South Africa Advances Local Production of HIV Prevention Drug Lenacapavir

March 6, 2026 – In a significant step towards bolstering HIV prevention efforts and strengthening regional pharmaceutical manufacturing, the South African government is actively pursuing an agreement with Gilead Sciences to enable local production of lenacapavir. This long-acting injectable drug, considered a revolutionary tool in HIV prevention, currently requires patients to receive an injection only twice a year.

Addressing a Critical Need

South Africa carries the world’s highest HIV burden, making access to innovative prevention methods a national priority. The government’s initiative aims to secure a more predictable, sustainable, and affordable supply of lenacapavir for its population. This move aligns with a broader strategy to shift towards longer-term domestic financing for healthcare initiatives Reuters.

Call for Local Manufacturers

To facilitate local production, the government has issued a call for expressions of interest, seeking to identify South African pharmaceutical manufacturers capable of producing quality-assured lenacapavir UNITAID. This process is being conducted in collaboration with Unitaid, USP, and other partners.

Expanding Global Access

Gilead Sciences has already taken steps to expand access to lenacapavir globally, granting six voluntary licenses to generic manufacturers in Egypt, India, and Pakistan in October 2024. These licenses allow for the production and supply of generic lenacapavir to 120 low- and middle-income countries UNITAID. A potential license for a South Africa-based manufacturer would further diversify the global supply chain and bring production closer to the region most affected by HIV.

Lenacapavir: A Breakthrough in HIV Prevention

Lenacapavir has demonstrated near-complete effectiveness in preventing HIV infection, offering a significant advantage over traditional prevention methods. Its twice-yearly injection schedule enhances adherence and discretion, particularly benefiting individuals in high-burden countries Bloomberg Law.

Negotiations Underway

The South African government is currently in negotiations with Gilead Sciences to finalize the licensing agreement for local production STAT News. This development follows months of discussion regarding access to this groundbreaking HIV prevention medicine.

This initiative represents a crucial step towards ensuring equitable access to life-saving HIV prevention tools and strengthening South Africa’s capacity to address its unique healthcare challenges.