South Africa Pioneers Access to Long-Acting HIV Prevention wiht lenacapavir Registration
Pretoria, South Africa – South africa has become the first African nation to register lenacapavir, a groundbreaking long-acting injectable medication for HIV prevention, marking a meaningful step forward in the country’s fight against the epidemic.The South African Health Products Regulatory Authority (SAHPRA) approved the registration, paving the way for potential rollout and integration into national healthcare programs.
With the highest HIV prevalence rate in the world, South Africa stands to benefit immensely from this new preventative measure. Currently, pre-exposure prophylaxis (PrEP) requires daily adherence, a challenge for many. Lenacapavir, administered as an injection, offers a potentially more effective and convenient option, and SAHPRA CEO Boitumelo Semete-Makokotlela hailed it as “the most effective HIV prevention measure thus far.”
The registration follows an announcement earlier this month by Minister of Health Joe Phaahla, outlining plans to incorporate lenacapavir into domestic financing mechanisms, with the goal of routine funding within two years. The medication will be available at a dramatically reduced cost thanks to agreements with pharmaceutical manufacturers. Gilead and six other companies, including one in Egypt, will produce the injection for US$40 per person per year – a reduction of 700 times from its previous price of US$28,000.
Further cost reductions will come from generic versions produced by companies like Hetero, alongside partnerships with the Gates Foundation, while South Africa simultaneously works to develop local manufacturing capabilities. SAHPRA is responsible for overseeing the regulation of all health products in the country, including clinical trials, medicines, medical devices, and radiation control.The agency will continue to monitor and evaluate lenacapavir’s performance post-implementation.
Officials emphasize that lenacapavir, like existing PrEP options, should be used in conjunction with safer sex practices, such as condom use, to reduce the risk of other sexually transmitted infections. This development builds on existing efforts to bolster HIV/AIDS treatment, including initiatives supported by the PEPFAR Bridge Plan.
