22/03/2025
Lenacapavir, a long-acting injectable HIV-1 capsid inhibitor, has shown promising results as a potential HIV prevention method, with studies demonstrating a high degree of efficacy and superiority to daily oral Truvada.
Here's a more detailed breakdown:
Efficacy in Prevention:
In a Phase 3 clinical trial (PURPOSE 1), twice-yearly lenacapavir demonstrated 100% efficacy in preventing HIV infection in cisgender women.
The study showed a 100% reduction in HIV infections compared to background HIV incidence (bHIV).
Lenacapavir was also statistically superior to daily Truvada in preventing HIV.
The study also found that lenacapavir reduced HIV incidence by 96% compared with background HIV incidence.
Safety:
Lenacapavir was well-tolerated in the trials, with no significant or new safety concerns identified.
Mechanism of Action:
Lenacapavir is an HIV-1 capsid inhibitor, meaning it works by interfering with the HIV virus's ability to replicate and infect cells.
Clinical Trial Results:
The PURPOSE 1 trial, which assessed lenacapavir for HIV prevention in cisgender women, showed that twice-yearly injections were highly effective.
Gilead expects results from the program's other pivotal trial, PURPOSE 2, which is assessing twice-yearly lenacapavir for PrEP among men, in late 2024/early 2025.
Current Status:
Lenacapavir is approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals.
The use of lenacapavir for HIV prevention is investigational, and the safety and efficacy for this use have not been established.
The US FDA accepted Gilead's New Drug Applications for twice-yearly lenacapavir for HIV prevention under priority review.
REFERENCES
Long-acting injectable lenacapavir continues to show promising results for HIV prevention
https://www.who.int/news/item/26-09-2024-long-acting-injectable-lenacapavir-continues-to-show-promising-results-for-hiv-prevention #:~:text=Lenacapavir%20demonstrated%20a%2096%25%20reduction,or%20new%20safety%20concerns%20identified.
Gilead’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention
https://www.gilead.com/news/news-details/2024/gileads-twice-yearly-lenacapavir-demonstrated-100-efficacy-and-superiority-to-daily-truvada-for-hiv-prevention #:~:text=Gilead's%20Twice%2DYearly%20Lenacapavir%20Demonstrated%20100%%20Efficacy%20and%20Superiority%20to%20Daily%20Truvada%C2%AE%20for%20HIV%20Prevention.&text=(Nasdaq:%20GILD)%20today%20announced%20topline%20results%20from,use%20of%20HIV%20prevention%20in%20cisgender%20women.
Full Efficacy and Safety Results for Gilead Investigational Twice-Yearly Lenacapavir for HIV Prevention Presented at AIDS 2024
https://www.gilead.com/news/news-details/2024/full-efficacy-and-safety-results-for-gilead-investigational-twice-yearly-lenacapavir-for-hiv-prevention-presented-at-aids-2024 #:~:text=Overall%2C%20lenacapavir%20was%20highly%20effective,CI%2C%20p%3C0.0001).
Twice-yearly lenacapavir demonstrated exceptional efficacy for HIV prevention
https://www.cell.com/the-innovation/fulltext/S2666-6758(24)00121-8 #:~:text=Recently%2C%20results%20from%20PURPOSE%201%20demonstrated%20that,achieved%20100%%20efficacy%20in%20preventing%20HIV%20infection%2C&text=These%20results%20underscored%20the%20superiority%20of%20twice%2Dyearly,with%20p%20%3C%200.0001%20for%20both%20endpoints.
Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women
https://www.nejm.org/doi/full/10.1056/NEJMoa2407001 #:~:text=Lenacapavir%20reduced%20HIV%20incidence%20by,0.001)%20(Figure%202C).
Drug Database: Lenacapavir (HIV prevention)
https://clinicalinfo.hiv.gov/en/drugs/lenacapavir-hiv-prevention #:~:text=Lenacapavir%20reduced%20HIV%20incidence%20by,more%20effective%20in%20preventing%20HIV.
Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multidrug-Resistant HIV-1: Week 104 Results of a Phase 2/3 Trial
https://academic.oup.com/cid/article-abstract/80/3/566/7745000
Lenacapavir
https://en.wikipedia.org/wiki/Lenacapavir #%3A%7E%3Atext%3DLenacapavir%2C_in_combination_with_other%2Cresistance%2C_intolerance_or_safety_considerations.?wprov=sfla1
