Lenacapavir: A New Era in HIV Prevention
- Karabo Makgato
SANAC in collaboration with the National Department of Health (NDoH), convened a National Roundtable on Lenacapavir Access and Sustainability from 14 -15 October 2025 in Pretoria. The high-level, multi-stakeholder dialogue brought together representatives from government, development partners, funders, pharmaceuticals, academia, and civil society to deliberate on the country’s readiness to introduce Lenacapavir, a groundbreaking HIV prevention method recommended by the World Health Organisation (WHO).
Lenacapavir is a long-acting antiretroviral injection administered twice a year. Clinical trials have demonstrated its near-total efficacy in preventing HIV infection when used correctly every six months (one injection every six months). It has already been approved for use in the United States, Europe, and Canada and is now being introduced in several low- and-middle-income countries, including South Africa.
The roundtable created a platform to address key issues such as licensing, affordability, access, local manufacturing, funding, and sustainability. In her opening remarks, Dr Xulu reaffirmed SANAC’s commitment to equitable access and sustainability, highlighting that the introduction of Lenacapavir aligns with Goal 2 of South Africa’s National Strategic Plan (NSP) for HIV, TB, and STIs (2023–2028), which prioritises access to innovative prevention interventions, including long-acting biomedical technologies.
“We do not see Lenacapavir as a standalone magic bullet, its power lies in its integration into our comprehensive HIV prevention response. With the Global Fund identifying South Africa as an early adopter country, this catalytic investment gives us an opportunity to explore real-world implementation and identify what must be in place for long-term sustainability,” said Dr Xulu.
The Global Fund has allocated Lenacapavir doses for approximately 450,000 people over two years as part of its Grant Cycle 7 (2025–2028), marking a significant step in expanding HIV prevention choices.
Delivering the keynote address, Minister of Health Dr Aaron Motsoaledi described the roundtable as a “pivotal moment” in South Africa’s HIV response. He underscored the importance of partnership, innovation, and sustainability in achieving epidemic control. “Lenacapavir represents a breakthrough in HIV prevention—two injections a year that could change lives,” he said. “But its true success depends on our ability to make it accessible, affordable, and sustainable for everyone at risk.”
Dr Motsoaledi noted that South Africa’s treatment and prevention programmes are among the largest in the world, with over 2 million people initiated on oral PrEP. Yet, he cautioned, challenges remain—particularly around adherence, stigma, and accessibility. Lenacapavir, he said, offers an empowering alternative for individuals who struggle with daily medication.
A major focus of the roundtable was ensuring affordability and local production. Encouraging developments include voluntary licensing agreements between Gilead Sciences (producer of the drug) and several pharmaceutical companies, supported by the Clinton Health Access Initiative (CHAI), UNITAID, and WITS RHI. Through these partnerships, the cost of Lenacapavir has been reduced from USD 28,000 to just USD 40 per person per year, a dramatic 700-fold price reduction that could make large-scale access feasible.
South Africa is also pursuing its own voluntary licensing agreement to enable local manufacturing, a move that aligns with the country’s broader industrialisation and health security goals. “True access security will come from local production,” Dr Xulu emphasised.
With shifts in the global donor landscape, both SANAC and the Department of Health highlighted the need for sustainable domestic financing. Dr Motsoaledi confirmed that Lenacapavir will be integrated into South Africa’s Essential Medicines List (EML), paving the way for inclusion in routine health budgets once donor funding concludes.
The roundtable featured active participation from key stakeholders including SAHPRA, Global Fund, UNAIDS, Gates Foundation, Gilead Sciences, and representatives from the SANAC Civil Society Forum and Private Sector Forum. Breakaway sessions focused on service delivery models, target populations, demand creation, and monitoring frameworks, all feeding into a draft National Lenacapavir Implementation Plan led by NDoH and SANAC.
As the country prepares to roll out Lenacapavir in 23 high-incidence districts beginning in 2026, the emphasis will be on community engagement, youth inclusion, and health system readiness. If implemented effectively, mathematical modelling suggests that Lenacapavir could help reduce new HIV infections to below 0.1% by 2032, achieving epidemic control a decade ahead of current projections.
“If Lenacapavir is to be remembered as a game changer,” added Dr Xulu, “it will be because South Africa ensured equitable access, sustainable financing, and local ownership. Together, we move from conversation to coordination, and from coordination to action.”