TABLE 5.
Safety results
| Parameter | No. of subjects (%) for regimen:
|
|||||
|---|---|---|---|---|---|---|
| ATV 400 | ATV/RTV 300/100 | ATV/RTV/RIF 300/100/600 | ATV/RTV/RIF 300/200/600 | ATV/RTV/RIF 400/200/600 | RIF 600 | |
| No. of deaths | 0 | 0 | 0 | 0 | 0 | 0 |
| No. of discontinuations due to AEs | 0 | 4 (8) | 0 | 0 | 0 | |
| No. of serious AEs | 0 | 0 | 0 | 0 | 0 | 0 |
| Total no. of AEs | 39 (74) | 47 (90) | 16 (94) | 16 (94) | 14 (100) | 17 (94) |
| No. of subjects with: | ||||||
| Jaundice | 4 (8) | 6 (12) | 0 | 0 | 0 | 0 |
| Total bilirubin > grade 2 (>5 × ULN) | 21 (40) | 45 (87) | 5 (29) | 13 (76) | 9 (64) | 0 |
| ALT/AST grade 2 (2.6 to 5 × ULN) | 1 (2) | 0 | 0 | 1 (6) | 1 (6) | 1 (6) |
| ALT/AST grade 3/4 (>5 × ULN) | 0 | 0 | 0 | 1 (6) | 1 (6) | 0 |