Prevention Breakthrough: A Historic HIV Innovation Delivered at Unprecedented Speed

The rollout of lenacapavir, a twice-yearly injectable form of PrEP that is nearly 100% effective at preventing HIV, marked a pivotal moment in the fight against HIV and AIDS.

In 2025, lenacapavir became the first HIV prevention innovation to reach both high-income and low- and middle-income countries in the same year. This is a historic departure from the inequitable delays that characterized the early rollout of antiretroviral therapy.

The Global Fund has played a key role in accelerating the introduction of lenacapavir, working closely with countries, communities, civil society, Gilead Sciences, the United States, CIFF, Gates Foundation, Unitaid, WHO, UNAIDS, and other partners. Drawing on our market-shaping expertise, the Global Fund helped make lenacapavir more affordable, secured financing and strengthened supply chains to speed up procurement and delivery, and partnered with countries and communities to support introduction, build demand and expand nationwide adoption.

Less than a year after the Global Fund announced a coordinated rollout, lenacapavir arrived in Eswatini and Zambia in November 2025 with first doses administered a month later. By the end of May 2026, 20,000 people had received this preventive medicine, and by the end of June, this figure had more than doubled to 49,000 people. By mid-August 2026, nearly 100,000 people had received it across nine high-burden countries in Africa. By the end of 2026, a total of 24 countries worldwide are expected to receive lenacapavir with support from the Global Fund, the United States and other partners.

According to a recent study,1 if scaled, lenacapavir could prevent nearly one-third of new HIV infections across parts of Eastern and Southern Africa and accelerate the end of the epidemic in some countries by up to 14 years.

Lenacapavir has the potential to transform HIV prevention and accelerate the path toward ending AIDS as a public health threat. But its promise will only be fully realized if people most at risk of HIV acquisition have access. Generic lenacapavir is expected to enter the market by the end of 2026, with rapid uptake in 2027 that could significantly expand access to the people who need it most.

[1]Taking injectable PrEP to scale: Optimising the value of lenacapavir for South Africa’s HIV response. Jamieson, L. et al., 2026. https://doi.org/10.64898/2025.12.14.25342211.