Table 2.
(Sustained Virologic Response percent) [95% Confidence Interval] | |||
---|---|---|---|
Peginterferon/ribavirin (N=55) | Peginterferon/placebo (N=57) | P-Value | |
Total | 29/55 (53%) [40%, 66%] | 12/57 (21%) [10%, 32%] | .0005 |
Genotype 1 | 21/45 (47%) [32%, 61%] | 8/46 (17%) [6%, 28%] | .0027 |
2 – 6 | 8/10 (80%) [55%, 100%] | 4/11 (36%) [8%, 65%] | .0563* |
Female | 15/28 (54%) [35%, 72%] | 8/23 (35%) [15%, 54%] | .1797 |
Male | 14/27 (52%) [33%, 71%] | 4/34 (12%) [1%, 23%] | .0007 |
Age <=11 years | 15/30 (50%) [32%, 68%] | 7/29 (24%) [9%, 40%] | .0400 |
>=12 years | 14/25 (56%) [37%, 75%] | 5/28 (18%) [4%, 32%] | .0038 |
White | 22/43 (51%) [36%, 66%] | 8/40 (20%) [8%, 32%] | .00031 |
Non-White | 7/12 (58%) [30%, 86%] | 4/17 (24%) [3%, 44%] | .0651* |
ALT Normal | 16/23 (70%) [51%, 88%] | 6/20 (30%) [10%, 50%] | 0.0096 |
> ULN | 13/32 (41%) [24%, 58%] | 6/37 (16%) [4%, 28%] | 0.0246 |
HCV RNA < 600,000 IU/ml | 16/23 (70%) | 10/13 (78%) | p = 0.73 |
HCV RNA ≥ 600,000 IU/ml | 16/32 (50%) | 5/46 (11%) | p = 0.0002 |
Inflammation (Histology Activity Index) | |||
Minimal (1–3) | 10/23 (43%) [23%, 64%] | 5/24 (21%) [5%, 37%] | 0.0959 |
Mild-Marked (4–12) | 18/31 (58%) [41%, 75%] | 6/30 (20%) [6%, 34%] | 0.0023 |
Fibrosis (Ishak stage) | |||
None | 3/7 (43%) [6%, 80%] | 3/8 (38%) [4%, 71%] | 0.8327 |
Stage 1–6 | 25/47 (53%) [39%, 67%] | 8/48 (17%) [6%, 27%] | 0.0003 |
Steatosis | |||
Present | 9/25 (36%) [17%, 55%] | 1/21 (5%) [0%, 14%] | 0.0105 |
Absent | 19/29 (66%) [48%, 83%] | 10/33 (30%) [15%, 46%] | 0.0056 |