Table 1.
Patient characteristic | Value(s) for patients without cirrhosis treated with: |
Value(s) for patients with cirrhosis treated with: |
||||||
---|---|---|---|---|---|---|---|---|
Placebob (n = 14) | 100 mg deleobuvir (n = 9) | 200 mg deleobuvir (n = 9) | 400 mg deleobuvir (n = 9) | 800 mg deleobuvir (n = 9) | 1,200 mg deleobuvir (n = 10) | 400 mg deleobuvir (n = 8) | 600 mg deleobuvir (n = 5) | |
Age (yrs, mean ± SD) | 47.2 ± 9.1 | 50.3 ± 11.9 | 51.7 ± 8.5 | 52.3 ± 8.7 | 47.3 ± 12.7 | 46.8 ± 8.6 | 55.4 ± 7.0 | 56.2 ± 8.1 |
Body mass index (kg/m2, mean ± SD) | 24.7 ± 2.9 | 26.7 ± 3.6 | 24.9 ± 2.8 | 24.5 ± 1.8 | 26.2 ± 3.4 | 23.9 ± 3.1 | 25.8 ± 3.8 | 24.6 ± 1.4 |
Baseline HCV RNA (mean log10 ± SD) | 6.39 ± 0.77 | 6.14 ± 0.55 | 6.49 ± 0.53 | 6.59 ± 0.51 | 6.35 ± 0.68 | 6.47 ± 0.47 | 6.52 ± 0.47 | 6.38 ± 0.39 |
Sex (n) | ||||||||
No. of males | 9 | 8 | 6 | 8 | 7 | 10 | 6 | 4 |
No. of females | 5 | 1 | 3 | 1 | 2 | 0 | 2 | 1 |
Time since HCV diagnosis (yrs, mean ± SD) | 10.4 ± 8.0 | 9.9 ± 7.2 | 9.0 ± 5.2 | 11.8 ± 7.7 | 8.1 ± 5.9 | 9.5 ± 10.0 | 15.3 ± 5.2 | 11.9 ± 7.2 |
No. with indicated HCV genotype (by sequencing) | ||||||||
Subtype 1a | 8 | 4 | 3 | 6 | 2 | 6 | 2 | 1 |
Subtype 1b | 6 | 5 | 6 | 3 | 7 | 4 | 6 | 4 |
No. PegIFN-RBV naive | 4 | 1 | 2 | 3 | 3 | 2 | 1 | |
Prior PegIFN-RBV response | ||||||||
No. whose data were missing/not assessable | 2 | 3 | 1 | 0 | 0 | 1 | 3c | 2 |
No. of nonrespondersa | 3 | 5 | 3 | 4 | 1 | 3 | 3 | 3 |
No. with breakthrough | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
No. with relapse | 5 | 0 | 3 | 2 | 4 | 4 | 2 | 0 |
Total | 10 | 8 | 7 | 6 | 6 | 8 | 8 | 5 |
The 19 nonresponders without cirrhosis were 6 null responders, 5 partial responders, and 8 nonresponders of unknown type. Of the 6 nonresponders with cirrhosis, there were 4 null responders, 1 partial responder, and 1 nonresponder of unknown type.
Patients were randomized 3:1 between active treatment and placebo; the data from all patients randomized to placebo are combined in the table.
Includes the PegIFN-RBV-naive patient.