Predictors of Response to 24-Week Telaprevir-Based Triple Therapy for Treatment-Naïve Genotype 1b Chronic Hepatitis C Patients
Table 2
Patient characteristics at the start of triple therapy for hepatitis C virus genotype 1b, according to achievement of a rapid virological response.
RVR
Non-RVR
RVR versus non-RVR (1: non-RVR/2: RVR)
Univariate analysis
Multivariate analysis
value
OR
95% CI
value
Pretreatment factors
Demographic data
Number of patients
116
34
Gender (male/female)
68/48
14/20
0.0724
0.462
0.200–1.065
0.0697
(1: male/2: female)
Age (years)
58 (18–75)
57 (29–74)
0.8152
Body weight (kg)
61.8 (41.2–101.6)
60.1 (44.1–115.8)
0.2956
Body mass index (kg/m2)
23.4 (18.1–34.3)
23.4 (17.3–37.8)
0.6846
Absence or presence of cirrhosis*
94/22
27/7
0.8331
(noncirrhosis/cirrhosis)
Histological fibrosis of liver (F0/1/2/3/4/ND)
2/26/24/11/8/45
1/10/4/2/3/14
Genetic variations
rs8099917 (TT/TG or GG)
94/22
21/13
0.0195
0.308
0.123–0.775
0.0116
(1: TT/2: TG or GG)
Amino acid substitutions in the HCV genotype 1b
Core amino acid substitution 70**
74/42
23/11
0.6793
(wild-type/mutant-type)
Number of amino acid substitutions in ISDR (0-1/2≤)
85/31
29/5
0.1490
Laboratory data
HCV-RNA ()
6.60 (5.0–7.7)
6.95 (5.2–7.8)
0.0153
0.293
0.127–0.675
0.0037
(by 1.0 )
White blood cells (/μL)
5300 (2000–8700)
4790 (3290–7900)
0.2152
Hemoglobin (g/dL)
14.1 (11.4–17.5)
14.45 (11.0–17.2)
0.5063
Platelets (/μL)
16.9 (7.0–35.3)
17.35 (7.0–28.8)
0.8858
Aspartate aminotransferase (IU/L)
42 (13–221)
51.5 (20–135)
0.2394
Alanine aminotransferase (IU/L)
49 (13–305)
51 (25–169)
0.5716
Gamma-glutamyl-transpeptidase (IU/L)
37 (12–427)
44.5 (12–359)
0.3205
Albumin (g/dL)
4.1 (3.3–4.7)
4.0 (3.3–4.7)
0.5075
Fasting low density lipoprotein-cholesterol (mg/dL)
99 (21–194)
87.5 (58–133)
0.1850
Fasting plasma glucose (mg/dL)
101 (74–215)
97.5 (80–158)
0.4837
Homeostasis model assessment-insulin resistance
1.73 (0.68–13.5)
2.24 (0.72–10.1)
0.3215
Alpha-fetoprotein (ng/mL)
4.4 (1.4–136)
5.35 (1–235)
0.0655
0.978
0.886–1.085
0.6998
(by 1.0 ng/mL)
Treatment
Initial dose of PEG-IFN (μg/kg)
1.50 (1.07–1.82)
1.49 (0.94–1.94)
0.5824
Initial dose of RBV (mg/kg)
11.3 (6.6–14.1)
11.8 (6.8–13.6)
0.2833
Initial dose of TVR (1500/2250 mg)
44/72
15/19
0.5161
Initial dose of TVR (mg/kg)
30.3 (16.7–51.1)
32.1 (19.4–47.1)
0.6470
After starting treatment factors
Adherence of PEG-IFN during 4 weeks (%)
100 (50–100)
100 (75–100)
0.4041
Adherence of RBV during 4 weeks (%)
94.4 (40.4–100)
100 (75–100)
0.1486
Adherence of TVR*** during 4 weeks (%)
83.3 (4.2–100)
84.7 (66.7–100)
0.7318
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).