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Table 3 Risk factors for occurence of serious adverse events in patients receiving triple therapy

From: Safety and efficacy of protease inhibitor based combination therapy in a single-center “real-life” cohort of 110 patients with chronic hepatitis C genotype 1 infection

  No SAE (N = 80) SAE (N = 22) P-Value
  Number (%) Number (%)  
  Mean (±SD) Mean (±SD)  
  Median (range) Median (range)  
Male sex 50 (62.5%) 13 (59.1%) 0.81
Age [years] 46.7 (±12.4) 53.5 (±7.3) 0.02
Age > 50 years 32 (40%) 16 (72.7%) <0.01
Liver cirrhosis 17 (23.9%) 12 (57.1%) <0.01
Diabetes mellitus type 2 8 (10%) 5 (22.7%) 0.15
Psychiatric disorders 16 (20%) 4 (18.2%) 1
Exclusion criteria for registration trials 48 (60%) 17 (77.3%) 0.210
Drug    0.45
Telaprevir 49 (61.3%) 16 (72.7%)  
Boceprevir 31 (38.8%) 6 (27.3%)  
Baseline laboratory    
Hemoglobin [g/dl] 14.7 (10.3-18.8) 14.6 (12.3-18.0) 0.69
Leukocytes [x10^9/l] 6.2 (3.1-13.1) 5.9 (2.7-9.5) 0.79
Platelets [x10^9/l] 199.5 (85–377) 127 (48–329) <0.01
ASAT [U/l] 49.5 (16–156) 67.5 (26–328) 0.04
ALAT [U/l] 70 (16–255) 91 (22–271) 0.28
γGT [U/l] 62.5 (57–1274) 72 (25–459) 0.18
Bilirubin [mg/dl] 0.5 (0.2-1.5) 0.75 (0.2-2.2) 0.01
Albumin [g/l] 40 (29–50) 39 (25–44) 0.11
Prothrombin time [INR] 1.00 (0.9-3.3) 1.13 (1.0-2.3) <0.01
Creatinine [mg/dl] 0.8 (0.5-5.8) 0.8 (0.5-1.1) 0.97
Platelets < 100,000/μl 5 (6.3%) 6 (27.3%) 0.01
ASAT > 100 U/l 11 (13.8%) 8 (36.4%) 0.03
Bilirubin ≥ 1.2 mg/dl 2 (2.5%) 6 (27.3%) <0.01
Albumin ≤ 35 g/l 3 (3.8%) 4 (18.2%) 0.04
Prothrombin time [INR] > 1.2 4 (5.3%) 3 (13.6%) 0.17
  1. [SAE = serious adverse event; N = number; SD = standard deviation; ASAT = aspartate aminotransferase; ALAT = alanine aminotransferase; γGT = gamma-glutamyltransferase; INR = international normalized ratio].