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South Africa has made history as the first African country to approve the revolutionary HIV prevention injection, lenacapavir (LEN), marking a major advancement in the global fight against HIV/AIDS. The South African Health Products Regulatory Authority (SAHPRA) became the third regulator worldwide—after the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA)—to authorize its use.
SAHPRA approved LEN on October 21, under the name Lenacapavir 464mg Solution Injection Gilead. Chief executive Boitumelo Semete-Makokotlela described the approval as a “gamechanger” given the country’s high HIV infection rate, calling LEN “the most effective prevention measure thus far.”
LEN is a capsid inhibitor, targeting the protective shell around the HIV virus’s genetic material. By disrupting this shell, the drug prevents HIV from infiltrating and replicating inside immune cells known as CD4 cells.
Unlike daily antiretroviral pills, LEN requires two injections every six months, releasing the medication slowly into the body. To ensure immediate protection, patients must also take four 300mg oral tablets—two on the day of the injection and two the following day.
Gilead Sciences applied for LEN’s registration in South Africa in March, but the process accelerated after approval through the EU-M4all program, which helps countries fast-track medicine registration.
The drug has been approved in South Africa specifically for HIV prevention (PrEP) rather than treatment.
The Global Fund has allocated USD 29.2 million (R503 million) for the initial rollout—enough for about 456,000 people over two years. However, studies suggest the country will need 1–2 million doses annually to end AIDS within the next 14–18 years. The South African Health Department is preparing to introduce LEN in 360 facilities across 22 high-risk districts from early next year, pending final approval of national guidelines.
The rollout will occur in three phases, with generic versions expected by 2027 at around USD 40 (R689) per year—similar in cost to the daily prevention pill but excluding the initial tablets.
Health Minister Aaron Motsoaledi confirmed that government funding plans are being aligned to ensure uninterrupted access once generic versions are available. Additionally, the US government’s Aids fund (PEPFAR) and CDC grants may support South Africa’s rollout, though allocation specifics remain under discussion. Gilead has not yet disclosed the final price for the public or private sectors but is in ongoing talks with the government to determine a sustainable pricing and distribution model. In summary, lenacapavir represents a transformative milestone in HIV prevention—offering a convenient, twice-yearly alternative to daily pills and giving new hope to millions in the fight to end HIV/AIDS.
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Six companies worldwide have licenses to produce generic LEN. Gilead assessed three South African firms—Aspen Pharmacare, Cipla Medpro, and Pharmacare—but none could currently produce the complex active pharmaceutical ingredient (API) required for LEN. Discussions continue between Gilead and the South African government about allowing local companies to manufacture LEN using imported API, supported by agencies such as the Industrial Development Corporation (IDC) and the Technology Innovation Agency (TIA).
