Table 1. Demographic and clinical characteristics of patients with Chronic HCV and HIV/HCV treated With OBV/PTV/r ± DSV ± RBV.
| Variable | HCV | HIV/HCV | Total N = 2,408* |
|---|---|---|---|
| Department, n (%) | |||
| Gastroenterology | 1,981 (98.0) | 25 (6.5) | 2,006 (83.3) |
| Infectious diseases | 41 (2.0) | 361 (93.5) | 402 (16.7) |
| Sex, male, n (%) | 1,138 (56.3) | 303 (78.5)† | 1,441 (59.8) |
| Age, mean (SD), y | 59.1 (11.9) | 50.8 (6.4)† | 57.8 (11.6) |
| <50 y, n (%) | 415 (20.5) | 129 (33.4)†§ | 544 (22.6) |
| ≥50 y, n (%) | 1,607 (79.5) | 257 (66.6) | 1,864 (77.4) |
| White ethnicity, n (%) | 1,992 (98.5) | 366 (95.6)†§ | 2,358 (98.0) |
| No alcohol consumption**, n (%) | 1,525 (76.2) | 278 (72.0) | 1,803 (75.5) |
| BMI, mean (SD), Kg/m2 | 26.60 (4.1) | 24.50 (3.8)† | 26.1 (4.1) |
| BMI group, overweight, (BMI = 25−30 Kg/m2), n (%) | 463 (45.3) | 117 (35.7) | 580 (43.0) |
| IL-28, genotype CC (SNP rs12979860), n (%) | 201 (22.4) | 83 (36.2)† | 284 (25.2) |
| Duration of chronic HCV***, mean (SD), y | 15.21 (9.1) | 18.2 (8.2)† | 15.7 (9.0) |
| HCV genotype, n (%) | |||
| GT1 | 1,841 (91.0) | 275 (71.2)†§ | 2,116 (87.9) |
| GT1a | 284 (14.0) | 173 (44.8) | 457 (19.0) |
| GT1b | 1,544 (76.4) | 99 (25.6) | 1,643 (68.2) |
| GT1 others | 13 (0.6) | 3 (0.8) | 16 (0.7) |
| GT4 | 181 (9.0) | 111 (28.8) | 292 (12.1) |
| HCV RNA Quant-Test result, mean (SD), IU/mL | 2 793 122.7 (4 301 803.4) |
3 849 702.9 (5 999 880.7) |
2 962 193.1 (4 630 442.9) |
| HCV RNA/Quant-Test, n (%) | |||
| Abbott Real-Time HCV (RT-PCR) | 443 (21.9) | 53 (13.7) | 496 (20.6) |
| Roche COBAS TaqMan HCV | 1,252 (61.9) | 203 (52.6) | 1,455 (60.4) |
| HCV RNA Quant-Test result (global), n (%) | |||
| Low HCV RNA (≤800 000 IU/mL) | 670 (33.1) | 110 (28.5) | 780 (32.4) |
| High HCV RNA (>800 000 IU/mL) | 1,352 (66.9) | 276 (71.5) | 1,628 (67.6) |
| Cirrhosis,**** n (%) | 742 (36.7) | 131 (33.9) | 873 (36.3) |
| Cirrhosis (F4) per fibrosis grade method, n (%) | |||
| Tested by Fibroscan® (F4) | n = 1860 631 (33.9) |
n = 373 123 (33.0) |
n = 2,233 754 (33.8) |
| Biopsy (F4) | n = 81 30 (37.0) |
n = 7 1 (14.3) |
n = 88 31 (35.2) |
| Fibroscan® (categorized),***** n (%) | |||
| <8.8 kPa | 613 (34.5) | 130 (35.7) | 743 (34.7) |
| 8.8− < 9.6 kPa | 146 (8.2) | 27 (7.4) | 173 (8.1) |
| 9.6−< 12.5 kPa | 386 (21.7) | 74 (20.3) | 460 (21.5) |
| 12.5−< 14.6 kPa | 153 (8.6) | 31 (8.5) | 184 (8.6) |
| 14.6−< 20.0 kPa | 181 (10.2) | 44 (12.1) | 225 (10.5) |
| >20.0 kPa+ | 298 (16.8) | 58 (15.9) | 356 (16.6) |
| Child Pugh Score, n (%) | |||
| Class A (5−6) | 713 (99.3) | 119 (98.3) | 832 (99.2) |
| Class B (7−9) | 5 (0.7) | 2 (1.7) | 7 (0.8) |
| HIV infection, n (%) | — | 386 (100) | 386 (16) |
| Duration of HIV infection, mean (SD), y | — | 21.9 (70) | 21.9 (70) |
| ALT, mean (SD), IU/L | 79.9 (60.5) | 73.5 (61.4)‡ | 78.9 (60.6) |
