Table 1.
Baseline demographic and clinical characteristics of the study patients
| Characteristic | Global (n = 2561) | G-1a (n = 572) | G-1b (n = 329) | G-2 (n = 28) | G-3 (n = 413) | G-4 (n = 565) |
|---|---|---|---|---|---|---|
| Age, yearsa | 49 (45–52) | 48 (44–53) | 49 (45–52) | 31 (26–57) | 49 (45–52) | 48 (45–52) |
| Age range, no. (%) | ||||||
| <40 | 133 (5.3) | 35 (6.1) | 18 (5.4) | 2 (7.1) | 18 (4.3) | 32 (5.6) |
| 41–50 | 1352 (52.8) | 304 (53.1) | 149 (45.2) | 11 (39.2) | 207 (50.1) | 317 (56.1) |
| 51–60 | 1017 (39.7) | 220 (38.4) | 148 (44.9) | 14 (50) | 170 (41.1) | 206 (36.4) |
| >60 | 59 (2.2) | 13 (2.4) | 14 (4.5) | 1 (3.7) | 17 (4.5) | 10 (1.9) |
| Gender, no. (%) | ||||||
| Male | 2118 (82.7) | 471 (82.3) | 283 (86) | 23 (82.1) | 327 (79.1) | 454 (80.3) |
| Female | 443 (17.3) | 101 (17.7) | 46 (14) | 5 (17.9) | 86 (20.9) | 111 (19.7) |
| Risk group for HCV infection, no. (%) | ||||||
| IDU | 2248 (87.7) | 499 (87.2) | 279 (84.8) | 24 (85.7) | 349 (84.5) | 495 (87.6) |
| Heterosexual | 219 (8.5) | 42 (7.5) | 32 (9.7) | 3 (10.7) | 49 (11.8) | 54 (9.5) |
| Homosexual | 75 (2.9) | 21 (3.6) | 14 (4.2) | 1 (3.6) | 12 (2.9) | 12 (2.1) |
| Blood derived | 19 (0.9) | 9 (1.7) | 3 (1.3) | 0 | 1 (0.8) | 2 (0.8) |
| HAART, no. (%) | ||||||
| Receiving | 2468 (96.2) | 556 (97.2) | 317 (96.3) | 27 (96.4) | 394 (95.3) | 542 (95.9) |
| Non-receiving | 93 (3.8) | 16 (2.8) | 12 (3.7) | 1 (3.6) | 19 (4.7) | 23 (4.1) |
| HIV viral load, no. (%)b | ||||||
| Undetectable | 2370 (92.5) | 527 (92.1) | 301 (91.4) | 27 (96.4) | 383 (92.7) | 521 (92.2) |
| Detectable | 191 (7.5) | 38 (7.9) | 21 (8.6) | 1 (3.6) | 26 (7.3) | 42 (7.8) |
| CD4+ total count, cells/mLa | 486 (308–697) | 470 (328–702) | 502 (304–694) | 400 (278–699) | 452 (321–693) | 513 (394–721) |
| CD4+ cell grading, no. (%) | ||||||
| <200 cells/mL | 339 (13.2) | 83 (14.6) | 31 (9.5) | 1 (3.6) | 62 (15.1) | 64 (11.4) |
| ≥200 cells/mL | 2222 (86.8) | 489 (85.4) | 298 (90.5) | 27 (96.4) | 351 (84.9) | 501 (88.6) |
| HCV genotype, no. (%) | ||||||
| Genotype 1 | 1490 (58.1) | – | – | – | – | – |
| Genotype 2 | 28 (1.1) | – | – | – | – | – |
| Genotype 3 | 413 (16.1) | – | – | – | – | – |
| Genotype 4 | 565 (22.1) | – | – | – | – | – |
| Non-genotyped | 65 (2.6) | – | – | – | – | – |
| HCV genotype 1 subtype, no. (%) | ||||||
| Genotype 1a | 572 (38.3) | – | – | – | – | – |
| Genotype 1b | 329 (22.1) | – | – | – | – | – |
| Other genotypec | 41 (2.7) | – | – | – | – | – |
| Non-subtyped | 552 (36.9) | – | – | – | – | – |
| Liver fibrosis stage, no. (%)d | ||||||
| F0–F1 | 636 (24.8) | 147 (25.7) | 79 (24) | 8 (28.5) | 89 (21.5) | 145 (25.6) |
| F2 | 716 (27.9) | 180 (31.4) | 103 (31.3) | 6 (21.4) | 83 (20.1) | 177 (31.3) |
