### Groundbreaking Approval: FDA Greenlights Gilead's Yeztugo for HIV Prevention The U.S. Food and Drug Administration (FDA) has made a significant advancement in the fight against HIV by approving Gilead Sciences' Yeztugo, a twice-yearly injectable medication designed for pre-exposure prophylaxis (PrEP). This approval marks a pivotal moment in HIV prevention, as it offers a long-acting alternative to daily oral medications, potentially transforming the landscape of HIV care. However, concerns regarding the drug's high cost and accessibility for vulnerable populations have emerged, raising questions about its equitable distribution and impact on public health [https://www.clinicaltrialsarena.com/analyst-comment/fda-approves-gilead-yeztugo-prep, https://von.gov.ng/new-hiv-drug-may-exclude-vulnerable-populations-experts]. ### Structure of the Response: Key Segments 1. **Overview of Yeztugo**: - Yeztugo is a long-acting injectable drug that requires administration only twice a year, offering a significant improvement over daily pills [https://www.financialexpress.com/business/healthcare-us-fda-approves-twice-a-year-hiv-shot-that-could-end-daily-pills-3888285]. 2. **Clinical Efficacy**: - Clinical trials have shown that Yeztugo provides near-complete protection against HIV, with efficacy rates reported as high as 99.9% [https://www.thehindu.com/sci-tech/health/us-approves-gileads-twice-yearly-injection-to-prevent-hiv/article69713366.ece]. 3. **Cost and Accessibility Concerns**: - The annual cost of Yeztugo is projected to be around $28,000, which has raised alarms among health advocates about its affordability and accessibility for at-risk populations [https://www.benzinga.com/news/fda/25/06/46023093/fda-approves-gileads-game-changing-twice-yearly-shot-to-prevent-hiv-transmission-critics-slam-28k-price-tag]. 4. **Global Implications**: - The approval of Yeztugo is expected to have a global impact, potentially protecting millions from HIV, but its high cost may limit its reach, particularly in low-income regions [https://www.oregonlive.com/health/2025/06/this-twice-a-year-shot-to-prevent-hiv-could-stop-transmission-if-people-can-get-it.html]. ### Supporting Evidence and Data - **Efficacy Rates**: - Yeztugo has demonstrated a **99.9% effectiveness** in preventing HIV in clinical trials, making it one of the most effective options available [https://www.statnews.com/2025/06/19/gilead-ceo-interview-approval-of-hiv-prevention-shot-yeztugo-lenacapavir]. - **Cost Analysis**: - The projected **annual cost of $28,000** for Yeztugo has been a focal point of criticism, with experts warning that such pricing could exclude many from accessing this life-saving treatment [https://www.benzinga.com/news/fda/25/06/46023093/fda-approves-gileads-game-changing-twice-yearly-shot-to-prevent-hiv-transmission-critics-slam-28k-price-tag]. - **Potential Reach**: - If made accessible, Yeztugo could significantly reduce HIV transmission rates globally, particularly in high-risk populations [https://www.devdiscourse.com/article/health/3463102-game-changer-in-hiv-prevention-lenacapavirs-historic-approval]. ### Conclusion: A New Era in HIV Prevention The FDA's approval of Yeztugo represents a **transformative step** in HIV prevention, offering a long-acting alternative that could significantly reduce infection rates. However, the **high cost** associated with the drug poses a serious challenge to its accessibility, particularly for vulnerable populations. 1. **Yeztugo's Approval**: The FDA has approved a twice-yearly injectable drug for HIV prevention, marking a significant advancement in treatment options. 2. **Efficacy and Impact**: Clinical trials indicate that Yeztugo is highly effective, with a 99.9% success rate in preventing HIV. 3. **Concerns Over Cost**: The drug's high price tag raises concerns about accessibility for those who need it most. 4. **Global Implications**: While the drug has the potential to protect millions, its impact may be limited by affordability issues. In summary, while Yeztugo could revolutionize HIV prevention, addressing the cost and ensuring equitable access will be crucial for maximizing its public health benefits [https://www.clinicaltrialsarena.com/analyst-comment/fda-approves-gilead-yeztugo-prep, https://von.gov.ng/new-hiv-drug-may-exclude-vulnerable-populations-experts].