Gilead Sciences has announced a new clinical study in Europe to evaluate lenacapavir for HIV prevention as part of the Landmark Purpose Program.

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.

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.”