Copyright
©2014 Baishideng Publishing Group Inc.
World J Hepatol. Sep 27, 2014; 6(9): 660-669
Published online Sep 27, 2014. doi: 10.4254/wjh.v6.i9.660
Published online Sep 27, 2014. doi: 10.4254/wjh.v6.i9.660
Table 1 Demographic and baseline characteristics n (%)
Triple therapy: Peg-IFNα2a + Ribavirin +Protease inhibitor, | 125 |
Telaprevir | 90 (72) |
Boceprevir | 35 (28) |
Ribavirin dosage mg/kg, mean (SD) | 14.4 (2.1) |
Age, yr, mean (SD) | 56.2 (9.7) |
Gender | |
Male | 81 (64.8) |
Female | 44 (35.2) |
HCV genotype | |
1a | 39 (31.2) |
1b | 71 (56.8) |
Undetermined subtype 1 | 15 (12) |
IL28B genotype (rs12979860) | |
C/T or T/T | 88 (84.6) |
Viral load, mean (log10 IU/ mL) | 6.3 (0.7) |
Prior response to anti-viral therapy | |
Relapsers | 46 (37.1) |
Null-responders | 78 (62.9) |
Liver fibrosis grade | |
Metavir F3 | 35 (28) |
Metavir F4 | 90 (72) |
Child-Pugh score | |
A | 123 (98.4) |
B | 1 (0.8) |
C | 1 (0.8) |
Liver stiffness values (kPa) | |
Mean (SD) | 17.5 (10.3) |
Median (IQR) | 14.3 (10.4-20.6) |
Oesophageal varices | |
None | 92 (75.4) |
Grade 1 | 16 (13.1) |
Grade 2 or 3 | 14 (11.5) |
Mean hemoglobin level (g/dL, mean (SD) | 15.1 (1.6) |
Mean platelet count × 103/mm3, mean (SD) | 165.69 (64.9) |
Mean neutrophil count × 103/mm3, mean (SD) | 3.4 (1.2) |
Table 2 Factors associated with sustained virological response n (%)
No sustained virological responsen = 49 | Sustained virological responsen = 73 | P valueunivariate analysis | P valuemultivariate analysisOR(95%CI) | |
Protease inhibitor | ||||
Telaprevir | 30 (34.1) | 58 (65.9) | 0.0276 | NS1 |
Boceprevir | 19 (55.9) | 15 (44.1) | ||
Gender | ||||
Male | 27 (34.2) | 52 (65.8) | 0.0675 | NS1 |
Female | 22 (51.2) | 21 (48.8) | ||
HCV genotype 1 subtype | ||||
1a | 17 (45.9) | 20 (54.1) | 0.8051 | - |
1b | 26 (37.1) | 44 (62.9) | ||
IL28B genotype, rs12979860, n (%) | ||||
C/C | 4 (25) | 12 (75) | 0.4420 | - |
C/T or T/T | 40 (45.5) | 48 (54.5) | ||
Response to prior therapy | 0.008 | |||
Null-responders | 40 (52.6) | 36 (47.4) | 0.0004 | 1.0 |
Relapsers | 9 (20) | 36 (80) | 3.9 (1.4-10.6) | |
Grade of liver fibrosis | ||||
Metavir F3 | 11 (31.4) | 24 (68.6) | 0.2118 | - |
Metavir F4 | 38 (43.7) | 49 (56.3) | ||
Liver stiffness value (kPa) | ||||
Median, kPa (IQR) | 17.3 (11.5-28.8) | 13.9 (9.4-19.7) | 0.0296 | 0.001 |
< 21.3 kPa | 21 (30) | 49 (70) | 0.002 | 8.2 (2.3-29.5) |
≥ 21.3 kPa | 14 (66.7) | 7 (33.3) | 1 | |
Rapid virological response | 18 (23.7) | 58 (76.3) | ≤ 0.0001 | ≤ 0.001 |
