Methods: TE subjects (exposured to ≥1 antiretroviral for ≥1 week) with susceptibility to all study drugs (BMS-626529 IC50<100 nM), were randomized equally to receive BMS-663068 (400 or 800 mg BID; 600 or 1200 mg QD) or ATV/r 300/100 mg QD, both given with RAL + TDF . The study was not powered to detect statistically significant differences between subgroups.
Results: 251 subjects were treated. Median age was 39 years, 60% were male and 38% white. Median baseline (BL) viral load (VL) was 4.85 log10 c/mL (43% >100,000 c/mL) and median CD4+ T-cell count 230 cells/mm3 (38% <200 CD4 cells/mm3). At Week 48, response rates (HIV-1 RNA <50 c/mL) were generally similar across the BMS-663068 arms and the ATV/r arm regardless of gender, age and race (Table). For the BMS-663068 arms and the ATV/r arm, response rates were generally higher in subjects with BL VL <100,000 c/mL and in those with BL CD4+ T-cell counts ≥200 cells/mm3, however the differences were not substantial. Mean increases in CD4+ T-cell count from baseline were generally higher among females, those with higher BL viral load, and those with lower BL CD4 count.
Conclusion: At Week 48, virologic response was generally similar across the BMS-663068 arms and the ATV/r arm in TE subjects, regardless of gender, race, age, BL VL, or BL CD4+ T-cell count. Mean increases in CD4+ T-cell count from baseline were generally higher among females, those with higher BL VL, and those with lower BL CD4+ T-cell count. These results are mostly in agreement with those reported at Week 24 and support the ongoing Phase III trial evaluating BMS-663068 for use in heavily treatment-experienced adults with limited therapeutic options (NCT02362503). xxxxxxxxxxxxx