FDA APPROVALS

FDA Approves New HIV Treatment Option

March 6, 2018

The FDA has approved a new option for treatment-experienced adults with HIV infection.

The FDA has approved Trogarzo (ibalizumab-uiyk), a new antiretroviral medication for the treatment of heavily treatment-experienced adults with HIV and whose infections cannot be treated with other therapies.

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

The safety and efficacy of Trogarzo was evaluated in a clinical trial of 40 patients who had sustained high levels of HIV-RNA despite antiretroviral treatment. Overall, a majority of patients experienced significant decreases in their HIV-RNA levels 1 week after treatment, and after 24 weeks, 43% of participants achieved HIV-RNA suppression.

The most common adverse effects were diarrhea, dizziness, nausea, and rash.

Michael Potts


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