- Proven efficacy and safety profile2
- Potency: Fully active agent with NO baseline resistance and NO known drug-drug interactions2,4
- Durability: Long-acting efficacy
TROGARZO® (ibalizumab-uiyk): For heavily treatment-experienced patients with virologic failure who need additional support to achieve long-term suppression.
* TROGARZO® is first administered with a 30-minute loading dose by intravenous (IV) infusion.
All subsequent doses can be given in 30 seconds every 2 weeks with the IV push or in 15 minutes every 2 weeks through IV infusion.
AFTER INITIAL LOADING DOSE INFUSION,
AT 7 DAYS POST-LOADING DOSE
(TROGARZO® functional monotherapy): 83% of patients achieved a virologic response vs. 3% of patients pre-loading dose (p < 0.0001; 95% CI: 67%, 93%).
ITT-MEF = Intent To Treat - Missing Equals Failure.
A single arm, multicenter study of 40 heavily treatment-experienced patients with multidrug resistant HIV-1. Patients were required to have viral load >1,000 copies/mL, documented resistance to at least 1 antiretroviral from each of 3 classes of antiretrovirals, been treated for at least 6 months and be failing or had recently failed therapy. Days 0-6 (Control period): Patients were monitored on their current failing regimens (or no therapy). Days 7-13 (Functional monotherapy period): Patients continued on background failing regimens and received 2,000 mg of TROGARZO® (loading dose). Day 14: Background regimen was optimized to include at least one active agent. Day 21-Week 25 (Maintenance period): Patients received 800 mg of TROGARZO® every 2 weeks (maintenance dose). The primary efficacy endpoint was the proportion of patients achieving a –0.5 log10 decrease in viral load during the Functional monotherapy period, as compared to the proportion of patients achieving a –0.5 log10 decrease during the Control period.
‡ Study design and results: Open-label, non-randomized study in clinically stable patients while on TROGARZO®-containing ARV regimens for at least 3 months (N=9) and HIV-uninfected individuals (N=10). All subjects received TROGARZO® maintenance dose as IV infusion and IV Push, and pharmacokinetics (PK), safety, and efficacy were evaluated. Bioequivalence was demonstrated between IV infusion and IV Push methods of administration and IV Push over 30-seconds was safe and well tolerated.