South Africa to Locally Produce HIV Prevention Drug Lenacapavir | Gilead & Unitaid Partnership

South Africa is taking a significant step toward bolstering its HIV prevention efforts with a new initiative to enable local production of lenacapavir, a long-acting injectable medication. The announcement, made on March 5, 2026, signals a commitment to increasing access to this innovative drug and strengthening regional health security. This move comes as part of a broader effort to diversify global supply and ensure more sustainable access to vital HIV prevention tools, particularly in the region most affected by the epidemic.

Expanding Access to Long-Acting HIV Prevention

Lenacapavir represents a breakthrough in HIV prevention, offering a long-acting alternative to daily oral medications. Administered as an injection, it can provide protection for several months, potentially improving adherence and reducing the burden of ongoing treatment. Currently, access to lenacapavir is limited, and local production within South Africa could dramatically increase availability for those who need it. The South African government, in collaboration with Unitaid, the U.S. Pharmacopeia (USP), and other partners, has issued a call for expressions of interest to identify South African pharmaceutical manufacturers capable of producing quality-assured lenacapavir. More details on the initiative are available from Unitaid.

This initiative builds on previous efforts to expand access to lenacapavir globally. In October 2024, Gilead Sciences, the manufacturer of lenacapavir, granted voluntary licenses to generic manufacturers in Egypt, India, and Pakistan, allowing them to produce and distribute the drug to 120 low- and middle-income countries. Reuters reported on this licensing agreement. Adding a South African manufacturer to this network would further diversify the supply chain and bring production closer to the region with the highest HIV burden.

Why Local Production Matters

The decision to pursue local production is driven by several key factors. Producing lenacapavir within South Africa could accelerate access to the drug, ensuring it reaches those who need it more quickly. It also promises a more predictable and sustainable supply, reducing reliance on international sources and potential disruptions. Strengthening local manufacturing capacity will bolster the region’s ability to respond to its own health priorities and transition towards long-term domestic financing of HIV prevention programs. This aligns with global efforts to empower countries to take ownership of their health security.

South Africa carries a disproportionately high burden of HIV, making it a critical location for both prevention and treatment efforts. According to UNAIDS, in 2022, South Africa accounted for approximately 20% of all new HIV infections globally. UNAIDS provides comprehensive data on the HIV epidemic in South Africa. Increasing access to effective prevention tools like lenacapavir is therefore paramount.

Lenacapavir: How it Works and What it Offers

Lenacapavir is a first-in-class capsid inhibitor. Unlike many other HIV medications that target specific stages of the viral lifecycle, lenacapavir disrupts the assembly of the virus itself, preventing it from infecting new cells. This unique mechanism of action makes it effective against HIV strains that have developed resistance to other drugs. It’s administered as an intramuscular injection, initially with two injections given a month apart, followed by injections every three months. This long-acting formulation offers a significant advantage over daily oral medications, potentially improving adherence and reducing the risk of missed doses.

However, it’s important to note that lenacapavir is not a standalone solution. It is currently approved for use in people who have limited treatment options due to resistance to other HIV medications. Its role in broader HIV prevention strategies is still being evaluated. Clinical trials are ongoing to assess its effectiveness in different populations, and settings.

Quality Assurance and Manufacturing Standards

The South African government’s call for expressions of interest emphasizes the importance of quality-assured manufacturing. Manufacturers must demonstrate their ability to meet stringent international standards to ensure the safety and efficacy of the locally produced lenacapavir. The USP, a non-profit scientific organization, will play a key role in providing technical assistance and quality control support throughout the process. This commitment to quality is crucial for building trust and ensuring that the drug is safe and effective for all who use it.

What’s Next: Strengthening Regional Health Capacity

The next steps involve evaluating the expressions of interest received from South African pharmaceutical manufacturers. The government will assess their capabilities, infrastructure, and commitment to quality standards. Following this assessment, negotiations will initiate with the selected manufacturer to finalize an agreement for local production. This process is expected to take several months, with the goal of initiating local manufacturing as soon as possible.

Beyond lenacapavir, this initiative could pave the way for local production of other essential medicines and vaccines, strengthening South Africa’s overall health security and reducing its reliance on external suppliers. It also serves as a model for other African countries seeking to build their own pharmaceutical manufacturing capacity and improve access to vital health technologies. South Africa’s launch of this bid was also highlighted by Unitaid, emphasizing the broader implications for global health.