Prospective Study
Copyright ©The Author(s) 2015.
World J Gastroenterol. Aug 14, 2015; 21(30): 9163-9174
Published online Aug 14, 2015. doi: 10.3748/wjg.v21.i30.9163
Table 1 Group of patients according to hepatitis C virus treatment history n (%)
All patientsBOCTVRP valueFibrosisNon-F4F4P value
(n = 1057) (100)(n = 405) (38)(n = 652) (62)All patients(n = 423) (44)(n = 545) (56)
(n = 958) (100)
TN319 (30)130 (32)189 (29)0.000294 (30)129 (31)165 (30)0.010
TE738 (70)275 (68)463 (71)664 (70)294 (67)380 (70)
R298 (28)77 (19)221 (34)270 (28)138 (33)132 (24)
PR123 (12)55 (14)68 (10)113 (12)44 (10)69 (13)
NR260 (25)119 (29)141 (22)238 (25)86 (20)152 (28)
Unknown responders57 (5)24 (6)33 (5)53 (6)26 (6)27 (5)
Table 2 Baseline characteristics of the study patients (unknown previous virologic response patients, n = 57)
All patients (n = 1057)
TN (n = 319)
R (n = 298)
PR (n = 123)
NR (n = 260)
All (n = 1057)BOC (n = 405)TVR (n = 652)P valueBOC (n = 130)TVR (n = 189)P valueBOC (n = 77)TVR (n = 221)P valueBOC (n = 55)TVR (n = 68)P valueBOC (n = 119)TVR (n = 141)P value
Age (yr), mean ± SD54 ± 854 ± 953 ± 852 ± 1053 ± 954.6 ± 853 ± 854.6 ± 853 ± 854 ± 954 ± 7
Male sex724 (69)264 (65)460 (71)NS85 (65)124 (66)NS46 (60)157 (71)NS35 (64)55 (81)0.0385 (71)101 (72)NS
HCV genotype 1 subtype
1a239 (26)102 (28)137 (24)NS32 (27)47 (29)NS18 (25)38 (20)NS15 (31)13 (23)NS34 (32)31 (24)NS
1b692 (74)263 (72)429 (76)85 (73)116 (71)54 (75)151 (80)34 (69)44 (77)72 (68)99 (76)
IL28b genotype
CC157 (20)55 (18)102 (20)NS27 (26)35 (23)NS8 (16)46 (29)NS5 (13)5 (9)NS9 (10)9 (8)NS
CT510 (63)191 (64)319 (63)57 (54)94 (61)36 (74)97 (61)24 (63)38 (72)61 (70)77 (68)
TT138 (17)54 (18)84 (17)21 (20)24 (16)5 (10)16 (10)9 (24)10 (19)17 (20)27 (24)
Stage of fibrosis
F0F181 (8)46 (12)35 (6)0.00219 (15)4 (2)011 (15)27 (14)NS8 (16)2 (3)0.033 (3)1 (1)NS
F2138 (14)42 (11)96 (16)17 (14)28 (16)7 (10)31 (16)3 (6)9 (14)14 (12)20 (16)
F3204 (21)76 (20)128 (22)27 (22)34 (20)21 (29)41 (21)7 (14)15 (24)16 (14)32 (25)
F4545 (56)217 (57)328 (56)60 (49)105 (62)34 (46)98 (49)32 (64)37 (59)80 (71)72 (58)
Hb (g/dL)15 ± 115 ± 1.515.1 ± 1.5NS15 ± 1.614.8 ± 1.5NS15 ± 1.615.3 ± 1.3NS14.9 ± 1.515.2 ± 1.5NS15.2 ± 1.515.3 ± 1.6NS
PMN (mL)3228 ± 13053241.4 ± 1329.63220.4 ± 1290.3NS3317.8 ± 1250.43155.1 ± 1276.1NS3499 ± 14053366 ± 1392NS3002 ± 1364.53168 ± 1182.5NS3156 ± 1385.53176.0 ± 1208.1NS
