Table 1.
Baseline Demographic and Disease Characteristics
| Simeprevir + Sofosbuvir (n = 291) | Simeprevir + Sofosbuvir + Ribavirin (n = 17) | Total (N = 315)a | |
| Demographic characteristics | |||
| Age, median (range), year | 58.0 (18–82) | 59.0 (42–68) | 58.0 (18–82) |
| Gender, n (%) | |||
| Female | 111 (38.1) | 3 (17.6) | 116 (36.8) |
| Male | 180 (61.9) | 14 (82.4) | 199 (63.2) |
| Race, n (%)b | |||
| White | 174 (59.8) | 11 (64.7) | 191 (60.6) |
| Black/African American | 102 (35.1) | 6 (35.3) | 108 (34.3) |
| Otherc | 15 (5.2) | 0 | 16 (5.1) |
| Ethnicity, n (%)b | |||
| Hispanic/Latino | 45 (15.5) | 0 | 46 (14.6) |
| Not Hispanic/Latino | 241 (82.8) | 17 (100) | 264 (83.8) |
| Otherd | 5 (1.7) | 0 | 5 (1.6) |
| BMI, median (IQR), kg/m2e | 28.3 (24.6–32.2) | 28.5 (24.7–30.1) | 28.1 (24.6–32.1) |
| Disease characteristics | |||
| HCV RNA level, median (range), log10 IU/mL | 6.3 (1.4–7.6) | 6.2 (5.6–7.8) | 6.2 (1.4–7.8) |
| HCV genotype/subtype, n (%) | |||
| 1a | 209 (71.8) | 13 (76.5) | 226 (71.7) |
| 1b | 62 (21.3) | 3 (17.6) | 67 (21.3) |
| Indeterminate/other | 20 (6.9) | 1 (5.9) | 22 (7.0) |
| Presence of cirrhosis, n (%) | 116 (39.9) | 6 (35.3) | 124 (39.4) |
| Hepatic decompensation, n (%) | 40 (13.7) | 1 (5.9) | 41 (13.0) |
| Esophageal and/or gastric varices, n (%) | |||
| History, not active | 13 (4.5) | 0 | 13 (4.1) |
| Active | 27 (9.3) | 0 | 27 (8.6) |
| Ascites, n (%) | |||
| History, not active | 7 (2.4) | 0 | 7 (2.2) |
| Active | 15 (5.2) | 1 (5.9) | 16 (5.1) |
| Hepatic encephalopathy, n (%) | |||
| History, not active | 1 (0.3) | 0 | 1 (0.3) |
| Active | 16 (5.5) | 0 | 16 (5.1) |
| Calculated MELD score category, n (%)f | |||
| ≤10 | 90 (76.9) | 6 (100) | 96 (78.0) |
| ≥11 to ≤18 | 26 (22.2) | 0 | 26 (21.1) |
| ≥19 to ≤24 | 0 | 0 | 0 |
| ≥25 | 1 (0.9) | 0 | 1 (0.8) |
| HIV coinfection, n (%) | 23 (7.9) | 0 | 23 (7.3) |
Abbreviations: BMI, body mass index; IQR, interquartile range; HCV, hepatitis C virus; HIV, human immunodeficiency virus; MELD, Model for End-stage Liver Disease; RNA, ribonucleic acid.
aIncludes 7 patients treated with simeprevir + peginterferon + ribavirin.
bRace and ethnicity data were obtained from patients’ medical records.
c“Other” includes Asian, American Indian or Alaska Native, other, unknown, and not reported.
dOther includes unknown and not reported.
en = 288 for the simeprevir + sofosbuvir group; total N = 312.
fn = 117 for the simeprevir + sofosbuvir group; n = 6 for the simeprevir + sofosbuvir + ribavirin group; total N = 123.