Ibalizumab: The First Monoclonal Antibody for the Treatment of HIV-1 Infection.

ABSTRACT

OBJECTIVE: To review the efficacy and safety of ibalizumab (IBA) in the treatment of HIV-1 infection. DATA SOURCES A literature search was performed using PubMed and Google Scholar (2010 to mid-June 2020) with the search terms TMB-355, TNX-355, and ibalizumab. Other resources included abstracts presented at recent conferences and the manufacturer's website and prescribing information. STUDY SELECTION AND DATA EXTRACTION All relevant English-language articles of studies assessing the efficacy and safety of IBA were included. DATA SYNTHESIS: IBA is a monoclonal antibody that blocks HIV-1 from infecting CD4+ T cells. IBA is approved by the Food and Drug Administration, in combination with other antiretrovirals (ARVs), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant (MDR) HIV-1 infection failing their current ARVs. IBA demonstrated significant and sustained antiviral activity in patients with MDR HIV-1 infection who had advanced disease and limited treatment options. It carries a warning regarding the development of immune reconstitution inflammatory syndrome. Common adverse reactions include diarrhea, dizziness, nausea, and rash. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE IBA represents an attractive option for treatment-experienced adults with advanced HIV-1 infection who are no longer able to achieve viral suppression on oral ARV therapy alone and who are able to adhere to an infusion therapy every 2 weeks. As with other biologics, there is a potential for the development of antibodies to IBA that can compromise its efficacy and safety. CONCLUSION: IBA provides a needed treatment option to achieve and maintain viral suppression in heavily treatment-experienced adults with MDR HIV-1 infection.