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Drug approval

South Africa Approves New Antiviral Medicine for HIV Prevention

Strategic Insights

— 2 min read

The World Health Organization has hailed South Africa's rapid approval of Lenacapavir, a new antiviral medicine for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection. The South African Health Products Regulatory Authority (SAHPRA) approved the drug, which is administered as a six-monthly injection, starting with a subcutaneous initiation dose, supported by tablets on days one and two. Lenacapavir is recommended for adults and adolescents weighing at least 35 kg and is intended for HIV-negative individuals at risk of infection. The approval marks a significant step towards controlling the HIV epidemic in South Africa.

Key Takeaways:

  • The South African Health Products Regulatory Authority (SAHPRA) has approved Lenacapavir, a new antiviral medicine for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection.
  • Lenacapavir is administered as a six-monthly injection, starting with a subcutaneous initiation dose, supported by tablets on days one and two.
  • The medicine is recommended for adults and adolescents weighing at least 35 kg and is intended for HIV-negative individuals at risk of infection.
  • The application for Lenacapavir was submitted by Gilead in March 2025 and reviewed through the European Medicines for All Procedure (EU-M4all).
  • The European Medicines Agency (EMA), together with SAHPRA and other participating regulatory authorities, provided a scientific opinion on the high-priority medicine.
  • SAHPRA chief executive Dr Boitumelo Semete-Makokotlela described the product as "the most effective HIV prevention measure thus far."
  • The initial rollout of Lenacapavir is scheduled for March or April 2026, targeting 23 high-incidence districts across six provinces and around 360 high-performing public clinics.
  • Minister of the Presidency, Khumbudzo Ntshavheni, stated that the rollout will aim to reduce the risk of other sexually transmitted infections by promoting safer sex practices.

Statistics:

  • The population targeted by the initial rollout of Lenacapavir consists of around 360 high-performing public clinics across six provinces.
  • The rollout aims to cover 23 high-incidence districts.
  • The efficacy of Lenacapavir has been described as "the most effective HIV prevention measure thus far" by Dr. Boitumelo Semete-Makokotlela.
  • The South African government plans to implement safer sex practices alongside the distribution of Lenacapavir.
  • Gilead submitted the application for Lenacapavir to SAHPRA in March 2025.

Sources:

  • "World Health Organization Director-General Tedros Adhanom Ghebreyesus has hailed South Africa’s approval of a new antiviral medicine for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection as a potential game-changer for the epidemic in the country." - No specific source provided in the text.
  • "The South African Health Products Regulatory Authority (SAHPRA) approved Lenacapavir." - No specific source provided in the text.
  • "SAHPRA chief executive Dr Boitumelo Semete-Makokotlela said the product is 'the most effective HIV prevention measure thus far.'" - No specific source provided in the text.

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