Table 3.
Artemether and dihydroartemisinin pharmacokinetic parameters in HIV-1 infected patients who are antiretroviral (ARV)-naïve or on lopinavir-based antiretroviral therapy (ART), after artemether-lumefantrine dose 1 (0–8 hours) and dose 6 (60–68 hours)
| 0–8 hours | 60–68 hours | |||||
|---|---|---|---|---|---|---|
| ARV-Naïve group | Lopinavir group | p value | ARV-Naïve group | Lopinavir group | p value | |
| Artemether | ||||||
| Cmax (ng/mL) | 59.7 (37.8–88.9) | 85.8 (39.7–145) | 0. 16 | 11.9 (8.2–17.5) | 16.5 (7.2–50.5) | 0.35 |
| Tmax (h) | 1.5 (1.5–2.0) | 1.8 (1.5–3.0) | 0. 97 | 61.5 (61.5–62.0) | 61.5 (61.5–62.0) | 0. 84 |
| AUC(0-inf) (ng.h/mL) | 151.0 (110.7–220.6) | 220.0 (113.9–431.2) | 0.17 | 71.1 (45.5–114.2) | 93.8 (37.5–219.1) | 0. 37 |
| t1/2 (hr) | 1.5 (1.1–1.7) | 1.4 (0.9–1.6) | 0. 39 | 2.9 (1.8–5.4) | 3.0 (1.9–3.4) | 0. 68 |
| Dihydroartemisinin | ||||||
| Cmax (ng/mL) | 42.2 (31.8–63.1) | 77.5 (59.4–102) | 0.004 | 40.0 (31.2–66.7) | 65.8 (38.2–92.7) | 0.21 |
| Tmax (h) | 2.0 (1.5–4.0) | 2.0 (1.5–3.0) | 0.41 | 61.5 (61.5–62.0) | 61.6 (61.5–62.5) | 0.71 |
| AUC(0-inf) (ng.h/mL) | 123.8 (101.3–235.6) | 283.6 (178.1–340.7) | 0.001 | 165.7 (143.7–246.5) | 243.5 (145.1–305.0) | 0.27 |
| T1/2 (h) | 1.6 (1.3–2.1) | 1.4 (1.1–1.6) | 0. 07 | 2.0 (1.8–2.7) | 1.8 (1.5–2.0) | 0. 02 |
Values are reported as median (interquartile range [IQR]). Cmax, maximal concentration; Tmax, time at the maximal concentration; AUC (0-inf), area under the plasma concentration-time curve, from 0 h to infinity; t1/2, elimination half-life. Statistical significance (p values) calculated using the Kruskal-Wallis test