Individuals at risk of HIV often rely on daily antiretroviral pills to stay protected. However, a groundbreaking alternative is on the horizon—an injectable medication administered just twice a year. This innovation not only simplifies HIV prevention but also demonstrates superior efficacy compared to daily pills, according to new clinical trial results published in the New England Journal of Medicine.

The injectable drug, Sunlenca (lenacapavir), has been shown to reduce the risk of HIV infection by an impressive 96%, significantly outperforming oral pre-exposure prophylaxis (PrEP) options like Truvada.

“Seeing these high levels of efficacy—at almost 100%—in an injectable that people only need twice a year is incredible,” said Dr. Colleen Kelley, lead researcher and professor of medicine at Emory University. “This is a profound advancement, particularly for individuals who face barriers to taking daily oral medications or those from populations disproportionately impacted by HIV.”

Key Findings from the Clinical Trial

In the trial, 99% of participants who received Sunlenca injections remained HIV-free. Among 2,179 individuals receiving Sunlenca, only two infections occurred, compared to nine infections among 1,086 people taking Truvada.

The study also highlighted better adherence rates with the injectable treatment. While the effectiveness of daily pills like Truvada diminishes with inconsistent use, Sunlenca’s twice-yearly regimen proved far more manageable for patients.

“About half of people who start daily oral PrEP stop within a year due to various challenges,” noted Dr. Kelley. “Having a highly effective injectable available twice annually is a significant breakthrough for individuals with limited access to healthcare or difficulty adhering to daily medication.”

Transformative Potential for Vulnerable Populations

People at the highest risk of HIV often face systemic healthcare disparities, making it challenging to maintain consistent medication routines. Sunlenca offers a viable solution, potentially expanding prevention options for underserved communities.

“We are not reaching everyone we need to with current HIV prevention strategies,” Kelley said. “Injectable agents like Sunlenca could be a game changer, especially for those unable to take daily pills.”

FDA Approval and Future Prospects

The U.S. Food and Drug Administration (FDA) approved Sunlenca in December 2022 as a treatment for people already living with HIV. Now, researchers are seeking FDA approval to use the drug for HIV prevention, with hopes for a green light by 2025.

“Long-acting antiretrovirals offer new hope for those who cannot adhere to oral medications,” said Dr. Carlos del Rio, chair of medicine at Emory University. “The challenge now is to roll out these tools equitably so they can significantly reduce HIV infections locally and globally.”

If approved for preventative use, Sunlenca could revolutionize HIV prevention, offering a simpler and more effective solution for millions worldwide.