As the world commemorates World AIDS Day, South Africa has begun administering Lenacapavir, a ground-breaking six-monthly HIV-prevention injection, to participants in an early implementation study placing the country among the first globally, and the first in Africa, to use the drug outside of clinical trials.
Lenacapavir is the world’s first injectable pre-exposure prophylaxis (PrEP) specifically designed to reduce the risk of contracting HIV. The long-acting drug represents a breakthrough in HIV prevention, offering a far more convenient alternative to daily PrEP pills.
The rollout marks a significant moment for the continent, where women and girls continue to bear a disproportionate share of new HIV infections. Across sub-Saharan Africa, they account for more than 60% of new cases each year. In this context, Lenacapavir’s long-acting, under-the-skin injection offers a highly effective new prevention option, shown in trials to be nearly 100% effective, and could reshape Africa’s HIV-response landscape.
An estimated eight million people in South Africa are living with HIV, roughly 12.8% of the population. In 2023/2024 alone, there were around 178 000 new HIV infections, while approximately 105 000 people living with HIV died during the same period, underscoring that, despite progress, the burden remains deep.
The South African study will generate the first real-world evidence on how the medicine works in public health settings on the continent. The data will inform South Africa’s national rollout planned for early 2026, and it is expected to support other African governments preparing to introduce the drug in the coming years.
South Africa’s Minister of Health, Dr Aaron Motsoaledi, said the country is committed to ensuring vulnerable communities benefit first. He said the early efforts from Unitaid and Wits RHI will help the country fine-tune how Lenacapavir is delivered through its health system so they can reach as many people as possible with this new PrEP option.
The rapid progress comes just months after the US FDA approved Lenacapavir for HIV prevention, triggering a wave of regulatory activity in Africa. South Africa authorised the drug at the end of October, followed by Zambia in November, while other African nations are expected to follow suit. Some countries, such as Zambia and Eswatini, have already received initial doses through support from The Global Fund and PEPFAR.
Affordability remains a critical concern for widespread African access. In response, Unitaid, Wits RHI and the Clinton Health Access Initiative (CHAI) announced a major pricing agreement with Dr Reddy’s Laboratories to supply generic Lenacapavir at US$40 per person per year by 2027. This commitment is expected to substantially expand access across the continent.
For Africa, home to two-thirds of the world’s population living with HIV, the early rollout of Lenacapavir in South Africa signals a potential shift in the epidemic. If scaled successfully, long-acting prevention could address barriers such as stigma, adherence challenges, and limited access to daily medication.
