Table 1.
Baseline sociodemographic and clinical characteristics of the United States fibrosis gain study cohort.
| Variable | No progression (n = 848) | Progressed (n = 141) | All patients (n = 989) |
| Age, mean (SD), yr | 50.8 (10.9) | 52.7 (10.3) | 51.1 (10.8) |
| Sex, female, n (%) | 407 (48) | 47 (33) | 454 (46) |
| Race or ethnicity, n (%) | |||
| White | 28 (3) | 3 (2) | 31 (3) |
| Other | 820 (97) | 138 (98) | 958 (97) |
| Height, mean (SD), meters | 1.7 (0.2) | 1.7 (0.2) | 1.7 (0.2) |
| BMI, mean (SD), kg/m2 | 32.8 (13.5) | 33.6 (12.3) | 32.9 (13.4) |
| BMI, physician-reported | |||
| Underweight | 10 (1) | 3 (2) | 13 (1) |
| Normal | 186 (22) | 27 (19) | 213 (22) |
| Overweight | 156 (18) | 26 (18) | 182 (18) |
| Obese | 496 (59) | 85 (60) | 581 (59) |
| Alcohol consumption, n (%) | |||
| Never | 369 (44) | 40 (28) | 409 (41) |
| Once per mo | 248 (29) | 42 (30) | 290 (29) |
| 2 to 4 times per mo | 133 (16) | 35 (25) | 168 (17) |
| 4 to 6 times per mo | 50 (6) | 17 (12) | 67 (7) |
| More than 6 times per mo | 11 (1) | 3 (2) | 14 (1) |
| Unknown | 37 (4) | 4 (3) | 41 (4) |
| Smoking status, n (%) | |||
| Non-smoker | 457 (54) | 60 (43) | 517 (52) |
| Ex-smoker | 256 (30) | 44 (31) | 300 (30) |
| Current smoker | 93 (11) | 28 (20) | 121 (12) |
| Unknown | 42 (5) | 9 (6) | 51 (5) |
| Employment, n (%) | |||
| Full-time | 430 (51) | 45 (32) | 475 (48) |
| Part-time | 142 (17) | 30 (21) | 172 (17) |
| Self-employed | 79 (9) | 12 (9) | 91 (9) |
| Student | 16 (2) | 3 (2) | 19 (2) |
| Retired | 72 (9) | 23 (16) | 95 (10) |
| Unemployed | 62 (7) | 16 (11) | 78 (8) |
| Homemaker | 36 (4) | 8 (6) | 44 (4) |
| Physically unable to work due to NASH or related complications | 3 (0.4) | 3 (2) | 6 (1) |
| Physically unable to work due to other reason(s) | 8 (1) | 1 (1) | 9 (1) |
| Years since diagnosis | |||
| Mean (SD) | 2.1 (2.4) | 4.4 (5.1) | 2.4 (3.0) |
| Median (IQR) | 1.2 (0.9, 27.9) | 2.1 (1.0, 21.0) | 1.3 (0.9, 27.9) |
| Liver biopsy, n (%) | 488 (58) | 90 (64) | 578 (58) |
| Fibrosis stage at diagnosis, n (%) | |||
| F0 | 171 (20) | 30 (21) | 201 (20) |
| F1 | 240 (28) | 53 (38) | 293 (30) |
| F2 | 192 (23) | 41 (29) | 233 (24) |
| F3 | 121 (14) | 15 (11) | 136 (14) |
| F4CC | 124 (15) | 2 (1) | 126 (13) |
| Number of comorbidities, n (%) | |||
| 0 | 310 (37) | 32 (23) | 342 (35) |
| 1 | 207 (24) | 30 (21) | 237 (24) |
| 2 | 141 (17) | 19 (14) | 160 (16) |
| ≥3 | 190 (22) | 60 (43) | 250 (25) |
| Comorbidities, n (%) | |||
| Obesity from calculated BMI | 496 (59) | 85 (60) | 581 (59) |
| Obesity from physician notes | 332 (39) | 83 (59) | 415 (42) |
| Type 2 diabetes mellitus | 203 (24) | 40 (28) | 243 (25) |
| Cardiovascular disease | 22 (3) | 8 (6) | 30 (3) |
| Hypertension | 234 (28) | 53 (38) | 287 (29) |
| Dyslipidemia | 257 (30) | 56 (40) | 313 (32) |
| Weight loss, past 12 mo | |||
| 0 | 820 (97) | 133 (94) | 953 (97) |
| <5% | 10 (1) | 3 (2) | 13 (1) |
| 5% to <7% | 8 (1) | 3 (2) | 11 (1) |
| 7% to 10% | 6 (1) | 1 (1) | 7 (1) |
| >10% | 3 (0.4) | 1 (1) | 4 (0.4) |
| Missing data | 1 | 0 | 1 |
| Non-pharmacological NASH treatment proposed at diagnosis | |||
| Lifestyle change | 415 (49) | 83 (59) | 498 (50) |
| Diet change | 409 (48) | 81 (57) | 490 (50) |
| Behavioral strategies | 28 (3) | 3 (2) | 31 (3) |
| Bariatric or intragastric surgery | 66 (8) | 16 (11) | 82 (8) |
| Liver transplantation | 19 (2) | 10 (7) | 29 (3) |
| Pharmacological NASH treatment | |||
| Lipid-lowering drugs | 126 (15) | 28 (20) | 154 (16) |
| Vitamin E | 128 (15) | 12 (9) | 140 (14) |
| Metformin | 99 (12) | 20 (14) | 119 (12) |
| Sulfonylurea | 2 (0.2) | 0 | 2 (0.2) |
| Thiazolidinediones | 23 (3) | 14 (10) | 37 (4) |
| GLP-1 receptor agonist | 8 (1) | 0 | 8 (1) |
| SGLT-2 | 1 (0.1) | 0 | 1 (0.1) |
| DPP-4 | 1 (0.1) | 0 | 1 (0.1) |
| Other anti-diabetic medication(s) | 18 (2) | 3 (2) | 21 (2) |
| Other medication(s) | 60 (7) | 16 (11) | 76 (8) |
BMI = body mass index, CC = compensated cirrhosis, DPP-4 = dipeptidyl peptidase-4, GAIN = Global Assessment of the Impact of NASH study, GLP-1 = glucagon-like peptide-1, NASH = nonalcoholic steatohepatitis, SD = standard deviation, SGLT-2 = sodium-glucose co-transporter-2.
Proportions may not sum to 100% due to rounding.