The Food and Drug Administration (FDA) has approved Trogarzo (ibalizumab-uiyk; Theratechnologies and TaiMed Biologics) for the treatment of adults with HIV infection who are heavily treatment-experienced and whose infections are multidrug resistant (MDR). It is intended for use with other antiretroviral medications

Trogarzo, a humanized monoclonal antibody, is administered as an intravenous (IV) injection once every 14 days. Unlike other antiretroviral drugs, ibalizumab binds primarily to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites. It prevents HIV from infecting CD4+ immune cells while preserving normal immunological function. Ibalizumab is active against HIV-1 resistant to all approved antiretroviral agents.  

The approval of Trogarzo was supported by a clinical trial (N=40) of heavily treatment-experienced adults with MDR HIV-1 infection who continued to have high levels of HIV RNA in their blood despite antiretroviral therapy. Many of the study patients had previously been treated with ≥10 antiretroviral medications. 

A significant decrease in patients’ HIV RNA levels was seen after 1 week of adding Trogarzo to their current antiretroviral regimen. After 24 weeks, 43% of study patients achieved HIV RNA suppression. Regarding safety, diarrhea, dizziness, nausea, and rash were the most common adverse reactions; rash and immune reconstitution syndrome have been reported as severe adverse reactions. 

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Jeff Murray, MD, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, stated, “Trogarzo is the first drug in a new class of antiretroviral medications that can provide significant benefit to patients who have run out of HIV treatment options. New treatment options may be able to improve their outcomes.” 

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