Unitaid welcomes the extraordinary news that Gilead’s PURPOSE 1 trial has demonstrated 100% efficacy of lenacapavir, a twice-yearly injectable, in preventing new HIV infections among cisgender women and adolescent girls. These results are especially significant given that adolescent girls and young women are particularly vulnerable to HIV. According to UNAIDS, 4,000 adolescent girls and young women globally were infected with HIV every week of 2022, the vast majority in sub-Saharan Africa.
Unitaid also welcomes Gilead’s announcement of its intention to ensure accelerated access to this product for the communities affected by HIV, including the originator product until generics can be made available. Unitaid calls again on Gilead to ensure that regulatory steps, pricing and production planning, and support for generic development all are conducted as quickly and broadly as possible to reach all in need. Unitaid urges Gilead to make the terms of their access strategies – including any voluntary licensing agreements – transparent, global health-oriented, and equitable. Ensuring global access to this game-changing tool is critical, and we should strive for all people in low- and middle-income countries (LMICs) to have equitable opportunities to benefit from it as quickly as possible. Lack of prompt and broad action would jeopardize translating the clinical trial results into real-life impact.
Unitaid remains committed to working with its partners, at the national and international level, together with Gilead, to accelerate affordable access for people in urgent need in LMICs through quality-assured, low-cost generics. Unitaid is dedicated to leveraging its recent investment through the Wits RHI, University of the Witwatersrand to facilitate market shaping interventions on long-acting pre-exposure prophylaxis (PrEP) options (in partnership with the Clinton Health Access Initiative), as well as its continued support to enabling elements such as the key work of WHO and the WHO Prequalification program, the Medicines Patent Pool and other intellectual property grants, to ensure access to this life-saving product is as broad as possible.
Unitaid recognizes the excellent contributions of governments, clinicians, scientists, and community groups from LMICs to the generation of the clinical evidence, as well as on the use of PrEP, including long-acting options. The pioneering work of countries preparing for the roll out of long-acting injectable HIV PrEP, including work supported by Unitaid with the national programs in South Africa and Brazil, will facilitate the accelerated introduction of this new game-changing tool.
Results are expected from Gilead’s other pivotal trial that includes sites in Africa, Asia, and Latin America, PURPOSE 2, in late 2024 or early 2025. Unitaid applauds Gilead’s approach to including priority populations in the PURPOSE trials and looks forward to the forthcoming results of trials in men who have sex with men, transgender women, transgender men, gender non-binary individuals, and people who inject drugs, as well as further evidence on safety in pregnant and breastfeeding women. This medicine will play a key role both in the prevention of HIV – and potentially treatment, if evidence on adequate combination therapies is collected in a timely manner.
The speedy introduction of lenacapavir across all geographies and populations that require this product should be the priority focus of Gilead and all relevant stakeholders. Collectively, together with people affected by HIV, we need to ensure that every step of the pathway for product introduction and access is compressed and accelerated so no time is lost. People in need, wherever they live, should have rapid access to this promising innovation for the prevention of HIV, a disease for which vaccines are not available. No one should be left behind this time.
