FDA Approves Yeztugo: First Twice‑Yearly HIV Prevention Shot
— 'This really has the possibility of ending HIV transmission,' said Greg Millett of amfAR.
The U.S. Food and Drug Administration has granted approval to Yeztugo (lenacapavir), a long‑acting injectable designed to prevent HIV, making it the world’s first twice‑yearly PrEP shot.
Manufactured by Gilead Sciences, Yeztugo is a capsid inhibitor that demonstrated near‑100% effectiveness in two large clinical trials across various high‑risk groups. This innovation outperforms daily PrEP pills and a bi‑monthly injectable option.
Administered in two subcutaneous injections every six months, the medication forms a depot beneath the skin, enabling sustained release. It is intended for individuals who test negative for HIV and is a complementary tool to, but not a replacement for, condoms.
Though hailed as a potential game‑changer—“This really has the possibility of ending HIV transmission,” said Greg Millett of amfAR—experts warn that gaps in healthcare funding, Medicaid coverage, and global aid could hinder access.
Priced at approximately $28,218 per year in the U.S., Gilead plans to offer insurance coverage and patient‑assistance. For international distribution, licensing agreements for generic production in 120 low‑income countries are in place, though many middle‑income nations may face challenges due to cost and infrastructure constraints.
According to the latest data, around 30,000 new HIV infections occur in the U.S. each year, with about 1.3 million globally. Despite current PrEP use by roughly 400,000 Americans, infection rates remain high in areas with low uptake.
