Predictors of Response to 24-Week Telaprevir-Based Triple Therapy for Treatment-Naïve Genotype 1b Chronic Hepatitis C Patients
Table 3
Background characteristics of hepatitis C virus genotype 1b patients, based on their achieving sustained virological response.
SVR
Non-SVR
SVR versus non-SVR (1: non-SVR/2: SVR)
Univariate analysis
Multivariate analysis
value
OR
95% CI
value
Pretreatment factors
Demographic data
Number of patients
131
19
Gender (male/female)
74/57
8/11
0.2392
Age (years)
58 (18–75)
57 (40–68)
0.7495
Body weight (kg)
61.1 (41.2–115.8)
62.5 (45–92.8)
0.8698
Body mass index (kg/m2)
23.4 (17.3–37.8)
23.3 (17.7–31.9)
0.8321
Absence or presence of cirrhosis*
107/24
14/5
0.4095
(1: noncirrhosis/2: cirrhosis)
Histological fibrosis of liver (F0/1/2/3/4/ND)
3/32/25/11/9/51
0/4/3/2/2/8
Genetic variations
rs8099917 (TT/TG or GG)
112/19
3/16
1.33 × 10−10
0.071
0.015–0.337
7.38 × 10−4
(1: TT/2: TG or GG)
Amino acid substitutions in the HCV genotype 1b
Core amino acid substitution 70**
85/46
12/7
0.8830
(wild-type/mutant-type)
Number of amino acid substitutions in ISDR (0-1/2≤)
100/31
14/5
0.8003
Laboratory data
HCV-RNA ()
6.7 (5.0–7.8)
6.8 (5.8–7.6)
0.7495
White blood cells (/μL)
5300 (2000–8700)
4590 (3290–7900)
0.1117
Hemoglobin (g/dL)
14.2 (11.0–17.4)
13.6 (11.1–17.5)
0.2681
Platelets (×104/μL)
17.2 (7.0–35.3)
16.5 (7.6–33.6)
0.9123
Aspartate aminotransferase (IU/L)
43 (13–221)
60 (22–134)
0.1671
Alanine aminotransferase (IU/L)
48 (13–305)
56 (20–161)
0.2868
Gamma-glutamyl-transpeptidase (IU/L)
34.5 (12–272)
82 (14–427)
0.0459
0.973
0.872–1.085
0.6134
(by 10 IU/L)
Albumin (g/dL)
4.1 (3.3–4.7)
4.0 (3.3–4.7)
0.0968
8.639
0.875–85.736
0.0617
(by 1.0 g/dL)
Low density lipoprotein-cholesterol (mg/dL)
99 (51–194)
82 (58–128)
0.1140
Fasting plasma glucose (mg/dL)
101 (74–210)
91 (80–116)
0.0549
1.621
0.853–3.082
0.1346
(by 10 mg/dL)
Homeostasis model assessment-Insulin Resistance
2.15 (0.68–13.5)
1.98 (0.79–12.6)
0.4320
Alpha-fetoprotein (ng/mL)
4.5 (1–234.7)
12.5 (2.4–117.5)
0.3595
Treatment
Initial dose of PEG-IFN (μg/kg)
1.50 (0.94–1.94)
1.48 (1.22–1.72)
0.5049
Initial dose of RBV (mg/kg)
11.4 (6.6–14.0)
11.6 (6.8–13.3)
0.9482
Initial dose of TVR (1500/2250 mg)
50/81
9/10
0.4429
Initial dose of TVR (mg/kg)
30.1 (16.7–51.1)
32.2 (22.2–38.3)
0.8102
On-treatment factors
Treatment
Adherence to PEG-IFN (%)
100 (12.5–100)
94.4 (8.3–100)
0.2302
Adherence to RBV (%)
66.7 (25.0–100)
67.7 (7.7–100)
0.7006
Adherence to TVR*** (%)
69.4 (25.0–100)
66.7 (15.5–100)
0.1669
Early virological response
Achievement of RVR (yes/no)
109/22
7/12
2.47 × 10−5
PEG-IFN: peginterferon; RBV: ribavirin; TVR: telaprevir; HCV: hepatitis C virus; ISDR: interferon-sensitivity determining region; RVR: rapid virological response.
*Determined by the liver biopsy METAVIR scores within 12 months of enrollment or by an aspartate aminotransferase to platelet ratio index (APRI) >1.5.
**“Wild-type” (arginine) or “mutant-type” (glutamine or histidine).
***Calculated on the basis of 2250 mg/day. Data expressed as number of patients or median (range).
