Table 4.
Arm A (12 Weeks G/P) | Arm B (16 Weeks G/P) | |||
---|---|---|---|---|
1:1 Randomized | ||||
Event, n (%) | Treatment‐Naive With Cirrhosis (n = 40) | Treatment‐Experienced Without Cirrhosis (n = 22) | Treatment‐experienced Without Cirrhosis (n = 22) | Treatment‐Experienced With Cirrhosis (n = 47) |
Any AE | 32 (80) | 12 (55) | 17 (77) | 34 (72) |
Serious AE | 1 (3) | 1 (5) | 1 (5) | 3 (6) |
Serious AE related to study drugs | 0 | 0 | 0 | 0 |
AE leading to study drug d/c | 0 | 0 | 0 | 0 |
AEs occurring in ≥ 10% of patients | ||||
Fatigue | 5 (13) | 4 (18) | 4 (18) | 16 (34) |
Headache | 10 (25) | 5 (23) | 4 (18) | 6 (13) |
Key laboratory abnormalities,a n (%) | ||||
ALTb | ||||
Grade ≥ 3 (>5 × ULN) | 0 | 2 (9) | 0 | 0 |
Total bilirubin | ||||
Grade ≥ 3 (>3 × ULN) | 0 | 0 | 0 | 1 (2) |
Laboratory abnormalities based on the Common Terminology Criteria for Adverse Events, version 4.
ALT must have been increased post nadir in grade.
Abbreviations: d/c, discontinuation; ULN, upper limit of normal.