FDA Approves First Twice‑Yearly HIV Prevention Injection: A New Era in PrEP
Recently, the U.S. Food and Drug Administration granted approval for lenacapavir, marketed under Yeztugo, marking a historic milestone as the **first-ever HIV prevention shot administered only twice a year.
Proven Near‑Total Protection
Clinical trials—PURPOSE 1 and PURPOSE 2—demonstrated staggering results: 99.9% of participants remained HIV‑negative. In PURPOSE 1 (predominantly cisgender women), efficacy was effectively 100%, while PURPOSE 2 reflected similar success rates among men who have sex with men and other high‑risk groups .
How It Works
Lenacapavir is a long‑acting capsid inhibitor. A small depot is injected under the skin every six months, steadily releasing the drug to stop HIV from replicating .
Advantages Over Existing PrEP
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Simplified schedule: Just two injections annually versus daily pills or bi-monthly shots like Apretude.
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Better adherence: Ideal for those with difficulty maintaining daily regimens or facing stigma.
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High efficacy: With 99.9% success, this long-acting option could reshape global HIV prevention strategies.
Cost & Access
The U.S. list price is approximately $28,218 per year ($14,109 per dose). Gilead has pledged support via insurance assistance and no-profit supply deals targeting low-income countries, offering generic licenses to help broaden affordability.
Why It Matters
This approval introduces a powerful alternative for HIV prevention. Experts believe that biannual dosing could significantly enhance uptake and retention among vulnerable communities—bringing us closer to controlling the HIV epidemic.
This groundbreaking development—yeztugo’s twice-yearly PrEP injection—offers near-perfect protection with just two shots a year. Yet, equitable distribution remains vital to realize its full global impact.
