Two Annual Injections to Prevent HIV: FDA Approves $40 Generic Version

The U.S. Food and Drug Administration (FDA) has given the green light to a generic version of lenacapavir, the only injectable drug administered every six months to prevent HIV. This approval marks a significant step that could reshape the global fight against the epidemic.

As reported by the Associated Press, the generic version was developed by the Indian company Dr. Reddy's Laboratories under a royalty-free voluntary license agreement with Gilead Sciences. This agreement was facilitated with contributions from Unitaid, the Clinton Health Access Initiative, and the African research institute Wits RHI.

Set at a cost of $40 per person annually, this medication will be available in roughly 120 low to middle-income countries. While this price aligns with current daily preventive pills, the injectable offers a crucial advantage: only two shots per year are required.

“With lenacapavir, we are much more optimistic,” stated Carmen Pérez Casas, Unitaid's HIV lead, emphasizing that daily pills lose their effectiveness if not consistently taken.

The FDA's approval is "tentative," a typical designation for generics while the original product is under patent protection, preventing its sale in the U.S.

Marketed as Yeztugo by Gilead Sciences, the branded lenacapavir costs $28,218 annually in the U.S., prompting international calls to extend access to less affluent nations.

Remarkable Effectiveness in Clinical Trials

The drug's effectiveness is noteworthy. During the PURPOSE 1 study with young women in South Africa and Uganda, no HIV infections were reported among those who received lenacapavir, compared to 16 infections in the daily Truvada group. In another study, PURPOSE 2, involving men and gender-diverse individuals, only two infections occurred among over 2,000 participants, showing a 96% reduction compared to the expected rate without prophylaxis.

Carolyn Amole, program director of the Clinton Health Access Initiative, highlighted the breakthrough's potential reach: “We could help scale this to the 20 million people worldwide in need of PrEP. At such levels, we can truly begin to end the HIV epidemic.”

Exclusions and Future Access

The generic licenses cover 24 Latin American and Caribbean countries within the total of 120 beneficiary nations. However, major countries like Argentina, Brazil, Mexico, and Peru were excluded from this agreement. For these nations, the Pan American Health Organization (PAHO) and Gilead announced an alternative procurement path through Regional Revolving Funds, set for 2026.

Cuba is also not included among the countries covered by the generic licenses, despite grappling with chronic shortages of antiretroviral drugs and condoms, complicating HIV prevention. Oral PrEP was introduced in Cuba through a pilot project in Matanzas in 2019 and has expanded to other provinces since 2022, though condom shortages continue to hinder virus prevention efforts.

Each lenacapavir injection requires a prior HIV test, as administering it to someone with an undiagnosed infection can lead to drug resistance. Common side effects include injection site reactions, headaches, and nausea.

According to the World Health Organization, 41 million people lived with HIV in 2025, with 1.2 million new infections and 570,000 HIV-related deaths recorded that year.

First shipments of the generic drug could arrive in some countries within weeks, with broader distribution anticipated for 2027, pending each nation’s regulatory approval processes. “The work is not done. Now we need the funding to purchase it for all who need it,” Amole warned. “But this is a major milestone.”