Table 1.

Baseline Characteristics according to Treatment Group

	Peginterferon + Ribavirin (n=55)	Peginterferon + Placebo (n=59)
Patient Characteristics
Age (Years)	10.7 (±3.3)	10.8 (±3.6)
5–11	30 (54%)	30 (51%)
12–18	25 (46%)	29 (49%)
Sex – Female	28 (51%)	23 (39%)
Race – Non-Caucasian	12 (22%)	17 (29%)
BMI Z-scores	0.8 (±1.0)	0.7 (±1.1)
Total CDI raw score	5.9 (±4.2)	5.9 (±4.6)
Mode of acquisition
Maternal-infant	39 (71%)	47 (80%)
Transfusion	6 (11%)	2 (3%)
Other	10 (19%)	10 (18%)
Est. duration of infection (mo.)	105 (±56)	111 (±55)
Genotype
1	45 (82%)	47 (80%)
2	4 (7%)	3 (5%)
3	6 (11%)	7 (12%)
6	0 (0%)	2 (3%)
Baseline Laboratory Measures
ALT (U/L)	49 (±59)	49 (±59)
ALT > Upper Limit of Normal	32 (58%)	38 (64%)
AST (U/L)	45 (±40)	45 (±29)
AST > Upper Limit of Normal	28 (51%)	28 (47%)
Baseline HCV RNA Levels
HCV RNA log10 IU/mL	6.2 (±0.8)	6.3 (±0.9)
HCV RNA ≥ 600,000 IU/mL	32 (70%)	46 (82%)
Histology Results
Histology Activity Index*
Minimal (1–3)	23 (43%)	24 (43%)
Mild (4–6)	10 (19%)	10 (18%)
Moderate (7–9)	19 (35%)	21 (38%)
Marked (10–12)	2 (4%)	1 (2%)
Steatosis*
None	29 (54%)	34 (61%)
Minimal (≤ 5% of tissue)	21 (39%)	17 (30%)
Mild (6%–33%)	4 (7%)	5 (9%)
Fibrosis Score*
None	7 (13%)	8 (14%)
Portal-Periportal fibrosis (Ishak 1–2)	43 (80%)	46 (82%)
Bridging Fibrosis (Ishak 3–4)	4 (7%)	1 (2%)
Cirrhosis (Ishak 5–6)	0 (0%)	1 (2%)

Note: Results presented as n (%) or mean ± s.d. Results for ALT, AST and HCV RNA presented as geometric mean ± s.d. No comparison shows a significant difference (p<0.05) between Peg interferon + Ribavirin and Peginterferon + Placebo groups. CDI=Childhood Depression Index

^*Sample size for pathology variables: Peg interferon + Ribavirin therapy n=54, Peginterferon + Placebo n=56