[Source: Antimicrobial Agents and Chemotherapy, full page: (LINK). Abstract, edited.]
Ibalizumab: A novel monoclonal antibody for the management of multidrug resistant HIV-1 infection
Mario V. Beccari [PharmD, BCPS, AAHIVP], Bryan T. Mogle [PharmD, BCPS, AAHIVP], Eric F. Sidman [PharmD, BCPS, AAHIVP], Keri A. Mastro [BA], Elizabeth Asiago-Reddy [MD, MS],Wesley D. Kufel [PharmD, BCIDP, BCPS, AAHIVP]
Limited antiretrovirals are currently available for the management of multidrug resistant (MDR) HIV-1 infection. Ibalizumab, a recombinant humanized monoclonal antibody, represents the first novel agent for HIV-1 management in over a decade, and is the first monoclonal antibody for the treatment of MDR HIV-1 infection in combination with other ART in heavily treatment-experienced adults who are failing their current antiretroviral regimen. Ibalizumab demonstrates a novel mechanism of action as a CD4-directed post-attachment inhibitor, and has a favorable pharmacokinetic profile that allows for a dosing interval of every 14 days after an initial loading dose. Clinical studies have demonstrated reasonably substantial antiretroviral activity with ibalizumab among a complex patient population with advanced HIV-1 infection who are receiving an optimized background regimen, where limited therapeutic options exist. Ibalizumab was well-tolerated in clinical trials, and the most common adverse effects included diarrhea, nausea, dizziness, fatigue, pyrexia, and rash. Resistance to ibalizumab has also been observed via reduced expression or loss of the potential N-linked glycosylation sites in the V5 loop of the envelope glycoprotein 120. The mechanism of action, pharmacokinetic parameters, efficacy, and safety of ibalizumab present an advance in the management of MDR HIV-1 infection. Future studies and post-marketing experience will further determine longer-term clinical efficacy, safety, and resistance data for ibalizumab.
Copyright © 2019 American Society for Microbiology. All Rights Reserved.
Keywords: Antivirals; Drugs Resistance; HIV; Monoclonal antibodies; Ibalizumab.