Trogarzo® (ibalizumab-uiyk injection)

Covered: Trogarzo (ibalizumab-uiyk) is authorized for heavily treatment‑experienced adults (≥18) with multidrug‑resistant HIV‑1 who are failing their current antiretroviral regimen and have documented resistance to at least one agent in ≥3 antiretroviral classes (not authorized for patients <18 or as monotherapy). Key requirements: must be used with an optimized background regimen, prescribed or consulted by an HIV specialist, given IV (2,000 mg loading then 800 mg every 2 weeks), initial approval 6 months (reauthorization 12 months) and require documented virologic/immunologic response (e.g., HIV‑1 RNA <50 copies/mL or ≥0.5 log10 reduction and/or CD4 stabilization/improvement) for continued coverage.

"Has multiple antiretroviral drug resistance to at least one antiretroviral from at least THREE of the following antiviral classes:"

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