South Africa is preparing to roll out lenacapavir, the world’s first twice-yearly HIV prevention injection, in April 2026, marking a significant milestone in the fight against HIV. Funded by a $29.2 million Global Fund grant and an additional $5 million from the Networking HIV and AIDS Community of Southern Africa (NACOSA), the initial supply will provide nearly half a million people with access to the drug, targeting 23 high-incidence districts across six provinces through 360 public clinics. Health Minister Aaron Motsoaledi described lenacapavir as a “groundbreaking” tool but cautioned that demand will likely exceed supply during the initial phase.
The rollout is strategically focused on high-burden districts to maximize the impact in preventing new HIV infections, with the government emphasizing the need for sustainable integration into South Africa’s healthcare system despite recent cuts in funding from USAID and other U.S. sources, which had affected HIV/AIDS and tuberculosis programs. Gilead Sciences has reduced the annual per-person cost from the initially proposed $28,000 to $40, making the program more feasible for South Africa to fund independently. The World Health Organization has endorsed lenacapavir as part of a combination prevention strategy, and Gilead is fast-tracking registration in 18 high-incidence countries, with generic versions expected by 2027.
Controversy has emerged over Gilead’s voluntary licensing agreements, which exclude South African manufacturers despite the country’s participation in clinical trials. Civil society representatives, including Sheila Mbele-Khama of SANAC, criticized this exclusion as unfair, noting that one in four new HIV infections occurs in countries left out of the licensing agreements. Gilead maintains that South African manufacturers evaluated in 2024 did not meet technical specifications for producing sterile injectables but is open to future licensing if capabilities are developed.
UNAIDS South Africa country director Eva Kiwango welcomed the $34 million investment for the rollout, emphasizing that long-acting injectable medicines like lenacapavir offer a “fresh option for all people at risk.” While not a cure or vaccine, lenacapavir has the potential to transform HIV prevention by expanding patient choice, reducing adherence challenges, and overcoming barriers related to stigma or disclosure. The rollout is being discussed at a two-day national healthcare roundtable in Johannesburg, underscoring both the promise of the new drug and the urgency of ensuring equitable access amid limited initial supply.
