Theratechnologies’ antibody treatment Trogarzo (ibalizumab-uiyk), approved in 2018 for those with multidrug-resistant HIV who are on a failing antiretroviral (ARV) regimen, is safe and effective over the long term. Approval was based on 48-week data from a Phase III trial; 27 of its participants continued for a second year of treatment. Throughout, they received biweekly Trogarzo infusions plus an optimized background regimen of daily oral ARVs. At the study’s outset, these participants had a median viral load of 21,700 and a median CD4 count of 102. The median viral load declined by 316-fold by week 25 and by 631-fold by week 96. At week 96 of treatment, 56% of the participants had a fully suppressed viral load, and the median CD4 count increased by 45. Trogarzo remained well tolerated at week 96, by which point no new safety concerns had arisen.


Courtesy of Theratechnologies
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