in PrEP usage. The hope now is that long-acting options like lenacapavir will further accelerate this progress and bring the world closer to ending HIV for good.
