TMC278 | TMC278 | TMC278 | TMC278 | |||
---|---|---|---|---|---|---|
Parameter | Wk | 25 mg qd (n = 93) | 75 mg qd (n = 95) | 150 mg qd (n = 91) | All (n = 279) | EFV 600 mg gd (n = 89)1 |
48 | 80(71–88) | 80(72–88) | 77(68–86) | 79(74–84) | 81(73–89) | |
VL <50 cps/mL (ITT-TLOVR algorithm), % (95% CI) | 96 | 76(68–85) | 72(62–81) | 71(62–81) | 73(68–78) | 71(61–80) |
Mean (SE) increase from baseline in CD4 cell count, cells/mm3 | 48 | 122(12) | 145(15) | 143(15) | 137(8) | 127(11) |
96 | 146(12) | 172(16) | 159(16) | 159(9) | 160(13) | |
AE incidence at Wk 96 (%) | ||||||
Any AE | 90 | 97 | 92 | 93 | 93 | |
AEs leading to discontinuation | 9 | 12 | 14 | 12 | 9 | |
Any grade 3 or 4 AEs | 30 | 25 | 26 | 27 | 21 | |
Any serious AEs | 13 | 14 | 10 | 12 | 15 | |
Grade 3 or 4 lab abnormalities | 33 | 22 | 24 | 27 | 24 | |
AEs of interest* † | ||||||
Any Rash | 5 | 10 | 13 | 9‡ | 21 | |
Nervous system AEs | 32 | 32 | 30 | 31‡ | 48 | |
Headache | 17 | 23 | 19 | 20 | 16 | |
Dizziness | 13 | 10 | 10 | 11‡ | 30 | |
Somnolence | 3 | 3 | 4 | 4§ | 11 | |
Psychiatric AEs | 17 | 17 | 14 | 16 | 21 | |
Insomnia | 8 | 6 | 7 | 7 | 6 | |
Depression | 7 | 6 | 3 | 5 | 7 | |
Abnormal dreams/nightmares | 1 | 6 | 0 | 3 | 11 | |
Mean (SD) changes from baseline in lipids (mg/dL) | ||||||
Total cholesterol (TC) | 10(28) | 8(35) | 9(29) | 9(31)‡ | 34(31 | |
LDL-C | 5(25) | 5(30) | 3(25) | 5(27)‡ | 18(28) | |
HDL-C | 6(10) | 7(11) | 6(12) | 6(11)‡ | 11(12) | |
Ratio TC/HDL-C | -0.4(1.3) | -0.5(1.1) | -0.3(1.0) | -0.4(1.1) | 0.1(0.9) | |
Triglycerides | -8(75) | -15(79) | -7(90) | -10(81)‡ | 29(87) |