Table 8.
ALT/bilirubin, hepatobiliary AEs/discontinuation in MOTIVATE studies.
| MOTIVATE Studies 96 Week Data [104] | |||
|---|---|---|---|
| MVC 300 mg Once Daily + OBT n = 408 |
MVC 300 mg Twice Daily + OBT n = 421 |
Placebo + OBT n = 207 |
|
| Grade 3/4 Treatment-related hepatobiliary AE |
1 (0.2%) | 2 (0.5%) | 1 (0.5%) |
| Discontinuation due to any hepatobiliary AE | 2 (0.5%) | 2 (0.5%) | 1 (0.5%) |
| ALT: Events per 100 years of exposure (% incidence of maximum lab value) | |||
| Grade 1/2 (≥1.25 to <5× ULN) |
55.4 (50.2%) | 54.2 (51.5%) | 86.8 (50.7%) |
| Grade 3 (≥5 to <10× ULN) |
3.5 (4.4%) | 1.9 (2.4%) | 5.2 (3.9%) |
| Grade 4 (≥10× ULN) |
0.4 (0.5%) | 0.7 (1.0%) | 1.3 (1.0%) |
| Bilirubin-Total: Events per 100 years of exposure (% incidence of maximum lab value) | |||
| Grade 1/2 (≥1.25 to <2.5× ULN) |
36.4 (38.2%) | 30.4 (33.3%) | 56.8 (36.2%) |
| Grade 3 (≥2.5 to <5× ULN) |
7.7 (9.1%) | 4.7 (5.7%) | 6.7 (4.8%) |
| Grade 4 (≥5× ULN) |
1.4 (1.7%) | 0.7 (1.0%) | 1.9 (1.4%) |
Abbreviations: AE, adverse event; OBT, optimized background regimen, MVC, maraviroc; ULN, upper limit of normal.