SA Adds Breakthrough HIV Injection Lenacapavir to Essential Medicines List

The Department of Health said the decision reflects its mandate to ensure that all citizens have access to safe, effective, high-quality and affordable medicines across the public health sector. e

South Africa has taken a major step forward in expanding its HIV-prevention toolbox, with the Department of Health confirming that the National Essential Medicines List Committee (NEMLC) has approved the inclusion of injectable lenacapavir in the country’s Essential Medicines List (EML). The move follows the medicine’s recent registration by the South African Health Products Regulatory Authority (SAHPRA), which positioned South Africa as the first country in Africa to authorise the groundbreaking, twice-yearly HIV-prevention injection.

The Department of Health said the decision reflects its mandate to ensure that all citizens have access to safe, effective, high-quality and affordable medicines across the public health sector. By placing lenacapavir on the EML, the department aims to accelerate availability, regulatory readiness and long-term affordability.

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A Critical Step for Access and Affordability

According to the department, including medicines such as lenacapavir on the EML is vital for encouraging the local and global production of generics, which in turn helps drive down future costs. This is especially significant for low- and middle-income countries, where high drug prices often limit access to cutting-edge treatments.

The EML also plays a powerful role beyond South Africa’s borders. As one of the most influential public health tools globally, the list often guides developing nations in shaping their national treatment and procurement strategies.

The department emphasised that the EML ensures that “people have access to carefully selected and cost-effective medicines that satisfy priority health care needs, are of quality, and are affordable”.

In a resource-strained environment such as South Africa, where the country faces one of the highest HIV burdens in the world, the standardisation of treatment protocols through the EML is considered essential to ensuring equitable access.

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What Is Lenacapavir and Why It Matters

Lenacapavir, developed by Gilead Sciences, is a long-acting injectable HIV prevention option that requires just two doses per year. Its unique six-monthly regimen is seen as a potential game-changer for populations at high risk of HIV infection, particularly young women, adolescent girls and key populations who often face barriers to adherence with daily or monthly prevention methods.

Clinical trials have shown that lenacapavir provides highly effective protection against HIV, with efficacy rates surpassing many existing oral and injectable options. Public health experts believe the treatment could significantly close gaps in prevention, especially for individuals unable to consistently use daily pre-exposure prophylaxis (PrEP) pills.

Last month’s SAHPRA approval came after Gilead submitted its regulatory application, following strong evidence from global trial sites — including those in sub-Saharan Africa — showing lenacapavir’s ability to transform HIV-prevention strategies.

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Implementation: A 2026 Rollout

The Department of Health confirmed that South Africa is preparing to roll out lenacapavir publicly as early as March 2026. Over the coming year, national and provincial structures will focus on:

• updating clinical guidelines for HIV prevention

• training healthcare workers

• preparing supply chains and procurement systems

• developing educational materials for communities

• engaging civil society and youth-led organisations

Experts say early planning is necessary given the large scale of potential demand and the need for equitable distribution across urban and rural facilities.

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Strengthening South Africa’s HIV Prevention Strategy

The addition of lenacapavir comes at a critical time for the country’s HIV response. While South Africa has made significant progress in expanding antiretroviral treatment (ART), new HIV infections remain unacceptably high, particularly among young women.

Health officials believe that more choices in prevention empower individuals and reduce barriers linked to behavioural, social and structural factors. Long-acting prevention technologies such as lenacapavir are expected to be particularly impactful for:

• people who struggle with daily pill adherence

• young people facing stigma or disclosure concerns

• populations with limited access to regular healthcare visits

• individuals at high risk who prefer discreet prevention options

With the upcoming rollout, South Africa aims to strengthen its HIV prevention arsenal and advance closer to the UNAIDS goal of ending AIDS as a public health threat by 2030.

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The Role of the NEMLC

The National Essential Medicines List Committee is a non-statutory advisory body established under the National Drug Policy. Appointed by the Minister of Health, the committee develops and regularly reviews the EML and the Standard Treatment Guidelines (STGs) used across all three levels of care: primary, secondary, and tertiary.

Through evidence-based decision-making, the committee ensures that medicines included in the EML are:

• clinically proven

• cost-effective

• prioritised based on national disease burden

• feasible for implementation in the public sector

The department reiterated that the STGs and EML are indispensable in a system constrained by funding and confronted by high disease prevalence, noting: “In our resource-constrained environment with the high burden of disease, the value of the Standard Treatment Guidelines and EML in ensuring affordable and equitable access to medicines should not be underestimated.”

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A Transformative Moment for HIV Prevention

South Africa’s approval and adoption of lenacapavir into the Essential Medicines List marks a turning point for HIV-prevention innovation on the continent. With its twice-yearly dosing and strong prevention profile, the injection is expected to address long-standing gaps in current HIV-prevention strategies and reach populations historically underserved by traditional options.

As the country moves towards a 2026 public rollout, health leaders, clinicians and community organisations are preparing for what could become one of the most significant shifts in HIV prevention in over a decade.