TABLE 2.
Baseline characteristics of patients and predictive factors of different types of responses to peg-IFN plus RBV therapya
| Patients | Age (yr)
|
Sex
|
Epidemiologyb
|
Genotype
|
Viral load
|
Activity gradec | Fibrosis stagec | PKRBD mutations
|
ISDR mutations
|
V3 mutations
|
PePHD mutations (n = 23)
|
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ≤40 | >40 | Male | Female | Parenteral | Non- parenteral | ALT (IU/liter) | AST (IU/liter) | GGT (IU/liter) | 1a | 1b | ≤600,000 | >600,000 | ≤4 | >4 | Without | ≥1 | ≤5 | >5 | Without | 1 | |||
| All (n = 60) | 30 (50) | 30 (50) | 34 (57) | 26 (43) | 46 (84) | 9 (16) | 117 ± 92 | 68 ± 67 | 74 ± 63 | 13 (22) | 47 (78) | 12 (20) | 48 (80) | 4 ± 2.2 | 2.1 ± 1.1 | 41 (68) | 19 (32) | 22 (37) | 38 (63) | 39 (65) | 21 (35) | 21 (91) | 2 (9) |
| RVR (n = 21) | 13 (62) | 10 (42) | 16 (59) | 7 (39) | 18 (58) | 3 (33) | 136 ± 115 | 86 ± 87 | 63 ± 82 | 8 (67) | 15 (45) | 4 (40) | 19 (54) | 3.89 ± 2.68 | 2.00 ± 1.19 | 15 (50) | 8 (53) | 8 (47) | 15 (54) | 12 (41) | 11 (69) | 9 (45) | 1 (50) |
| Non-RVR (n = 19) | 8 (38) | 14 (49) | 11 (41) | 11 (61) | 13 (42) | 6 (67) | 106 ± 67 | 60 ± 28 | 69 ± 40 | 4 (33) | 18 (55) | 6 (60) | 16 (46) | 4.63 ± 1.98 | 2.44 ± 1.29 | 15 (50) | 7 (47) | 9 (53) | 13 (46) | 17 (59) | 5 (31) | 11 (55) | 1 (50) |
| EVR (n = 52) | 27 (90) | 25 (83) | 31 (91) | 21 (81) | 42 (91) | 6 (67) | 113 ± 71 | 69 ± 41 | 59 ± 52 | 10 (77) | 42 (89) | 11 (92) | 41 (85) | 4.05 ± 2.3 | 2.07 ± 1.1 | 33 (80) | 19 (100)f | 17 (77) | 35 (92) | 33 (85) | 19 (90) | 17 (81) | 2 (100) |
| Non-EVR (n = 8) | 3 (10) | 5 (17) | 3 (9) | 5 (19) | 4 (9) | 3 (33) | 146 ± 183 | 107 ± 137 | 123 ± 116 | 3 (23) | 5 (11) | 1 (8) | 7 (15) | 3.67 ± 1.8 | 2.29 ± 0.44 | 8 (20) | 0 (0) | 5 (23) | 3 (8) | 6 (15) | 2 (10) | 4 (19) | 0 (0) |
| SVR (n = 36) | 22 (73)d,e | 14 (47) | 22 (65) | 14 (54) | 29 (63) | 4 (44) | 116 ± 98 | 72 ± 42 | 55 ± 41 | 9 (69) | 27 (57) | 9 (75) | 27 (56) | 4.3 ± 2.2 | 2 ± 1.1 | 19 (46) | 17 (89)g,h | 10 (45) | 26 (68) | 21 (54) | 15 (71) | 11 (52) | 0 (0) |
| NR (n = 24) | 8 (27) | 16 (53) | 12 (35) | 12 (46) | 17 (37) | 5 (56) | 173 ± 112 | 53 ± 17 | 52 ± 35 | 4 (31) | 20 (43) | 3 (25) | 21 (44) | 4 ± 2.4 | 2.1 ± 0.7 | 22 (54) | 2 (11) | 12 (55) | 12 (32) | 18 (46) | 6 (29) | 10 (48) | 2 (100) |
Data are expressed as means ± standard deviations or as numbers of patients with percentages in parentheses. Comparisons between groups were made by the χ2 or Fisher exact test for the categorical variables and the Student t test for the quantitative variables. A P value of <0.05 was considered statistically significant. The variables included in the multivariate analysis were age, epidemiology, viral load, PKRBD mutations, and ISDR mutations.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma glutamyltransferase.
Scheuer's grading of necroinflammatory activity, with slight modifications. Activity grade is periportal inflammation (score, 0 to 4) plus intralobular degeneration and focal necrosis (score, 0 to 4); the total score for activity could range from 0 to 8. Fibrosis stages are no fibrosis (0), periportal fibrous expansion without septum formation (1), periportal fibrous expansion with some septum formation (2), periportal fibrous expansion with septum formation (3), and cirrhosis (4).
Statistically significant difference between the values for SVR and NR patients (P = 0.03).
Logistic regression analysis of the values for SVR patients yielded an odds ratio of 3.2, a 95% confidence interval of 1 to 10.3, and a P value of 0.056.
Statistically significant difference between the values for EVR and non-EVR patients (P = 0.037).
Statistically significant difference between the values for SVR and NR patients (P = 0.001).
Logistic regression analysis of the values for SVR patients yielded an odds ratio of 9.9, a 95% confidence interval of 1.9 to 50.3, and a P value of 0.006.