US regulators have approved a new option for treating HIV, marking the first therapy with a new mode of action in a decade.
Theratechnologies and partner TaiMed Biologics’ Trogarzo (ibalizumab-uiyk) has been cleared for use in combination with other antiretroviral (ART) therapies for HIV-1 infection in heavily treatment-experienced adults with multidrug resistant infection who are failing their current ART regimen.
Trogarzo is a CD4-directed post-attachment HIV-1 inhibitor that binds to CD4+ receptors on host cells and blocks the HIV virus from infecting the cells. Aside from offering an alternative treatment approach, it is also the only ART that does not require daily dosing, being infused every two weeks instead.
Highlighting the need for new therapies despite current options, Theratechnologies noted that up to 25,000 people in the US with HIV are currently multidrug resistant, of which 12,000 are experiencing a rise in viral load to detectable levels, “jeopardizing their health and making HIV transmittable”.
“In Phase III ibalizumab trials, we saw marked improvements in patients’ health who not only were heavily treatment-experienced and had limited remaining treatment options, but in cases they also had extremely high viral loads and significantly impaired immune systems,” said Edwin DeJesus, medical director for the Orlando Immunology Center.
“As an investigator for ibalizumab clinical trials over nearly 10 years, it was remarkable and inspiring to see the dramatic effect ibalizumab had on such vulnerable patients. As a clinician, I am excited that we will now have another option with a different mechanism of action for our heavily pretreated patients who are struggling to keep their viral load below detection because their HIV is resistant to multiple drugs.”