Table 1.
Baseline Characteristics of the Study Patients, According to Study Group.*
| Characteristic | Randomly Assigned to T12PR24 (N = 162) | Randomly Assigned to T12PR48 (N = 160) | Nonrandomly Assigned to T12PR48 (N = 118) | Discontinued Treatment before Wk 20 (N = 100) |
|---|---|---|---|---|
| Age — yr | ||||
| Median | 51 | 50 | 51 | 52 |
| Range | 22–70 | 19–67 | 20–63 | 21–66 |
| Body-mass index† | ||||
| Median | 28 | 27 | 27 | 27 |
| Range | 18–53 | 19–49 | 19–54 | 19–44 |
| Distribution | ||||
| <25 | 44 (27) | 60 (38) | 35 (30) | 38 (38) |
| ≥25 to <30 | 56 (35) | 51 (32) | 49 (42) | 32 (32) |
| ≥30 | 61 (38) | 49 (31) | 34 (29) | 30 (30) |
| Missing data | 1 (1) | 0 | 0 | 0 |
| Male sex — no. (%) | 104 (64) | 97 (61) | 70 (59) | 54 (54) |
| Race — no. (%)‡ | ||||
| White | 135 (83) | 131 (82) | 86 (73) | 75 (75) |
| Black | 17 (10) | 17 (11) | 20 (17) | 19 (19) |
| Other | 10 (6) | 12 (8) | 12 (10) | 6 (6) |
| Hispanic or Latino ethnic group — no. (%)‡ | ||||
| Yes | 18 (11) | 11 (7) | 8 (7) | 17 (17) |
| No | 140 (86) | 146 (91) | 105 (89) | 82 (82) |
| Missing data | 4 (2) | 3 (2) | 5 (4) | 1 (1) |
| HCV genotype 1 subtype — no. (%)§ | ||||
| 1a | 115 (71) | 117 (73) | 84 (71) | 72 (72) |
| 1b | 46 (28) | 43 (27) | 33 (28) | 27 (27) |
| Unknown | 1 (1) | 0 | 1 (1) | 1 (1) |
| HCV RNA log10 — IU/ml¶ | 6.3±0.9 | 6.4±0.7 | 6.7±0.6 | 6.4±0.7 |
| HCV RNA level ≥800,000 IU/ml — no. (%)¶ | 124 (77) | 126 (79) | 108 (92) | 87 (87) |
| Stage of fibrosis and cirrhosis — no. (%) | ||||
| None or minimal fibrosis | 46 (28) | 48 (30) | 27 (23) | 26 (26) |
| Portal fibrosis | 78 (48) | 79 (49) | 49 (42) | 38 (38) |
| Bridging fibrosis | 20 (12) | 21 (13) | 30 (25) | 17 (17) |
| Cirrhosis | 18 (11) | 12 (8) | 12 (10) | 19 (19) |
Plus–minus values are means ±SD. None of the characteristics differed significantly between the randomized groups (P>0.05 for all comparisons). Patients received telaprevir (750 mg every 8 hours) for 12 weeks, as well as peginterferon alfa-2a (180 μg per week) and ribavirin (1000 or 1200 mg per day, according to body weight) for a total of either 24 weeks (T12PR24) or 48 weeks (T12PR48). Patients who had an extended rapid virologic response were randomly assigned to either the T12PR24 group or the T12PR48 group. Patients who did not have an extended rapid virologic response were nonrandomly assigned to the T12PR48 group. The remaining patients discontinued the treatment regimen before week 20 or nonrandom assignment. HCV denotes hepatitis C virus.
The body-mass index is the weight in kilograms divided by the square of the height in meters.
Race and ethnic group were self-reported and were not mutually exclusive. The “other” race category included patients self-identifying as Asian, American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, or other self-reported races, as well as 13 patients for whom local regulations did not permit asking about race or ethnic group.
HCV genotype and subtype were ascertained by means of line-probe assay (Inno-LiPA, Innogenetics).
HCV RNA levels were measured with the use of the COBAS TaqMan HCV assay (Roche Molecular Systems), which has a lower limit of quantification of 25 IU per milliliter and a lower limit of detection of approximately 10 to 15 IU per milliliter.