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South Africa Approves Twice-Yearly HIV Prevention Shot, Clearing Path to 2026 Rollout

A donor-funded start will focus on high-incidence districts, with cheaper generics expected from 2027.

Overview

  • SAHPRA registered lenacapavir for PrEP in HIV‑negative adults and adolescents weighing at least 35 kg, to be used alongside safer sex practices after an accelerated review that relied on the EU‑M4all pathway.
  • The Health Department plans a limited public rollout from April 2026 in 23 high-incidence districts, initially at about 360 clinics—roughly 10% of public facilities—prioritising groups at highest risk.
  • A Global Fund contribution of about $29 million will supply roughly 912,000 doses, enough to start around 456,000 people on the twice‑yearly injections over two years.
  • Modelling by HE2RO indicates a targeted allocation toward pregnant and breastfeeding women, men who have sex with men, and female sex workers could avert an estimated 20,500 infections over five years.
  • Generics from Indian manufacturers Dr Reddy’s and HETERO are slated to be available from 2027 at about $40 per person per year as South Africa moves to Essential Medicines List inclusion and routine procurement.