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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