In a major breakthrough, the U.S. Food and Drug Administration has approved lenacapavir, marketed as Yeztugo, as the first-ever twice-yearly injectable pre-exposure prophylaxis (PrEP) for HIV prevention in adults and adolescents weighing at least 35 kg .
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What is Yeztugo?
- A capsid inhibitor developed by Gilead Sciences, it works by blocking multiple stages of HIV replication .
- It is administered as two subcutaneous injections every six months, creating a long-lasting drug depot
💯 Efficacy That’s Nearly Unmatched
- In the phase 3 PURPOSE 1 and 2 trials, Yeztugo achieved ≥99.9% protection, with zero HIV cases in cisgender women and an overall 99.9% prevention rate.
- Adherence was stellar—over 91% of participants received on-time injections at 6 and 12 months.
Why This Matters
- Simplified regimen: Only two visits per year might reduce stigma and improve adherence compared to daily pills (Truvada, Descovy) or bimonthly injections like Apretude .
- Global potential: Recognized as a 2024 “Breakthrough of the Year” by Science, Gilead is working with generics manufacturers to expand availability in low-income countries.
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Access, Costs & Challenges
- List price is set around $28,000 per year in the U.S., similar to existing brand-name PrEP options .
- Gilead is planning broad insurance coverage, co-pay help, and partnerships to mitigate cost burdens .
- However, funding cuts to HIV programs, Medicaid, and global aid may impede access—particularly among marginalized communities .
