TABLE 2.
Lumefantrine and desbutyl-lumefantrine pharmacokinetics in pregnant compared with nonpregnant HIV-positive subjects with ongoing efavirenz medication
| Drug and pharmacokinetic parameterb | Values fora: |
% difference | GMR (95% CI) | P valuec | |
|---|---|---|---|---|---|
| Pregnant women (n = 27) | Nonpregnant women (n = 25) | ||||
| Lumefantrine | |||||
| Cmax (ng/ml) | 6,750 (4,820–9,620) | 7,860 (4,450–9,400) | −14.07 | 1.03 (1.01–1.05) | 0.89 |
| C12 (ng/ml) | 2,870 (2,180–4,880) | 2,080 (1,190–2,970) | 37.87 | 1.75 (1.7–1.80) | 0.017 |
| C7 (ng/ml) | 279 (120–610) | 212 (133–400) | 31.64 | 1.16 (1.15–1.16) | 0.66 |
| CL (h) | 2.66 (1.73–4.32) | 4.23 (2.71–6.6) | −37.12 | 0.07 | |
| AUC0–96 (ng · h/ml) | 155,832 (102,400–214,011) | 90,594 (58,869–149,775) | 72.01 | 1.44 (1.41–1.46) | 0.03 |
| AUCt (ng · h/ml) | 191,441 (111,190–277,538) | 112,086 (70,865–177,053) | 70.80 | 1.62 (1.59–1.70) | 0.02 |
| Desbutyl-lumefantrine | |||||
| Cmax (ng/ml) | 162 (141–238) | 154 (92–207) | 5.56 | 0.33 | |
| C7 (ng/ml) | 13.2 (6.6–28.5) | 15.92 (7.99–24.1) | −17.21 | 0.42 | |
| AUC0–96 (ng · h/ml) | 3,824 (1,383–5,084) | 2,780 (1,360–5,214) | 37.53 | 0.79 | |
| MRd | 0.021 (0.013–0.034) | 0.036 (0.016–0.049) | −41.67 | 0.08 | |
Values are presented as the median (interquartile range). The values of the pharmacokinetic parameters were determined following the 6th dose of artemether-lumefantrine. Significant differences are in boldface.
Cmax, maximum plasma concentration; C12, plasma concentration at 12 h postdose; CL, clearance; AUC0–96, area under the concentration-time curve from 0 to 96 h; AUCt, area under the concentration-time curve at time t; MR, metabolic ratio, which is calculated from the ratio of the AUC for desbutyl-lumefantrine to the AUC for lumefantrine.
P values were determined using the Mann-Whitney U test.