HIV Drug FDA Approval & Treatment Overview
- Yeztugo—the brand name for lenacapavir—has earned FDA approval (June 18, 2025) as the first and only twice‑yearly injectable PrEP option in the U.S.verywellhealth.com+12r
- Administered as two subcutaneous injections every six months, it offers a powerful alternative to daily or bimonthly PrEP regimenshcplive.com.
Clinical Trial Success
- In two large Phase 3 trials—PURPOSE 1 (young women in Africa) and PURPOSE 2 (men, trans, and gender-diverse individuals globally), Yeztugo prevented ≥99.9% of HIV infections, with zero cases in women and only two among 2,179 participants in the broader groupverywellhealth.com+2drugtopics.com+2gilead.com+2.
- The drug’s high efficacy led Science to name it 2024 “Breakthrough of the Year.”apnews.com+4gilead.com+4reuters.com+4
Market & Economic Forecast
- Priced at US $28,218 annually, Yeztugo is positioned similarly to other branded PrEP options. Gilead aims for broad insurance coverage and support programs to ease patient costshcplive.com+10wsj.com+10barrons.com+10.
- Analysts predict sales to grow from $117.5 million in 2025 to $1.6 billion by 2028, competing with other long-acting PrEP like Apretude and oral pills such as Descovywsj.com+1barrons.com+1.
Public Health Significance
- This breakthrough addresses common PrEP adherence issues: fewer dosing events mean less chance of missed doses, reduced stigma, and improved access—especially among women, rural, Black, and Latino communitiesreuters.com+9gilead.com+9wsj.com+9.
- Approximately 100 new HIV diagnoses occur daily in the U.S., with 1.3 million cases globally each year—underlining the urgent need for more accessible prevention toolsabcnews.go.com+2apnews.com+2investors.com+2.
Access & Equity Challenges
- Although Gilead plans to roll out generic versions in 120 low-income countries, middle-income countries may face price or regulatory gapsreuters.com+3apnews.com+3time.com+3.
- In the U.S., barriers such as cuts to Medicaid, public health funding, and PrEP awareness could slow adoption, despite assistance programsapnews.com.
Safety & Usage Guidelines
- Before each injection, individuals must test HIV-negative to avoid drug-resistant virus formationapnews.com+7gilead.com+7wsj.com+7.
- Common side effects include injection-site reactions, headaches, and nauseawsj.com.
Global Strategy
- Gilead is filing for Yeztugo approval in other regions, including the EU, Canada, Australia, Brazil, and South Africa, with further filings anticipated in Latin Americaapnews.com+10gilead.com+10hcplive.com+10.
Conclusion
Yeztugo’s FDA approval marks a pivotal moment in HIV prevention, offering unmatched convenience, efficacy, and potential impact on ending the epidemic. However, its true success hinges on overcoming healthcare access gaps, funding shortages, and ensuring widespread adoption—both in the U.S. and globally.