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FDA Approves New Twice-Yearly Shot for Disease Prevention

FDA Approves Yeztugo: A Twice-Yearly Injection for HIV Prevention

in a meaningful advancement for HIV prevention, the Food and Drug Management (FDA) approved Yeztugo (lenacapavir) on June 18, 2025. Developed by gilead Sciences, this long-acting injectable offers a twice-yearly option to daily oral pre-exposure prophylaxis (PrEP) medications, perhaps revolutionizing prevention efforts, especially among high-risk populations.

Yeztugo’s Efficacy and Impact

Yeztugo demonstrated near-total effectiveness in clinical trials, marking a major step forward in the fight against HIV. The PURPOSE 1 and PURPOSE 2 trials, both funded by Gilead, showcased the drug’s ability to substantially reduce the risk of HIV infection in adults and adolescents.

Did You know? The CDC estimates that about 1.2 million people in the U.S. could benefit from PrEP, but only a fraction are currently taking it.

This new option addresses a critical need for more accessible and convenient prevention methods. Experts believe that the twice-yearly injection could improve adherence rates compared to daily pills,especially for individuals who struggle with consistent medication schedules.

Addressing Disparities in HIV Prevention

Access to HIV prevention therapies like PrEP remains unequal, with disparities affecting Black, African American, and Latin or Hispanic communities, as well as those residing in the Southern U.S. These disparities often stem from stigma, lack of affordability, insurance coverage, and limited access to healthcare services.

Long-acting PrEP options like yeztugo have the potential to bridge these gaps by offering a discreet and less frequent method of prevention. Studies have shown higher retention rates among individuals using long-acting PrEP compared to daily oral PrEP.

Pro Tip: Check with local health departments and AIDS service organizations for assistance programs that may help cover the cost of PrEP.

Expert Perspectives on Yeztugo

Dr. Monica Gandhi, a professor of medicine at the University of California, San Francisco, highlighted the potential of long-acting lenacapavir to improve access for people with and without insurance, and to bolster adherence rates. She noted that long-acting PrEP has shown promise in serving low-income individuals facing challenges such as housing insecurity and substance use.

Dr. William Schaffner, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, described Yeztugo as a potential “game-changer.” He emphasized its potential to efficiently prevent HIV infection in large populations at high risk, both in developed and developing countries, provided resources are allocated to reach those in need.

Global Implications and Availability

While the United States is currently the only country to have approved Yeztugo for HIV prevention, regulators worldwide are reviewing the drug. Its availability and cost remain key concerns. Gilead estimates the annual cost of lenacapavir at around $28,218 per person.

The cost-effectiveness and accessibility of yeztugo will be crucial in determining its impact on public health. Concerns have been raised about whether large health insurance companies will cover the drug, particularly given potential cuts to Medicaid.

High-Risk Populations and the Need for Prevention

Within the United States,men who have sex with men and heterosexual individuals with multiple partners are considered at high risk for HIV transmission. Accessible HIV prevention therapies like PrEP are essential for these populations.

What steps can be taken to ensure equitable access to Yeztugo for all at-risk populations?

How will the introduction of Yeztugo impact the overall rates of HIV infection in the coming years?

Key Facts About Yeztugo

Feature Details
Drug Name Lenacapavir (Yeztugo)
Manufacturer Gilead Sciences
Administration twice-yearly injection
FDA Approval Date June 18, 2025
Estimated Annual Cost $28,218

Evergreen Insights: HIV Prevention and PrEP

HIV (human immunodeficiency virus) is a virus that attacks the body’s immune system. If left untreated, it can lead to AIDS (acquired immunodeficiency syndrome). PrEP (pre-exposure prophylaxis) is a way for people who don’t have HIV but are at very high risk of getting it to prevent HIV infection by taking a pill every day or receiving injections.

The introduction of PrEP has significantly reduced the rate of new HIV infections, particularly among high-risk groups. However, challenges remain in ensuring widespread access and adherence to prep regimens. Long-acting options like Yeztugo represent a promising avenue for overcoming these challenges and further reducing the burden of HIV.

According to UNAIDS, an estimated 39 million people globally were living with HIV in 2022. Continued efforts in prevention, testing, and treatment are crucial to achieving the goal of ending the HIV epidemic.

Frequently Asked Questions About Yeztugo and HIV Prevention


Disclaimer: This article provides data about a new HIV prevention drug and should not be considered medical advice. Consult with a healthcare professional for personalized guidance.

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