Generic Name: Ibalizumab
Other Market Name: N/A
Drug Class: Entry Inhibitors
Company: TaiMed Biologics and Theratechnologies
Approval Status: Experimental
Generic Version Available: No
Experimental Code: TMB-355
Ibalizumab is not yet approved by the U.S. Food and Drug Administration (FDA), nor has it been been reviewed for inclusion in the DHHS list of recommended HIV treatments.
Ibalizumab is an experimental HIV medication. It is an entry inhibitor. Ibalizumab contains genetically engineered antibodies, known as monoclonal antibodies (it is therefore a “biologic,” not a “drug”). These antibodies bind to the CD4 receptor on CD4 cells. Once they do this, HIV cannot successfully latch onto these cells, thus preventing the virus from infecting them.
Ibalizumab is being developed by Taiwan-based TaiMed Biologics in partnership with Montreal-based Theratechnologies, Inc. The biologic is being developed specifically for people living with HIV whose virus is resistant to currently approved antiretrovirals. It is currently being evaluated in two small Phase III clinical trials. It is expected to be approved by the FDA in 2017.
Ibalizumab, an injectable biologic, needs to be combined with oral antiretrovirals, preferably HIV medications to which the virus is still at least partly sensitive. Drug-resistance testing will be very important in figuring out which antiretrovirals to combine with ibalizumab.
Adult Dose: The dose has not yet been determined. It will require intravenous (IV) administration every two or four weeks, depending on the dose comparisons being conducted in the Phase III trials.
Pediatric Dose: N/A
Dosing Info: NA
Ibalizumab’s side effect profile is not fully known. In a phase II trial of ibalizumab, the most comment side effects seen in people taking regimens containing ibalizumab were rash, diarrhea, headache, and nausea. Most side effects were mild and no study volunteers discontinued the drug because of side effects.
Ibalizumab’s interactions with drugs used to treat HIV or other medications are not fully known. Ibalizumab might interact with other medications, including those used to treat HIV. It is important that your personal physician and/or the research nurse or study investigator be aware of all drugs you are taking, including those you buy without a prescription.
Last Revised: February 4, 2017