In a significant development in the global fight against HIV, the US Food and Drug Administration (FDA) has approved the long-acting injection Lenacapavir for the prevention of HIV.

Marketed as Yeztugo by pharmaceutical company Gilead Sciences, the drug is administered just twice a year and has shown exceptional effectiveness in clinical trials. According to the trial results, 99.9% of those who received Lenacapavir remained HIV-negative.

Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences, described the approval as a historic moment. “This is a milestone in the decades-long battle against HIV,” he said in a statement.

“Yeztugo will help us prevent HIV on a scale never seen before. We now have a way to end the HIV epidemic once and for all.”

The Centers for Disease Control and Prevention (CDC) reported an estimated 31,800 new HIV infections in the United States in 2022, the most recent year for which data is available.

While oral pre-exposure prophylaxis (PrEP) medications like Truvada and Descovy have significantly reduced infection rates, Lenacapavir offers a new level of convenience and adherence with its biannual dosing schedule. This could be especially beneficial for people who struggle with daily or monthly medication routines.

Although Lenacapavir is not a vaccine, its effectiveness mirrors that of one. Vaccines typically work by stimulating the immune system to recognise and attack viruses. In contrast, Lenacapavir provides protection by maintaining a consistent level of antiviral drug in the bloodstream, ready to neutralise any virus that might enter the body.

The approval of the drug also presents a challenge for ongoing HIV vaccine research. Given the high efficacy of both oral PrEP and now long-acting injectables, it may no longer be ethically justifiable to ask participants in clinical trials to take a placebo. Withholding proven protection in order to evaluate new vaccines could expose participants to unnecessary risk.

As Lenacapavir injection becomes more widely available, it sets a new standard for HIV prevention and forces a re-evaluation of future research approaches, potentially reshaping the path to an eventual vaccine.

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