The U.S. Food and Drug Administration’s (FDA) final guidance on HIV drug development aims to promote and facilitate more drug development for treatment-experienced patients. In addition to encouraging sponsors to seek traditional approval for new antiretroviral drugs, the FDA introduced new detailed definitions for treatment-naïve and treatment-experienced HIV patients and lays out recommendations for designing switch trials (i.e., trials in which patients who are already suppressed on one treatment are changed to a new treatment regimen). Read more on the finalized guidance here.
Last Updated on May 7, 2020 by Aimed Alliance
