The US Food and Drug Administration (FDA) approved this new intravenously-administered HIV medication for patients who are suffering from multidrug-resistant HIV who have failed other antiretroviral therapies.
TaiMed Biologics USA Corp.'s Trogarzo (ibalizumab-uiyk), an injectable antiretroviral medication for adult patients living with HIV who have not had success with other currently available therapies, including those with multidrug-resistant (MDR) HIV, has been made commercially available in the United States.
"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," President and CEO of Theratechnologies, Inc. Luc Tanguay, said in a recent statement. "Patients that have already been prescribed Trograrzo may now be able to receive treatment."
The medication was approved by the US Food and Drug Administration (FDA) on March 6, 2018.
The approval was based on a clinical trial that evaluated the safety and efficacy of ibalizumab-uiyk 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 MDR 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 showed that a majority of patients experienced a significant decrease in their HIV-RNA levels 1 week after ibalizumab-uiyk was added to their failing antiretroviral regimens. After 24 weeks of use, 43% of the trial’s participants achieved HIV-RNA suppression.
“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 added. “New treatment options may be able to improve their outcomes.”
The mediation is administered intravenously once every 14 days and should be used in combination with other antiretroviral medications.
The most serious side effects reported in the trial were diarrhea, dizziness, nausea, and rash. Severe side effects included rash and changes in the immune system.
Editor's Note: This article was previously published on March 6, 2018, and has since been updated.