Clinical Study

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.

RVRNon-RVR RVR versus non-RVR (1: non-RVR/2: RVR)
Univariate analysisMultivariate analysis
valueOR95% CI value

Pretreatment factors
 Demographic data
  Number of patients11634
  Gender (male/female)68/4814/200.07240.462 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*94/2227/70.8331
  (noncirrhosis/cirrhosis)
   Histological fibrosis of liver (F0/1/2/3/4/ND)2/26/24/11/8/451/10/4/2/3/14
 Genetic variations
  rs8099917 (TT/TG or GG)94/2221/130.01950.308 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**74/4223/110.6793
  (wild-type/mutant-type)
  Number of amino acid substitutions in ISDR (0-1/2≤)85/3129/50.1490
 Laboratory data
  HCV-RNA ()6.60 (5.0–7.7)6.95 (5.2–7.8)0.01530.293 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 resistance1.73 (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)0.06550.978 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)44/7215/190.5161
  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).