Table 3.
Artemether and dihydroartemisinin pharmacokinetic parametersa
| Parameterb | 0–8 h |
60–68 h |
||||
|---|---|---|---|---|---|---|
| Naive group | Nevirapine group | P value | Naïve group | Nevirapine group | P value | |
| Artemether | ||||||
| Cmax | ||||||
| Median (IQR) (ng/ml) | 59.7 (37.8–88.9) | 5.8 (3.9–21.7) | <0.0001 | 11.9 (8.2–17.5) | 5.2 (4.5–11.0) | 0.015 |
| CV (%) | 52.9 | 101.3 | 124.7 | 93.2 | ||
| Tmax | ||||||
| Median (IQR) (h) | 1.5 (1.5–2.0) | 2.0 (1.5–2.0) | 0.52 | 61.5 (61.5–62.0) | 61.5 (61.5–62.0) | 0.79 |
| CV (%) | 55.8 | 58.3 | 2.1 | 1.6 | ||
| AUC(0–inf) | ||||||
| Median (IQR) (ng·h/ml) | 151.0 (110.7–220.6) | 38.9 (25.5–98.7) | <0.0001 | 71.1 (45.5–114.2) | 31.9 (16.3–88.7) | 0.12 |
| CV (%) | 55.1 | 76.9 | 78.4 | 99.4 | ||
| t1/2 | ||||||
| Median (IQR) (h) | 1.5 (1.1–1.7) | 1.3 (0.9–1.9) | 0.52 | 2.9 (1.8–5.4) | 2.5 (1.9–3.7) | 0.61 |
| CV (%) | 44.2 | 77.6 | 96.7 | 43.8 | ||
| Dihydroartemisinin | ||||||
| Cmax | ||||||
| Median (IQR) (ng/ml) | 42.2 (31.8–63.1) | 47.3 (35.4–60.5) | 0.24 | 40.0 (31.2–66.7) | 34.5 (23.8–43.0) | 0.08 |
| CV (%) | 48.8 | 35.3 | 82.9 | 35.4 | ||
| Tmax | ||||||
| Median (IQR) (h) | 2.0 (1.5–4.0) | 2.0 (1.5–2.0) | 0.08 | 61.5 (61.5–62.0) | 61.5 (61.5–63.0) | 0.81 |
| CV (%) | 47.6 | 38.9 | 1.8 | 2.0 | ||
| AUC(0–inf) | ||||||
| Median (IQR) (ng·h/ml) | 123.8 (101.3–235.6) | 150.9 (126.1–208.9) | 0.21 | 165.7 (143.7–246.5) | 125.0 (94.6–165.1) | 0.01 |
| CV (%) | 46.8 | 29.5 | 66.4 | 44.4 | ||
| t1/2 | ||||||
| Median (IQR) (h) | 1.6 (1.3–2.1) | 1.6 (1.4–1.9) | 0.77 | 2.0 (1.8–2.7) | 1.5 (1.2–2.4) | 0.13 |
| CV (%) | 74.0 | 20.8 | 38.9 | 33.4 | ||
a
Values for HIV-1-infected patients who are antiretroviral na ï ive or on nevirapine-based antiretroviral therapy, after the 1st dose (0 to 8 h) and 6th dose (60 to 68 h). IQR, interquartile range.
b
CV, coefficient of variation; Cmax, maximal concentration; Tmax, time to maximum concentration; AUC(0-inf), area under the plasma concentration-time curve, from 0 h to infinity; t1/2, elimination half-life.