South Africa Receives First Shipment of Lenacapavir: A Fresh Era for HIV Prevention
South Africa has reached a pivotal milestone in its fight against HIV with the arrival of the first consignment of Lenacapavir. This groundbreaking, long-acting injectable medicine is designed for pre-exposure prophylaxis (PrEP), offering a powerful new tool to prevent HIV-1 infections in a country that manages the world’s largest HIV-positive population.
The first shipment consists of 37,920 doses, which arrived last week, as announced by the National Department of Health. This delivery is part of a broader strategy to scale up prevention efforts and protect vulnerable populations across the country.
What is Lenacapavir and How Does It Work?
Lenacapavir is an antiviral medicine recommended for adults and adolescents weighing at least 35 kg who are HIV negative but at risk of infection. Unlike daily oral PrEP pills, Lenacapavir is a long-acting injectable administered just twice a year.
The administration process involves a specific initiation phase:
- Initiation: A subcutaneous injection (administered just under the skin) combined with tablets taken on days 1 and 2.
- Maintenance: Following initiation, the medicine is administered as a six-monthly injection.
Whereas Lenacapavir is highly effective, health authorities emphasize that it should always be used in combination with safer sex practices, such as using condoms, to reduce the risk of contracting other sexually transmitted infections (STIs), according to the South African Health Products Regulatory Authority (SAHPRA).
The Rollout Strategy and National Impact
The arrival of these doses is a critical step toward the Global AIDS Strategy goal of ending AIDS as a public health threat by 2030. South Africa currently has approximately 8 million people living with HIV, with over 6 million receiving antiretroviral treatment.
Health Minister Aaron Motsoaledi and President Cyril Ramaphosa are working to officially launch the rollout in May. The National Department of Health expects the program to initiate and sustain nearly half a million people over the next two years. To ensure the most effective impact, the initial phase will target high-incidence districts and vulnerable groups.
This initiative is supported by a 29-million-U.S.-dollar grant from the Global Fund, providing the necessary financial reinforcement to implement the program at scale.
Regulatory Path and Implementation
The path to accessibility began in March 2025 when Gilead submitted an application to SAHPRA. The registration process was accelerated through collaboration with the European Medicines for All Procedure (EU-M4all), allowing the European Medicines Agency (EMA) and other regulatory authorities to provide scientific opinions on high-priority medicines intended for markets outside the European Union.
SAHPRA officially registered Lenacapavir on October 27, 2025. Dr. Boitumelo Semete-Makokotlela, CEO of SAHPRA, described the registration as a “game-changer,” noting that it is the most effective HIV prevention measure available to date.
To guide the clinical and operational deployment, the National Department of Health developed the South Africa Lenacapavir Implementation Guidelines, 2025. Released on December 8, 2025, these guidelines provide the framework for a safe, effective, and equitable rollout of the injectable PrEP option.
Key Takeaways
- Dosing Schedule: A six-monthly injection following an initial dose of subcutaneous injection and tablets.
- Target Population: HIV-negative adults and adolescents ($\ge 35$ kg) at risk of infection.
- Scale of Rollout: Goal to reach nearly 500,000 people over two years, starting with high-incidence areas.
- Funding: Supported by a \$29 million grant from the Global Fund.
- Regulatory Approval: Registered by SAHPRA in October 2025 in collaboration with the EMA.
As South Africa prepares for the official May launch, the introduction of Lenacapavir represents a significant shift in HIV prevention, moving toward more sustainable, long-acting options that reduce the burden of daily medication and increase adherence for those most at risk.
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