Johannesburg, South Africa – December 1, 2025 – On World AIDS Day, a historic breakthrough unfolded as South Africa, Eswatini, and Zambia became the first countries in Africa—and among the first globally—to begin public administration of lenacapavir, a revolutionary twice-yearly injectable that prevents HIV with near-perfect efficacy.
This long-acting drug, developed by Gilead Sciences and branded as Yeztugo (lenacapavir), represents the most powerful HIV prevention tool ever approved. Clinical trials showed it reduced the risk of HIV acquisition by more than 99.9%, effectively functioning as a preventable vaccine for those at high risk. In one major study among young women in South Africa and Uganda, not a single participant who received the injection contracted HIV. A second trial involving men who have sex with men, transgender individuals, and others across multiple continents confirmed similarly extraordinary results, with only two infections recorded among thousands of participants.
For Africa, home to two-thirds of the world’s 40.8 million people living with HIV, the arrival of lenacapavir could not be more timely. Sub-Saharan Africa continues to bear the heaviest burden of the epidemic, with adolescent girls and young women particularly vulnerable—accounting for six in ten new infections on the continent.
In South Africa, where approximately 8 million people—one in five adults—live with HIV, the first real-world doses were administered under the leadership of the Wits Reproductive Health and HIV Institute (Wits RHI) at the University of the Witwatersrand. Supported by Unitaid, a global health agency hosted by the World Health Organization, the program marks the first time this six-monthly injectable has been used outside clinical trials in low- and middle-income countries.
“The first individuals have begun using lenacapavir for HIV prevention in South Africa, making it among the first real-world use of the 6-monthly injectable in low- and middle-income countries,” Unitaid stated on December 1.
The rollout extends beyond South Africa. In Eswatini, a small kingdom with the world’s highest HIV prevalence (over 27% among adults), hundreds gathered in community celebrations as the first injections were given. Prime Minister Russell Dlamini called it “a turning point in our national HIV response,” expressing gratitude for the new tool that offers long-lasting protection with just two shots per year.
In Zambia, where 1.4 million people live with HIV, the launch took place amid marches and rallies in Lusaka’s Chawama township. Health Minister Elijah Muchima encouraged young people and vulnerable groups to access the injection at local clinics, describing it as a source of “renewed hope.”
Both Eswatini and Zambia each received an initial 500 doses through a U.S.-supported access program. South Africa, despite having conducted pivotal trials that proved the drug’s efficacy, was excluded from that shipment due to strained bilateral relations and recent U.S. foreign aid cuts. Undeterred, South Africa secured independent funding, including a R520 million grant from the Global Fund, and has committed to a phased national rollout beginning in early 2026.
The path to this moment has been swift by global health standards. Lenacapavir received U.S. FDA approval in late 2024, followed by WHO prequalification in July 2025. Within months, voluntary licensing agreements were signed with six generic manufacturers in India, paving the way for low-cost versions to reach over 100 countries starting in 2027 at an expected price of just $40 per person per year—a dramatic reduction from the U.S. list price of $28,000.
Experts describe the speed and scale of access as unprecedented. Dr. Linda-Gail Bekker, a lead investigator in the landmark PURPOSE trials and director of the Desmond Tutu HIV Centre, noted: “For the first time, a new HIV prevention medicine is reaching sub-Saharan Africa in the same year as its approval in high-income countries. That has never happened before.”
Despite the optimism, significant challenges remain. Daily oral PrEP, while effective, has suffered from low uptake and high discontinuation rates due to stigma, side effects, and the burden of taking a pill every day. While lenacapavir eliminates the daily requirement, health systems must now face the task of training providers, ensuring cold-chain storage, and reaching rural and marginalized communities. Funding uncertainty also looms large: global HIV financing fell in recent years, and many civil society organizations report service disruptions.
Still, the mood across the three pioneering nations is one of cautious celebration. In clinics from Johannesburg to Manzini to Lusaka, healthcare workers and community advocates spoke of a tangible shift—a sense that, after four decades of fighting HIV, a truly game-changing prevention option has finally arrived.
As one young woman in Eswatini said after receiving her first injection: “I feel protected. For the first time, I really feel like I can plan my future without fear.”
With seven African countries now meeting or exceeding UNAIDS’ 95-95-95 targets and new infections trending downward in many places, lenacapavir arrives at a critical inflection point. If access can be rapidly scaled and sustained, it has the potential not only to protect millions of individuals but to dramatically accelerate progress toward ending AIDS as a public health threat by 2030.
On this World AIDS Day, the twice-yearly shot is more than a medical innovation—it is a powerful symbol of resilience, scientific triumph, and renewed global commitment to the continent hardest hit by the epidemic.
