On June 18, the U.S. Food and Drug Administration (FDA) approved Lenacapavir, marketed under the name Yeztugo, as the first long-acting injectable drug for HIV prevention. This groundbreaking medication requires only two injections per year—once every six months—offering a major alternative to daily oral PrEP (pre-exposure prophylaxis) pills.

Daily oral PrEP has been highly effective in preventing HIV, but it depends heavily on users maintaining strict adherence. In contrast, Yeztugo could significantly ease that burden and improve overall prevention outcomes, especially for people who struggle with daily medication routines.

Up to 96–100% Effectiveness

Developed by pharmaceutical company Gilead Sciences, Lenacapavir has shown highly promising results in clinical trials. In women, the drug reduced the risk of HIV infection by 96% compared to traditional daily PrEP. Among men and LGBTQ+ individuals, the drug demonstrated 100% effectiveness in preventing infection.

Dr. David Ho, an HIV virologist and professor at Columbia University, hailed this development as a significant leap in the fight against HIV. He emphasized that Yeztugo is the first standalone medication capable of offering highly effective long-term protection against the virus, and he believes it could play a major role in curbing the global HIV epidemic.

Originally Developed as Treatment for Drug-Resistant HIV

Lenacapavir was previously approved in 2022 by the FDA as a treatment for people with multi-drug resistant HIV. However, during its development, Gilead researchers discovered two key attributes that made it ideal for prevention:

     - The drug remains in the body significantly longer than most antiretrovirals.

     - It blocks the HIV virus from replicating at multiple stages.

Tomas Cihlar, Vice President of Virology at Gilead, explained that initial trials in monkeys showed remarkable protection from HIV with just a single dose. These results inspired the team to pursue full-scale development of Lenacapavir as a preventative treatment.

Access Remains a Concern

Despite its potential, global AIDS organizations have raised concerns about equitable access. Budget cuts in the U.S. have reduced funding for HIV prevention programs abroad, raising fears that many who need the drug most may not be able to afford or access it. Without supportive policies and pricing strategies, the full benefits of Yeztugo might not reach those at highest risk.

 

Source:

Time