Clinical symptoms associated with administration of faldaprevir in chronic HCV G1 patients treated for 24 weeks with Peg-IFN/RBV in combination with placebo or faldaprevir (120 or 240 mg q.d.) in the phase IIb SILEN-C1 Trial
| Placebo | 120 mg q.d. LIa | 240 mg q.d. LIa | 240 mg q.d. | |||||
|---|---|---|---|---|---|---|---|---|
| Total Bilirubin ≤2× ULN | Total Bilirubin >2× ULN | Total Bilirubin ≤2× ULN | Total Bilirubin >2× ULN | Total Bilirubin ≤2× ULN | Total Bilirubin >2× ULN | Total Bilirubin ≤2× ULN | Total Bilirubin >2× ULN | |
| Patients,b n | 70 | 0 | 47 | 21 | 42 | 96 | 48 | 100 |
| Jaundice, n (%) | 2 (3) | 0 | 1 (2) | 4 (19) | 2 (5) | 31 (32) | 4 (8) | 35 (35) |
| Rash, n (%) | 18 (26) | 0 | 11 (23) | 8 (38) | 16 (38) | 48 (50) | 21 (44) | 40 (40) |
| Photosensitivity, n (%) | 1 (1) | 0 | 2 (4) | 0 (0) | 3 (7) | 14 (15) | 5 (10) | 16 (16) |
| Nausea, n (%) | 14 (20) | 0 | 11 (23) | 6 (29) | 14 (33) | 51 (53) | 21 (44) | 45 (45) |
| Diarrhea, n (%) | 13 (19) | 0 | 8 (17) | 1 (5) | 12 (29) | 32 (33) | 16 (33) | 24 (24) |
| Vomiting, n (%) | 4 (6) | 0 | 10 (21) | 4 (19) | 5 (12) | 20 (21) | 9 (19) | 24 (24) |