Lenacapavir: A New Approach for HIV Pre-Exposure Prophylaxis

Abstract

At present, HIV infection remains a major public health concern due to its continued transmission, which affects the quality of life of people living with HIV and contributes to ongoing morbidity and mortality related to HIV-associated complications. To achieve the goal of ending the AIDS epidemic by 2030, the development of new pre-exposure prophylaxis (PrEP) agents that offer more convenient administration and improved adherence has become an important strategy in HIV prevention. Lenacapavir is the first drug in capsid inhibitor class with long-acting properties and was approved by the U.S. Food and Drug Administration on 18 June 2025, as a drug for PrEP to prevent HIV-1 infection in adults and adolescents weighing at least 35 kilograms who are at high risk of acquiring HIV through sexual contact. Individuals must have a confirmed negative HIV test result before initiating the medication. The dosing regimen begins with an initial phase that includes both subcutaneous injection and oral administration, followed by continued subcutaneous injections every six months. This long-acting dosing schedule enhances convenience and promotes better adherence to treatment. The systematic literature review showed that the drug is generally effective and safe, with some reports of adverse events at the injection site. However, its long-term use data as well as its use in certain populations, namely the elderly, pregnant and breastfeeding women, remains limited. Further studies are needed to evaluate the safety and efficacy of lenacapavir in long-term use and in these specific populations.