🌟 What’s the big breakthrough?
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Approved by FDA in June 2025 as a twice‑yearly injection for HIV prevention (PrEP), specifically against sexually acquired HIV in adults and adolescents king5.com+15wired.com+15ndtv.com+15barrons.com+6en.wikipedia.org+6washingtonpost.com+6.
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Clinical trials show ** >99.9% effectiveness**, even achieving 100% protection in a major trial with young women barrons.com+3science.org+3mokokchungtimes.com+3. Another trial saw only 2 infections out of ~2,000 participants (96–99.9% efficacy) science.org+1ndtv.com+1.
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Named Science magazine’s 2024 “Breakthrough of the Year” theguardian.com+14advisory.com+14science.org+14.
🚀 Why it matters
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Adherence solved: Daily pills (like Truvada/Descovy) work—but only if taken consistently. A shot every six months removes that burden barrons.com+7mainepublic.org+7mokokchungtimes.com+7.
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“Vaccine-like” protection: Some trials were so compelling—they were halted early due to outstanding results reddit.com.
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Novel approach: Targets the HIV capsid protein, preventing viral replication in a way previous drugs didn’t wsj.com+15science.org+15wired.com+15.
đź’° Accessibility & challenges
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U.S. list price: about $28,218 per year—a big barrier for many science.org+6washingtonpost.com+6wired.com+6.
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Gilead’s global strategy: Contracted generics and pledged affordable/no-profit versions in 120+ low and lower-middle‑income countries; aiming for 10 million doses by 2026 and delivery across low-income countries by end‑2025 science.org+3wired.com+3reuters.com+3.
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Support from global health partners: Global Fund, PEPFAR, Gates Foundation, etc., collaborating to remove financial and regulatory bottlenecks reuters.com.
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Middle‑income country challenges: Some regions, like India, still worry about high costs and lack of tiered pricing economictimes.indiatimes.com.
🧩 Where things stand now
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Regulatory green-light: FDA cleared it in June 2025; WHO guidance and approvals in Africa & beyond are likely soon reuters.com.
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Roll‑out timeline: Aiming to launch deliveries in the poorest countries between late 2025–early 2026 .
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Next steps: Monitoring real-world use, pricing negotiations, insurance coverage (especially in U.S.), and awareness—plus pairing with other prevention tools and ultimately seeking a vaccine wired.com+14science.org+14washingtonpost.com+14.
🔎 Bottom line
Lenacapavir (Yeztugo) is a game‑changer—a single shot every six months with near‑total protection. It could transform HIV prevention, especially for people who find daily pills hard or stigmatizing. But the full impact depends on making it affordable and accessible worldwide. The science is incredible; now the task is global delivery.