Table 4.
Comparison of efavirenz and nelfinavir pharmacokinetic characteristics at week 56 with the proportion of children with HIV RNA ≤ 400 and > 400 copies/ml at week 48
| AUC24 (mg h/l) |
C24(mg/l) |
Cmax (mg/l) |
CL/F (l/h/kg) | % Δ CL/F weeks 2–56 |
No. at target AUC (%) |
|
|---|---|---|---|---|---|---|
| Efavirenz pharmacokinetic characteristics (mean and range) at week 56 | ||||||
| Plasma HIV RNA at week 48 (N) | ||||||
| ≤ 400 copies/ml (n=27) | 68 (25–176) | 1.66 (0.20–6.20) | 4.55 (1.50–9.00) | 0.24 (0.05–0.73) | 34 (−45–181) | 14 (52%) |
| >400 copies/ml (n=7) | 64 (9–148) | 1.58 (BLQ–4.40) | 3.74 (0.90–6.80) | 0.37 (0.08–1.07) | 63 (−75–227) | 2 (29%) |
| P-value | 0.55 | 0.97 | 0.34 | 0.39 | 0.33 | 0.41* |
| CD4 cell difference from weeks 0 to 48 | ||||||
| P-value | 0.12 | 0.73 | 0.07 | 0.32 | 0.24 | |
|
AUC8 (mg h/l) |
C8 (mg/l) |
Cmax (mg/l) |
CL/F (l/h/kg) |
% Δ CL/F week 2–56 |
No. at AUC target (%) |
|
| Nelfinavir pharmacokinetic characteristics (mean and range) at week 56 | ||||||
| Plasma HIV RNA at week 48 (N) | ||||||
| ≤ 400 copies/ml (n=27) | 16 (4–34) | 0.8 (BLQ–3.8) | 3.0 (1.2–6.0) | 1.80 (0.40–5.60) | 80 (−33–475) | 22 (81%) |
| > 400 copies/ml (n=6)a | 14 (5–27) | 0.6 (BLQ–2.0) | 3.2 (1.2–4.8) | 2.96 (0.86–5.00) | 91 (−53–258) | 3 (50%) |
| P-value | 0.44 | 0.42 | 0.85 | 0.20 | 0.78 | 0.14* |
| CD4 cell difference from weeks 0 to 48 | ||||||
| P-value | 0.11 | 0.52 | 0.31 | 0.05 | 0.01 | |
AUC24, area under the plasma concentration–time curve from time 0 to 24 h post-dose; AUC8, area under the plasma concentration–time curve from time 0 to 8 h post-dose; BLQ, below the limit of quantitation; C24, measured concentration 24 h post-dose; C8, measured concentration 8 h post-dose; HIV, human immunodeficiency virus; CL/F, apparent oral clearance; Cmax, observed maximum concentration.
All P-values are Wilcoxon rank-sum test except those designated with an *, which is from the Fisher‘s Exact test.
a
One AUC for nelfinavir was not evaluable in the > 400copies/ml group.