Ibalizumab-uiyk (Trogarzo®)

Ibalizumab-uiyk (Trogarzo) is covered only for adults (≥18) with HIV-1 who are heavily treatment‑experienced and failing their current regimen with documented multiclass resistance (resistance to ≥1 drug in ≥3 antiretroviral classes); pediatric use, use for patients not failing therapy, monotherapy, or non‑FDA indications are excluded. Initial approval is for 6 months (reauthorize for 12 months) and requires combination with an optimized background regimen, prescription by or consultation with an HIV specialist, documentation of the specified resistance pattern, and for reauthorization evidence of virologic response (e.g., ≥0.5 log10 reduction in HIV RNA).

"Trogarzo, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug..."

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