In a hyper-connected world where diseases cross borders with increasing ease, American leadership in disease prevention and treatment is vital to protect Americans at home and abroad. In 2024, 40.8 million people—and 4.2 million Americans—were living with HIV worldwide. Each year 630,000 people die of HIV-related illnesses globally. It is in the United States’ strategic interest to work with urgency toward an HIV-free generation.

In the last five months, the first doses of a new breakthrough HIV prevention drug called Lenacapavir have begun to arrive in Eswatini, Zambia, and Kenya, marking the first steps of a partnership with the U.S. Department of State. On April 15, the State Department announced an expansion to its original goal of delivering two million doses to ten high-burden countries within three years, now committing to the delivery of three million doses within the same timeframe. This announcement comes as part of President Trump’s broader promise to end mother-to-child transmission of HIV by the end of his second term.

Lenacapavir & Gilead Sciences

Lenacapavir is a twice-yearly injectable drug expected to be particularly effective in protecting vulnerable populations. California-based company Gilead Sciences is delivering Lenacapavir in partnership with the State Department and the Global Fund to Fight HIV, Tuberculosis, and Malaria as part of President Trump’s larger America First Global Health Strategy.

Although the delivery of the drug is a more recent advancement, it has been in development for nearly two decades, with Gilead facing issues surrounding speed, price, volume, and implementation before introducing it more widely. It became the first U.S. HIV medication to both get approval from the Food and Drug Administration (FDA) and reach communities in Sub-Saharan Africa in the same year.

Gilead, a U.S. Global Leadership Coalition member, is offering Lenacapavir as part of a commitment to provide the drug to low and lower-middle-income countries, particularly those affected by HIV, at no profit until licensed generic versions become available.

How We Got Here

In October 2024, the FDA granted Lenacapavir a “Breakthrough Therapy Designation” for use as pre-exposure prophylaxis (PrEP), recognizing its potential to significantly improve HIV prevention compared to existing options. The FDA also initiated a rolling review of the application from Gilead Sciences, allowing the company to submit data in stages.

By working to provide preventative medication at HIV epicenters, Gilead, alongside the Global Fund and the State Department, is strengthening local healthcare systems and economies while simultaneously fostering American businesses and global security.

Impact + Challenges

Countries like Zimbabwe, Eswatini, and Zambia are now among the world’s newest successful models of controlling the HIV epidemic. In Zimbabwe, 46,000 people across twenty-four sites are expected to initially benefit, with more to come as the medication continues to roll out.

According to Emily Gibbons, Senior Director of International Government Affairs & Policy for Gilead Sciences, generic companies will be offering Lenacapavir for $40 a year, but as the medication continues to scale, the prices will continue to decrease. In Kenya, the government said the medication would be offered at a negotiated price of $54 per person per year, a heavy financial burden to carry for many.

Though some health experts describe Lenacapavir as a turning point in HIV medication, its production, delivery, and cost still present several challenges. Despite Gilead’s partnership with the State Department and the Global Fund, the manufacturer faces constraints in funding due to official development assistance cuts in countries around the world.

Governments globally must navigate the barriers of fragile health care systems. In many African countries, gender inequality, poverty, and uneven access to medical resources negatively impact adolescent girls and young women, underscoring the necessity of American leadership in HIV treatment and global health more broadly.

What Comes Next?

The State Department expects to exceed three million doses by the deadline, even with the expanded goal. Gilead’s two-pronged approach works to supply the drug to vulnerable populations at cost, while simultaneously collaborating with generic companies to move faster to produce, register, and distribute Lenacapavir. Gilead expects generic Lenacapavir to be available in 2027.

Lenacapavir alone will not be enough to stop the spread of HIV across borders. Governments around the world must work to develop plans for HIV prevention beyond Lenacapavir, as this medication serves as a complement to other tools of prevention, not a replacement. Ensuring the next generation can live HIV-free necessitates American leadership, widespread access, and scale.