Copyright
©The Author(s) 2017.
World J Hepatol. Apr 18, 2017; 9(11): 551-561
Published online Apr 18, 2017. doi: 10.4254/wjh.v9.i11.551
Published online Apr 18, 2017. doi: 10.4254/wjh.v9.i11.551
Table 1 Baseline characteristics of the study group
n | Continuous variables: Median (IQR)/categorical variables: n (%) | Range | |
Telaprevir | 223 | 172 (77) | - |
Demographics and anthropometrics | |||
Age, yr | 223 | 57 (51-61) | 22-74 |
Gender, male | 223 | 144 (65) | - |
Race, white | 223 | 182 (82) | - |
BMI, kg/m3, 17-24: Normal; 25-30: Overweight; > 30: Obesea | 186 | 27.1 (24.5-30.7) | 16.3-49.3 |
Past medical history | |||
Diabetes | 223 | 48 (22) | - |
Depression | 223 | 47 (21) | - |
IL28B genotype | 223 | ||
CC | 20 (9) | - | |
CT | 50 (22) | - | |
TT | 21 (10) | - | |
Unknown | 132 (59) | - | |
Treatment history | 223 | ||
Naïve | 68 (31) | - | |
Non-responder | 95 (43) | - | |
Relapser | 45 (20) | - | |
Intolerance | 12 (5) | - | |
Unknown | 3 (1) | - | |
HCV treatment related characteristics | |||
HCV viral load, log IU/mL | 221 | 6.31 (5.89-6.66) | 3.07-7.64 |
Sub-genotype | 223 | ||
1a | 118 (53.5) | - | |
1b | 72 (32) | - | |
1a/1b | 1 (0.5) | - | |
Unknown | 32 (14) | - | |
Laboratory tests | |||
Hemoglobin, g/dL, female:12-15.5 g/dL; male: 13.5-17.5 g/dLa | 220 | 14.3 (13.2-15.3) | 9.2-18.2 |
AFP, ng/mL, 1.6-4.5 ng/mLa | 158 | 6.85 (3.58-13.83) | 0.80-208.60 |
Albumin g/dL, 3.5-4.9 g/dLa | 219 | 4.20 (3.90-4.50) | 2.60-5.30 |
AST, U/L, 1-50 U/La | 221 | 62 (39-106) | 19-324 |
ALT, U/L, 1-53 U/La | 221 | 67 (44-107) | 15-403 |
Platelets, × 103/μL, 150-450 × 103/μLa | 223 | 152 (106-195) | 14-365 |
Creatinine, mg/dL, 0.60-1.40 mg/dLa | 205 | 0.91 (0.81-1.04) | 0.58-10.2 |
Ferritin, ng/mL, 15-150 ng/mLa | 54 | 184 (113-373) | 22-893 |
eGFR, mL/min/1.73 m2 < 60 mL/min per 1.73 m2ab | 204 | 88 (75-99) | 6-125 |
Indication of liver fibrosis | |||
APRI score | 221 | 0.82 (0.43-1.82) | 0.10-12.48 |
FIB-4 score | 221 | 2.65 (1.77-5.66) | 0.35-35.30 |
FIB-4, advanced fibrosis/cirrhosisc | 221 | 98/221 (44) | - |
Cirrhosis, biopsy | 189 | 85/189 (45) | - |
Transient elastography score, kPa | 80 | 11.8 (7.2-20.3) | 3.9-55.1 |
Cirrhosis, transient elastographyd | 80 | 36/80 (45) | - |
Cirrhosis, transient elastography/biopsy | 202 | 96/202 (48) | - |
Table 2 Univariable and multivariable logistic regression for baseline factors associated with sustained virological response
Univariable | Multivariablea | |||||
OR | 95%CI | P | OR | 95%CI | P | |
Protease inhibitor, telaprevir | 1.62 | 0.84-3.12 | 0.15 | - | - | - |
Age, yr | 0.98 | 0.96-1.01 | 0.23 | - | - | - |
Gender, male | 1.11 | 0.64-1.94 | 0.71 | - | - | - |
Race, white | 3.12 | 1.41-6.90 | < 0.01 | 5.92 | 2.34-14.96 | < 0.01 |
Diabetes | 0.43 | 0.21-0.87 | 0.02 | - | - | - |
Depression | 1.58 | 0.83-3.02 | 0.17 | - | - | - |
BMI, kg/m2 | 0.98 | 0.93-1.04 | 0.52 | - | - | - |
IL28B, CC vs CT/TT | 3.56 | 1.31-9.64 | 0.01 | 3.54 | 1.19-10.53 | 0.02 |
Treatment history, naïve/relapser | 1.86 | 1.08-3.20 | 0.03 | - | - | - |
HCV viral load, log IU/mL | 0.79 | 0.54-1.14 | 0.21 | - | - | - |
Sub-genotype, 1b (vs all other) | 2.06 | 1.17-3.65 | 0.01 | 2.81 | 1.45-5.44 | 0.02 |
Hemoglobin, g/dL | 1.03 | 0.86-1.23 | 0.78 | - | - | - |
AFP, ng/mL | 0.95 | 0.92-0.98 | < 0.01 | - | - | - |
Albumin, g/dL | 2.56 | 1.33-4.92 | < 0.01 | - | - | - |
AST, U/L | 0.99 | 0.99-0.99 | 0.02 | - | - | - |
ALT, per U/L | 1.00 | 0.99-1.01 | 0.61 | - | - | - |
