In a landmark move hailed as a breakthrough in HIV prevention, the South African Health Products Regulatory Authority (SAHPRA) has approved the use of Lenacapavir, a long-acting injectable medicine that could transform the fight against HIV in the country.

Lenacapavir, developed by Gilead Sciences, is an antiviral medication recommended for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection in adults and adolescents weighing at least 35 kg. The approval positions South Africa among the first nations in the world to authorise the use of the six-monthly injectable, which significantly reduces the risk of HIV infection when combined with safe sex practices.

SAHPRA CEO Dr. Boitumelo Semete-Makokotlela described the development as “a game-changer, given the high prevalence rate of HIV in South Africa,” adding that “this product is the most effective HIV prevention measure thus far.”

The registration follows a rigorous review process under the European Medicines for All Procedure (EU-M4all), a collaborative framework involving the European Medicines Agency (EMA) and partner regulatory bodies. This global partnership accelerates access to high-priority medicines for countries outside the European Union, ensuring safety, efficacy, and quality.

Lenacapavir is administered as a subcutaneous injection every six months, following an initial two-day oral tablet regimen. Designed for individuals who are HIV-negative but at substantial risk of infection, it offers a practical and discreet alternative to daily oral PrEP regimens.

The decision has drawn international praise. World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus congratulated South Africa for its “rapid action to register the use of Lenacapavir for prevention of HIV, a potential game-changer for the epidemic in your country.”

Health experts say the approval marks a major step toward curbing new infections in a country that still carries one of the world’s highest HIV burdens. By offering a longer-acting prevention option, Lenacapavir could improve adherence and widen protection, especially for women and young people disproportionately affected by the epidemic.

As SAHPRA continues to regulate and monitor health products under its mandate of safety, efficacy, and quality, the approval of Lenacapavir underscores South Africa’s commitment to advancing innovative, evidence-based solutions in public health.

_{Press Release By The South African Health Products Regulatory Authority (SAHPRA)}