Table 1.
Baseline patient demographics and pharmacokinetic outcomes of 8-hourly lopinavir/ritonavir-4:1
| All patients (N = 11) | Characteristics by adequate lopinavir Cmin ≥1 mg/L |
|||
|---|---|---|---|---|
| adequate trough achieved (N = 7; 64%) | adequate trough not achieved (N = 4; 36%) | P | ||
| Patient characteristics | ||||
| age (months), median (IQR) | 15.0 (12.6–28.8) | 19.5 (12.4–32.6) | 14.9 (13.7–21.9) | 0.85 |
| male, n (%) | 7 (64) | 5 (71) | 2 (50) | 0.47 |
| weight (kg), median (IQR) | 9.8 (8.2–10.7) | 10.2 (8.2–10.7) | 9.2 (8.2–10.9) | 0.57 |
| height (m), median (IQR) | 0.71 (0.70–0.81) | 0.71 (0.70–0.86) | 0.73 (0.70–0.81) | 0.85 |
| weight-for-age z score, median (IQR) | −1.5 (−2.6 to −0.6) | −1.5 (−2.7 to −0.6) | −1.4 (−2.2 to −0.7) | 0.78 |
| weight-for-height z score, median (IQR) | 0.1 (−0.6 to 0.8) | −0.1 (−0.6 to 0.8) | 0.4 (−0.6 to 0.8) | 0.71 |
| body surface area (m2), median (IQR) | 0.42 (0.39–0.50) | 0.42 (0.39–0.51) | 0.41 (0.39–0.47) | 0.57 |
| median CD4 (cells/mm3) (n = 9), median (IQR) | 1234 (813–1749) | 910 (434–1234) | 1764 (1192–2002) | 0.14 |
| median CD4% (%) (n = 9), median (IQR) | 13.7 (10.4–24.9) | 13.7 (13.6–24.5) | 19.1 (10.0–31.5) | 0.62 |
| viral load (log copies) (n = 9), median (IQR) | 4.2 (3.7–5.5) | 3.7 (3.3–4.0) | 5.7 (5.3–6.1) | 0.01 |
| rifampicin dose (mg/kg), median (IQR) | 13.5 (11.8–14.2) | 13.9 (11.8–14.8) | 12.9 (11.8–13.8) | 0.45 |
| lopinavir dose (mg/kg), median (IQR) | 21.5 (20.3–22.4) | 22.2 (21.5–22.6) | 20.3 (20.2–20.8) | 0.06 |
| lopinavir weight bands (kg), n (%) | ||||
| 6–9.9 | 6 (55) | 3 (43) | 3 (75) | 0.55 |
| 10–13.9 | 5 (45) | 4 (57) | 1 (25) | |
| NRTI backbone of ABC+3TC, n (%) | 11 (100) | |||
| Pharmacokinetic outcomes | ||||
| lopinavir pharmacokinetic parameters | ||||
| AUC2–10 (mg·h/L), median (IQR) | 48.7 (4.6–72.7) | 67.6 (48.7–119.1) | 2.7 (0.5–5.6) | 0.008 |
| Tmax (h), median (IQR) | 8 (2–10) | 4 (2–10) | 10 (6–10) | 0.32 |
| Cmax (mg/L), median (IQR) | 7.3 (2.0–13.4) | 10.9 (7.3- 14.5) | 1.2 (0.3–2.2) | 0.008 |
| Cmin (mg/L), median (IQR) | 3 (0.1–5.5) | 4.8 (3.0–10.6) | 0.03 (0–0.05) | 0.008 |
| Cmin <1 mg/L, n (%) | 4 (36) | |||
| ritonavir pharmacokinetic parameters | ||||
| AUC2–10 (mg·h/L) | 2.09 (0.41–3.34) | 3.01 (2.09–3.82) | 0.26 (0.06–0.47) | 0.008 |
| Tmax (h) | 10 (4–10) | 10 (4–10) | 7 (3–10) | 0.53 |
| Cmax (mg/L) | 0.39 (0.07–0.81) | 0.51 (0.39–0.81) | 0.05 (0.01–0.16) | 0.008 |
| Cmin (mg/L) | 0.11 (0.02–0.22) | 0.20 (0.11–0.23) | 0.01 (0.001–0.02) | 0.008 |
| Cmin <0.1 mg/L, n (%) | 5 (45) | 1 (14) | 4 (100) | 0.015 |