PEPFAR, together with manufacturer Gilead Sciences and the Global Fund, has announced a new initiative aimed at the large-scale distribution of lenacapavir for HIV prevention among populations in countries with high prevalence and limited resources. The drug, which belongs to the class of capsid inhibitors, is administered as an injection only twice a year after a short oral course.
Under the agreement, Gilead will supply up to two million people in low- and middle-income countries over three years. The company will provide the drug at no profit until generic manufacturers can fully meet demand. Royalty-free licensing agreements have also been signed with six generic manufacturers, covering 120 countries with high HIV prevalence.
Applications for regulatory approval of lenacapavir for prevention are expected by the end of 2025 in 18 priority countries, and the World Health Organization is considering adding the drug to its list of prequalified products.
According to the initiative’s participants, the new approach has the potential to significantly facilitate access to HIV prevention, as daily pill-taking has been a major barrier for many people. Twice-yearly injections could help reduce the number of new infections, especially in countries with weak medical infrastructure.
At the same time, partners face challenges ranging from setting up production and logistics to securing funding and training medical staff. Equally important is the rapid completion of regulatory procedures in different countries.
It should be noted that lenacapavir, marketed under the brand name Yeytuo, received EU approval shortly after a similar move by the FDA in the US, where the drug, marketed under the brand name Yeztugo, was approved in June 2024. In the US, Yeztugo costs $28,218 per year per patient.