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US FDA approves Lenacapavir for HIV prevention

Writer: Ms. Roma Joglekar
Ms. Roma Joglekar
Sep 8, 2025
2 min read

Updated: Sep 8



According to recent estimates, there are around 2.14 million HIV cases in India. Around 83% of these are in the age group 15-49 years (1). Antiretroviral therapy is the common treatment strategy followed which involves taking a combination of HIV medicines daily, monthly, or every other month. Although there is no cure for HIV, prompt treatment can help HIV patients live a healthy life and reduce the risk of transmission (2). 


On June 18th, 2025, the USFDA approved Gilead's Yeztugo® (Lenacapavir) for HIV prevention. Yeztogo® is an injectable HIV-1 capsid inhibitor offering 6 months protection as pre-exposure prophylaxis (PrEP). The FDA approval is based on the Phase 3 trials, PURPOSE 1 and PURPOSE 2, which demonstrated remarkable efficacy and safety. This is the only available option that can be given twice yearly as a preventive therapy (3). Lenacapavir is a culmination of research spanning over 20 years and is considered a significant milestone in HIV prevention.   


Summary of PURPOSE 1 Study



Summary of PURPOSE 2 Study



In both PURPOSE 1 and PURPOSE 2 trials, Lenacapavir demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated (4, 5).


About the Author


Ms. Roma Joglekar is a Sports Physiotherapist with three years of on-field experience in helping athletes recover, improve and excel in their performance. Roma is passionate about medical science and has keen interest in simplifying complex medical information and share it with healthcare professionals, patients, care givers and the general population.


Source


  1. HIV/AIDS in India. Available at https://www.worldbank.org/en/news/feature/2012/07/10/hiv-aids-india. Accessed on 25 June, 2025.  

  2. HIV Treatment: The Basics. Available at: https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv-treatment-basics. Accessed on 25 June, 2025.  

  3. Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection. Available at: https://www.gilead.com/news/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection. Accessed on 25 June, 2025. 

  4. Bekker LG, Das M, Abdool Karim Q, et al; PURPOSE 1 Study Team. Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women. N Engl J Med. 2024 Oct 3;391(13):1179-1192. 

  5. Kelley CF, Acevedo-Quiñones M, Agwu AL, et al; PURPOSE 2 Study Team. Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons. N Engl J Med. 2025 Apr 3;392(13):1261-1276.  

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