Ibalizumab

Ibalizumab Brand Name– Trogarzo

What is Ibalizumab

Ibalizumab is an intravenous recombinant humanized monoclonal antibody indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-infection failing other therapies.

Ibalizumab is the first drug in a new class of antiretrovirals that can provide significant benefit to patients who have failed several other antiretrovirals and who have run out of treatment options.

In clinical studies of patients with viral load more than 1,000 copies/mL and documented resistance to at least 1 antiretroviral medication from each of 3 classes (NRTI, NNRTI, and PI), 83% of patients met the primary endpoint, achieving at least a 0.5 log₁₀ decrease in viral load at the end of the functional monotherapy period compared with 3% of patients at the end of the control period. At week 25, 43% and 50% of patients, respectively, achieved a viral load less than 50 copies/mL and HIV-1 RNA less than 200 copies/mL.

The mean and median CD4 count increased by 44 cells/mm³ and 17 cells/mm³, respectively, from baseline to week 25.

Ibalizumab is given as a single IV loading dose, followed by a maintenance dose every 2 weeks.

Indications

• human immunodeficiency virus (HIV)
• human immunodeficiency virus (HIV) infection

Side Effects

1. anaphylactoid reactions
2. antibody formation
3. diarrhea
4. dizziness
5. hyperbilirubinemia
6. hyperglycemia
7. infusion-related reactions
8. maculopapular rash
9. nausea
10. neutropenia
11. progressive multifocal leukoencephalopathy
12. pruritus
13. rash
14. thrombocytopenia

Monitoring Parameters

• blood glucose
• CBC with differential
• CD4+ T cell count
• LFTs
• plasma HIV RNA
• pregnancy testing
• serum bilirubin (total and direct)
• serum creatinine/BUN

Contraindications

• autoimmune disease
• breast-feeding
• Graves’ disease
• Guillain-Barre syndrome
• immune reconstitution syndrome
• infusion-related reactions
• pregnancy
• progressive multifocal leukoencephalopathy

Interactions

There are no drug interactions associated with Ibalizumab products.