Table 7.
ALT/Bilirubin and hepatobiliary discontinuation related to maraviroc in MERIT.
| MERIT Study 96 Week Data [102] | ||
|---|---|---|
| MVC 300 mg Twice Daily + AZT/3TC n = 353 |
EFZ 600 mg Daily + AZT/3TC n = 350 |
|
| ALT: Maximum value by patient over 96 weeks | ||
| Grade 1/2 (≥1.25 to <5× ULN) |
134 (38.0%) | 139 (39.7%) |
| Grade 3 (≥5 to <10× ULN) |
11 (3.1%) | 12 (3.4%) |
| Grade 4 (≥10× ULN) |
3 (0.8%) | 2 (0.6%) |
| Bilirubin-total: Maximum value by patient over 96 weeks | ||
| Grade 1/2 (≥1.25 to <2.5× ULN) |
47 (13.3%) | 5 (1.4%) |
| Grade 3 (≥2.5 to <5× ULN) |
3 (0.8%) | 0 |
| Grade 4 (≥5× ULN) |
0 | 0 |
| Discontinuation due to a treatment-related hepatobiliary AE | ||
| 1 (0.3%) | 2 (0.6%) | |
Abbreviations: AE, adverse event; AZT, zidovudine; MVC, maraviroc; ULN, upper limit of normal; 3TC, lamivudine.