Wayne Lumbasi
South Africa has made history by becoming the first African country to register the twice-a-year anti-HIV injection, Lenacapavir, marking a major milestone in the fight against HIV/AIDS on the continent.
The South African Health Products Regulatory Authority (SAHPRA) approved the drug on October 21, 2025, clearing the way for its rollout as part of the country’s ongoing HIV prevention efforts. The injection, developed by Gilead Sciences, offers protection for about six months with each dose and is designed for HIV-negative individuals who are at substantial risk of infection.
The new drug forms part of the pre-exposure prophylaxis (PrEP) strategy, aimed at preventing HIV infection before exposure. Unlike daily oral pills, Lenacapavir requires only two injections a year, making it a game-changer for adherence and convenience. The first dose involves two injections and four tablets, followed by a second injection after 24 to 26 weeks, providing a full year of protection with just two visits.
Health experts believe this will make it easier for individuals to stay consistent with prevention treatment, especially in high-risk communities where daily pill regimens have been difficult to maintain.
South Africa’s approval of Lenacapavir comes as the country continues to battle one of the world’s highest HIV burdens. According to the Health Department, the new injectable drug could significantly reduce new infections if effectively distributed. The Global Fund to Fight AIDS, Tuberculosis and Malaria has already committed $29.2 million to support the initial rollout, targeting over 450,000 people across 22 health districts. The first phase will see the drug stocked in more than 360 health facilities nationwide, prioritizing areas with the highest rates of new infections.
However, health officials have cautioned that while this is a breakthrough, challenges remain. The drug is not yet a full-scale national rollout, as issues such as supply limitations, pricing negotiations, and training of healthcare workers still need to be addressed.
Gilead is currently working with global partners to make the injection more affordable and accessible through generic licensing. Experts also emphasize that Lenacapavir is not a vaccine, but rather a preventive antiretroviral, meaning it must be used alongside other protective measures such as condoms and regular testing.
South Africa’s rapid regulatory approval sets an important precedent for other African nations, including Kenya, Uganda, and Nigeria, which may soon follow suit. The move signals a turning point in HIV prevention strategies across the continent, offering new hope in the decades-long fight against the virus.
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