Ibalizumab Made Commercially Available for HIV Patients With Limited Treatment Options

APRIL 30, 2018
Jenna Payesko
FDA, HIV, TrogarzoUPDATE: Theratechnologies has announced that its novel antiretroviral agent ibalizumab-uiyk (Trogarzo), for the treatment of adults with multidrug-resistant HIV type 1, has been made commercially available in the US.

“Given the clinical significance of Trogarzo for patients with multidrug-resistant HIV-1, our goal was to ensure that it would be available as quickly as possible. Patients that have already been prescribed Trogarzo may now be able to receive treatment,” Luc Tanguay, MSc, the president and CEO of Theratechnologies, said in a statement. “We are also quite pleased that some payers have already updated their reimbursement policy to include Trogarzo™. While it will take a few more months before access is optimized, the initial feedback from payers is definitely going in the right direction."

MARCH 6, 2018: The US Food and Drug Administration (FDA) approved ibalizumab-uiyk, a new type of antiretroviral medication for adult patients living with HIV who have not had success with other currently available therapies including multidrug-resistant HIV or MDR HIV, announced TaiMed Biologics USA Corp.

The FDA granted this application fast track, priority review and breakthrough therapy designations. Trogarzo also received orphan drug designation.

The approval was based on a clinical trial that evaluated the safety and efficacy of Trogarzo in 40 heavily treatment-experienced patients with MDR HIV-1 who continued to have high levels of the virus in their blood, despite using antiretroviral drugs. Several of the trial participants had previously been treated with 10 or more antiretroviral drugs.

“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 HIV, limiting their treatment options and putting them at a high risk of HIV-related complications and progression to death,” Jeff Murray, MD, deputy director, Division of Antiviral Products, FDA’s Center for Drug Evaluation and Research, said in a statement.

The findings concluded that a majority of patients experienced a significant decrease in their HIV-RNA levels 1 week after Trogarzo was added to their failing antiretroviral regimens. After 24 weeks of use, 43% of the trial’s participants achieved HIV-RNA suppression. More than 80% of patients achieved the study's primary endpoint, of at least a 70% viral load reduction from baseline 7 days after receiving a 2000 mg dose of Trogarzo, and no adjustment to the failing background regimen.  

The average viral load reduction after 24 weeks was 1.6 log10 with 43% of patients achieving an undetectable viral load.

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

Trogarzo is administered intravenously once every 14 days by a trained medical professional and is used in combination with other antiretroviral medications.

In total, 292 patients with HIV-1 infection have been exposed to Trogarzo IV infusion.

The most serious side effects were diarrhea (8%), dizziness (8%), nausea (5%) and rash (5%). The severe side effects included rash and changes to the immune system. There were no drug-drug interactions reported with other antiretroviral therapies (ART) or medications, and no cross-resistance with other ARTS were indicated.

Unlike other antiretroviral agents, Trogarzo binds primarily to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites, potentially prevents HIV from infecting CD4+ immune cells while still preserving normal immunological function.

This story was originally published on March  6, 2018.

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