The Food and Drug Administration (FDA) has approved Trogarzo™ (ibalizumab-uiyk; Theratechnologies and TaiMed Biologics) for the treatment of adults with HIV infection who are heavily treatment-experienced and whose infections are multidrug-resistant (MDR). It is intended for use with other antiretroviral medications.
Trogarzo, a humanized monoclonal antibody, is administered as an intravenous (IV) injection once every 14 days. Unlike other antiretroviral drugs, ibalizumab binds primarily to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites. It prevents HIV from infecting CD4+ immune cells while preserving normal immunological function. Ibalizumab is active against HIV-1 resistant to all approved antiretroviral agents.
The approval of Trogarzo was supported by a clinical trial (N=40) of heavily treatment-experienced adults with MDR HIV-1 infection who continued to have high levels of HIV RNA in their blood despite antiretroviral therapy. Many of the study patients had previously been treated with ≥10 antiretroviral medications.
A significant decrease in patients’ HIV RNA levels was seen after 1 week of adding Trogarzo to their current antiretroviral regimen. After 24 weeks, 43% of study patients achieved HIV RNA suppression. Regarding safety, diarrhea, dizziness, nausea, and rash were the most common adverse reactions; rash and immune reconstitution syndrome have been reported as severe adverse reactions.
Jeff Murray, MD, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, stated, “Trogarzo is the first drug in a new class of antiretroviral medications that can provide significant benefit to patients who have run out of HIV treatment options. New treatment options may be able to improve their outcomes.”
FDA approves new HIV treatment for patients who have limited treatment options [press release]. Silver Springs, Maryland: US Food and Drug Administration. Published March 6, 2018. Accessed March 7, 2018.
This article originally appeared on MPR