Table 1.
Demographics and Baseline Medical History of ASTRAL-2 and ASTRAL-3 Participants
| Parameter | SOF + RBV (%) | SOF/VEL (%) | P Value |
|---|---|---|---|
| N | 407 | 411 | |
| Age, y | 52.5 ± 10.3 | 51.8 ± 11.0 | .36 |
| Male gender | 246 (60.4) | 256 (62.3) | .59 |
| Race White |
350 (86.0) | 374 (91.0) | .0249 |
| African-American | 13 (3.2) | 9 (2.2) | .37 |
| Asian | 34 (8.4) | 24 (5.8) | .16 |
| Enrolled in the United States | 190 (46.7) | 188 (45.7) | .79 |
| Employed at baseline | 215 (59.1) | 229 (61.2) | .55 |
| Hemoglobin, g/dL | 14.9 ± 1.4 | 14.9 ± 1.3 | .89 |
| Treatment naive | 316 (77.6) | 321 (78.1) | .87 |
| Cirrhosis | 102 (25.4) | 99 (24.1) | .66 |
| HCV genotype 2 | 132 (32.4) | 134 (32.6) | .96 |
| HCV genotype 3 | 275 (67.6) | 277 (67.4) | .96 |
| ALT > 1.5 × ULN | 238 (58.5) | 236 (57.4) | .76 |
| HCV RNA > 6 log 10/mL | 282 (69.3) | 286 (69.6) | .93 |
| History of: | |||
| Anxiety or panic disorders | 60 (14.7) | 73 (17.8) | .24 |
| Depression | 95 (23.3) | 116 (28.2) | .11 |
| Clinically overt fatigue | 63 (15.5) | 59 (14.4) | .65 |
| Sleep disorders | 80 (19.7) | 70 (17.0) | .33 |
| Type 2 diabetes or hyperglycemia | 37 (9.1) | 28 (6.8) | .23 |
| Body mass index, kg/m2 | 27.4 ± 6.0 | 26.9 ± 5.1 | .41 |
Abbreviations: ALT, alanine aminotransferase; HCV, hepatitis C virus; RBV, ribavirin; SOF, sofosbuvir; ULN, upper limit of the norm; VEL, velpatasvir.