FDA Approves Twice-Yearly HIV Prevention Injection, Marking a New Era in Epidemic Control
Washington, D.C. – June 20, 2025 – In a landmark decision that could reshape the landscape of HIV prevention, the Food and Drug Administration (FDA) has approved Gilead Sciences’ Yeztugo, a first-of-its-kind, twice-yearly injectable antiviral medication designed to prevent HIV infection. This approval marks a significant milestone in the ongoing efforts to combat the HIV epidemic, offering a more convenient and potentially more effective alternative to existing daily pill regimens.
The introduction of yeztugo (Lenacapavir), aims to address some critical challenges associated with current HIV prevention strategies, particularly adherence to daily medication schedules. With its less frequent dosing, Yeztugo promises to be a game-changer, especially for populations where consistent daily adherence is difficult.
groundbreaking Clinical trials demonstrate High Efficacy
Data from two pivotal clinical trials in 2024 showcased Yeztugo’s remarkable ability to virtually eliminate new HIV infections when administered every six months. This represents a significant advancement over existing HIV prevention medications, including daily pills and other injectable options requiring more frequent doses.
The World Health Organization (WHO) reports that approximately 1.3 million new HIV infections occurred globally in 2023, contributing to 630,000 deaths. In the United States alone, there are roughly 700 new cases and 100 HIV-related deaths each week. The burden of HIV continues to disproportionately affect specific communities,including people of color,gay and bisexual men,other men who have sex with men,and transgender women.
Pricing and Accessibility: Overcoming barriers to Access
Yeztugo is priced at $28,218 annually in the U.S., before insurance, aligning with existing branded pre-exposure prophylaxis (PrEP) medications. Gilead has stated that they are committed to ensuring broad insurance coverage and have established a copay savings program to reduce out-of-pocket expenses for eligible insured patients. Uninsured individuals can access the injection for free through a dedicated gilead program.
Convenience and Privacy: Addressing Stigma and Improving Adherence
While prep in the form of daily pills has been available for a decade, infection rates have remained stubbornly high in many regions. One significant barrier is the stigma associated with HIV and PrEP,particularly in communities outside the demographic of white men who have sex with men. The twice-yearly injection offers a level of privacy that daily pills cannot provide.
According to data from AIDSVu, Black Americans account for 39% of new HIV diagnoses but only 14% of PrEP users, while Hispanic people represent 31% of new diagnoses but just 18% of PrEP users. In late-stage trials, Yeztugo demonstrated notable results, with one study showing a 99.9% success rate in preventing HIV infection among participants. Another trial involving over 5,000 cisgender women found 100% efficacy.
Federal Funding Concerns: Ensuring Continued Access to HIV Prevention
Despite the promising efficacy and convenience of Yeztugo, potential threats loom, including proposed cuts to federal funding for HIV prevention programs. Medicaid, a critical source of insurance coverage for people living with HIV, could be considerably impacted by these cuts.
Advocates emphasize the importance of maintaining robust federal support for HIV prevention efforts to ensure that medications like Yeztugo reach those who need them most. Without sustained funding, there is a risk that progress in curbing the HIV epidemic could be undermined.
Comparative Analysis of HIV Prevention medications
Hear’s a quick comparison of available HIV prevention medications:
| Medication | Frequency | Annual cost (before insurance) | Efficacy |
|---|---|---|---|
| Yeztugo (Lenacapavir) | Twice-yearly injection | $28,218 | ~99-100% |
| Truvada | Daily pill | ~$24,000 | High |
| Descovy | Daily pill | ~$24,000 | High |
| Apretude | Every other month inject. | ~$24,000 | High |
Reader Engagement
- How do you think the availability of a twice-yearly HIV prevention injection will impact communities disproportionately affected by HIV?
- What steps do you believe are necessary to ensure equitable access to new HIV prevention technologies like Yeztugo?
The Enduring Fight Against HIV: A Look Back and a Glimpse Ahead
While the approval of Yeztugo represents a major step forward, the fight against HIV is far from over. The global effort to combat HIV/AIDS has seen remarkable progress over the past four decades, transforming a once-certain death sentence into a manageable chronic condition for many.
Looking ahead,scientists are exploring even more innovative approaches to HIV prevention and treatment,including vaccines and gene therapies. The ultimate goal remains to eradicate HIV entirely, and with continued research, collaboration, and commitment, that vision may one day become a reality.
Frequently Asked questions About Yeztugo and HIV Prevention
- What is Yeztugo?
Yeztugo is a twice-yearly antiviral injection developed by gilead Sciences to prevent HIV infection.
- How effective is the HIV prevention injection?
Clinical trials have demonstrated that Yeztugo is highly effective, virtually eliminating new HIV infections when administered every six months.
- How does the price of Yeztugo compare to other PrEP medications?
The annual list price of yeztugo is comparable to existing pre-exposure prophylaxis (PrEP) medications, such as Truvada and descovy.
- Are there programs to help with the cost of HIV prevention?
Yes, Gilead offers a copay savings program for eligible insured patients and a program for eligible uninsured individuals to receive the injection for free.
- Who is most affected by HIV?
HIV continues to disproportionately affect people of color, gay and bisexual men, other men who have sex with men, and transgender women.
