Introduction
Methods
Study design and population
Assessed parameters
FIB-4 and liver stiffness measurement
Statistical analysis
Results
Patient characteristics
Comparison of patients with and without information on TE
Patient characteristics | All patients (n = 210) | Underwent TE (n = 114) | Without TE (n = 96) |
P-value |
---|---|---|---|---|
Epidemiological characteristics
| ||||
Sex
| ||||
Male | 65% (136/210) | 68% (77/114) | 61% (59/96) | 0.358 |
Female | 35% (74/210) | 32% (37/114) | 39% (37/96) | |
Age
| 39.1 ± 10.8 | 41.5 ± 11.0 | 36.3 ± 10.0 | <0.001 |
Transmission
| ||||
MSM | 5% (10/210) | 7% (8/114) | 2% (2/96) | 0.233 |
IVDU | 75% (158/210) | 71% (81/114) | 80% (77/96) | |
Heterosexual | 14% (30/210) | 17% (19/114) | 12% (11/96) | |
Others | 6% (12/210) | 5% (6/114) | 6% (6/96) | |
Laboratory parameters
| ||||
Hemoglobin (g dl−1) | 13.8 (2.55) | 13.8 (2.25) | 13.6 (2.90) | 0.066 |
Platelet count (109 l−1) | 196 (96.3) | 195 (94) | 199 (102) | 0.731 |
White blood cell count (109 l−1) | 6.42 (3.35) | 6.45 (3.38) | 6.28 (3.36) | 0.900 |
Prothrombin time (%) | 95.4 ± 25.4 | 97.3 ± 25.4 | 92.9 ± 25.1 | 0.249 |
Albumin (g dl−1) | 42.7 (6) | 43.2 (5.8) | 42.0 (7.2) | <0.001 |
Creatinine (mg dl−1) | 0.82 (0.26) | 0.84 (0.24) | 0.81 (0.30) | 0.189 |
Bilirubin (mg dl−1) | 0.50 (0.4) | 0.50 (0.46) | 0.49 (0.39) | 0.524 |
AST (U l−1) | 44.0 (31) | 43.5 (27.3) | 47.0 (35.5) | 0.474 |
ALT (U l−1) | 40.5 (42.8) | 41.0 (28.5) | 38.5 (58.0) | 0.847 |
GGT (U l−1) | 76.0 (88.0) | 76.0 (86.0) | 70.5 (96.3) | 0.973 |
HIV infection parameters
| ||||
CD4+ T‑lymphocyte count (cells μl
−1
)
| 455 (368) | 511 (414) | 352 (380) | 0.001 |
HIV-RNA <50 copies ml
−1
| 63% (130/207) | 74% (84/113) | 49% (46/94) | <0.001 |
HIV-RNA <400 copies ml
−1
| 76% (157/207) | 89% (100/113) | 61% (57/94) | <0.001 |
cART
| 91% (190/210) | 95% (108/114) | 85% (82/96) | 0.022 |
PI | 57% (108/190) | 44% (48/108) | 73% (60/82) | <0.001 |
N(t)RTI | 93% (177/190) | 94% (102/108) | 92% (75/82) | 0.420 |
NNRTI | 18% (35/190) | 21% (23/108) | 15% (12/82) | 0.241 |
II/EI | 25% (47/190) | 35% (38/108) | 11% (9/82) | <0.001 |
HCV infection parameters
| ||||
HCV-RNA (log IU ml
−1
)
| 5.93 (1.40) | 6.00 (1.07) | 5.75 (2.02) | 0.214 |
HCV genotype
| 87% (183/210) | 94% (107/114) | 79% (76/96) | – |
1 | 57% (104/183) | 56% (60/107) | 58% (44/76) | 0.123 |
2 | 1% (3/183) | 0% (0/107) | 4% (3/76) | |
3 | 32% (58/183) | 32% (34/107) | 32% (24/76) | |
4 | 10% (18/183) | 12% (13/107) | 6% (5/76) | |
Liver stiffness
| ||||
F0/F1 (<7.1 kPa) | – | 42% (48/114) | – | – |
F2 (≥7.1 and <9.5 kPa) | – | 31% (35/114) | – | – |
F3 (≥9.5 and <12.5 kPa) | – | 7% (8/114) | – | – |
F4 (≥12.5 kPa) | – | 20% (23/114) | – | – |
Significant liver fibrosis (≥7.1 kPa) | – | 58% (66/114) | – | – |
Advanced liver fibrosis (≥9.5 kPa) | – | 27% (31/114) | – | – |
FIB-4 <1.45 | 52% (110/210) | 50% (57/114) | 55% (53/96) | 0.452 |
FIB-4 ≥1.45 | 48% (100/210) | 50% (57/114) | 45% (43/96) |
