TABLE 1.
Pretreatment clinical, virologic, biochemical, and histological characteristics of patientsa
| Category and no. of patientsb | Sex (male/ female) | Age (yr) | Wt (kg) | Body surface area (m2) | No. (%) of patients belonging to genotypec:
|
Amt of pretreatment HCV RNA (copies/ml) | Amt of ALTd (U/liter) at:
|
Total HAIe score | No. (%) of patients at histological stage of:
|
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1a/b | 2 | 3 | 4 | Other/ untypeable | Baseline | End of treatment (week 48) | End of follow-up (week 72) | Non-cirrhosis | Bridging fibrosis | Cirrhosis | |||||||
| Virologic sustained responders (78) | 46/32 | 39 ± 9.8 | 71 ± 14.2 | 1.8 ± 0.2 | 35 (45) | 13 (17) | 27 (35) | 2 (2) | 1 (1) | (4.2 ± 6.9) × 106 | 156 ± 137 | 44 ± 22 | 22 ± 16 | 9.1 ± 3.2 | 65 (83) | 9 (12) | 4 (5) |
| Virologic relapse patients (60) | 43/17 | 43 ± 9.7 | 77 ± 12.7 | 1.9 ± 0.2 | 44 (73) | 3 (5) | 10 (17) | 2 (3) | 1 (2) | (9.2 ± 9.1) × 106 | 107 ± 73 | 38 ± 19 | 94 ± 70 | 9.1 ± 3.0 | 51 (85) | 5 (8) | 4 (7) |
| Virologic nonresponders (39) | 22/17 | 44 ± 11 | 79 ± 18.3 | 1.9 ± 0.2 | 31 (79) | 1 (3) | 7 (18) | 0 | 0 | (11.5 ± 17.2) × 106 | 97 ± 59 | 77 ± 48 | 98 ± 80 | 8.0 ± 3.3 | 36 (92) | 2 (5) | 1 (3) |
All ± values represent means ± standard deviations.
Sustained responders, HCV RNA undetectable on week 72 (24 weeks after discontinuation of therapy; relapsers (end of treatment responders), HCV RNA undetectable on week 48 (end of treatment) but with virologic relapse thereafter; nonresponders, HCV RNA positive at end of treatment and thereafter. Classification of the three groups was based on results of Cobas Amplicor HCV version 2.0.
Genotyping was performed with a reverse hybridization assay (INNO LiPA HCV-II; Innogenetics, Ghent, Belgium).
Normal ranges for ALT: male patients, 6 to 43 U/liter; female patients, 6 to 34 U/liter.
HAI, histology activating index.