Table 1 Baseline features of the study population
Patients (N = 144) | Group A (N = 101) | Group B (N = 43) | p-value | |
|---|---|---|---|---|
Sex, males.n(%) | 71 (49.3%) | 42 (41.6%) | 29 (67.4%) | 0.006 |
Age, years, mean (SD) | 60 ± 13,5 | 64.9 ± 11.7 | 50.6 ± 12.1 | < 0.001 |
Risk Factorsn(%) | ||||
IDU | 37 (25.7%) | 17 (16.9%) | 20 (46.5%) | < 0.001 |
Heterosexual | 10 (7.0%) | 8 (7.9%) | 2 (4.7%) | 0.720 |
MSM | 1 (0.7%) | 0 | 1 (2.3%) | 0.290 |
Nosocomial | 38 (26.4%) | 31 (30.6%) | 7 (16.3%) | 0.150 |
Unknown | 58 (40.2%) | 45 (44.6%) | 13 (30.2%) | 0.138 |
HCV Genotypesn(%) | ||||
1a | 32 (22.2%) | 17 (16.8%) | 15 (34.9%) | 0.020 |
1b | 51 (35.4%) | 44 (43.6%) | 7 (16.3%) | 0.002 |
2 | 37 (25.7%) | 31 (30.7%) | 6 (13.9%) | 0.038 |
3 | 18 (12.5%) | 5 (4.9%) | 13 (30.2%) | < 0.001 |
4 | 6 (4.2%) | 4 (4%) | 2 (4.7%) | 1.000 |
Duration of HCV infection, years (range) | 18 (10–25.5) | 20 (11–26) | 17 (9–23) | 0.199 |
Log 10 HCV-RNA, IU/mL, median (range) | 6.00 (5.48–6.52) | 5.9 (5.6–6.5) | 6.2 (5.6–6.6) | 0.095 |
Liver stiffness, Kpa, mean (SD) | 10,8 ± 9,9 | 11.5 ± 11.2 | 9.1 ± 5.2 | 0.518 |
Previous failure,n(%) | 32 (22.2%) | 29 (28.7%) | 3 (7.0%) | 0.004 |
INF-based tx | 31 | 28 | 3 | |
DAAs-based tx | 1 | 1 | 0 | |
Fibrosis stage,n(%) | ||||
F0-F2 | 78 (54.1%) | 51 (50.5%) | 27 (62.8%) | 0.203 |
F3 | 24 (16.7%) | 19 (18.8%) | 5 (11.6%) | 0.338 |
F4 | 42 (29.2%) | 31 (30.7%) | 11 (25.6%) | 0.689 |
FIB-4 score median (range) | 2.02 (1.40–3.35) | 2.2 (1.5–3.4) | 1.6 (1.2–2.9) | 0.009 |
APRI score median (range) | 0.40 (0.60–1.22) | 0.6 (0.4–1.2) | 0.7 (0.4–1.2) | 0.315 |
MELD score median (range) | 7 (6.5–8.5) | 7.0 (6.0–8.0) | 7.0 (6.0–7-0) | 0.923 |
Child-Pugh classn(%) | ||||
A | 142 (98.6%) | 100 (99.1%) | 42 (97.7%) | 0.510 |
B | 2 (1.4%) | 1 (0.99%) | 1 (2.3%) | 0.510 |
Cirrhosis,n(%) | 46 (31.9%) | 34 (33.66%) | 12 (27.9%) | 0.562 |
Oesophageal varices or portal hypertension,n(%) | 15 (10.4%) | 11 (10.89%) | 4 (9.3%) | 1.000 |
Type of HCV therapyn(%) | ||||
SOF + RBV | 7 (4.8%) | 6 (5.9%) | 1 (2.3%) | 0.670 |
SOF + SMV ± RBV | 5 (3.5%) | 4 (3.9%) | 1 (2.3%) | 1.000 |
SOF + LDV ± RBV | 21 (14.6%) | 15 (14.9%) | 6 (13.9%) | 1.000 |
SOF + DCV ± RBV | 13 (9.0%) | 10 (10%) | 3 (7%) | 0.750 |
OMB + PTV/r + DAS ± RBV | 15 (10.4%) | 15 (14.9%) | 0 | 0.006 |
OMB + PTV/r + RBV | 2 (1.4%) | 2 (1.9%) | 0 | 1.000 |
SOF + VEL ± RBV | 37 (25.7%) | 15 (14.9%) | 22 (51.2%) | < 0.001 |
GLE + PIB | 24 (16.7%) | 17 (16.8%) | 7 (16.3%) | 1.000 |
GRZ + EBR ± RBV | 20 (13.9%) | 17 (16.8%) | 3 (7%) | 0.186 |
Duration of therapyn(%) | ||||
8w | 20 (13.9%) | 15 (14.9%) | 5 (11.6%) | 0.794 |
12w | 101 (70.1%) | 67 (66.3%) | 34 (79.1%) | 0.164 |
16w | 6 (4.2%) | 4 (3.9%) | 2 (4.65%) | 1.000 |
24w | 17 (11.8%) | 15 (14.9%) | 2 (4.65%) | 0.097 |
Addition of RBVn(%) | 33 (22.9%) | 24 (23.74%) | 9 (20.9%) | 0.829 |
ALT, UI/L, median (range) | 50 (30–80) | 47 (26.5–78.5) | 58 (43–93) | 0.029 |
Total bilirubin, mg/dL, median (range) | 0.62 (0.45–0.85) | 0.65 (0.47–0.82) | 0.60 (0.40–0.87) | 0.323 |
Serum creatinine, mg/dL, median (range) | 0.78 (0.61–0.93) | 0.78 (0.60–0.95) | 0.78 (0.62–0.90) | 0.795 |
Platelets (×10^9/L), median (range) | 183.5 (140.5–217.5) | 184 (145–219) | 182 (137–214) | 0.936 |
Albumin, mg/dL, median (range) | 4.0 (3.7–4.2) | 4.0 (4.7–4.2) | 4.0 (3.8–4.1) | 0.976 |
Body mass index, median (range) | 25.3 (23.3–28.7) | 25.5 (23.8–29.1) | 25.1 (22.4–27.4) | 0.936 |
Patients with at least 1 other comorbidity, n (%) | 101 (70.10%) | 79 (78.2%) | 22 (51.2%) | 0.002 |
Diabetes,n(%) | 20 (13.9%) | 16 (15.8%) | 4 (9.3%) | 0.431 |
Hypertension,n(%) | 61 (42.4%) | 53 (52.5%) | 8 (18.6%) | < 0.001 |
HBsAg positive,n(%) | 2 (1.4%) | 0 | 2 (4.7%) | 0.087 |
HIV infected,n(%) | 19 (13.2%) | 9 (8.9%) | 10 (23.3%) | 0.030 |
N aviremic pts on ART, n (%) | 19 (100%) | 9 (100%) | 10 (100%) | 1.000 |
CD4+(cells/μl) median (range) | 85 (42–171) | 98 (50–171) | 83.5 (42–186.5) | 0.903 |
CDC-C Stage n (%) | 7 (4.8%) | 4 (3.9%) | 3 (7%) | 0.650 |