Comparison of patients with FIB-4 index <1.45 and FIB-4 ≥1.45
Comparison of patients with FIB-4 index <1.45 and FIB-4 ≥1.45 who underwent TE
Patient characteristics | All patients (n = 114) | FIB-4 <1.45 (n = 57) | FIB-4 ≥1.45 (n = 57) |
P-value |
---|---|---|---|---|
Epidemiological characteristics
| ||||
Sex
| ||||
Male | 68% (77/114) | 72% (41/57) | 63% (36/57) | 0.317 |
Female | 33% (37/114) | 28% (16/57) | 37% (21/57) | |
Age
| 43.5 (17.7) | 34.2 (16.1) | 49.4 (11.0) | <0.001 |
Transmission
| ||||
MSM | 7% (8/114) | 5% (3/57) | 9% (5/57) | 0.648 |
IVDU | 71% (81/114) | 72% (41/57) | 70% (40/57) | |
Heterosexual | 17% (19/114) | 19% (11/57) | 14% (8/57) | |
Others | 5% (6/114) | 4% (2/57) | 7% (4/57) | |
Laboratory parameters
| ||||
Hemoglobin (g dl−1) | 13.8 (2.85) | 13.9 (2.32) | 13.8 (2.62) | 0.375 |
Platelet count (G l−1) | 200 ± 74.62 | 241 ± 63.8 | 158 ± 60.7 | <0.001 |
White blood cell count (G l−1) | 6.54 ± 2.67 | 7.28 ± 2.11 | 5.79 ± 2.97 | 0.003 |
Prothrombin time (%) | 93.0 (33.5) | 96.0 (37.5) | 91.5 (39.3) | 0.167 |
Albumin (g dl−1) | 42.9 ± 4.66 | 43.5 ± 4.41 | 42.3 ± 4.86 | 0.166 |
Creatinine (mg dl−1) | 0.84 (0.24) | 0.80 (0.24) | 0.88 (0.23) | 0.205 |
Bilirubin (mg dl−1) | 0.50 (0.46) | 0.43 (0.34) | 0.53 (0.46) | 0.011 |
AST (U l−1) | 43.5 (27.3) | 37.0 (21.0) | 51.0 (31.0) | <0.001 |
ALT (U l−1) | 41.0 (28.5) | 40.0 (22.5) | 44.0 (39.5) | 0.451 |
GGT (U l−1) | 76.0 (86.0) | 62.5 (75.8) | 90.0 (80.0) | 0.002 |
HIV infection parameters
| ||||
CD4+ T‑lymphocyte count (cells μl
−1
)
| 523 ± 272 | 628 ± 279 | 421 ± 224 | <0.001 |
HIV-RNA <50 copies ml
−1
| 74% (84/113) | 75% (42/56) | 74% (42/57) | 0.873 |
HIV-RNA <400 copies ml
−1
| 89% (100/113) | 86% (48/56) | 91% (78/57) | 0.358 |
cART
| 95% (108/114) | 93% (53/57) | 97% (55/57) | 0.679 |
PI | 44% (48/108) | 45% (24/53) | 44% (24/55) | 0.863 |
N(t)RTI | 94% (102/108) | 96% (51/53) | 93% (51/55) | 0.679 |
NNRTI | 21% (23/108) | 21% (11/53) | 22% (12/55) | 0.893 |
II/EI | 35% (38/108) | 36% (19/53) | 35% (19/55) | 0.887 |
HCV infection parameters
| ||||
HCV-RNA (log IU ml
−1
)
| 6.00 (1.07) | 5.80 (1.23) | 6.24 (0.99) | 0.72 |
HCV genotype
| 94% (107/114) | 93% (53/57) | 95% (54/57) | – |
1 | 56% (60/107) | 58% (31/53) | 54% (29/54) | 0.145 |
2 | 0% (0/107) | 0% (0/53) | 0% (0/54) | |
3 | 32% (34/107) | 25% (13/53) | 39% (21/54) | |
4 | 12% (13/107) | 17% (9/53) | 7% (4/54) | |
Liver stiffness
| ||||
F0/F1 (<7.1 kPa) | 42% (48/114) | 60% (34/57) | 25% (14/57) | <0.001 |
F2 (≥7.1 and <9.5 kPa) | 31% (35/114) | 23% (13/57) | 39% (22/57) | 0.068 |
F3 (≥9.5 and <12.5 kPa) | 7% (8/114) | 7% (4/57) | 7% (4/57) | 1 |
F4 (≥12.5 kPa) | 20% (23/114) | 11% (6/57) | 30% (17/57) | 0.010 |
Significant liver fibrosis (≥7.1 kPa) | 58% (66/114) | 40% (23/57) | 75% (43/57) | <0.001 |
Advanced liver fibrosis (≥9.5 kPa) | 27% (31/114) | 18% (10/57) | 37% (21/57) | 0.021 |
Treatment initiation
Patient characteristics | All patients (n = 114) | No treatment (n = 72) | Treatment (n = 42) |
