FDA Approves Shot to Prevent HIV Needed Just Twice a Year

A new HIV prevention shot that requires just two injections a year has received FDA approval after clinical trials showed it nearly eliminated HIV transmission—offering fresh hope in the decades-long fight against the virus. Yeztugo, whose generic name is lenacapavir, is produced by Gilead Sciences, NBC News reports. Administered as an injection every six months, it nearly eliminated the spread of HIV among clinical trial participants. The medication showed an 89% lower HIV rate among gay and bisexual men and transgender people compared to those on the daily pill Truvada. For those not taking any preventive medication, the rate fell 96%. In a separate trial with cisgender women in sub-Saharan Africa, no one receiving Yeztugo contracted HIV.

"This is the single best opportunity in 44 years of HIV prevention," said Mitchell Warren of the HIV advocacy nonprofit AVAC. Yeztugo is the first in a new class of antiretrovirals. Current oral PrEP drugs need to be taken daily, while Yeztugo requires only two clinic visits a year. Advocates hope the difference could address challenges with daily adherence, particularly among high-risk groups, and help close racial gaps in HIV prevention. However, the drug's high price tag—$14,109 per injection—may limit access, and insurers may favor cheaper alternatives like generic Truvada. And other factors could slow rollout. Recent cuts to CDC staffing and research funding, along with pending legal challenges to Affordable Care Act provisions that require no-cost preventive care, make widespread access uncertain.

In addition, experts warn that complicated insurance authorization and high copays could reinforce existing disparities. Gilead says it will offer financial assistance for qualified patients and has partnerships with telehealth and community clinics ready to provide the drug. But it's not clear that enough at-risk individuals will switch to the twice-yearly shot to make a major dent in annual HIV transmission rates, which have declined just 17% over the past decade. The label warns that Yeztugo should be given only to people who are HIV-negative, per the Wall Street Journal. (This content was created with the help of AI. Read our AI policy.)