Platelets (%)161358 ± 66199162194.7 ± 65144.4160841.2 ± 66889.7NS169727.3 ± 68082159038.1 ± 72104.9NS172671 ± 69822178393 ± 66412NS156907 ± 57085147308 ± 61828NS154046 ± 62558144128.6 ± 55066NS
Prothrombin (%)94 ± 1494.7 ± 12.692.7 ± 14.8NS93.7 ± 1195.6 ± 15.3NS94.2 ± 13.090 ± 15NS95.8 ± 16.093.4 ± 11.0NS95.6 ± 0.792.6 ± 15.5NS
ALT (IU/mL)89 ± 6588.9 ± 70.189.8 ± 61.6NS80.6 ± 5592.4 ± 62.0NS80 ± 6476.0 ± 51.2NS90 ± 5387 ± 46NS93.6 ± 48.8106.3 ± 77.0NS
GGT (IU/mL)107 ± 103115.3 ± 106.1101.8 ± 101.30.05090.6 ± 86.5107.0 ± 133.8NS110 ± 14481.2 ± 70.0NS116.8 ± 79.0113.0 ± 87.5NS143.1 ± 107.0117.7 ± 93.00.040
Alkaline phosphatase (mL)95 ± 4693.6 ± 40.895.2 ± 49.6NS88.4 ± 3199 ± 57NS89.4 ± 30.089.3 ± 43.0NS99.6 ± 50.6101.8 ± 48.1NS96.7 ± 46.695.1 ± 49.1NS
Albumin (g/L)4.0 ± 0.54.18 ± 0.4284.25 ± 0.520.0404.2 ± 0.54.2 ± 0.4NS4.2 ± 0.44.4 ± 0.40.0304.1 ± 0.44.3 ± 0.50.0204.2 ± 0.44.0 ± 0.6NS
Creatinine (mg/dL)0.8 ± 0.20.79 ± 0.160.81 ± 0.2NS0.8 ± 0.20.8 ± 0.1NS0.8 ± 0.20.8 ± 0.2NS0.8 ± 0.20.8 ± 0.2NS0.7 ± 0.20.8 ± 0.22NS
HCV viral load (IU/mL)3.3 × 106± 6 × 1063.5 × 106± 5.9 × 1063.2 × 106± 5.9 × 106NS3.5 × 106± 6.2 × 1063.8 × 106± 8.9 × 106NS2.8 × 106± 3.8 × 1063 × 106± 4.1 × 106NS4.1 × 106± 9.5 × 1062.3 × 106± 2.6 × 106NS3.3 × 106± 4.7 × 1063 × 106± 4 × 106NS
Table 3 Analyses of factors related to sustained virologic response: Univariate and multivariate effectiveness analysis
ITT
mITT
Univariate
Multivariate
Univariate
Multivariate
OR95%CIP valueOR95%CIP valueOR95%CIP valueOR95%CIP value
Previous response1
R2.61.8-3.70.0001.81.09-3.10.0222.41.6-3.50.0001.91.1-3.30.019
PR0.90.6-1.3NS0.90.5-1.7NS0.90.6-1.3NS0.80.4-1.6NS
NR0.40.2-0.50.0000.60.37-0.90.3300.50.3-0.70.0000.70.39-1.1NS
IL28B2
CC3.62.2-5.90.0003.071.5-5.90.0013.21.9-5.40.0003.01.4-6.00.002
CT1.81.2-2.60.0031.61.001-2.60.0491.81.2-2.80.0041.60.9-2.7NS
Fibrosis3
Non-F42.11.6-2.80.0002.01.33-3.00.0012.261.7-3.040.0002.11.4-3.30.000
Treatment4
TVR1.71.3-2.10.0001.51.02-2.20.0381.10.9-1.5NS1.10.7-1.7NS
LogGGT0.190.12-0.30.0000.30.18-0.600.20.15-0.230.0000.40.2-0.70.004
LogViral load0.80.6-1.003NS0.70.5-0.990.0480.80.6-1.003NS0.70.4-1.1NS
Table 4 Stop treatment modified-intention-to-treatment group n (%)
All patients (n = 952)
TN (n = 298)
TE (n = 654)
