Ibalizumab: Ph III TMB-301 data

The 24-week, open-label, international Phase III TMB-301 trial in 40 treatment-experienced patients with multidrug-resistant HIV-1 infection showed that IV ibalizumab met the primary endpoint of a greater proportion of patients achieving a ≥0.5 log10 copies/mL reduction in HIV-1 RNA levels from baseline to day 7 vs. a 7-day control period (83% vs. 3%, p<0.0001). Patients were monitored on their current failing therapy or no therapy for a 7-day control period. Patients then received a single 2,000 mg loading dose of ibalizumab followed 7 days later by an 800 mg dose of ibalizumab every 2 weeks through week 24 in combination with an optimized background regimen. Additionally, 60% of patients receiving ibalizumab achieved a ≥1 log10 reduction in HIV-1 RNA levels from baseline to day 7. At week 24, ibalizumab reduced mean viral load from baseline by 1.6 log10 copies/mL and 43% of patients achieved HIV-1 RNA levels of <50 copies/mL. Furthermore, ibalizumab led to a mean increase in CD4+ T cells of 48 cells/µL from baseline to week 24...