TABLE 5.
Multiple-dose pharmacokinetic parameters for NFV in HIV-infected infants reported in the literature
Reference | Age and wt | Dose (mg/kg/day) | No. of subjects | Elimination half-life (h) | CL/F (liters/h/kg) | V/F (liters/kg) | M8/NFV |
---|---|---|---|---|---|---|---|
Rongkavilit et al. (21) | 14 days | 30 BID | 6 | 3.3 | 1.05 | 5.5 | |
60 BID | 5 | 4.2 | 1.55 | 10.3 | |||
90 BID | 11 | 5.0 | 1.92 | 13.4 | |||
28 days | 30 BID | 6 | 4.7 | 1.73 | 10.5 | ||
60 BID | 5 | 4.2 | 1.90 | 14.7 | |||
90 BID | 11 | 4.8 | 2.43 | 18.7 | |||
Litalien et al. (13) | 2.3-8.5 mo | 109.4-172.4 BID or TID | 14 | NFV, 2.6; M8, 2.2 | 4.2 | 22.3 | 0.12-0.89a |
Capparelli et al. (4) | 15 days-2 yr | 75-110 BID or TID | 8 | 2.7 | 0.09b | ||
Capparelli et al.c | 0.8-21.1 yr | 90 TID | 7 | 1.87 | |||
Capparelli et al.d | ≤3 mo | 75 TID | 5 | 3.2 | |||
Krogstad et al. (12) | 3.6-22 mo | 69 TID | 19 | 0.8-1.8 | |||
Van Heeswijk et al. (27) | 2.1-10.8 yr | 90 BID or TID | 12 | 2.5-3.1 | 1-1.3 | 3.9-6 | |
Pai and Nahata (16) | 2-7 yr | 60 TID | 8 | 1.25 | |||
7-13 yr | 60 TID | 7 | 2.08 | ||||
Floren et al. (7) | 0.6-7 yr | 90 TID | 9 | 2.4 | 0.13-0.71a | ||
7.2-16 yr | 90 TID | 11 | 0.9 | ||||
3.4-11 yr | 110 BID | 6 | 1.2 | ||||
Bergshoeff et al. (3) | <2 yr | 87 TID | 7 | 2.8 | 0.31a | ||
≥2 yr | 84 TID | 17 | 1.9 | 0.29a | |||
Schuster et al. (22) | 2-14 yr | 18 | |||||
<25 kg | 90-111 TID | 8 | 1.72 | ||||
90-110 BID | 1.54 | ||||||
>25 kg | ≤90 TID | 10 | ≤2.30 | ||||
≤100 BID | ≤1.47 | ||||||
This study | 1.5-16.2 mo | 81-203 BID and TID | 18 | NFV, 4.3; M8, 2.04 | 2.13 | 12.3 | 0.1-0.96a,e |
0.64b |
Area under the concentration-time curve ratio.
Concentration ratio.
Abstr. 7th Conf. Retrovir. Opportunistic Infect., 2000.
40th ICAAC.
Computed from 19 kinetic values by a simple noncompartmental approach between two drug administrations.