MedicalResearch.com Interview with:
Brinda Emu, MD
Assistant Professor of Medicine (Infectious Diseases)
Yale School of Medicine
MedicalResearch.com: What is the background for this study?
Response: This was a Phase 3 study of a new antiretroviral agent, ibalizumab, for the treatment of HIV-1 infection. Ibalizumab is a monoclonal antibody that targets the CD4 receptor on host cells. CD4 is the receptor that HIV uses to infect CD4+ T cells. By binding to the CD4 receptor, ibalizumab prevents viral entry. This study recruited patients that harbor multi-drug resistant HIV and were failing their current regimen of antiretroviral agents, and thus had limited options for treatment of their HIV-1 infection using approved medications.
MedicalResearch.com: What are the main findings?
Response: The main findings from this study are that with a single dose of ibalizumab added to their failing regimen, 83% of patients achieved at least a 0.5 log reduction of their viral load. In addition, at 6 months after treatment with ibalizumab combined with an individually optimized background antiretroviral therapy regimen, 43% of patients achieved viral suppression (less than 50 copies/mL in the blood).
In addition to viral suppression, patients also had a mean increase in CD4+ T cells of 75 cells/mcl. An increase in CD4+ T cells is a measurement of improvement in immune health.
MedicalResearch.com: What should readers take away from your report?
Response: Ibalizumab is a drug with a new mechanism of action to combat HIV-1 infection in patients with multi-drug resistant HIV. It is the first new mechanism for HIV approved in the last 10 years. In this setting of multi-drug resistant HIV, ibalizumab has demonstrated antiviral activity in the majority of patients on the drug and it has demonstrated durable viral suppression in almost half of patients on study. This is a very promising result among patients with very limited treatment options, and thus provides a new promising option for treatment of HIV in these patients. Ibalizumab has no overlapping resistance to other antiretroviral agents, and has no antagonism to other drugs. This allows it to be combined with any other anti-HIV agents. Ibalizumab, as with all antiretroviral medications, works best when combined with other antiretroviral agents to which the virus is fully susceptible. Because of the small number of patients enrolled in the Phase 3 study (40), we will need to be vigiliant as providers for any unexpected adverse events.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: I think that the approval of ibalizumab is a huge milestone in the treatment of HIV infection. It provides us with the first monoclonal antibody , the first intravenous antiretroviral therapy, and the first long-acting antiretroviral agent for the treatment of HIV, with a new mechanism of action that is non-overlapping to existing classes of medication. The clinical development targeted those patients who are most at need for new therapies, those that have highly drug-resistant virus, thus providing potentially life-saving option for our most vulnerable patients.
Disclosures: I am a consultant for Taimed and TheraTechnologies and was an investigator in the Phase 3 study.
Brinda Emu et al. Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1. NEJM, 2018 DOI: 1056/NEJMoa1711460
The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.