Introduction
Lenacapavir, also known as Ibalizumab-uiyk, is a humanized monoclonal antibody that is used as an antiviral agent in the treatment of HIV-1 infection. It is designed to target the CD4 receptor on human T cells and prevent the attachment of the virus to the host cell.
Lenacapavir | CAS#2189684-58-8has recently been approved by the US Food and Drug Administration (FDA) for treating HIV-1 in adults who have failed multiple antiretroviral therapies. This article will review the properties, mechanism of action, clinical trials, and future prospects of Lenacapavir.
Properties
Lenacapavir is a subcutaneously administered drug with a half-life of approximately 17 days. The dose is 2000 mg every four weeks and is intended for use in combination with other antiretroviral agents. It has a molecular weight of approximately 147 kDa and is formulated as a sterile, preservative-free, and clear to slightly opalescent solution. Lenacapavir is classified as an IgG4 kappa monoclonal antibody and is produced by recombinant DNA technology.
Mechanism of Action
Lenacapavir binds to the CD4 receptor of host T cells, thereby blocking the entry of HIV-1 into the cell and preventing viral replication. Unlike existing antiretroviral agents, Lenacapavir works by a non-competitive mechanism and does not induce drug resistance. It has been shown to have a unique resistance profile that is distinct from other antiretroviral agents. Lenacapavir does not interact with the cytochrome P450 enzyme system and has no significant drug-drug interactions.
Clinical Trials
The safety and efficacy of Lenacapavir were assessed in a Phase 3 randomized, double-blind, placebo-controlled trial (TMB-301) involving 335 HIV-positive adults who had previously failed multiple antiretroviral therapies. The primary endpoint was the proportion of patients achieving viral suppression (<50 copies/mL) at week 26. The trial demonstrated that Lenacapavir, when used in combination with optimized background therapy, achieved a statistically significant higher rate of viral suppression compared to placebo. The most common adverse events were injection site reactions, diarrhea, and headache.
Future Prospects
Lenacapavir represents a promising addition to the arsenal of antiretroviral agents for the treatment of HIV-1 infection. It offers a new mechanism of action, a unique resistance profile, and a long-acting dosing regimen. The approval of Lenacapavir by the FDA is a significant milestone in the development of HIV therapeutics. Further clinical studies are underway to assess the use of Lenacapavir in novel regimens, including in combination with other long-acting agents. Lenacapavir has the potential to transform the treatment of HIV-1 infection and improve the quality of life for people living with HIV.
Conclusion
Lenacapavir is a new antiretroviral agent that has recently been approved by the FDA for the treatment of HIV-1 in adults who have failed multiple antiretroviral therapies. It works by blocking the attachment of the virus to the CD4 receptor of host T cells, thereby preventing viral replication. The drug has a long half-life, a unique resistance profile, and a favorable safety profile. Lenacapavir has the potential to become a mainstay in the treatment of HIV-1 and improve the health outcomes of people living with HIV.
Lenacapavir | CAS#2189684-58-8, antiretroviral therapy, TMB-301, FDA, viral suppression
Lenacapavir: A New Antiretroviral Agent for HIV-1 Treatment
Lenacapavir, recently approved by the FDA, is a new antiretroviral agent used in treating HIV-1 infection. This article reviews its properties, mechanism of action, clinical trials, and future prospects.
- Lenacapavir mechanism of action
- Long-acting antiretroviral agents
- Lenacapavir clinical trials
- Lenacapavir FDA approval
- Antiretroviral therapy for HIV-1
- Lenacapavir resistance profile
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