Platelets, per × 104/µL | 1.08 | 1.03-1.13 | < 0.01 | 1.10 | 1.05-1.16 | < 0.01 |
Creatinine, per mg/dL | 0.8 | 0.42-1.53 | 0.50 | - | - | - |
Ferritin, per ng/mL | 0.99 | 0.99-1.00 | 0.63 | - | - | - |
eGFR, per mL/min per 1.73 m2 | 1.00 | 0.99-1.02 | 0.65 | - | - | - |
APRI | 0.84 | 0.70-1.02 | 0.08 | - | - | - |
FIB-4 | 0.91 | 0.83-0.99 | 0.02 | - | - | - |
APRI > 1.5 | 0.44 | 0.24-0.82 | 0.01 | - | - | - |
FIB-4 ≥ 3.25 | 0.39 | 0.22-0.68 | < 0.01 | - | - | - |
Cirrhosis transient elastography/biopsy | 0.5 | 0.29-0.87 | 0.01 | - | - | - |
Table 3 Comparison of on-treatment variables in the sustained virologic response and non- sustained virologic response group
Total cohort Categorical: n (%) Continous: Median (IQR) | SVR (n = 94) | Fail to achieve SVR (n = 129) | P | |
Discontinuation due to adverse events | 44/223 (20%) | 13/94 (14%) | 31/94 (24%) | 0.06a |
Change in ferritin from baseline to week 4 of treatment, ng/mL | 91 (45-212) | 146 (81-331) | 62 (-20-175) | 0.08b |
Development of severe anemia | 94/223 (42%) | 54/94 (57%) | 66/129 (51%) | 0.35a |
Change in eGFR from baseline to week 4c, mL/min per 1.73 m2 | -4.41 (-14.87-3.23) | -6.59 (-16.98-0.52) | -1.68 (-13.99-5.00) | 0.04b |
Fast viral kinetics | 139/223 (62%) | 83/94 (88%) | 56/129 (43%) | < 0.01a |
Table 4 Univariable and multivariable logistic regression of factors associated with relapse
Univariable | Multivariable | |||||
OR | 95%CI | P | OR | 95%CI | P | |
Protease inhibitor, Telaprevir | 0.41 | 0.15-1.10 | 0.08 | - | - | - |
Age, yr | 1.00 | 0.96-1.05 | 0.95 | - | - | - |
Gender, female | 1.36 | 0.53-3.48 | 0.52 | - | - | - |
Race, black | 1.16 | 0.28-4.71 | 0.84 | - | - | - |
Diabetes | 1.86 | 0.65-5.28 | 0.25 | - | - | - |
Depression | 0.54 | 0.17-1.75 | 0.30 | - | - | - |
BMI, per kg/m2 | 0.98 | 0.88-1.10 | 0.76 | - | - | - |
IL28B, CC vs CT/TTa | - | - | - | - | - | - |
Treatment history, naïve/relapser | 1.10 | 0.45-2.72 | 0.84 | - | - | - |
HCV viral load, log IU/mL | 1.74 | 0.80-3.78 | 0.16 | - | - | - |
Sub-genotype, 1a (vs all other) | 6.26 | 1.75-22.45 | 0.01 | 5.15 | 1.40-18.97 | 0.01 |
Hemoglobin, g/dL | 1.24 | 0.88-1.73 | 0.22 | - | - | - |
AFP, ng/mL | 1.02 | 0.99-1.05 | 0.15 | - | - | - |
Albumin, g/dL | 1.02 | 0.34-3.08 | 0.97 | - | - | - |
AST, U/L | 1.01 | 1.00-1.02 | 0.06 | - | - | - |
ALT, U/L | 1.00 | 0.99-1.01 | 0.23 | - | - | - |
Platelets, × 104/µL | 0.95 | 0.89-1.02 | 0.19 | - | - | - |
Creatinine, mg/dL | 1.41 | 0.72-2.74 | 0.31 | - | - | - |
Ferritin, ng/mL | 1.00 | 0.99-1.01 | 0.26 | - | - | - |
eGFR, mL/min per 1.73 m2b | 0.99 | 0.97-1.02 | 0.66 | - | - | - |
APRI score | 1.16 | 0.94-1.43 | 0.17 | - | - | - |
FIB-4 score | 1.03 | 0.94-1.13 | 0.49 | - | - | - |
APRI > 1.5 | 2.33 | 0.87-6.23 | 0.09 | - | - | - |
FiB-4 ≥ 3.25 | 2.77 | 1.12-6.86 | 0.03 | 2.77 | 1.07-7.22 | 0.04 |
Cirrhosis, transient elastography/biopsy | 2.55 | 1.05-6.19 | 0.04 | - | - | - |
- Citation: Bichoupan K, Tandon N, Martel-Laferriere V, Patel NM, Sachs D, Ng M, Schonfeld EA, Pappas A, Crismale J, Stivala A, Khaitova V, Gardenier D, Linderman M, Olson W, Perumalswami PV, Schiano TD, Odin JA, Liu LU, Dieterich DT, Branch AD. Factors associated with success of telaprevir- and boceprevir-based triple therapy for hepatitis C virus infection. World J Hepatol 2017; 9(11): 551-561
- URL: https://www.wjgnet.com/1948-5182/full/v9/i11/551.htm
- DOI: https://dx.doi.org/10.4254/wjh.v9.i11.551