HIV/HBV and/or HCV co-infected patients | HIV mono-infected patients | |||
---|---|---|---|---|
TMC278 25mg qd | EFV 600mg qd | TMC278 25mg qd | EFV 600mg qd | |
Efficacy (Week 48 outcomes)* | N=49 | N=63 | N=621 | N=602 |
% (95% CI) with viral load <50 copies/mL, ITT-TLOVR | 73.5 (60.7-86.3) | 79.4 (69.1-89.6) | 85.0 (82.2-87.8) | 82.6 (79.5-85.6) |
Mean CD4 count (95% CI) | N=48 | N=63 | N=621 | N=602 |
Baseline, cells/mm3 | 230 (198-263) | 246 (216-276) | 262 (251-273) | 274 (262-285) |
Change from baseline, NC=F†, cells/mm3 | +137 (100-175) | +192 (147-238) | +197 (186-209) | +173 (161-185) |
Change from baseline, NC=F†, % | +6.6 (5.0-8.3) | +7.7 (6.4-9.0) | +8.6 (8.1-9.0) | +8.4 (7.9-8.8) |
Safety ‡ , § | ||||
Treatment-emergent hepatic AEs of interest, n (%) | N=54 | N=66 | N=632 | N=616 |
Any hepatic AE | 15 (27.8) | 17 (25.8) | 23 (3.6) | 28 (4.5) |
Hepatobiliary disorders¶ | 3 (5.6) | 7 (10.6) | 6 (0.9) | 9 (1.5) |
HBV or HCV reported as an AE | 3 (5.6) | 5 (7.6) | - | - |
Hepatic laboratory abnormalities reported as an AE | 9 (16.7) | 8 (12.1) | 19 (3.0) | 21 (3.4) |
Grade 3 to 4 hepatic laboratory abnormalities, n (%) | N=54 | N=66 | N=631 | N=604 |
ALT increased | 9 (16.7) | 11 (16.7) | 1 (0.2) | 12 (2.0) |
AST increased | 7 (13.0) | 5 (7.6) | 7 (1.1) | 14 (2.3) |
Hyperbilirubinaemia | 0 | 0 | 4 (0.6) | 1 (0.2) |