Trogarzo (ibalizumab-uiyk injection) has been made available by Theratechnologies for the treatment of human immunodeficiency virus type-1 (HIV-1) infection, in combination with other antiretroviral(s), in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.

Trogarzo, a CD4-directed post-attachment HIV-1 inhibitor, is administered as an intravenous (IV) infusion 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 multidrug resistant 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.

The most common adverse events associated with Trogarzo include diarrhea, dizziness, nausea, and rash. Immune reconstitution inflammatory syndrome has been reported in one patient treated with Trogarzo in combination with other antiretrovirals.

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Trogarzo is available in a single-dose, 2mL vial containing ibalizumab-uiyk 150mg/mL. Each vial delivers approximately 1.33mL containing 200mg of ibalizumab-uiyk. The product is supplied in a carton containing 2 single-dose vials. Once diluted, the solution should be administered immediately. Patients should be observed for 1 hour after completion of administration for at least the first infusion; if no infusion-related adverse reactions are noted, the post-infusion observation time can be reduced to 15 minutes thereafter.

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