Ibalizumab in Multidrug-Resistant HIV — Accepting Uncertainty

• Published in: The New England journal of medicine Vol. 379; no. 7; pp. 605 - 607
• Main Authors: Sheikh, Virginia, Murray, Jeffrey S, Sherwat, Adam
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 16.08.2018
• Subjects: Acquired immune deficiency syndrome; AIDS; Anti-HIV Agents - therapeutic use; Antibodies, Monoclonal - therapeutic use; Antiretroviral drugs; Causality; Clinical trials; Design; Disclosure; Disease; Disease Progression; Drug development; Drug resistance; Drug Resistance, Multiple, Viral; Drug screening; Food; HIV; HIV Fusion Inhibitors - therapeutic use; HIV Infections - drug therapy; Human immunodeficiency virus; Humans; Infections; Monoclonal antibodies; Multidrug resistance; Patients; Research Design; Researchers; Uncertainty; United States > US

The FDA has recommended a streamlined trial design for assessing drugs’ safety and efficacy in patients with multidrug-resistant HIV infection, and ibalizumab has recently undergone such a trial. But clinicians and patients should recognize this design’s limitations.