The Phase II PURPOSE 5 trial will evaluate the persistence of the therapy against emtricitabine/tenofovir disoproxil fumarate (F/TDF) in individuals who could benefit from pre-exposure prophylaxis (PrEP) but are not currently using it.
It will focus on recruiting participants from groups across the UK and France that experience a disproportionate impact from HIV and are frequently underrepresented in trials.
Lenacapavir is a first-in-class HIV capsid inhibitor, which is designed to be administered as a twice-yearly subcutaneous injection.
It is presently approved for use alongside other antiretroviral medications to treat individuals with multidrug-resistant HIV-1 infection.
Lenacapavir is also under assessment for the prevention of HIV. Its efficacy and safety for preventing HIV have not been established.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below formBy GlobalData
If lenacapavir receives approval, its twice-yearly dosing regimen may offer a potential long-acting option to cater to the diverse requirements and preferences of individuals who could benefit from PrEP.
Gilead Sciences HIV clinical development vice-president Jared Baeten said: “Since Gilead launched the PURPOSE clinical trials in 2019, we have actively engaged a diverse group of global stakeholders who informed not only what we were studying in our innovative HIV prevention research program, but how we conduct that work and continually evolve it.
“There is a critical need to bring forward new PrEP options that are informed by and designed for the communities that could benefit from PrEP in Europe.”