Lenacapavir HIV Prevention: Gilead’s Strategic Agreement to Enhance Access in Low-Income Countries

Gilead Sciences has finalized a strategic partnership with the Global Fund. The agreement aims to supply lenacapavir HIV prevention, a twice-yearly injectable for pre-exposure prophylaxis (PrEP) against HIV, to up to two million individuals over three years in primarily low- and lower-middle-income countries (LLMICs). Under this agreement, Gilead will provide lenacapavir at no profit until licensed generics become available. This accelerates access to an innovative prevention tool in regions with high HIV incidence.

Transformative Access to Long-Acting HIV Prevention

The agreement between Gilead and the Global Fund represents a significant advancement in global HIV prevention, particularly for resource-limited settings. Lenacapavir, recently approved in the United States as Yeztugo®, is the first and only twice-yearly injectable PrEP. The medication’s long-acting profile addresses key adherence challenges linked to daily oral PrEP regimens. These challenges have historically impeded broader uptake and sustained HIV prevention in high-risk populations. The Global Fund will prioritize access based on epidemiological need and national strategies, ensuring a targeted approach to maximize health impact.

Gilead’s access strategy is notable for its scale and speed. Voluntary, royalty-free licensing agreements with six generic manufacturers across 120 countries were established before regulatory approval. This expedites the introduction of generics once authorized. Complementary mechanisms—including at-risk manufacturing, early regulatory filings in Africa and Latin America, and support for tiered pricing—demonstrate a multifaceted commitment to sustainable access. The company’s approach responds to calls from global health leaders to ensure lifesaving innovations reach those most in need.

Addressing Global HIV Prevention Needs

HIV remains a pressing public health issue, with nearly two million new infections reported globally in 2023. These infections are disproportionately concentrated in low-resource settings. Traditional daily PrEP options, while efficacious, face barriers such as stigma, limited healthcare infrastructure, and adherence challenges. Scaling up access to diverse, user-friendly PrEP modalities is critical to reaching global HIV prevention targets. The introduction of long-acting injectable agents like lenacapavir reflects a broader trend in HIV prevention—shifting from one-size-fits-all strategies to user-centered, differentiated care.

From an economic perspective, innovative access programs such as Gilead’s align with the growing recognition that cost barriers are a primary determinant of uptake and adherence, especially in LLMICs. Previous global efforts, including the Medicines Patent Pool and international donor funding, have shown that voluntary licensing and early technology transfers can rapidly catalyze generic competition. However, transition periods before generics enter the market remain critical. During this window, originator pricing policies and strategic public-private partnerships can significantly influence health outcomes.

Implications for Health Economics and Outcomes Research

This agreement has several implications for health economics, market access, and reimbursement landscapes. First, the commitment to provide lenacapavir at no profit in LLMICs directly addresses affordability, a major barrier in the diffusion of new health technologies. By frontloading access while generics ramp up, Gilead may shorten the typical lag between product launch and widespread availability in resource-limited settings.

Second, the partnership exemplifies adaptive pricing and access models. These combine voluntary licensing, partnership-driven procurement, and tiered pricing for middle-income countries. Such structures may serve as templates for future innovations in infectious disease control. They could also influence payer policies and government procurement strategies.

Finally, large-scale deployment of lenacapavir for HIV prevention will generate real-world data on effectiveness, adherence, and incident HIV cases. These data will inform subsequent health technology assessments (HTAs) and cost-effectiveness analyses. Payers and policymakers will use them to evaluate the long-term impact of shifting from daily oral to long-acting injectable PrEP.

Advancing Equity and Innovation in HIV Prevention

The Gilead-Global Fund collaboration to supply twice-yearly lenacapavir for HIV prevention in LLMICs marks a pivotal advance in the global HIV response. By integrating strategic licensing, risk-sharing, and policy advocacy, the initiative supports equitable access to innovative prevention tools. It also sets a precedent for how public-private partnerships can accelerate health technology diffusion in high-need settings. Continued monitoring of real-world outcomes, pricing dynamics, and regulatory progress will be vital for optimizing the health and economic impact of such breakthrough innovations. For further insights on this initiative, you can explore more about Gilead’s strategic efforts here.