Lenacapavir: First Approval
Julia Paik
Abstract
) is a long-acting capsid inhibitor of human immunodeficiency virus type 1 (HIV-1) being developed by Gilead Sciences Inc. It is available as an oral tablet and injectable solution, with the latter being a slow-release formulation to allow bi-annual subcutaneous administration. In August 2022, lenacapavir received its first approval in the EU for use in combination with other antiretroviral(s) in adults with multi-drug resistant HIV infection, for whom it is otherwise not possible to construct a suppressive anti-viral regimen. This article summarizes the milestones in the development of lenacapavir leading to this first approval for the treatment of HIV-1 infection.
Topics & Concepts
MedicineHuman immunodeficiency virus (HIV)RegimenIntensive care medicinePharmacologyDrugDrug approvalDrug holidayVirologyImmunologyInternal medicineHIV Research and TreatmentHIV/AIDS drug development and treatmentHIV/AIDS Research and Interventions