Table 3.
Key Laboratory Abnormalities (Worsening From Baseline)
| Laboratory Abnormalities |
CERTAIN‐2 Without Cirrhosis |
CERTAIN‐1 Substudy 2 Compensated Cirrhosis |
|
|---|---|---|---|
|
Arm A G/P (n = 90), n (%) |
Arm B SOF + RBV (n = 46), n (%) |
Arm C G/P (n = 18), n (%) |
|
| Hemoglobin | |||
| Grade 2 (8‐10 g/dL)a | 1 (1) | 4 (9) | 2 (11) |
| Grade ≥3 (<8 g/dL) | 0 | 1 (2) | 0 |
| Alanine aminotransferase | |||
| Grade 2 (>3‐5 × ULN) | 0 | 0 | 0 |
| Grade ≥3 (>5 × ULN) | 0 | 0 | 0 |
| Aspartate aminotransferase | |||
| Grade 2 (>3‐5 × ULN) | 0 | 0 | 1 (6) |
| Grade ≥3 (>5 × ULN) | 0 | 0 | 0 |
| Total bilirubin | |||
| Grade 2 (>1.5‐3 × ULN)b | 4 (4) | 9 (22) | 2 (11) |
| Grade ≥3 (>3 × ULN) | 0 | 1 (2) | 1 (6) |
a
Difference in grade ≥2 between arms A and B was statistically significant (P = 0.017).
b
Difference in grade ≥2 between arms A and B was statistically significant (P = 0.005).
Abbreviation: ULN, upper limit of the normal range.