| F3 | 428 (16.7) | 81 (14.1) | 52 (15.8) | 5 (17.8) | 81 (19.6) | 95 (16.8) |
| F4 | 538 (21) | 121 (21.1) | 66 (20.1) | 4 (14.2) | 101 (24.4) | 87 (15.5) |
| Not staged | 243 (9.6) | 43 (7.5) | 29 (8.8) | 5 (17.5) | 59 (14.4) | 61 (10.8) |
| Child-PT, no. (%) | ||||||
| A | 345 (65.8) | 74 (61.5) | 43 (65.1) | 4 (100) | 65 (64.3) | 49 (56.3) |
| B | 53 (9.8) | 10 (8.2) | 4 (6) | 0 | 14 (13.8) | 10 (11.4) |
| C | 17 (3.1) | 8 (6.6) | 1 (1.5) | 0 | 1 (1.2) | 3 (2.5) |
| Not available | 123 (21.3) | 29 (23.7) | 18 (27.4) | 0 | 21 (20.7) | 26 (29.8) |
| HCV therapy previous experience, no. (%) | ||||||
| Naïve | 1743 (68.05) | 379 (66.2) | 207 (62.9) | 22 (78.5) | 269 (65.1) | 384 (67.9) |
| Non-responder to Peg-IFN/RBV | 743 (29.01) | 167 (29.1) | 102 (31) | 6 (21.5) | 143 (34.6) | 178 (31.5) |
| Non-responder to DAA-based regimen | 75 (2.94) | 26 (4.7) | 20 (6.1) | 0 | 1 (0.3) | 3 (0.6) |
| Previous response to Peg-IFN/RBV, no. (%) | ||||||
| Non-responders | 451 (60.7) | 93 (55.6) | 53 (51.9) | 6 (100) | 35 (24.4) | 130 (73) |
| Viral relapse | 123 (16.5) | 21 (12.5) | 19 (18.6) | 0 | 63 (44) | 25 (14) |
| Therapy withdrawne | 169 (22.8) | 53 (31.9) | 30 (29.5) | 0 | 45 (31.6) | 23 (13) |
| Previous response to DAA-based regimen, no. (%) | ||||||
| Non-responders | 46 (61.3) | 5 (19.2) | 7 (37.1) | 0 | 0 | 2 (66.6) |
| Viral relapse | 13 (17.3) | 17 (65.3) | 11 (54.2) | 0 | 1 (100) | 0 |
| Therapy withdrawne | 16 (21.4) | 4 (15,5) | 2 (18.7) | 0 | 0 | 1 (33.4) |
| IFN-based therapy contraindication, no. (%)f | 198 (7.7) | 41 (7.1) | 26 (7.9) | 1 (3.5) | 43 (10.4) | 33 (5.8) |
| Alcohol abuse, no. (%)g | 55 (2.1) | 16 (2.7) | 6 (1.8) | 1 (3.5) | 7 (1.6) | 8 (1.4) |
Number of cases (no.); percentage (%); genotype 1a (G-1a); genotype 1b (G-1b); genotype 2 (G-2); genotype 3 (G-3); genotype 4 (G-4); hepatitis C virus (HCV); injecting drug user (IDU); highly active antiretroviral therapy (HAART); human immunodeficiency virus (HIV); milliliter (mL); Child–Pugh–Turcotte score (Child-PT); pegylated interferon plus ribavirin (Peg-IFN/RBV); direct-acting antiviral (DAA) agent
aExpressed as the median (interquartile range)
bUndetectable plasmatic HIV viral loads were defined as HIV-RNA <50 IU/mL
cGenotypes 1c or 1a/b
dLiver fibrosis was measured by liver biopsy or liver stiffness
ePatients who voluntarily dropped out of therapy or withdrew because of adverse events
fIncluding patients with severe adverse events to previous interferon-based therapy, advanced or decompensated liver cirrhosis, oncological patients, those with severe renal impairment, uncontrolled psychiatric disorders, or autoimmune diseases
gDefined as a daily alcohol ingestion >100 mg