New low-cost HIV shot approved for global use

People in 120 low- and middle-income countries can now access a twice-yearly HIV prevention shot for $40 U.S. a year. The U.S. Food and Drug Administration approved a generic version of lenacapavir on Monday. This price matches the current cost of daily preventive pills but offers a more convenient dosing schedule for patients.

The approval follows years of development by Dr. Reddy's Laboratories, an India-based manufacturer. The work was coordinated by Unitaid, the Clinton Health Access Initiative, and Wits RHI. These organizations sought to accelerate production and lower costs for regions with high infection rates. Previously, Gilead Sciences was the sole supplier, and demand frequently outstripped available supply.

Carmen Pérez Casas, the HIV lead at Unitaid, noted that daily pills lose their protective effect if a person misses a dose. She stated that the new injection provides a more reliable option for maintaining protection against the virus.

The brand-name version, Yeztugo, retails in the United States for $28,218 U.S. per year before insurance. Gilead officials say this price is comparable to other forms of pre-exposure prophylaxis. The generic cannot be sold in the U.S. yet because the original drug remains under patent protection.

Carolyn Amole, who leads the HIV program at the Clinton Health Access Initiative, said the affordable generic allows organizations to target the 20 million people worldwide who need preventive medication. She described the approval as a milestone that could help bring an end to the epidemic if scaled properly.

Health officials noted that only a generic version would allow large-scale roll-out. South Africa, which has the largest population of people living with HIV at around eight million, began using the drug earlier this year. The Global Fund signed an agreement with Gilead in 2025 to provide the medication to low- and middle-income countries.

The FDA designated the approval as tentative, which is standard for generics while the originator drug is under patent. The generic should become available in some locations within weeks. Other manufacturers' versions have not yet received FDA approval. Common side effects of the injection include site reactions, headache, and nausea. Patients must test for HIV before starting treatment and before each subsequent injection.