Table 1.
Baseline Demographic and Clinical Characteristics*
| Characteristic | Ledipasvir + Sofosbuvir + GS-9451 (n = 25) | Ledipasvir + Sofosbuvir + GS-9451 + GS-9669 (n = 25) |
|---|---|---|
| Mean age (SD), y | 54 (10) | 58 (8) |
| Male | 17 (68) | 19 (76) |
| Race† | ||
| African American | 19 (76) | 19 (76) |
| White | 5 (20) | 6 (24) |
| Ethnicity† | ||
| Hispanic | 1 (4) | 0 (0) |
| Non-Hispanic | 24 (96) | 25 (100) |
| Mean BMI (SD), kg/m2 | 28 (5) | 27 (5) |
| HCV genotype | ||
| 1a | 18 (72) | 16 (64) |
| 1b | 7 (28) | 9 (36) |
| HCV RNA level >6 × 106 IU/mL IFNL3/IL28B genotype‡ | 11 (44) | 10 (40) |
| CC | 3 (12) | 2 (8) |
| CT | 18 (72) | 14 (56) |
| TT | 4 (16) | 8 (32) |
| IFNL4 genotype‡ | ||
| TT/TT | 2 (8) | 1 (4) |
| ΔG/TT | 18 (72) | 15 (60) |
| ΔG/ΔG | 5 (20) | 8 (32) |
| Knodell HAI, METAVIR, or FibroSURE score§ | ||
| 0 | 5 (20) | 8 (32) |
| 1 | 14 (56) | 12 (48) |
| 2 | 6 (24) | 4 (16) |
| 3 | 0 (0) | 1 (4)∥ |
| Presence of any NS3, NS5A, or NS5B RAV | 10 (40) | 10 (40) |
| Presence of NS3, NS5A, or NS5B RAV with >20-fold resistance | 3 (12) | 7 (28) |
BMI = body mass index; HAI = Histology Activity Index; HCV = hepatitis C virus; RAV = resistance-associated variant.
Values are numbers (percentages) unless otherwise indicated.
Self-reported.
Could not be typed in 1 patient.
In the 3-drug group, fibrosis staging was done with the FibroSURE test/aspartate aminotransferase–platelet ratio in 8 patients (32%), the Knodell HAI system in 15 patients (60%), and the METAVIR system in 2 patients (8%). In the 4-drug group, staging was done with the FibroSURE test/aspartate aminotransferase–platelet ratio in 5 patients (20%), the Knodell HAI system in 16 patients (64%), and the METAVIR system in 3 patients (12%). For fibrosis scores reported as a range, the maximum value in the range was used.
One patient with stage 2 fibrosis by the METAVIR system was considered eligible before enrollment but was deemed to have stage 3 fibrosis when the slide was reread at the National Institutes of Health using the Knodell HAI system.