TABLE 2.
Subject | Child-Pugh score | Estimated AUC0–∞ (ng · h/ml)b | AUC0–∞ ratio for healthy subjects:cirrhotic subjects | Recommended dose (mg) for equivalent exposure |
---|---|---|---|---|
Healthy subject | 0 | 9,790 | 1.00 | 1,200 |
Hepatic failure, Child-Pugh score group A | 5 | 26,125 | 0.37 | 450 |
6 | 29,392 | 0.33 | 450 | |
Hepatic failure, Child-Pugh score group B | 7 | 32,659 | 0.30 | 450 |
8 | 35,926 | 0.27 | 450 | |
9 | 39,193 | 0.25 | 300 | |
Hepatic failure, Child-Pugh score group Cc | 10 | 42,460 | 0.23 | 300 |
11 | 45,727 | 0.21 | 300 | |
12 | 48,994 | 0.20 | 300 | |
13 | 52,261 | 0.19 | 300 | |
14 | 55,528 | 0.18 | 300 | |
15 | 58,795 | 0.17 | 300 |
Proposed doses were rounded up to the nearest 150-mg dose to account for the amprenavir capsule strength.
Estimated for the 600-mg dose used in this study by the linear model y = 3,267x + 9,790. See Results for details.
No subjects with a Child-Pugh score of >12 were enrolled; therefore, extrapolation of results to subjects with higher Child-Pugh scores should be made with caution.