Gilead Highlights Collaborative Efforts to Launch Lenacapavir for HIV Prevention in South Africa
Gilead Sciences has commended the leadership of the Government of South Africa and the Global Fund for their efforts to accelerate access to lenacapavir, a long-acting HIV prevention medicine that represents a significant advancement in the global HIV prevention landscape. The announcement underscores growing international collaboration aimed at expanding equitable access to innovative prevention tools for communities disproportionately affected by HIV.
According to the company, the introduction and planned rollout of lenacapavir in South Africa marks a major milestone in global HIV prevention efforts. South Africa remains at the center of the global HIV epidemic, with approximately 7.8 million people living with HIV and an estimated 170,000 new infections occurring each year. Epidemiological data further indicate that women and young girls continue to bear a disproportionate share of new infections, highlighting persistent gaps in prevention coverage despite years of progress in treatment scale-up and awareness campaigns.
Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences, emphasized the significance of South Africa’s leadership in advancing access to next-generation prevention tools. He noted that the country plays a pivotal role in global efforts to end HIV and that the deployment of lenacapavir has the potential to accelerate progress toward that goal. He also highlighted the importance of coordinated partnerships between governments, global health organizations, and the private sector in ensuring that innovative therapies reach populations most in need.
Lenacapavir, a first-in-class long-acting HIV capsid inhibitor, has been studied extensively as part of Gilead’s broader HIV prevention research program. Its long-acting profile is designed to offer extended protection against HIV infection with infrequent dosing, which may address key adherence challenges associated with daily oral pre-exposure prophylaxis (PrEP) regimens. By reducing the frequency of administration, long-acting prevention options such as lenacapavir could improve uptake and continuity of protection in high-risk populations.
The Phase 3 clinical development program for lenacapavir, including the PURPOSE 1 and PURPOSE 2 trials, included multiple study sites in South Africa. This reflects Gilead’s strategy of conducting clinical research in regions most affected by the epidemic, ensuring that trial populations reflect real-world epidemiology and that results are relevant to the communities most likely to benefit from the intervention. These studies are central to evaluating the safety and efficacy of lenacapavir as a prevention option across diverse populations.
Gilead’s access strategy for lenacapavir is built on a multi-pronged framework aimed at accelerating availability while supporting long-term affordability and sustainability. The company has committed to working closely with global health partners, including the Global Fund and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), to facilitate initial supply of the medicine at no profit to Gilead. This approach is intended to ensure rapid early deployment in high-need regions while broader manufacturing capacity is being developed.
In parallel, Gilead has established voluntary licensing agreements with six generic manufacturers. These agreements are designed to enable the production and distribution of affordable generic versions of lenacapavir across 120 low- and lower-middle-income countries. By expanding manufacturing capacity through multiple partners, the company aims to strengthen global supply resilience and reduce long-term costs, thereby improving access in resource-limited settings.
The company also highlighted ongoing efforts to support local and regional manufacturing capabilities, which are considered essential for ensuring sustainable access to HIV prevention medicines. Strengthening regional production infrastructure is expected to reduce supply chain vulnerabilities, improve distribution efficiency, and support faster delivery to high-burden communities over time.
Gilead reiterated its commitment to broad, equitable, and sustainable access to lenacapavir as part of its overall HIV strategy. The company views collaboration between governments, international funding agencies, and industry partners as essential to achieving meaningful reductions in new HIV infections worldwide. The coordinated leadership demonstrated by South Africa and the Global Fund is being positioned as a model for how innovative health technologies can be rapidly deployed in high-need settings.
Public health experts continue to emphasize that while significant progress has been made in HIV treatment and prevention, the global goal of ending HIV as a public health threat remains challenging. Persistent disparities in access to prevention tools, particularly in sub-Saharan Africa, underscore the need for new interventions that are both effective and scalable. Long-acting agents like lenacapavir are increasingly seen as a potential game changer in this context, particularly for populations facing barriers to daily medication adherence.
As global health systems work toward expanding access, the introduction of lenacapavir in South Africa represents an important step in translating scientific innovation into real-world impact. Continued collaboration among stakeholders will be essential to ensure that these advances reach the populations most affected by HIV and contribute meaningfully to reducing new infections over the coming years.
