TABLE 2.
Incidence (Unadjusted), n(%) |
Incidence (Adjusted) Event Counts Adjusted to 100 Years of Patient Exposure, n (%) |
|||||
---|---|---|---|---|---|---|
Placebo + OBT | MVC Every Day + OBT | MVC Twice a Day + OBT | Placebo + OBT | MVC Every Day + OBT | MVC Twice a Day + OBT | |
Week 48 | ||||||
AST: >3.0 × ULN | 17 (8) | 39 (10) | 45 (11) | 16.2 | 13.8 | 15.7 |
ALT: >3.0 × ULN | 13 (6) | 29 (7) | 37 (9) | 12.4 | 10.1 | 12.7 |
Total bilirubin: >1.5 × ULN | 30 (14) | 66 (16) | 51 (12) | 31.9 | 25.3 | 18.5 |
EBT | ||||||
AST: >3.0 × ULN | 19 (9) | 45 (11) | 46 (11) | 13.3 | 9.4 | 9.5 |
ALT: >3.0 × ULN | 15 (7) | 37 (9) | 39 (9) | 10.0 | 7.8 | 7.8 |
Total bilirubin: >1.5 × ULN | 31 (15) | 68 (17) | 54 (13) | 23.8 | 16.0 | 11.3 |
ULN, upper limit of normal; MVC, maraviroc.
Total patient-years of exposure to study drug at week 48: placebo + OBT, 111, MVC, QD + OBT 300, MVC BID + OBT, 309. Total years of exposure to study drug at EBT: placebo + OBT, 160, MVC QD + OBT, 522, MVC BID + OBT, 551.