Table 2.
Efficacy at 48 Weeks.*
| End Point | MOTIVATE 1 (N = 585) | MOTIVATE 2 (N = 464) | MOTIVATE 1 and 2 Pooled Data (N = 1049) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (N = 118) | Maraviroc Once Daily (N = 232) | Maraviroc Twice Daily (N = 235) | Placebo (N = 91) | Maraviroc Once Daily (N = 182) | Maraviroc Twice Daily (N = 191) | Placebo (N = 209) | Maraviroc Once Daily (N = 414) | Maraviroc Twice Daily (N = 426) | |
| HIV-1 RNA — log10 copies/ml† | |||||||||
| Mean change from baseline | −0.80 | −1.66 | −1.82 | −0.76 | −1.72 | −1.87 | −0.79 | −1.68 | −1.84 |
| Difference from placebo group (97.5% CI) | −0.85 (−1.22 to −0.49) | −1.02 (−1.39 to −0.66) | −0.96 (−1.38 to −0.54) | −1.11 (−1.52 to 0.70) | −0.90 (−1.17 to −0.62) | −1.05 (−1.33 to −0.78) | |||
| HIV-1 RNA — no. (%) | |||||||||
| <50 copies/ml | 19 (16) | 97 (42) | 109 (46) | 16 (18) | 82 (45) | 85 (45) | 35 (17) | 179 (43) | 194 (46) |
| <400 copies/ml | 26 (22) | 118 (51) | 135 (57) | 21 (23) | 96 (53) | 105 (55) | 47 (22) | 214 (52) | 239 (56) |
| Decrease from baseline of ≥1.0 log10 or to <400 copies/ml | 37 (31) | 134 (58) | 148 (63) | 25 (27) | 107 (59) | 121 (63) | 61 (29) | 241 (58) | 270 (63) |
| CD4 count — cells/mm3 | |||||||||
| Mean change from baseline‡ | 54 | 113 | 122 | 69 | 122 | 128 | 61 | 116 | 124 |
| Difference from placebo group (95% CI) | 59 (34 to 84) | 69 (44 to 93) | 52 (23 to 81) | 59 (30 to 87) | 55 (36 to 74) | 63 (44 to 82) | |||
*
All regimens in MOTIVATE 1 and MOTIVATE 2 included optimized background therapy. Efficacy was assessed for all patients who received at least one dose of the study drug. P<0.001 for each comparison of a maraviroc group with the placebo group in the individual and combined studies.
†
Missing values for patients who discontinued the study for any reason at or before week 48 were defined as equal to the baseline values.
‡
Data were available for 116 patients in the placebo group, 227 in the group receiving maraviroc once daily, and 233 in the group receiving maraviroc twice daily in MOTIVATE 1 and for 90, 180, and 185 patients, respectively, in MOTIVATE 2. This was a last-observation-carried-forward analysis.