Lenacapavir: the Role of a Supposed Miracle Drug Amid Global Health Uncertainty
Photo Credits: "Alison Saeng", published on November 15, 2022, licensed under Unsplash+. No changes were made.

Lenacapavir: the Role of a Supposed Miracle Drug Amid Global Health Uncertainty

This year, with the United States leading in cuts to global health funding, the future of the fight against HIV/AIDS has become increasingly precarious. Lenacapavir, a long-acting antiretroviral drug, has emerged as a potential saviour. But with continued donor support uncertain and concerns about worldwide affordability, its impacts risk falling short of expectations.

2025 has been a tumultuous year for global health funding. The United States has cut support for the U.S. Agency for International Development (USAID), and many other donor countries have followed suit. According to estimates reported by National Public Radio (NPR), as many as 14 million lives could be lost due to the resulting gaps in essential health services. HIV prevention is one of the areas that will be most impacted by these cuts. 

Amid these concerns, lenacapavir, a supposed miracle drug for HIV prevention, has arrived. Existing pre-exposure prophylaxis (PrEP) options require patients to take oral medications daily. This is a significant limitation, especially in countries in the Global South, where accessing and self-administering daily treatment can be difficult due to a variety of factors, including limited healthcare infrastructure, social barriers, and economic constraints. Currently, 82 percent of people who could benefit from PrEP do not have access. 

This long-acting antiretroviral, which requires only one injection every six months to be effective, has the potential to greatly impact the fight against HIV/AIDS around the world. Despite  significant efforts to combat this epidemic, there were still more than 600,000 deaths from AIDS-related illnesses in 2024. By drastically reducing the burden of daily pill-taking, lenacapavir could increase adherence rates and protect more people from infection. Even if just 4 percent of the population were to have access, as many as 20 percent of new HIV infections could be prevented. Thus, lenacapavir use has positive externalities. Furthermore, Gilead Sciences, the pharmaceutical company that developed the drug, had an 100 percent success rate in its trial in June 2024. Its promise cannot be overstated. 

However, the price of lenacapavir has been a cause for concern. Gilead Sciences initially planned to put the drug on the market at a price of US$28,218 per person per year. At that cost, access would be limited to the most privileged patients and health systems, leaving behind much of the world’s population, including those in regions hardest hit by the HIV epidemic. 

In response to growing global concern, three private organizations have entered into an agreement to bring the price down. Unitaid, the Clinton Health Access Initiative (CHAI), and the Wits Reproductive Health and HIV Institute (Wits RHI) negotiated a deal with a licensed generic manufacturer, Hetero Drugs. Under this agreement, the injection will be priced at US$40 per year in 120 low- and middle-income countries. The drug also requires an initial two-pill dosage, which will cost an additional US$17. 

There are still some risks involved in this rollout. For one, the reduced prices will not be available until 2027 due to supply constraints. Additionally, the successful implementation of this agreement depends on continued donor support, which is increasingly uncertain given the current landscape of global health financing. 

Without sufficient resources, even affordable pricing may not be enough to ensure widespread access. Another issue with lenacapavir’s rollout is that Gilead’s voluntary licensing agreement does not cover all countries. Several middle-income and high-income nations, including Brazil, are excluded from this deal. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), these countries account for about 20 percent of new HIV infections globally. This exclusion raises serious concerns about equitable access to life-saving medicines.

The science behind lenacapavir has arrived at an apt time to change the trajectory of the HIV epidemic. However, due to external constraints, it is unclear if this supposed miracle drug will be able to live up to the expectations for its success. 

 

Edited by Alex Ritch

This is an article written by a Staff Writer. Catalyst is a student-led platform that fosters engagement with global issues from a learning perspective. The opinions expressed above do not necessarily reflect the views of the publication.

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