The US Food & Drug Administration (FDA) has approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for heavily treated adult patients with HIV and whose HIV infections cannot be successfully treated with other currently available therapies.

The drug is administered intravenously once every 14 days and used in combination with other antiretroviral medications.

“While most patients living with HIV can be successfully treated using a combination of 2 or more antiretroviral drugs, a small percentage of patients who have taken many HIV drugs in the past have multidrug-resistant (MDR) HIV, limiting their treatment options and putting them at a high risk of HIV-related complications and progression to death,” said Jeff Murray, MD, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.

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Trogarzo’s effectiveness was evaluated in a clinical trial of 40 heavily treatment-experienced patients with MDR HIV-1 who continued to have high levels of virus (HIV-RNA) in their blood, despite treatment with antiretroviral drugs. The majority of participants experienced a significant decrease in their HIV-RNA levels 1 week after Trogarzo was introduced with other antiretroviral regimens. After 24 weeks of Trogarzo plus other antiretroviral drugs, 43% of the trial’s participants achieved HIV RNA suppression.

A total of 292 patients with HIV-1 infection have been exposed to Trogarzo IV infusion (TaiMed Biologics USA Corp). The most common adverse reactions were diarrhea, dizziness, nausea, and rash. Severe side effects included rash and changes in the immune system (immune reconstitution syndrome).

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“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,” Dr Murray concluded. “New treatment options may be able to improve their outcomes.”  


FDA approves new HIV treatment for patients who have limited treatment options [news release]. US Food & Drug Administration. March 6, 2018. Accessible at: