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Table 1 Baseline demographics and clinical characteristics

From: Simeprevir with peginterferon α-2a/ribavirin for chronic hepatitis C virus genotype 1 infection in treatment-experienced patients: an open-label, rollover study

Characteristic

Phase 2/3 group (N = 125)

Phase 1 group (N = 16)

Male, n (%)

80 (64.0)

13 (81.3)

Age (years), median (range)

51.0 (22–72)

52.5 (33–65)

BMI (kg/m2), median (range)

27.4 (18.9–45.8)

27.1 (20.4–35.3)

Race, n (%)

 White

121 (96.8)

14 (87.5)

 Black/African American

3 (2.4)

1 (6.3)

 American Indian/Alaskan native

0

1 (6.3)

 Native Hawaiian or other Pacific Islander

1 (0.8)

0

Ethnicity, n (%)

 Hispanic or Latino

7 (5.6)

1 (6.3)

 Not Hispanic or Latino

118 (94.4)

15 (93.8)

Time since diagnosis (years), median (range)

7.1 (2.1–35.4)

6.1 (0.7–20.4)

SMV therapy-experienced, yes, n (%)

125 (100)

8 (50)

PegIFN/RBV therapy-experienced, yes, n (%)

125 (100)

9 (56.2)

Response to last course of PegIFN/RBV therapy, n (%)

 Viral relapser

55 (44.0)

 Viral breakthrough

10 (8.0)

 Non-responder

60 (48.0)

 Partial responder

28 (22.4)

 Null responder

30 (24.0)

 Other (non-classifiable non-responder)

2 (1.6)

Baseline HCV RNA (log10 IU/ml), median (range)

6.53 (4.9–7.8)

6.68 (5.6–7.2)

IL28B genotype, n (%)

 CC

20 (16.0)

1 (6.3)

 CT

87 (69.6)

9 (56.3)

 TT

18 (14.4)

6 (37.5)

HCV geno/subtype

 1a

50 (40.0)

14 (87.5)

  1a with Q80K

12/50 (24.0)

3/14 (21.4)

  1a without Q80K

38/50 (76.0)

11/14 (78.6)

 1b

75 (60.0)

2 (12.5)

HOMA-IR,a n (%)

  <2

46/120 (38.3)

4/14 (28.6)

  ≥2 to ≤4

43/120 (35.8)

7/14 (50.0)

  >4

31/120 (25.8)

3/14 (21.4)

METAVIR fibrosis score, n (%)

 F0, 1, or 2

85 (68.0)

13 (81.3)

 F3

18 (14.4)

3 (18.8%)

 F4

22 (17.6)

0

Baseline ALT WHO toxicity grade, n (%)

 Grade 0

66 (52.8)

10 (62.5)

 Grade 1/2

56 (44.8)

6 (37.5)

 Grade 3

3 (2.4)

0

 Grade 4

0

0

  1. a N = 120 (Phase 2/3 group), N = 14 (Phase 1 group)
  2. ALT alanine aminotransferase, BMI body mass index, HCV hepatitis C virus, HOMA-IR homeostatic model assessment of insulin resistance, IL28B interleukin-28b, PegIFN/RBV peginterferon with ribavirin, SMV simeprevir, WHO World Health Organization