By Carmen Pèrez Casas, Unitaid’s Senior Strategy Lead and PPPR Head.

It is rare that a truly revolutionary medicine comes along – one that could change the course of a global pandemic. Lenacapavir, a groundbreaking HIV prevention drug, offers just that kind of promise. Two injections per year, under the skin, provide effective protection. Yet, despite its extraordinary promise, lenacapavir will not be a game-changer unless it reaches everybody in need – fast.

High stakes

HIV continues to exact a devastating toll. While scientific breakthroughs have greatly improved treatment outcomes and confirmed the power of effective treatment in preventing transmission, antiretrovirals are not yet reaching all in need. In approximately 20% of cases the virus is not effectively under control and continues to spread. In the absence of a vaccine in the near horizon and with only partial success from existing prevention methods, new infections remain alarmingly high, with 1.3 million new infections each year.

For the first time, lenacapavir offers a prevention tool that works exceptionally well for those at risk and at the same offers unprecedented ease of use. But the barriers to equitable access are high – affordability chief among them. Without interventions to bring its cost in line with the current standard of care for preventative treatments known as pre-exposure prophylaxis (PrEP) – approximately US$40 per person per year for existing oral PrEP medicines – lenacapavir risks being priced out of reach for low- and middle-income countries, where the vast majority of new HIV infections occur. Further challenges, including limited production, potential delays in market entry by additional manufacturers, and barriers to access for key populations in need, risk keeping this lifesaving innovation out of reach for those who need it most.

The cost of inaction is high – impacting not just individual and public health, but also the economy. The thousands of new HIV infections occurring each day add an estimated US$52 million annually in treatment costs for medication alone. Without significant progress in reducing transmission, these costs will accumulate year after year, adding up to an additional US$20 billion in treatment costs over the next decade. These numbers are not inevitable – but without decisive action, they could become our reality and would stretch the financially stagnated HIV response even further.

Learning from success: The dolutegravir model

Unitaid has long been at the forefront of efforts to dismantle barriers to access to lifesaving health innovations, and lenacapavir presents a unique opportunity to apply these lessons at scale. The case of dolutegravir, a revolutionary HIV treatment first introduced a decade ago, provides a clear model for how to ensure equitable access. When dolutegravir was first approved in 2013/2014, it faced significant challenges, including high price, limited availability, and insufficient data for certain populations such as women of reproductive age.

Through coordinated efforts, Unitaid and its partners were able to address these barriers. Investments in clinical trials in low- and middle-income countries ensured the drug’s safety and efficacy for women, children and people with coinfections like tuberculosis. Broad licensing agreements, demand-generation and volume guarantees facilitated the introduction of affordable generic versions. Financial incentives and support for optimal formulations, including for children, closed a major gap among the most vulnerable. In parallel, catalytic funding supported health system readiness, while collaboration with communities and civil society drove demand and adoption.

Thanks to a collaborative effort and a clear roadmap, dolutegravir was introduced in low- and middle-income countries within three years of its debut in high-income settings – three times faster than previous treatments. Today, over 24 million people are using dolutegravir-based regimens, supported by scale-up efforts from countries and major HIV donors like the Global Fund to Fight AIDS, Tuberculosis and Malaria and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). Available globally at the lowest price ever for an HIV treatment – now less than US$40 per person per year –dolutegravir is projected to save countries and health partners US$8 billion by 2030. This success underscores the power of a multi-pronged, coordinated approach to overcoming access barriers, and the same strategies must now guide our work with lenacapavir. And we must do it even faster.

Urgent action needed to unlock lenacapavir’s potential

Fortunately, with lenacapavir, some of the early hurdles have already been cleared. Rigorous clinical trials have demonstrated lenacapavir’s safety and efficacy, including for some of the most vulnerable populations, such as pregnant women and adolescents. This is an encouraging foundation to build upon. However, as with dolutegravir, other challenges must now be addressed to ensure widespread access and impact.

