Table 1
DRV/r | LPV/r | DRV/r-LPV/r [95% CI] | |||
|---|---|---|---|---|---|
N | % | N | % | ||
VL <50cpm (ITT-TLOVR) | |||||
All patients | 343 | 68.8 | 346 | 57.2 | 11.6 [4.4-18.8] |
BL VL <100,000 | 226 | 69.5 | 226 | 60.2 | 9.3 [0.5-18.1] |
BL VL ≥100,000 | 117 | 67.5 | 120 | 51.7 | 15.9 [3.5-28.3] |
BL CD4 <200 | 141 | 65.2 | 148 | 54.1 | 11.2 [-0.1-22.5] |
BL CD4 ≥200 | 202 | 71.3 | 198 | 59.6 | 11.7 [2.4-21.0] |
VL <50cpm (sensitivity analyses) | |||||
TLOVR non-VF censored | 270 | 87.4 | 245 | 80.8 | 6.6 [0.3-12.9] |
On protocol TLOVR | 340 | 69.1 | 345 | 57.1 | 12.0 [4.8-19.2] |
Missing=failure | 343 | 68.5 | 346 | 60.1 | 8.4 [1.3-15.5] |
FDA snapshot | 343 | 68.5 | 346 | 59.8 | 8.7 [1.5-15.8] |
Treatment-emergent adverse events (AEs) | |||||
AEs leading to permanent stop of study medication | 343 | 7.6 | 346 | 14.5 | p=0.005* |
Grade 2-4 treatment-related diarrhoea | 343 | 5.0 | 346 | 11.3 | p=0.003* |
Changes in lipid parameters, median increase mmol/L (min; max) | |||||
Triglycerides‡ | 254 | 0.1 (-5; 3) | 228 | 0.6 (-3; 10) | p<0.0001¶ |
Total cholesterol§ | 254 | 0.6 (-2; 4) | 228 | 1.0 (-1; 4) | p<0.0001¶ |