Table 5.
Comparison of responders and virological non-responders to antiviral therapy
|
Parameter
|
Responders (n = 3271)
|
Non-responders (n = 171)
|
P
value
|
| Gender, females/males, n (%) | 1539 (47)/1732 (53) | 42 (24.6)/129 (75.4) | < 0.0001 |
| Age (yr), mean ± SD; min-max | 58.0 ± 12.6; 21-97 | 55.0 ± 10.5; 29-84 | 0.0002 |
| Females | 61.6 ± 11.8; 21-91 | 59.9 ± 10.6; 35-81 | 0.3173 |
| Males | 54.8 ± 12.4; 21-97 | 53.4 ± 10; 29-84 | 0.1045 |
| BMI, mean ± SD; min-max | 27.4 ± 5.0; 13.4-57.4 | 28.7 ± 4.6; 16-47.5 | 0.0001 |
| Current treatment regimen | |||
| Genotype-specific treatment regimens | |||
| ASV + DCV | 47 (1.4) | 8 (4.7) | 0.0001 |
| LDV/(SOF ± RBV) | 748 (22.9) | 30 (17.5) | 0.1047 |
| OBV/PTV/(r ± DSV ± RBV) | 1052 (32.2) | 24 (14) | < 0.0001 |
| GZR/(EBR ± RBV) | 387 (11.8) | 11 (6.4) | 0.0314 |
| Pangenotypic regimens | |||
| GLE/PIB | 420 (12.8) | 15 (8.8) | 0.1186 |
| GLE/(PIB + SOF + RBV) | 2 (0.1) | 0 | 0.7464 |
| SOF/(VEL ± RBV) | 477 (14.6) | 44 (25.7) | 0.0001 |
| VOX/VEL/SOF | 7 (0.2) | 0 | 0.5448 |
| GT, n (%) | < 0.0001 | ||
| 1 | 63 (1.9) | 2 (1.2) | |
| 1a | 70 (2.2) | 1 (0.6) | |
| 1b | 2624 (80.2) | 89 (52.0) | |
| 3 | 397 (12.1) | 76 (44.4) | |
| 4 | 110 (3.4) | 3 (1.8) | |
| Other | 7 (0.2) | 0 | |
| Comorbidities, n (%) | |||
| Any comorbidity | 2498 (76.4) | 131 (4) | 0.9425 |
| Hypertension | 1533 (46.9) | 66 (2) | 0.0345 |
| Diabetes | 731 (22.3) | 46 (1.4) | 0.1651 |
| Renal disease | 124 (3.8) | 8 (0.2) | 0.5558 |
| Autoimmune diseases | 63 (1.9) | 0 | 0.0670 |
| Non-HCC tumors | 68 (2.1) | 6 (0.2) | 0.1963 |
| Other | 1783 (54.5) | 96 (2.9) | 0.6762 |
| Concomitant medications, n (%) | 2389 (73.0) | 136 (79.5) | 0.0610 |
| Treatment experienced | 1039 (31.8) | 69 (40.4) | 0.0208 |
| History of hepatic decompensation, n (%) | |||
| Ascites | 297 (9.0) | 21 (12.2) | 0.1588 |
| Encephalopathy | 65 (2.0) | 7 (4.1) | 0.0606 |
| Documented esophageal varices, n (%) | 780 (23.8) | 64 (37.4) | 0.0001 |
| Hepatic decompensation at baseline, n (%) | 173 (5.3) | 18 (10.5) | 0.0035 |
| HCC history, n (%) | 117 (3.6) | 9 (5.3) | 0.2523 |
| OLTx history, n (%) | 28 (0.9) | 1 (0.6) | 0.7052 |
| Child-Pugh class, n (%) | |||
| B or C | 296 (9) | 29 (17) | 0.0006 |
| HBV coinfection (HBsAg+), n (%) | 50 (1.5) | 2 (1.2) | 0.7075 |
| HIV coinfection, n (%) | 79 (2.4) | 6 (3.5) | 0.3690 |
| ALT IU/L, mean ± SD | 101.2 ± 80.8 | 106.9 ± 82.0 | 0.3385 |
| Bilirubin mg/dL, mean ± SD | 1.1 ± 0.9 | 1.2 ± 0.7 | < 0.0001 |
| Albumin g/dL, mean ± SD | 4.5 ± 7.7 | 3.9 ± 3.1 | 0.0002 |
| Creatinine mg/dL, mean ± SD | 0.9 ± 2.3 | 0.8 ± 0.2 | 0.8562 |
| Hemoglobin g/dL, mean ± SD | 14.1 ± 1.8 | 13.9 ± 1.8 | 0.1319 |
| Platelets, × 1000/μL, mean ± SD | 132.6 ± 66.8 | 109.2 ± 59.4 | < 0.0001 |
| HCV RNA × 106 IU/ml, mean ± SD | 2.2 ± 10.0 | 2.0 ± 2.9 | 0.1123 |
SD: Standard deviation; BMI: Body mass index; ASV: Asunaprevir; DCV: Daclatasvir; LDV: Ledipasvir; SOF: Sofosbuvir; RBV: Ribavirin; OBV: Ombitasvir; PTV/r: Paritaprevir; DSV: Dasabuvir; GZR: Grazoprevir; EBR: Elbasvir; GLE: Glecaprevir; PIB: Pibrentasvir; VEL: Velpatasvir; VOX: Voxilaprevir; GT: Genotype; HCC: Hepatocellular carcinoma; OLTx: Orthotopic liver transplantation; HBV: Hepatitis B virus; HBsAg: Hepatitis B surface antigen; HIV: Human immunodeficiency virus; ALT: Alanine transaminase; HCV RNA: Ribonucleic acid of hepatitis C virus.