South Africa has launched lenacapavir (Yeztugo®), the first twice‑yearly injectable PrEP, following SAHPRA approval and supported by Gilead, PEPFAR, and the Global Fund. PURPOSE trial data showed unprecedented efficacy, positioning the rollout as a landmark step in global HIV prevention access.
Written By: Kalyani Boharapi,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Gilead Sciences has welcomed the launch of lenacapavir (Yeztugo®) for HIV prevention in South Africa, marking a pivotal milestone in expanding access to long‑acting HIV prevention tools. The rollout is supported by the South African government, the Global Fund, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), and other global health partners.
South Africa carries the world’s largest HIV burden, with approximately 7.8 million people living with HIV and an estimated 170,000 new infections annually. Women and adolescent girls continue to experience disproportionate impact, underscoring the urgent need for more effective and accessible prevention strategies.
PURPOSE Trials Demonstrated Unprecedented Efficacy
Lenacapavir, a first‑in‑class HIV capsid inhibitor administered twice yearly, offers a differentiated approach that may reduce adherence barriers associated with daily oral PrEP. The therapy gained global attention following results from Gilead’s Phase 3 PURPOSE program, which included substantial participation from South African sites.
In the pivotal PURPOSE 1 trial (NCT04994509), no HIV infections were observed among women receiving twice‑yearly lenacapavir. The PURPOSE 2 (NCT04925752) study demonstrated a 96% reduction in HIV infections among diverse populations, including men who have sex with men, transgender people, and gender‑diverse individuals. These findings highlight lenacapavir’s potential to transform prevention outcomes across high‑risk groups.
Regulatory and Implementation Milestones
The South African launch follows SAHPRA approval of lenacapavir for PrEP, positioning the country among the first globally to implement long‑acting injectable prevention at scale. Initial rollout will prioritize public sector clinics and high‑burden districts, with expansion planned through coordinated national and international procurement programs.
Global Partnerships Driving Access
Gilead’s broader access strategy combines partnerships with governments, donors, and public health organizations to accelerate availability in regions with the highest HIV burden. The company is supplying lenacapavir at no profit during the initial rollout, supported by PEPFAR and the Global Fund.
To strengthen long‑term supply resilience, Gilead has established royalty‑free voluntary licensing agreements with six manufacturers to enable generic production and distribution across 120 low‑ and lower‑middle‑income countries. Parallel efforts to support local and regional manufacturing pathways are designed to ensure sustainable access.
Implications for Epidemic Control
Global health organizations have identified long‑acting HIV prevention technologies as potentially transformative in reducing new infections, particularly among populations facing adherence challenges. The introduction of lenacapavir in South Africa represents one of the earliest opportunities to evaluate integration of long‑acting PrEP into public health systems.
As implementation expands through international partnerships and future generic supply pathways, lenacapavir could play an increasingly critical role in advancing epidemic control goals. The coordinated leadership demonstrated by South Africa and its partners may provide a model for other countries seeking to accelerate access to next‑generation HIV prevention technologies and move closer to ending HIV as a public health threat.
Reference
Gilead Applauds Collaborative Efforts to Launch Lenacapavir for HIV Prevention in South Africa
About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.