FDA Approves Lenacapavir as Novel HIV Prevention Method with Twice-Yearly Dosing

On June 26, 2025, the U.S. Food and Drug Administration (FDA) granted approval for lenacapavir, a groundbreaking antiretroviral drug, for use as pre-exposure prophylaxis (PrEP) against HIV. This innovative treatment option allows for a twice-annual injectable administration, which promises to significantly reduce new HIV infections and enhance adherence among at-risk populations.

Lenacapavir was recognized as the Breakthrough of the Year by *Science* in 2024 due to its remarkable efficacy in clinical trials. In the PURPOSE studies, which included diverse demographics such as cisgender men and women, transgender individuals, and gender-diverse populations, the drug demonstrated a 100% success rate in preventing HIV transmission (amfAR, 2025). According to Kevin Robert Frost, Chief Executive Officer of amfAR, “PrEP is one of the most indispensable tools we have for ending the HIV epidemic.” He emphasized that the availability of a twice-yearly injection will facilitate adherence, which has been a challenge with daily oral PrEP regimens.

The significance of this approval cannot be overstated. Recent findings published in *The Lancet HIV* reveal that states with high oral PrEP coverage witnessed a 38% decline in new HIV diagnoses over the past decade, contrasting sharply with the 27% increase observed in states with low coverage (The Lancet HIV, 2025). However, despite the potential benefits of PrEP, usage in the United States remains critically low. The Centers for Disease Control and Prevention (CDC) reports that out of 1.2 million Americans who could benefit from PrEP, only about 400,000—approximately 36%—are currently accessing it (CDC, 2022).

Inconsistent adherence to a daily oral regimen has hindered long-term efficacy, making lenacapavir's long-acting injectable form a significant advancement in HIV prevention strategies. The FDA's indication for lenacapavir targets sexually active adults and adolescents who are at high risk of acquiring HIV-1.

Additional studies are already underway to further explore lenacapavir's efficacy across various populations. These include PURPOSE 3, focusing on cisgender women in the U.S. who have sexual partners assigned male at birth; PURPOSE 4, which examines injection drug users; and PURPOSE 5, comparing Truvada (a daily pill) with lenacapavir among key populations (amfAR, 2025).

The implications of lenacapavir's approval extend beyond individual health outcomes. If made accessible and affordable, this drug could play a pivotal role in the broader fight against the HIV epidemic. Nevertheless, amfAR calls on Gilead Sciences, the drug's manufacturer, along with the U.S. government, to ensure that lenacapavir is widely available to those who need it most.

In conclusion, lenacapavir's approval marks a significant milestone in HIV prevention. As healthcare providers and policymakers work to increase access, the focus will remain on overcoming barriers to PrEP utilization, ultimately striving to end the HIV epidemic through innovative and effective treatment options.