TABLE 1.
Demographics and baseline characteristicsa
| Moderate hepatic impairment (n = 10) |
Normal hepatic function (n = 10) |
Severe renal impairment (n = 10) |
Normal renal function (n = 10) |
|
|---|---|---|---|---|
| Sex (at birth), n (%) | ||||
| Male | 7 (70.0) | 7 (70.0) | 7 (70.0) | 7 (70.0) |
| Female | 3 (30.0) | 3 (30.0) | 3 (30.0) | 3 (30.0) |
| Age, median (range), years | 56 (39–71) | 55 (31–69) | 69 (18–77) | 63 (21–73) |
| Race, n (%) | ||||
| White | 10 (100.0) | 10 (100.0) | 9 (90.0) | 10 (100.0) |
| Black | 0 | 0 | 1 (10.0) | 0 |
| Ethnicity, n (%) | ||||
| Hispanic or Latinx | 7 (70.0) | 5 (50.0) | 7 (70.0) | 5 (50.0) |
| Not Hispanic or Latinx | 3 (30.0) | 5 (50.0) | 2 (20.0) | 5 (50.0) |
| Not provided | 0 | 0 | 1 (10.0) | 0 |
| ALT, median (range), units/L | 23 (11–312) | 17 (8–32) | 15 (8–30) | 18 (8–45) |
| AST, median (range), units/L | 33 (14–129) | 17 (11–19) | 16 (9–24) | 18 (12–27) |
| Serum creatinine, median (range), mg/dL | 0.83 (0.55–1.19) | 0.84 (0.55–1.05) | 3.24 (1.81–5.03) | 0.83 (0.51–1.05) |
| CLcr, median (range), mL/min | 113 (69.4–224) | 117 (90.4–193) | 21.9 (15.8–30.8) | 98.4 (90.0–130) |
| Weight, median (range), kg | 81.8 (54.8–127) | 93.0 (58.5–113.2) | 75.6 (41.4–114) | 78.8 (64–97.6) |
| Height, median (range), cm | 168.9 (151–188) | 174.5 (152-191) | 168.5 (145-185) | 173.5 (161-179) |
| BMI, median (range), kg/m2 | 31.9 (23.5–37.8) | 29.5 (25.0–36.1) | 26.6 (19.7–33.2) | 26.6 (23.7–30.5) |
| CPT score, n (%) | ||||
| 7 | 7 (70) | NA | NA | NA |
| 8 | 3 (30) | NA | NA | NA |
a
BMI, body mass index; CPT, Child–Pugh–Turcotte; ALT, alanine aminotransferase, AST, aspartate transaminase, NA, not available.