Lenacapavir Set to Expand HIV Prevention Access, Replacing Cabotegravir

South Africa is poised to roll out lenacapavir, a twice-yearly HIV prevention injection, at 360 government clinics, marking a significant step forward in combating the HIV epidemic. This introduction comes as another preventative jab, long-acting cabotegravir (CAB-LA), quietly exits the market, largely due to cost considerations.

The Shift from CAB-LA to Lenacapavir

CAB-LA, approved in South Africa over three years ago, never reached widespread use in government clinics. Its high cost – approximately $180 (R2,900) per person annually – proved to be a major barrier. This price point is roughly four times more expensive than generic lenacapavir. A potential PEPFAR donation that could have mitigated the cost issue was frozen by the Trump administration’s 2025 aid stop-work orders, preventing any doses from being delivered.

Lenacapavir: A More Affordable Option

Lenacapavir, marketed as Sunlenca in the United States where two injections cost $42,250, is being made available at no profit through a partnership between Gilead Sciences and PEPFAR. This collaboration aims to provide access to lenacapavir for up to two million people over three years in countries supported by both organizations [1]. Gilead is actively working with PEPFAR and the Global Fund to assess product demand and has secured manufacturing capacity to produce the necessary vials for PrEP and oral initiation doses [2].

Building on Existing Infrastructure

Despite CAB-LA’s limited rollout, the groundwork laid for its implementation – including training programs, established systems, and collected real-world data – will be instrumental in facilitating the successful introduction of lenacapavir. Advocates emphasize that these efforts were not in vain and now provide a solid foundation for the latest injectable PrEP option.

PEPFAR and Gilead’s Commitment

The partnership between the U.S. State Department, PEPFAR, and Gilead Sciences signifies a strong commitment to accelerating access to lenacapavir for HIV prevention, particularly in high-incidence, resource-limited countries. Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences, stated that PEPFAR’s support will expedite access to lenacapavir and contribute to ending the HIV epidemic [2].

This initiative represents a crucial component of Gilead’s broader coordinated efforts, involving both PEPFAR and the Global Fund, to enhance access to lenacapavir for PrEP.