Table 1.
Baseline Demographic and Clinical Characteristics of Study Participants
| Characteristic | Participants, No. (%)a |
P Value | |
|---|---|---|---|
| Treatment Naive (n = 25) | Treatment Experienced (n = 25) | ||
| Age, mean (SD), y | 57.3 (5.6) | 58.8 (3.3) | .25 |
| Male | 18 (72) | 15 (60) | .37 |
| Raceb | |||
| Black | 20 (80) | 10 (40) | .01 |
| White | 4 (16) | 13 (52) | |
| Other (multiracial or unknown) | 1 (4) | 2 (8) | |
| Ethnicityb | |||
| Hispanic | 0 (0) | 3 (12) | .23 |
| Non-Hispanic | 25 (100) | 22 (88) | |
| BMI, mean (SD) | 29.9 (4.9) | 31.2 (8.1) | .49 |
| HCV genotypec | |||
| 1a | 15 (60) | 23 (92) | .02 |
| 1b | 9 (36) | 2 (8) | |
| 1a or 1b | 1 (4) | 0 (0) | |
| HCV RNA >6 million IU/mL | 6 (24) | 5 (20) | .73 |
| IL28B genotype | |||
| CC | 5 (20) | 10 (40) | .15 |
| CT | 17 (68) | 10 (40) | |
| TT | 3 (12) | 5 (20) | |
| IFNL4 genotype | |||
| TT/TT | 1 (4) | 1 (4) | .85 |
| ΔG/TT | 21 (84) | 19 (76) | |
| ΔG/ΔG | 3 (12) | 5 (20) | |
| Knodell HAI, METAVIR, or FibroSure fibrosis scored | |||
| 1 | 1 (4)e | 0 (0) | .78 |
| 2 | 0 (0) | 0 (0) | |
| 3 | 14 (56) | 13 (52) | |
| 4 | 10 (40) | 12 (48) | |
| Presence of NS3, NS5A, or NS5B RAV with >5-fold resistance | |||
| No | 20 (80) | 19 (76) | .73 |
| Yes | 5 (20) | 6 (24) | |
Abbreviations: BMI, body mass index; HAI, histology activity index; HCV, hepatitis C virus; RAV, resistance-associated variant; SD, standard deviation.
a Data represent No. (%) of participants unless otherwise specified.
b Race and ethnicity were self-reported.
c HCV genotyping was inconclusive in 1 treatment-naive patient, who may have been infected with HCV genotype 1a or 1b/6.
d Liver biopsy was required in patients in whom a FibroSure score of >0.48 and an aspartate aminotransferase–platelet ratio index (APRI) of >1 within 6 months of screening were not available or in whom these results were discordant. In the treatment-naive cohort, 2 patients (8%) met FibroSure/APRI eligibility criteria, 10 (40%) had liver biopsy specimens scored using the Knodell HAI system, and 13 (52%) had specimens scored using the METAVIR scoring system. In the treatment-experienced cohort, liver fibrosis scoring was completed with FibroSure/APRI in 4 patients (16%), with Knodell HAI in 9 (36%), and with METAVIR in 12 (48%). Fibrosis scores reported as 2.5 or 2–3 were categorized as stage 3, and those reported as 3–4 or 3.5–4 were categorized as stage 4.
e One patient was deemed eligible for the study because of stage 3 fibrosis shown by the METAVIR scoring system before enrollment. However, this patient was deemed to have stage fibrosis 1 after the slide was read again at the National Institutes of Health using the Knodell HAI system.