Drug Watch: Ibalizumab

Ibalizumab is a humanized monoclonal antibody that binds to CD4 on human cells and thereby prevents HIV entry (a CD4-directed postattachment inhibitor). The medication was approved on March 6, 2018, for treatment of multidrug-resistant HIV in adults failing antiretroviral therapy (ART).

In a phase 3 trial, 40 heavily treatment experienced patients with resistance to three antiretroviral drug classes, but with at least one active remaining drug, were enrolled in a single-arm trial (NCT02475629, clinicaltrials.gov). Following a loading dose of ibalizumab, 83% of participants had a ≥0.5 log drop in HIV RNA level. After receiving the loading dose, participants had optimization of their regimen with addition of other antiretroviral agents, includ…