Therapy Areas: AIDS & HIV
Gilead Sciences initiates Phase 2 trial in Europe to evaluate lenacapavir for HIV prevention
18 October 2023 -

Biopharmaceutical company Gilead Sciences Inc (Nasdaq:GILD) announced on Wednesday the launch of PURPOSE 5, the first Phase 2 clinical trial to evaluate an investigational long-acting HIV prevention solution in Europe.

This study will assess the persistence of lenacapavir compared to emtricitabine/tenofovir disoproxil fumarate (F/TDF) in individuals who could benefit from pre-exposure prophylaxis (PrEP) but are not currently using it. The trial notably targets recruitment from underrepresented groups in France and the United Kingdom, populations that bear a disproportionate HIV burden.

HIV remains a pressing public health concern in Europe, with over 100,000 new HIV diagnoses in 2022. While HIV prevention holds significant potential to curb the epidemic, stigma and access barriers hinder the broad impact of PrEP medications in Europe. At present, less than 15% of those who could benefit from PrEP are accessing it. Existing PrEP options may not align with the diverse needs of potential beneficiaries, limiting their effectiveness in reducing new infections.

Lenacapavir, an HIV capsid inhibitor, is administered as a twice-yearly subcutaneous injection. It is currently approved for treating multidrug-resistant HIV-1 infection when combined with other antiretrovirals and is also being explored for HIV prevention. If approved, lenacapavir's semiannual dosing could provide a long-acting alternative to cater to the diverse preferences of PrEP candidates.

Use of lenacapavir for HIV prevention remains investigational, with safety and efficacy in this context yet to be determined.

Lenacapavir, marketed as Sunlenca, is currently approved in several countries for treating multi-drug resistant HIV in conjunction with other antiretrovirals.