Observational Study
Copyright ©The Author(s) 2022.
World J Gastroenterol. Dec 7, 2022; 28(45): 6380-6396
Published online Dec 7, 2022. doi: 10.3748/wjg.v28.i45.6380
Table 5 The comparison of virological responders and non-responders to direct-acting antiviral therapy
Parameter
Responders, n = 10903
Non-responders, n = 209
P value
Sex, females/males, n (%)5891 (54)/5012 (46)78 (37.3)/131 (62.7)< 0.001
Age in yr, mean ± SD; min-max52.9 ± 14.8; 17-9753.4 ± 13; 25-840.69
BMI, kg/m2 mean ± SD; min-max26.3 ± 4.5; 13.2-57.427 ± 4.6; 15.4-480.005
Genotype-specific treatment regimens, n (%)
      ASV + DCV119 (1.1)13 (6.2)< 0.001
      LDV/SOF ± RBV2534 (23.2)48 (22.9)0.99
      OBV/PTV/r + DSV ± RBV3563 (32.6)64 (30.7)0.58
      GZR/EBR ± RBV2179 (20)37 (17.7)0.46
      Other (SOF ± SMV ± DCV ± RBV, SMV ± DCV ± RBV)14 (0.1)2 (1)0.03
Pangenotypic regimens, n (%)
      GLE/PIB1625 (14.9)18 (8.6)0.01
      GLE/PIB + SOF + RBV3 (< 0.1)00.06
      SOF/VEL ± RBV857 (7.8)27 (12.9)0.01
      VOX/VEL/SOF9 (0.2)00.42
Regimen, n (%)0.65
      Genotype-specific8409 (77.1)164 (80.5)
      Pangenotypic2494 (22.9)45 (21.5)
Comorbidities, n (%)
      Any comorbidity6958 (63.8)138 (65.7)0.55
      Hypertension3842 (35.2)75 (35.7)0.90
      Diabetes1369 (12.6)24 (11.4)0.72
      Renal disease446 (4.1)7 (3.3)0.71
      Autoimmune diseases240 (2.2)4 (1.9)0.96
      Non-HCC tumors214 (2)6 (2.9)0.49
      Other5085 (46.6)106 (50.5)0.27
Concomitant medications, n (%)6517 (59.8)141 (67.5)0.03
Liver fibrosis, n (%)
      F0229 (2.1)2 (1)0.37
      F14308 (39.5)50 (23.9)< 0.001
      F22054 (18.8)38 (18.2)0.88
      F31522 (14)25 (12)0.47
      F42590 (23.8)88 (42.1)< 0.001
      No data200 (1.8)6 (2.9)0.40
History of previous therapy, n (%)
      Treatment-naïve8138 (74.6)140 (67)0.01
      Non-responder908 (8.3)24 (11.5)0.13
      Relapser803 (7.4)21 (10)0.18
      Discontinuation due to safety reason320 (2.9)9 (4.3)0.34
      Unknown type of response695 (6.4)15 (7.2)0.74
      No data39 (0.4)00.78
      Previous DAA treatment120 (1.2)18 (9)< 0.001
History of hepatic decompensation, n (%)
      Ascites286 (2.6)14 (6.7)< 0.001
      Encephalopathy75 (0.7)7 (3.3)< 0.001
Documented esophageal varices, n (%)778 (7.1)38 (18.2)< 0.001
Hepatic decompensation at baseline, n (%)
      Ascites136 (1.3)10 (4.8)< 0.001
      Encephalopathy58 (0.5)6 (2.9)< 0.001
HCC history, n (%)150 (1.4)8 (3.8)0.01
OLTx history, n (%)117 (1.1)2 (0.9)0.86
Child-Pugh, n (%)
      B306 (2.8)23 (11)< 0.001
      C15 (0.1)00.67
HBV coinfection (HBsAg+), n (%)102 (0.9)2 (0.9)0.74
HIV coinfection, n (%)327 (3)14 (6.7)0.004
ALT IU/L, mean ± SD75.6 ± 65.385.5 ± 71.10.005
Bilirubin mg/dL, mean ± SD0.8 ± 0.81 ± 0.7< 0.001
Albumin g/dL, mean ± SD4.3 ± 3.34.1 ± 2.8< 0.001
Creatinine mg/dL, mean ± SD0.9 ± 1.90.8 ± 0.20.93
Hemoglobin g/dL, mean ± SD14.4 ± 1.814.3 ± 1.90.71
Platelets, × 1000/μL, mean ± SD196.5 ± 77.4160.6 ± 73.3< 0.001
HCV RNA × 106 IU/mL, mean ± SD2.1 ± 4.82.2 ± 2.80.02