FDA Approves HIV-1 Treatment Ibalizumab for 30-Second IV Push

The Food and Drug Administration (FDA) has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies Inc) for administration by intravenous push.

Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug resistant HIV-1. It is used in combination with other antiretroviral drugs.

Prior to this approval, the drug was administered intravenously as a single 2000 mg loading dose, followed by an 800 mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15 to 30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by IV push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.

"The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their healthcare providers, possibly allowing for more clinics to administer this treatment," said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an October 3 press release.

The FDA approval of the IV push method was based on a clinical study which found that ibalizumab administered via IV push had similar safety and pharmacokinetic profiles as the IV infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via IV push. The medication is also being studied for administration via intramuscular injection, the press release said.

The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.

While multidrug resistant HIV that would require ibalizumab is not very common — one study found it occured in fewer than 2% of people with HIV in Western Europe — it is a "very difficult problem because we need to treat these patients to try to achieve virologic suppression," noted Monica Gandhi, MD, MPH, associate chief of the Division of HIV, Infectious Diseases, and Global Medicine at the University of California San Francisco in an email to Medscape Medical News. While providers generally try to use non-intravenous medications when possible, ibalizumab is an important medication for people with multidrug resistant HIV and limited treatment options, she said.

"One barrier to administration was the need for IV infusion over 15-30 minutes," Gandhi added. "The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it."

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Cite this: Lucy Hicks. FDA Approves HIV-1 Treatment Ibalizumab for 30-Second IV Push - Medscape - Oct 04, 2022.