P-value |
---|---|---|---|---|
Epidemiological characteristics
| ||||
Sex
| ||||
Male | 68% (77/114) | 75% (54/72) | 55% (23/42) | 0.026 |
Female | 33% (37/114) | 25% (18/72) | 45% (19/42) | |
Age
| 43.5 (17.7) | 41.0 (16.3) | 46.75 (16.9) | 0.078 |
Transmission
| ||||
MSM | 7% (8/114) | 6% (4/72) | 10% (4/42) | 0.468 |
IVDU | 71% (81/114) | 74% (53/72) | 67% (28/42) | |
Heterosexual | 17% (19/114) | 14% (10/72) | 21% (9/42) | |
Others | 5% (6/114) | 7% (5/72) | 2% (1/42) | |
Laboratory parameters
| ||||
Hemoglobin (g dl−1) | 13.8 (2.85) | 13.9 (2.18) | 13.6 (3.17) | 0.106 |
Platelet count (G l−1) | 200 ± 74.6 | 206 ± 66 | 189 ± 87.2 | 0.232 |
White blood cell count (G l−1) | 6.54 ± 2.67 | 6.76 ± 2.67 | 6.15 ± 2.66 | 0.238 |
Prothrombin time (%) | 93 (33.5) | 89 (32.0) | 98 (43.5) | 0.589 |
Albumin (g dl−1) | 42.91 ± 4.66 | 43.35 ± 4.99 | 42.14 ± 3.95 | 0.184 |
Creatinine (mg dl−1) | 0.84 (0.24) | 0.81 (0.18) | 0.90 (0.35) | 0.102 |
Bilirubin (mg dl−1) | 0.50 (0.46) | 0.50 (0.33) | 0.52 (0.58) | 0.920 |
AST (U l−1) | 43.5 (27.3) | 47.0 (33.0) | 39.5 (25.3) | 0.203 |
ALT (U l−1) | 41.0 (28.5) | 45.0 (36.8) | 37.5 (24.8) | 0.102 |
GGT (U l−1) | 76.0 (86.0) | 77.5 (86.3) | 72.0 (83.0) | 0.960 |
HIV infection parameters
| ||||
CD4+ T‑lymphocyte count (cells μl
−1
)
| 522.53 ± 272.21 | 514.76 ± 256.03 | 535.98 ± 301.02 | 0.693 |
HIV-RNA <50 copies ml
−1
| 74% (84/113) | 72% (51/71) | 79% (33/42) | 0.428 |
HIV-RNA <400 copies ml
−1
| 89% (100/113) | 86% (61/71) | 93% (39/42) | 0.264 |
cART
| 95% (108/114) | 92% (66/72) | 100% (42/42) | 0.084 |
PI | 44% (48/108) | 53% (35/66) | 31% (13/42) | 0.024 |
N(t)RTI | 94% (102/108) | 96% (63/66) | 93% (39/42) | 0.676 |
NNRTI | 21% (23/108) | 23% (15/66) | 19% (8/42) | 0.649 |
II/EI | 35% (38/108) | 23% (15/66) | 55% (23/42) | 0.001 |
HCV infection parameters
| ||||
HCV-RNA (log IU ml
−1
)
| 6.0 (1.07) | 5.97 (1.05) | 6.11 (1.12) | 0.645 |
HCV genotype
| 94% (107/114) | 90% (65/72) | 100% (42/42) | – |
1 | 56% (60/107) | 57% (37/65) | 55% (23/42) | 0.687 |
2 | 0% (0/107) | 0% (0/65) | 0% (0/42) | |
3 | 32% (34/107) | 29% (19/65) | 36% (15/42) | |
4 | 12% (13/107) | 14% (9/65) | 9% (4/42) | |
FIB-4
| ||||
<1.45
| 50% (57/114) | 54% (39/72) | 43% (18/42) | 0.244 |
≥1.45
| 50% (57/114) | 46% (33/72) | 57% (24/42) | 0.244 |
Liver stiffness
| ||||
F0/F1 (<7.1 kPa) | 42% (48/114) | 60% (43/72) | 12% (5/42) | 0.001 |
F2 (≥7.1 and <9.5 kPa) | 31% (35/114) | 24% (17/72) | 43% (18/42) | 0.032 |
F3 (≥9.5 and <12.5 kPa) | 7% (8/114) | 3% (2/72) | 14% (6/42) | 0.028 |
F4 (≥12.5 kPa) | 20% (23/114) | 14% (10/72) | 31% (13/42) | 0.029 |
Significant liver fibrosis (≥7.1 kPa) | 58% (66/114) | 40% (29/72) | 88% (37/42) | 0.001 |
Advanced liver fibrosis (≥9.5 kPa) | 27% (31/114) | 17% (12/72) | 45% (19/42) | 0.001 |
-
Sofosbuvir (SOF)/ribavirin (RBV) – 5% (2/42)
-
SOF/daclatasvir (DCV) – 55% (23/42)
-
SOF/ledipasvir (LDV) – 29% (12/42)
-
Ombitasvir/paritaprevir/dasabuvir (3D) ± RBV – 12% (5/42)