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. 2014 Jun;58(6):3429–3436. doi: 10.1128/AAC.02497-13

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.