Lenacapavir: A first-in-class capsid inhibitor for the treatment of highly treatment-resistant HIV.

Purpose: The purpose of this article is to review the pharmacology, efficacy, and safety of the capsid inhibitor lenacapavir for the treatment of multidrug-resistant human immunodeficiency virus type 1 (HIV-1) infection.

Summary: A review of the literature was performed by searching PubMed/MEDLINE for all relevant articles published between February 2021 and March 2023 using the keywords "lenacapavir," "Sunlenca," "human immunodeficiency virus," and "treatment" together with "multidrug resistant human immunodeficiency virus." All English-language articles describing clinical trials assessing the efficacy and safety of lenacapavir when used in humans for the treatment of HIV infection were included. Review articles, conference abstracts, and article references were evaluated for relevant information, and data were also obtained from the manufacturer's website and the package insert. Lenacapavir has been approved by the Food and Drug Administration (FDA) for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistance for whom the current antiretroviral regimen is failing due to resistance, intolerance, or safety considerations. It is the first in a new class of drugs called capsid inhibitors to receive FDA approval. Lenacapavir is a long-acting subcutaneous injectable to be administered once every 6 months. The phase 3 clinical trial evaluating lenacapavir has demonstrated its efficacy in viral load reduction from baseline compared to placebo in patients receiving optimized background therapy. The most common adverse events reported in the clinical trial were injection site reactions, occurring in 63% of participants.

Conclusion: Lenacapavir is a novel capsid inhibitor indicated, in combination with other antiretroviral therapy, for treatment of multidrug-resistant HIV-1 infection.