Just in: FDA approves first twice-a-year injection to prevent HIV infections

DDM News

In a landmark decision, the US Food and Drug Administration (FDA) has approved a new long-acting injectable medication to prevent HIV, the first of its kind to require only two doses per year.

Diaspora Digital Media (DDM) reports that the injectable medication, called lenacapavir and branded as Yeztugo, was developed by Gilead Sciences.

It is now officially approved in the United States for pre-exposure prophylaxis (PrEP), adding a powerful new tool to the existing HIV prevention options and potentially reshaping the global fight against the virus.

Unlike the current daily PrEP pill Truvada or the bi-monthly injectable Apretude, Yeztugo requires only two injections per year to maintain efficacy, making it a groundbreaking alternative.

In clinical trials, lenacapavir demonstrated a 96% reduction in HIV risk, offering what scientists describe as near-total protection against HIV infection.

“Yeztugo could be the transformative PrEP option we’ve been waiting for,” said Dr. Carlos del Rio, a professor of medicine at Emory University School of Medicine and co-director of the Emory Center for AIDS Research.

He emphasized the drug’s potential to address significant challenges such as medication adherence and social stigma associated with more frequent PrEP dosing.

The twice a year shot represents a major leap forward in simplifying HIV prevention.

Many people at risk for HIV prefer less frequent medical regimens, a preference that has been observed consistently in PrEP-related research.

Dr. Jared Baeten, Gilead’s senior vice president of clinical development and virology therapeutic area head, explained how the drug works:

“By having that medicine in your bloodstream or in your body, if you encounter HIV, it blocks it from taking hold. It arrests infection from taking hold.”

HIV, or human immunodeficiency virus, primarily spreads through unprotected sexual contact or sharing of needles.

The virus weakens the body’s immune system, and without treatment, it can lead to AIDS (Acquired Immunodeficiency Syndrome).

While new HIV infections have declined in recent years in the United States, approximately 1.2 million people are estimated to be living with the virus, and about 13% of them are unaware of their status.

For people facing barriers to daily pills or monthly injections, lenacapavir may offer both a practical and discreet alternative.

“People can get it privately, discreetly, and then set it and forget it and not have to think about it until six months later,” Baeten noted.

The recent PURPOSE 2 trial, which focused on men who have sex with men and transgender women, confirmed that just two shots of lenacapavir per year reduced the risk of HIV infection by 96%.

A separate trial, PURPOSE 1, found the injection to be 100% effective in preventing HIV among women, indicating broad efficacy across genders.

This approval marks a significant public health milestone and a major achievement in the decades-long global campaign to end HIV/AIDS.

With the addition of a twice-a-year PrEP option, healthcare providers may now be able to reach underserved populations, increase uptake, and reduce overall transmission rates more effectively than before.

Experts hope the convenience and privacy of this injectable option will increase uptake, particularly in communities where stigma, medical access, or consistent adherence to a daily regimen remain persistent challenges.

The FDA’s approval of Yeztugo could also reshape public health approaches across the globe, especially in countries where HIV prevalence remains high but adherence to daily medication remains low.

Gilead’s announcement and the FDA’s decision together offer renewed hope in the long-standing effort to curb the spread of HIV, particularly among at-risk groups that have historically been underserved or overlooked in HIV prevention strategies.

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