Prospective Study
Copyright ©The Author(s) 2020.
World J Hepatol. Sep 27, 2020; 12(9): 672-684
Published online Sep 27, 2020. doi: 10.4254/wjh.v12.i9.672
Table 1 Patient characteristics
n = 265
Age in yr68 (17-86)
≥ 75 yr83 (31%)
Sex as male/female150/115 (57%/43%)
Cirrhosis91 (34%)
Moderate chronic kidney disease, eGFR < 60 mL/min/1.73 m253 (20%)
History of HCC treatment33 (12%)
History of pegylated IFN + ribavirin therapy39 (15%)
Height in cm160.2 (134.0-182.0)
Weight in kg58.0 (32.3-99.3)
BMI in kg/m222.6 (15.5-35.0)
Baseline HCV-RNA in logIU/mL6.0 (1.4-7.4)
WBC as /mm35000 (1810-13260)
Hb in g/dL13.6 (10.2-20.1)
Platelets as × 104/mm316.2 (4.6-38.9)
AST in IU/L43 (12-257)
ALT in IU/L39 (6-394)
γ-GT in IU/L32 (5-898)
eGFR73 (31-156)
AFP in ng/mL4.3 (1.0-88.3)
Table 2 Comparison of pre-treatment factors between patients ≥ 75-years-old and < 75-years-old
FactorsPatients ≥ 75-yr-old, n = 83Patients < 75-yr-old, n = 182P value
Age in yr79 (75-86)64 (17-74)< 0.001
Sex as male/female42/41 (51%/49%)108/74 (59%/41%)0.183
Height in cm156.7 (134.0-170.0)162.0 (140.0-182.0)< 0.001
Weight in kg53.5 (32.3-81.4)60.0 (37.6-99.3)< 0.001
BMI in kg/m222.2 (15.5-29.5)23.1 (16.5-35.0)0.009
Cirrhosis41 (49%)50 (28%)< 0.001
CKD, eGFR < 60 mL/min/1.73 m228 (34%)25 (14%)< 0.001
History of HCC treatment18 (22%)15 (8%)0.002
History of IFN-based therapy21 (25%)42 (23%)0.693
HCV-RNA as logIU/mL6.1 (2.3-7.3)5.9 (1.4-7.4)0.894
WBC in mm34540 (1810-13260)5200 (2200-11400)0.004
Hb in g/dL12.9 (10.2-20.1)14.1 (10.6-17.6)< 0.001
Platelets as × 104/mm314.2 (4.9-32.8)17.4 (4.6-38.9)< 0.001
AST in IU/L40 (14-183)42 (12-252)0.589
ALT in IU/L30 (6-139)44 (6-394)< 0.001
γ-GT in IU/L25 (7-361)37 (5-888)0.001
AFP in ng/mL3.9 (1-32.9)4.8 (1.1-88.3)0.014
eGFR66.0 (33.0-106.9)77.6 (30.9-156.0)< 0.001
Table 3 Uni- and multivariate analyses of pre-treatment factors contributing to sustained virological response
Univariate
Multivariate
FactorsP valueOR95%CIP valueOR95%CI
Age, per 1-yr increase0.7820.9910.931-1.055
≥ 75 yr0.8741.1440.217-6.022
Sex, female0.9771.0230.224-4.663
Height, per 1-cm increase0.3160.9570.879-1.043
Weight, per 1-kg increase0.5680.9820.924-1.044
BMI, per 1-kg/m2 increase0.9290.9900.792-1.238
Cirrhosis0.2140.3820.084-1.743
CKD, eGFR > 60 mL/min/1.73 m20.5690.6160.116-3.266
History of HCC treatment0.0270.1750.037-0.8220.0720.2250.044-1.145
History of IFN-based therapy0.7630.7740.146-4.091
HCV-RNA, per 1-logIU/mL increase0.6440.8310.380-1.821
WBC in mm30.7031.0090.963-1.057
Hb, per 1-g/dL increase0.1961.4110.837-2.380
Platelets, per 1 × 104/mm3 increase0.7900.9840.873-1.109
AST, per 1-IU/L increase0.5521.0070.983-1.033
ALT, per 1-IU/L increase0.6081.0050.987-1.023
γ-GT, per 1-IU/L increase0.4901.0070.987-1.027
AFP, per 1-ng/mL increase0.0040.9550.926-0.9850.0150.9590.926-0.992
eGFR, per 1-mL/min/1.73 m2 increase0.1241.0360.990-1.083
Table 4 Comparison of factors between patients with and without sustained virological response
FactorsSVR, n = 258Non-SVR, n = 7P value
Age in yr, n (range)68 (17-86)74 (39-79)0.682
Sex as male/female146/1124/31.000
Height in cm160.1 (134.0-182.0)161.5 (155.0-177.0)0.350
Body weight in kg58.0 (32.3-99.3)63.2 (54.0-66.2)0.267
BMI in kg/m222.6 (15.5-38.0)22.6 (20.2-25.9)0.778
Cirrhosis8740.237
CKD5120.630
History of HCC treatment3030.044
History of IFN-based therapy6120.672
HCV-RNA as logIU/mL6.1 (2.7-7.6)6.3 (3.3-7.0)0.713
White blood cells as /mm35005 (1810-13260)4100 (2260-8700)0.581
Hemoglobin in g/dL13.6 (10.2-20.1)12.5 (11.6-14.7)0.793
Platelets as × 104/mm316.2 (4.6-38.9)14.9 (9.9-30.3)0.930
AST in IU/L42 (12-252)37 (19-90)0.789
ALT in IU/L39 (6-394)57 (19-79)0.843
γ-GTP in IU/L32 (5-888)36 (13-461)0.942
AFP in ng/mL5.2 (1.0-445.0)10.6 (1.3-29.7)0.521
eGFR in mL/min/1.73 m273.1 (30-240.2)72.2 (50.5-105.8)0.166
Ribavirin adherence in %100 (28-100)100 (100-100)0.323
Table 5 Adverse events during treatment
Total,n = 265Patients ≥ 75-yr-old, n = 83Patients < 75-yr-old, n = 182P value
Treatment discontinuation due to adverse events11 (0.4%)1 (1.2%)00.313
Dose reduction or interruption of ribavirin due to anemia232 (13.2%)18 (21.7%)14 (7.7%)0.002
Dermatitis9 (3.4%)1 (1.2%)8 (4.4%)0.281
Depression3 (1.1%)1 (1.2%)2 (0.5%)1.000
Headache4 (1.5%)04 (2.2%)0.313
Infection4 (1.5%)1 (1.2%)3 (1.6%)1.000
Other adverse events11 (4.2%)5 (6.0%)6 (3.3%)0.328
Elevated bilirubin level2 (0.8%)1 (1.2%)1 (0.5%)0.529
Elevated transaminase level4 (1.5%)2 (2.4%)2 (1.1%)0.592
Elevated serum ammonia level5 (1.9%)2 (2.4%)3 (1.6%)0.650
Elevated uric acid level26 (9.8%)10 (12.0%)16 (8.8%)0.504