Theratechnologies’ biweekly injectable antibody treatment Trogarzo (ibalizumab-uiyk) maintained its safety and efficacy over a second year of therapy among a group of people with highly drug resistant HIV.
Trogarzo, which is administered via transfusion, was approved in March 2018 among those with multidrug-resistant HIV and extensive experience with antiretroviral (ARV) treatment whose current regimen is failing.
Approval was based on 48-week data of the Phase III TMB-301 trial. Findings from an additional 48 weeks of follow-up of 27 members of that study, who were enrolled in the TMB-311 trial were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.
At the outset of TMB-301, the 27 participants who ended up in TMB-311 had a median viral load of 21,700 and a median CD4 count of just 102. Nineteen percent of them had a viral load of at least 100,000. They received the biweekly infusions of Trogarzo along with an optimized background regimen of daily ARVs, including at least one drug to which their virus would be sensitive according to drug resistance testing.
At weeks 25 and 96 of treatment, 15 (56 percent) of the participants had a fully suppressed viral load. Compared with the group’s baseline median viral load, the median viral load at weeks 25 and 96 declined 316-fold and 631-fold, respectively. The median CD4 count increased by 45 by week 25 and by 42 by week 96.
Trogarzo remained well tolerated at week 96. The study saw no new concerns regarding the treatment’s safety.
To read the conference abstract, click here.
To read a press release about the study, click here.