Table 1.
Patients’ characteristics at baseline. Differences between cirrhotic and non-cirrhotic patients are reported with p-values.
| Characteristics | All Cases | Genotypes 1 and 3 | No Ecographic Cirrhosis Diagnosis | Ecographic Cirrhosis Diagnosis | Statistical Significance (p-Value) | ||||
|---|---|---|---|---|---|---|---|---|---|
| n | 245 | 201 | 183 | 62 | / | ||||
| Age (year), median (IQR) | 51 (48–60) | 53 (48–62) | 54 (48–63) | 51.5 (41.9–60.2) | 0.125 | ||||
| Male sex, n (%) | 188 (76.7) | 156 (77.6) | 135 (73.8) | 53 (85.5) | 0.081 | ||||
| BMI (Kg/m2), median (IQR) | 26 (24–30) | 25.7 (23.5–28.5) | 26.8 (23.8–30) | 25.9 (24.4–32.8) | 0.297 | ||||
| HCV-RNA (Log IU/mL), median (IQR) | 6.5 (5.7–6.9) | 6.3 (5.8–6.7) | 3.38 (3.07–4.07) | 3.64 (3.3–4.5) | 0.033 | ||||
| Cryoglobulinemia, n (%) | 86 (35.1) | 67 (33.3) | 56 (30.6) | 30 (48.4) | 0.014 | ||||
| Insulin resistance, n (%) | 28 (11.4) | 21 (10.4) | 15 (8.2) | 13 (21) | 0.010 | ||||
| Metavir score, n (%) | F0–F3 F4 |
114 (46.5) 131 (53.5) |
F0–F3 F4 |
88 (43.8) 113 (56.2) |
F0–F3 F4 |
108 (59) 75 (41) |
F0–F3 F4 |
6 (9.7) 56 (90.3) |
<0.001 <0.001 |
| Alanine-aminotransferase (IU/mL), median (IQR) |
78.5 (58.7–95.7) | 80 (47–119) | 86 (71.5–213) | 91.5 (51–128.) | 0.295 | ||||
| Albumin (g/L), median (IQR) | 39.5 (31.7–43) | 40 (36–43) | 41 (39.5–45) | 37.5 (32–43) | <0.001 | ||||
| Hemoglobin (g/dL), median (IQR) | 14.7 (13.6–16.4) | 15.1 (14.3–16.0) | 15.2 (14.2–16.1) | 14.6 (13.2–15.7) | <0.004 | ||||
| Hematocrit (%), median (IQR) | 43.5 (40–46.8) | 44 (41.3–46.1) | 44.3 (41.7–46.6) | 41.9 (38.8–45.2) | <0.004 | ||||
| Mean corpuscular volume (fL), median (IQR) | 88.7 (84.3–93.5) | 89 (86.4–92.6) | 89.6 (86.3–92) | 88.2 (87–93) | 0.038 | ||||
| Estimated glomerular filtration rate (mL/min), median (IQR) | 104.8 (82.5–121.2) | 101 (84.4–116.1) | 99.3 (88.1–108) | 100.2 (66.9–124) | 0.638 | ||||
| Hepatocarcinoma n (%) | 4 (1.6) | 4 (2) | 0 | 4 (6.5) | NC | ||||
| Patients treated with ribavirin, n (%) | 85 (34.7) | 61 (30.3) | 67 (36.6) | 18 (29) | 0.281 | ||||
| Patients treated with daclatasvir, n (%) | 62 (25.3) | 55 (24.7) | 39 (21.3) | 23 (37.1) | 0.018 | ||||
| Patients treated with ledipasvir, n (%) | 66 (26.9) | 63 (31.3) | 42 (23) | 24 (38.7) | 0.020 | ||||
| Median GS-331007 plasma concentrations at 1 month of therapy (ng/mL), median (IQR) | 274 (198–367) | 335 (239.3–490.8) | 298.5 (198.7–459.5) | 243 (184–356) | 0.273 | ||||
| Median GS-331007 intracellular concentrations at 1 month of therapy (ng/mL), median (IQR) | 1118.8 (355.9–2794.5) | 1126.1 (416.2–2937.9) | 799.5 (10.5–2293.7) | 1126.5 (690.3–5155.8) | 0.086 | ||||
| Median GS-331007 plasma/intracellular concentrations at 1 month of therapy, median (IQR) |
0.1 (0.07–0.2) | 0.21 (0.08–0.57) | 0.22 (0.1–0.6) | 0.14 (0.05–0.2) | 0.048 | ||||
| Median daclatasvir concentrations at 1 month of therapy (ng/mL), median (IQR) | 182 (104–294) | 176.5 (93.8–277.0) | 177 (88.2v314.7) | 203 (149.5v294) | 0.475 | ||||
| Median ledipasvir concentrations at 1 month of therapy (ng/mL), median (IQR) | 232 (172–329) | 235.5 (158.5–332.3) | 227.5 (157.5–328.2) | 232 (187.5–412) | 0.560 | ||||
| Genotype, n (%) | 1 | 158 (64.5) | 1 | 158 (78.6) | 1 | 119 (65) | 1 | 39 (62.9) | 0.048 |
| 2 | 12 (4.9) | 2 | 10 (5.5) | 2 | 2 (3.2) | ||||
| 3 | 43 (17.6) | 3 | 43 (21.4) | 3 | 26 (14.2) | 3 | 17 (27.4) | ||
| 4 | 32 (13.1) | 4 | 28 (15.3) | 4 | 4 (6.5) | ||||