TABLE 5.
Incidence of marked laboratory changes during 12 or 24 weeks of treatment with faldaprevir plus pegylated interferon α-2a and ribavirin
| Laboratory parametera | Value (no [%]) by faldaprevir treatment duration |
|
|---|---|---|
| 12 wk (n = 81) | 24 wk (n = 79) | |
| Total bilirubin | 79 | 78 |
| 1.1–1.5× ULN | 25 (31.6) | 22 (28.2) |
| 1.6–2.5× ULN | 18 (22.8) | 24 (30.8) |
| 2.6–5.0× ULN | 6 (7.6) | 6 (7.7) |
| >5.0× ULN | 0 | 2b (2.6) |
| ALT | 79 | 78 |
| 1.25–2.5× ULN | 37 (46.8) | 38 (48.7) |
| 2.6–5.0× ULN | 15 (19.0) | 17 (21.8) |
| 5.1–10.0× ULN | 3 (3.8) | 4 (5.1) |
| >10.0× ULN | 0 | 0 |
| Hemoglobin | 80 | 78 |
| 10.0–10.9 g/dl | 18 (22.5) | 16 (20.5) |
| 9.0–9.9 g/dl | 13 (16.3) | 10 (12.8) |
| 7.0–8.9 g/dl | 3 (3.8) | 4 (5.1) |
| <7.0 g/dl | 0 | 0 |
a
Standard reference ranges are the following: total bilirubin, 0.1 to 1 mg/dl; ALT, 0 to 35 U/liter; hemoglobin, 12.5 to 18 g/dl.
b
Both patients had a conjugated/total bilirubin ratio of ≤0.5 and total bilirubin levels of 5.2× ULN and 6.6× ULN when the elevation occurred.