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Lenacapavir: A Twice-Yearly Injectable for HIV Preexposure Prophylaxis.

David E Koren¹, Elias B Chahine², Elizabeth M Sherman^3,4

¹Department of Pharmacy Services, Temple University Health System, Philadelphia, PA, USA.

The Annals of Pharmacotherapy

|October 23, 2025

Summary

Lenacapavir offers a novel, long-acting injectable option for HIV-1 prevention. This capsid inhibitor demonstrated superior efficacy and was generally well-tolerated, with injection site reactions not hindering treatment continuation.

Keywords:

HIV/AIDS PrEP lenacapavir long-acting injectable preexposure prophylaxis

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Area of Science:

Pharmacology
Infectious Diseases
Virology

Background:

Human Immunodeficiency Virus type 1 (HIV-1) remains a significant global health concern.
Current pre-exposure prophylaxis (PrEP) options primarily involve daily oral medications.
Novel delivery methods and mechanisms of action are needed to improve PrEP adherence and efficacy.

Purpose of the Study:

To review the efficacy and safety of lenacapavir for HIV-1 prevention.
To evaluate lenacapavir's potential role in a diverse patient population.
To compare lenacapavir's profile with existing HIV prevention strategies.

Main Methods:

Systematic review of clinical trials and relevant literature up to August 2025.
Inclusion of English-language articles, trials, and abstracts.
Search terms included lenacapavir, capsid inhibitor, and pre-exposure prophylaxis (PrEP).

Main Results:

Lenacapavir, a subcutaneous injectable capsid inhibitor, demonstrated superior efficacy in HIV-1 prevention across various populations.
Common adverse events were injection-site reactions (nodules, pain, swelling), but these did not impede treatment continuation.
Lenacapavir's unique mechanism and extended dosing offer an alternative for individuals unable or unwilling to use oral PrEP.

Conclusions:

Lenacapavir presents a promising long-acting injectable pharmacologic agent for HIV-1 prevention.
Its novel mechanism and favorable safety profile, despite common injection-site reactions, support its clinical utility.
Lenacapavir may reduce the risk of resistance to commonly used antiretroviral drug classes.