No rapid virological response | 26 (68.4) | 12 (31.6) | 6.9 (2.6-18.2) 1.0 | |
Decrease of ribavirin dosage | 18 (37.5) | 30 (62.5) | 0.6287 | - |
No decrease of ribavirin dosage | 31 (41.9) | 43 (58.1) |
Table 3 Safety profile of triple therapy: Severe adverse events grade 3 or 4 n (%)
Overall patients(n = 124) | Telaprevir(n = 89) | Boceprevir(n = 35) | P valueunivariateanalysis | |
Premature discontinuation due to SAE | 11 (8) | 10 (11.2) | 1 (2.9) | 0.178 |
Death | 0 | 0 | 0 | - |
Severe adverse events grade 3/4 | 63 (50.8) | 46 (51.7) | 17 (48.6) | 0.75 |
Infection | 4 (3.2) | 3 (3.4) | 1 (2.9) | 1 |
Liver decompensation | 2 (1.6) | 2 (2.2) | 0 | 1 |
Fatigue | 3 (2.4) | 3 (3.4) | 0 | 0.558 |
Skin rash | 2 (1.6) | 2 (2.2) | 0 | 1 |
Kidney failure | 1 (0.8) | 1 (1.1) | 0 | 1 |
Digestive adverse events | 1 (0.8) | 1 (1.1) | 0 | 1 |
Thromboembolic events | 1 (0.8) | 1 (1.1) | 0 | 1 |
Anemia | 18 (14.5) | 16 (18) | 2 (5.7) | 0.081 |
Neutropenia | 21 (16.8) | 14 (15.7) | 7 (20) | 0.568 |
Thrombocytopenia | 42 (33.6) | 32 (36) | 10 (28.6) | 0.434 |
Erythropoietin use1 | 65 (52) | 45 (90) | 20 (57.1) | 0.473 |
Blood transfusion1 | 17 (13.6) | 15 (16.7) | 2 (5.7) | 0.149 |
Table 4 Factors associated with the occurrence of severe adverse events of grade 3 or 4 n (%)
Severeadverse eventsn = 63 | No severeadverse eventsn = 61 | P valueunivariate analysis | P valuemultivariate AnalysisOR (95%CI) | |
Protease inhibitor | ||||
Telaprevir | 47 (51.7) | 43 (48.3) | 0.7548 | - |
Boceprevir | 17 (48.6) | 18 (51.4) | ||
Genre | 0.037 | |||
Male | 36 (44.4) | 45 (55.6) | 1.0 | |
Female | 27 (62.8) | 16 (37.2) | 0.0518 | 2.4 (1.1-5.6) |
Liver fibrosis | ||||
Metavir F3 | 15 (42.9) | 20 (57.1) | 0.2667 | - |
MetavirF4 | 48 (53.9) | 41 (46.1) | ||
Platelets | ||||
Mean × 10³/mm³ (SD) | 143.5 (65.43) | 191.1 (54.9) | ≤ 0.0001 | ≤ 0.001 |
< 150 × 10³/mm³ | 34 (75.6) | 11 (24.4) | 0.0001 | 1.0 |
≥ 150 × 10³/mm³ | 27 (37.5) | 45 (62.5) | 5.3 (2.3-12.4) | |
Albumin, mean, g/L, (SD) | 39.4 (4.9) | 42 (54.9) | 0.0196 | - |
Bilirubin, median μM/L, (IQR) | 13.1 (9.1-19.1) | 10.8 (8-13.5) | 0.0359 | - |
- Citation: Bonnet D, Guivarch M, Bérard E, Combis JM, Remy AJ, Glibert A, Payen JL, Metivier S, Barange K, Desmorat H, Palacin A, Nicot F, Abravanel F, Alric L. Telaprevir- and boceprevir-based tritherapies in real practice for F3-F4 pretreated hepatitis C virus patients. World J Hepatol 2014; 6(9): 660-669
- URL: https://www.wjgnet.com/1948-5182/full/v6/i9/660.htm
- DOI: https://dx.doi.org/10.4254/wjh.v6.i9.660