TABLE 3.
Elvucitabine (ELV) PK parameters estimated using IT2S population compartmental analyses
ELV regimen | Mean (CV [%]), median (range) [ratio (90% confidence interval)]
|
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---|---|---|---|---|---|---|---|---|---|---|---|---|
Peak 1% (%) | Day 1 lag 1 (h) | Day 1 lag 2 (h) | ka1 (h−1) | ka2 (h−1) | CL/F (liters/h) | Vc/F (L) | CLd/F (liters/h) | Vp/F (liters) | Vss/F (liters) | λZ-HL (h) | Residual variability (%) | |
Alone | 44.2 (47.4), 40.1 (9.9-99.0) | 1.60 (69.2), 1.39 (0.078-5.97) | 2.30 (46.0), 2.05 (0.607-6.38) | 0.183 (32.8), 0.192 (0.049-0.311) | 0.459 (21.0), 0.442 (0.275-0.679) | 17.8 (29.2), 16.1 (10.7-28.0) | 26.1 (67.5), 20.5 (6.9-73.8) | 16.3 (33.9), 15.5 (7.4-26.0) | 703 (30.5), 649 (336-1247) | 729 (29.9), 683 (376-1286) | 58.6 (12.0), 57.3 (46.8-75.7) | 9.1 |
With ritonavir | 53.9 (18.9), 56.2 (30.2-73.4) [134.7 (112.3-161.8)] | 2.96 (141.0), 2.43 (0.623-24.08) [166.2 (123.7-223.2)] | 3.54 (116.2), 2.85 (0.96-24.3) [126.3 (105.1-151.8)] | 0.127 (56.5), 0.141 (0.004-0.246) [61.4 (45.9-82.1)] | 0.483 (37.7), 0.450 (0.194-0.809) [102.3 (91.3-114.7)] | 29.2 (64.8), 20.2 (11.0-66.8) [135.0 (115.8-157.4)] | 24.8 (53.0), 26.8 (4.9-51.6) [96.6 (75.6-123.5)] | 19.3 (35.6), 18.1 (8.2-33.6) [116.0 (103.3-130.4)] | 897 (31.6), 825 (352-1435) [124.6 (111.9-138.8)] | 921 (30.3), 859 (375-1451) [123.7 (111.4-137.4)] | 60.2 (26.1), 58.9 (33.6-96.0) [101.3 (92.9-110.5)] | 9.2 |