South Africa’s medicines regulator has granted approval for lenacapavir, the innovative twice-yearly HIV prevention injection developed by Gilead Sciences, paving the way for its integration into the nation’s public health system. This registration, announced on 27 October 2025, positions the country as the first in Africa to endorse the drug for pre-exposure prophylaxis, heralding a potential shift in combating the world’s largest HIV epidemic. As reported by SAHPRA, the approval covers both public and private sectors for adults and adolescents weighing at least 35kg who are HIV-negative and at substantial risk, with the recommendation to pair it with safer sex practices like condom use to mitigate other sexually transmitted infections.
Clinical trials have demonstrated near-total efficacy, with no infections recorded among participants receiving lenacapavir, compared to expected background rates of around 2.41 per 100 person-years, according to data from the PURPOSE 1 study published in The Lancet HIV. This positions the injection as a superior alternative to daily oral pills or ViiV Healthcare’s bimonthly cabotegravir, addressing persistent barriers such as inconsistent adherence and limited healthcare access that have limited the impact of existing tools. SAHPRA’s CEO, Boitumelo Semete-Makokotlela, described the development as transformative, particularly in a nation where HIV prevalence remains alarmingly high, with approximately eight million people living with the virus and 173,000 new infections in 2024, per the Thembisa mathematical model cited in Health-e News.
The health department anticipates initiating rollout in April 2026, targeting 360 clinics in districts with elevated infection rates, supported by a R513 million grant from the Global Fund to Fight AIDS, Tuberculosis and Malaria. This funding will secure over 450,000 doses at $60 each, sufficient for the initial two-year phase and potentially reaching 456,000 individuals. Bhekisisa notes that South Africa boasts the globe’s largest oral PrEP programme, with two million users since 2016, yet adherence challenges persist, making lenacapavir’s biannual dosing a promising solution for vulnerable groups including pregnant and breastfeeding women, men who have sex with men, and sex workers.
Gilead submitted its application in March 2025, benefiting from an expedited review through the European Medicines for All procedure, which harnesses expertise from the European Medicines Agency to fast-track essential medicines for non-EU markets. This follows the US Food and Drug Administration’s endorsement in June 2025 and the World Health Organization’s recommendation a month later, as detailed in SAnews. The process underscores SAHPRA’s growing alignment with global standards, having collaborated on over 50 high-priority drugs since the initiative’s launch, enhancing regulatory capacity in resource-limited settings.
Access in the private sector remains uncertain, as Gilead continues negotiations with the health department to gauge public needs and has yet to set a registered price compliant with South Africa’s medicine pricing regulations. A company representative indicated ongoing evaluations for private market strategies to broaden availability swiftly. In the US, the branded version carries a steep annual price of $28,218, but modelling in The Lancet suggests generic equivalents could drop to $25-$46 per person yearly with high-volume uptake of five to ten million users, far below the current oral PrEP costs.
A September 2025 partnership between Dr Reddy’s Laboratories, Unitaid, the Clinton Health Access Initiative, and Wits Reproductive Health and HIV Institute promises generic lenacapavir at $40 annually across 120 low- and middle-income countries from 2027, including an initial oral loading dose at $17. Clinton Health Access Initiative highlights this as a multi-supplier strategy to foster competition and sustainability, complemented by PEPFAR and Global Fund commitments to procure doses for up to two million people in the interim. Complementary deals with Hetero Labs, backed by the Gates Foundation, aim to ensure diverse supply chains and further price erosion.
South African researchers’ earlier 2025 modelling study, presented at the Conference on Retroviruses and Opportunistic Infections, projects that broad adoption of lenacapavir could accelerate HIV elimination as a public health threat to 2032—ten years ahead of prior estimates—averting up to 18 per cent of infections over a decade at coverage rates of 1.6 to 4 per cent, even at $100 per dose. This surpasses the cost-effectiveness of scaling oral PrEP or cabotegravir, with a maximum viable price of $106 per dose in South Africa, according to simulations in The Lancet HIV. The Health Economics and Epidemiology Research Office estimates prioritising 55 per cent of doses for pregnant and breastfeeding women could maximise impact, aligning with national goals to curb the 89,000 annual infections among women.
As South Africa integrates lenacapavir into its arsenal, the focus shifts to implementation hurdles like community education and supply chain logistics. With generics on the horizon and donor support bridging the gap, experts see this as a pivotal step towards UNAIDS’ 2030 targets, potentially reshaping prevention paradigms and reducing stigma through discreet, effective options. Yet, sustained funding and equitable distribution will be key to realising its full potential in a landscape where 1.3 million global infections in 2024 far exceeded benchmarks.