To realize lenacapavir’s potential, three critical elements must still be addressed: affordability, use, and funding. Affordability remains a pressing issue – lenacapavir remains more than a thousand times more expensive than the current oral PrEP tablets. Strategic partnerships and market interventions are needed to expand and scale diversified production and to bring prices within reach as soon as possible.

In terms of use, grassroots organizations and trusted community leaders will be essential in driving adoption. Unlike dolutegravir, which integrated seamlessly into existing all-oral treatment regimens, lenacapavir as an injectable prevention tool requires cultural and behavioral shifts and health system adaptations to gain traction, particularly in regions where there is not yet widespread adoption of PrEP or experience with other long-acting PrEP products. In areas where health care access for key populations remains fragile, a long-acting product like lenacapavir offers a significant opportunity to bridge critical gaps.

Scaling up lenacapavir to reach beyond those already using existing prevention methods will require upfront investment. However, removing access barriers holds the promise of significant savings by preventing new infections and lowering lifetime treatment costs.

Building pathways to reach those most in need

Unitaid is already taking concrete steps to pave the way for a widescale rollout of lenacapavir, applying lessons learned from dolutegravir to address barriers to access. In addition, Unitaid is committing an additional US$22 million to accelerate access to lenacapavir through our partners in South Africa, including Wits RHI in collaboration with Clinton Health Access Initiative (CHAI), and in Brazil with Fiotec.
 
These pathfinder projects supported by Unitaid focus on the identification and scale-up of optimized options to meet the prevention needs of people at higher risk of HIV, such as adolescent girls, young women, men who have sex with men, and transgender and non-binary individuals. The addition of lenacapavir will build on the experiences implementing previous long-acting PrEP products and will generate practical insights to inform the scale of this innovative tool while national regulatory approvals are being sought. This will include working with communities to harness their insights and answering specific questions to support effective delivery and drive fast uptake of lenacapavir.

Through this new funding commitment, Unitaid will also help countries beyond South Africa and Brazil to prepare for the rapid adoption of lenacapavir. This work will include essential engagement with civil society organizations and communities affected by HIV to generate demand and will complement the work of countries and partners such as the Global Fund, PEPFAR and the Bill & Melinda Gates Foundation, by ensuring health systems are ready to scale up lenacapavir as quickly as possible.

At the same time, Unitaid is working to make lenacapavir affordable and widely accessible through market interventions within its existing investments. This includes accelerating the production of quality-assured generics at the lowest possible cost, in collaboration with partners such as Wits RHI and CHAI. These efforts are complemented by continued support for WHO’s Global HIV and prequalification programs, the Medicines Patent Pool, and other intellectual property initiatives.

Together, these efforts aim to transform lenacapavir’s potential into tangible, real-world impact. Unitaid remains dedicated to working closely with affected communities, countries and partners to address remaining gaps and ensure progress in the near future.

The path forward

If we fail to act now to change the access barriers for this product, it could take more than a decade for lenacapavir to be brought to scale in low- and middle-income countries. During this time, millions of preventable new infections could occur, compounding the economic and social toll of the virus. Conversely, investing in lenacapavir now, while continuing to ensure effective treatment for people living with HIV, offers an opportunity to bend the curve of the HIV epidemic, saving lives and reducing the long-term burden on health systems.

This is not the time to take a step back. Decades of progress have brought us within reach of ending HIV as a public health threat but closing the gaps and sustaining the political will for bold, coordinated action are essential to finishing the job.

Lenacapavir represents more than just a breakthrough in HIV prevention and treatment. It is a chance to rewrite the trajectory of the pandemic, and, together with successful treatment efforts, end HIV as a public health threat by 2030. But its success depends on our ability to act decisively and with urgency. The science is clear, the tools are at hand, and the pathway is well-defined. The question is not whether we can afford to invest in lenacapavir – it’s whether we can afford not to.

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