Home Business Healthcare FDA Approves Twice-Yearly HIV ...

FDA Approves Twice-Yearly HIV Prevention Shot Lenacapavir

Healthcare

Business Honor
25 June, 2025

New injection offers powerful HIV prevention but faces access and cost challenges.

The US FDA approved the new HIV prevention injection, lenacapavir, which is sold under the brand name Yeztugo by Gilead Sciences. The long-acting injection is to be administered only once every six months, offering a strong alternative to daily pills and regular injections used currently to prevent HIV.

Clinical tests proved lenacapavir to be nearly 100% effective in preventing HIV infection when taken every two years. It is designed for those at high risk of infection with HIV who may have difficulty with daily pills or frequent clinic visits.

Today, around 500,000 people in the US are on once-daily oral PrEP (pre-exposure prophylaxis), and around 21,000 take Apretude, another two-monthly shot. Experts say the twice-yearly shot could transform HIV prevention, especially for those who have been struggling to adhere to every-day treatment.

However, the cost of Yeztugo—over $28,000 a year—is a concern for access. Most patients will rely on Medicaid, insurance, or assistance plans to cover the shot. Generic PrEP pills, by comparison, are at least $1 a day, and Apretude is approximately $24,000 a year. Campaign organizations are worried that insurance limitations and unaffordable costs will limit access to this new treatment.

Globally, an estimated 1.3 million people were newly infected with HIV in 2023. Gilead plans to provide no-profit pricing to up to 2 million people in low- and middle-income countries and has licensed manufacturers to produce the drug in 120 high-prevalence HIV countries.

Despite this progress, experts warn that budget cuts to HIV prevention programs could slow access to this life-changing drug. They note that HIV prevention is central to steadying the epidemic and saving lives. The go-ahead for lenacapavir is a significant step forward, but ensuring its accessibility and affordability on a wide scale is a priority.