All patients (n = 952)TN (n = 298)TE (n = 654)P valueBOC (n = 321)TVR (n = 631)P valueBOC (n = 112)TVR (n = 186)P valueBOC (n = 209)TVR (n = 445)P value
Stop treatment263/952 (28)97/298 (33)166/654 (25)0.02288/321 (27)175/631 (28)NS33/112 (30)64/186 (34)NS55/209 (26)111/445 (25)NS
Non-VR133/263 (51)39/97 (40)94/166 (57)0.01048/88 (54)85/175 (49)NS11/33 (33)28/64 (44)NS37/55 (67)54/111 (51)NS
Severe AE83/263 (31)31/97 (32)52/166 (31)NS22/88 (25)61/175 (35)NS10/33 (30)21/64 (33)NS12/55 (22)40/111 (36)NS
Abandonment6/263 (2)2/97 (2)4/166 (2)NS4/88 (4)2/175 (1)NS2/33 (6)0/64 (0)NS2/55 (4)2/111 (2)NS
Infection6/263 (2)2/97 (2)4/166 (2)NS4/88 (4)2/175 (1)NS2/33 (6)0/64 (0)NS2/55 (4)2/111 (2)NS
Exitus11/263 (4)8/97 (8)3/166 (2)0.0203/88 (3)8/175 (5)NS2/33 (6)6/64 (9)NS1/55 (2)2/111 (2)NS
Other14/263 (5)5/97 (5)9/166 (5)NS3/88 (3)11/175 (6)NS2/33 (6)3/64 (5)NS1/55 (2)8/111 (7)NS
Table 5 Haematological adverse events n (%)
All patientsBoceprevirTelaprevirP valueNon-F4F4P value
Neutropaenian = 943n = 360n = 583n = 369n = 505
Grade 0-1-2:707 (75)241 (67)466 (80)0289 (78)370 (73)NS
> 750 μL
Grade 3-4:236 (25)119 (33)117 (20)80 (22)135 (27)
≤ 750 μL
Thrombocytopaenian = 935n = 359n = 576n = 365n = 501
Grade 0-1-2:0.000
> 50.000 μL753 (81)293 (82)460 (80)NS337 (92)371 (74)
Grade 3-4:
≤ 50.000 μL182 (20)66 (18)116 (20)28 (8)130 (26)
Anaemian = 1036n = 397n = 639n = 411n = 539
Grade 0-1-2:943 (91)367 (92)576 (90)NS384 (93)481 (89)0.025
> 8 g/dL
Grade 3-4:93 (9)30 (8)63 (10)27 (7)58 (11)
< 8 g/dL
Transfusionn = 1036n = 397n = 6390.001n = 411n = 539NS
150 (15)39 (10)111 (17)49 (12)85 (16)
EPOn = 1033n = 396n = 6370n = 410n = 539NS
218 (21)60 (15)158 (25)75 (18)117 (22)
Onset of anaemia ( ≤ 9.5 g/dL)12 ± 815 ± 119.5 ± 6.1011.3 ± 7.211.5 ± 9NS

  • Citation: Salmerón J, Vinaixa C, Berenguer R, Pascasio JM, Sánchez Ruano JJ, Serra M&, Gila A, Diago M, Romero-Gómez M, Navarro JM, Testillano M, Fernández C, Espinosa D, Carmona I, Pons JA, Jorquera F, Rodriguez FJ, Pérez R, Montero JL, Granados R, Fernández M, Martín AB, Muñoz de Rueda P, Quiles R, Alhambra Spanish Study Group. Effectiveness and safety of first-generation protease inhibitors in clinical practice: Hepatitis C virus patients with advanced fibrosis. World J Gastroenterol 2015; 21(30): 9163-9174
  • URL: https://www.wjgnet.com/1007-9327/full/v21/i30/9163.htm
  • DOI: https://dx.doi.org/10.3748/wjg.v21.i30.9163