| AST, mean (SD) IU/L | 67.1 (46.5) | 61.7 (40.6) | 66.2 (45.7) |
| Total bilirubin, mean (SD), mg/dL | 0.8 (0.5) | 0.76 (0.5) | 0.8 (0.5) |
| Hemoglobin, mean (SD) g/L | 147.4 (16.5) | 151.6 (15.8) | 148.1 (16.5) |
| Platelets, mean (SD), ×109/L | 174.8 (67.9) | 167.1 (63.6) | 173.5 (67.2) |
| eGFR, mean (SD), mL/min/1.73m2*** | 89.5 (21.9) | 93.2 (20.8) | 90.1 (21.7) |
| Creatinine clearance, mean (SD), mL/min*** | 98.3 (34.9) | 100.8 (30.9) | 98.7 (34.3) |
| Most likely mode of HCV infection | |||
| Drug use (i.v.) | 192 (9.5) | 305 (79.0) | 497 (20.6) |
| Drug use (non i.v.) | 18 (0.9) | 2 (0.5) | 20 (0.8) |
| Occupational* | 25 (1.2) | 25 (1.0) | |
| Blood transfusion or transplantation | 398 (19.7) | 3 (0.8) | 401 (16.7) |
| Perinatal | 25 (1.2) | 1 (0.3) | 26 (1.1) |
| Contaminated medical device (other than i.v. drug use) | 83 (4.1) | 83 (3.4) | |
| Heterosexual transmission | 11 (0.5) | 23 (6.0) | 34 (1.4) |
| Homosexual transmission (MSM) | 2 (0.1) | 30 (7.8) | 32 (1.3) |
| Other | 29 (1.4) | 29 (1.2) | |
| Unknown | 1239 (61.3) | 22 (5.7) | 1261 (52.4) |
| ART at baseline visit | 357 (92.5) | 357 (14.8) | |
| Nucleosides and nucleotides excl. reverse transcriptase inhibitors | 3 (0.8) | 3 (0.1) | |
| Protease inhibitors | 144 (37.3) | 144 (5.9) | |
| Nucleoside and nucleotide reverse transcriptase inhibitors | 98 (25.4) | 98 (4.1) | |
| Non-nucleoside reverse transcriptase inhibitors | 52 (13.5) | 52 (2.2) | |
| Antivirals for treatment of HIV infections, combinations | 223 (57.8) | 223 (9.3) | |
| Other antivirals | 165 (42.7) | 165 (6.9) |
Abbreviations: ALT, alanine transaminase; APRI, aspartate transaminase to platelet ratio index; ART, Antiretroviral treatment; AST, aspartate transaminase; BMI, body mass index; eGFR, estimated glomerular filtration rate; GT, genotype; HCV, hepatitis C virus; HIV, human immunodeficiency virus; OBV/PTV/r ± DSV ± RBV, ombitasvir/paritaprevir/ritonavir plus dasabuvir with or without ribavirin; SNP, single nucleotide polymorphism.
† p<0.0001;
†§ p<0.001 per distribution category;
‡ p = 0.0019.
* Not all patients had available data for all parameters.
**No alcohol consumption refers to the number of patients who reported that they were not consuming alcohol at that time of the study nor in the past.
***Duration of chronic HCV refers to the time from diagnosis of chronic HCV infection to the time of the study.
**** Cirrhosis level checked by the investigator based on invasive and/or non-invasive methods and clinical criteria. Regarding Fibroscan® levels, most patients were considered as having fibrosis stage F4 (≥12.5 kPa) (n: 632 [35.6%] monoinfected, 133 [35.5%] coinfected and 765 [35.3%] of the total cases, respectively).
***** For renal function, creatinine clearance and eGFR were calculated by imputing mean weight in missing cases (77.3 Kg for men and 66.0 Kg for women).