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. 2013 Oct;57(10):4727–4735. doi: 10.1128/AAC.00565-13

Table 1.

Baseline demographics of patients (randomized and treated)

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
a

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.

b

Patients were randomized 3:1 between active treatment and placebo; the data from all patients randomized to placebo are combined in the table.

c

Includes the PegIFN-RBV-naive patient.