Table 1 Baseline demographic, HIV, HCV, laboratory and fibrosis parameters in men and women.
Men (n = 264) | Women (n = 110) | P value | |
|---|---|---|---|
Age (years) | 50.46 (49.61–51.32) | 51.63 (49.92–53.33) | 0.2 |
HCV-related parameters | |||
HCV viral load (Log copies/mL) | 5.865 (5.708–6.022) | 5.969 (5.743–6.195) | 0.5 |
HCV genotype | |||
1 | 145 (75.9%) | 60 (75.0%) | 0.9 |
2 | 1 (0.5%) | 1 (1.3%) | |
3 | 28 (14.7%) | 28 (14.7%) | |
4 | 17 (8.9%) | 17 (8.9%) | |
HCV treatment | |||
Time on DAA therapy (weeks) | 13.06 (12.56–13.57) | 13.16 (12.34–13.99) | 0.8 |
Sofosbuvir | |||
Yes | 229 (86.7%) | 96 (87.3%) | 0.9 |
No | 35 (13.3%) | 14 (12.7%) | |
Drug combinations | |||
Sofosb + Velpatasvir | 104 (39.4%) | 45 (40.9%) | 0.9 |
Sofosb + Ledipasvir | 101 (38.3%) | 40 (36.4%) | |
Other combinations | 59 (22.3%) | 25 (22.7%) | |
HCV eradicated | |||
Yes | 254 (98.1%) | 99.1(%) | 0.7 |
No | 5 (1.9%) | 1 (0.9%) | |
HIV-related parameters | |||
HIV co-infection | |||
Yes | 148 (56.1%) | 66 (60.0%) | 0.5 |
No | 116 (43.9%) | 44 (40.0%) | |
Undetectable HIV viral load* | |||
Yes | 90 (85.7%) | 48 (69.8%) | 0.02 |
No | 39 (14.3%) | 8 (30.2%) | |
HIV viral load (if detectable)* (log copies/mL) | 2.587 (2.107–3.068) | 3.038 (1.621–4.456) | 0.4 |
CD4 lymphocytes* (cells/μL) | 592.0 (533.3–650.8) | 669.2 (585.1–753.2) | 0.15 |
Laboratory blood parameters at baseline | |||
Hemoglobin (g/dL) | 15.04 (14.83–15.24)) | 13.98 (13.74–14.23) | < 0.0001 |
Leukocytes (cells/μL) | 6766 (6453–7079) | 6251 (5877–6626) | 0.06 |
Platelets (× 1000/μL) | 172.2 (164.0–180.3) | 192.5 (177.8–207.2) | 0.01 |
Aspartate aminotransferase (U/L) | 70.0 (63.4–76.6) | 67.2 (51.8–82.5) | 0.7 |
Alanine aminotransferase (U/L) | 81.3 (72.2–90.4) | 66.3 (53.6–79.0) | 0.07 |
Alkaline phosphatase (U/L) | 90.8 (86.2–95.5) | 90.5 (84.5–96.5) | 0.9 |
γ-Glutamyl transferase (U/L) | 170.1 (124.4–215.9) | 88.5 (60.4–116.6) | 0.03 |
Total bilirubin (mg/dL) | 0.996 (0.931–1.061) | 0.873 (0.802–0.943) | 0.03 |
Total proteins (g/dL) | 7.638 (7.509–7.667) | 7.572 (7.437–7.707) | 0.5 |
Albumin (g/dL) | 4.301 (4.240–4.362) | 4.231 (4.146–4.317) | 0.2 |
Fibrinogen (mg/dL) | 367.6 (350.5–384.7) | 365.4 (340.3–390.6) | 0.9 |
INR | 1.077 (1.045–1.110) | 1.038 (1.008–1.069) | 0.15 |
Glucose (mg/dL) | 106.8 (101.4–112.3) | 100.1 (92.2–108.0) | 0.17 |
Urea (mg/dL) | 35.5 (33.9–37.1) | 33.2 (31.1–35.2) | 0.09 |
Creatinine (mg/dL) | 0.882 (0.858–0.906) | 0.772 (0.736–0.808) | < 0.0001 |
Total cholesterol (mg/dL) | 164.7 (159.8–169.6) | 180.8 (172.4–189.2) | 0.0007 |
HDL cholesterol (mg/dL) | 46.0 (43.7–48.3) | 57.8 (53.7–61.9) | < 0.0001 |
LDL cholesterol (mg/dL) | 93.8 (88.9–98.8) | 98.2 (89.9–106.5) | 0.4 |
Fibrosis parameters at baseline | |||
Transient elastometry (kPa) | 11.21 (10.26–12.24) | 8.77 (7.71–9.97) | 0.003 |
APRI index | 1.04 (0.93–1.17) | 0.79 (0.65–0.96) | 0.01 |
Forns index | 6.47 (6.19–6.75) | 5.44 (5.03–5.88) | < 0.0001 |
FIB-4 index | 2.21 (2.01–2.43) | 1.90 (1.64–2.20) | 0.08 |
Stage of liver fibrosis (measured by TE) | |||
F0–F1 | 78 (29.7%) | 47 (42.7%) | 0.02 |
F2 | 50 (19.0%) | 26 (23.6%) | |
F3 | 48 (18.3%) | 13 (11.8%) | |
F4 | 87 (33.1%) | 24 (21.8%) | |
Change in fibrosis parameters after 24 months | |||
Absolute change in TE‡ (kPa) | − 6.09 (− 8.02, − 4.16) | − 3.05 (− 4.45, − 1.64) | 0.07 |
Absolute change in APRI*‡ | − 1.15 (− 1.45, − 0.85) | − 1.08 (− 1.71, − 0.45) | 0.8 |
Absolute change in Forns‡ | − 1.37 (− 1.58, − 1.16) | − 1.19 (− 1.52 to 0.86) | 0.4 |
Absolute change in FIB-4‡ | − 1.16 (− 1.48, − 0.83) | − 0.67 (− 1.36, − 0.02) | 0.16 |
Relative improvement in TE§ (%) | 36.0% (40.9–30.7) | 27.5% (35.3–18.8) | 0.1 |
Relative improvement in APRI§ (%) | 61.4% (66.5–55.6) | 59.1% (69.0–45.9) | 0.7 |
Relative improvement in Forns§ (%) | 21.2% (24.5–17.8) | 21.2% (26.6–15.5) | 1 |
Relative improvement in FIB-4§ (%) | 32.2% (37.4–26.6) | 23.2% (35.5–8.5) | 0.14 |
