South Africa Becomes First African Country to Register Groundbreaking Twice-a-Year Anti-HIV Jab, Lenacapavir

Strategic Insights -

South Africa has made history by becoming the first African country to register the revolutionary twice-a-year anti-HIV jab, lenacapavir (LEN). This groundbreaking medicine offers almost full-proof protection against HIV transmission through sex for HIV-negative individuals and is also safe for pregnant and breastfeeding women to use. The registration of LEN is a significant milestone in the fight against HIV and Aids, with the South African Health Products Regulatory Authority (Sahpra) approving the jab in just 65 days, 10 days faster than the time it took to register the Johnson & Johnson COVID vaccine.

Key Takeaways:

  • The South African Health Products Regulatory Authority (Sahpra) approved the revolutionary twice-a-year anti-HIV jab, lenacapavir (LEN), in 65 days, making it the first African country to register the medicine.
  • The jab offers almost full-proof protection against HIV transmission through sex for HIV-negative individuals and is also safe for pregnant and breastfeeding women to use.
  • LEN is a capsid inhibitor that works by messing with the shell around the virus's DNA, making it impossible for the virus to infiltrate CD-4 cells and replicate.
  • The jab is administered via injection, with two doses given every six months, and is taken along with four 300mg LEN pills for the first dose and two pills for the second dose.
  • The South African government will roll out LEN in three phases, with the first phase starting in February 2026, and will stock LEN at 360 facilities in 22 of South Africa's 52 health districts.
  • The government has secured funding from the Global Fund to fight HIV, TB, and Malaria to purchase $29.2-million (around R520-million) worth of LEN, which will cover 456,360 people over two years.
  • The price of LEN will be kept secret, and the government is encouraging generic companies to produce the jab locally, with at least two generic companies planning to make LEN available at around the same price as the daily HIV prevention pill.

Statistics:

  • Sahpra approved the jab in 65 days, 10 days faster than the time it took to register the Johnson & Johnson COVID vaccine.
  • The South African government will roll out LEN in three phases, with the first phase starting in February 2026.
  • 456,360 people will be covered over two years with the $29.2-million (around R520-million) worth of LEN purchased by the Global Fund to fight HIV, TB, and Malaria.
  • At least two generic companies plan to make LEN available at around the same price as the daily HIV prevention pill, with prices ranging from $40 (around R692) to $40 (around R692) per year.

Sources:

  • Bhekisisa Centre for Health Journalism
  • Sahpra press release: https://bhekisisa.org/wp-content/uploads/2025/10/Lenacapavir-Media-Release-27-October-2025-1.pdf
  • Desmond Tutu Health Foundation
  • European Medicines Agency (EMA)
  • United States Food and Drug Administration
  • South African Health Department
  • Gilead Sciences
  • The Industrial Development Corporation and Technology Innovation Agency