Table 2.
Abacavir pharmacokinetic parameters
| PK parameter | Study (subdivided by age group) |
Evaluable patients, n |
GM (95% CI) twice-daily |
GM (95% CI) once-daily |
GMR (90% CI) once-daily versus twice-daily |
Reference |
|---|---|---|---|---|---|---|
| AUC0–24, h•mg/l | PENTA 15 | 18 | 10.85 (8.89–13.24) | 11.57 (9.89–13.53) | 1.07 (0.92–1.23) | – |
| 3–<12 months | 4 | 12.68 (6.52–24.64) | 15.90 (8.86–28.52) | 1.25(1.12–1.41) | – | |
| 12–<24 months | 6 | 13.89 (10.40–18.54) | 10.60 (7.68–14.63) | 0.76 (0.56–1.05) | – | |
| 24–<36 months | 8 | 8.34 (6.27–11.08) | 10.53 (8.87–12.50) | 1.26 (1.07–1.48) | – | |
| PENTA 13 | 14 | 9.91 (8.26–11.89)a | 13.37 (11.80–15.16)a | 1.35 (1.19–1.54) | [17] | |
| 2–6 years | 9 | 9.27 (7.06–12.18)a | 13.55 (11.19–16.42)a | – | – | |
| >6–13 years | 5 | 11.17 (8.76–14.24)a | 13.06 (10.91–15.63)a | – | – | |
| CAL102120b | 27 | 7.90 (6.66–9.39) | 8.52 (7.23–10.04) | 1.08(1.02–1.15) | [22] | |
| CL/F/kg, l/h•kg | PENTA 15 | 18 | 1.47 (1.21–1.79) | 1.38 (1.17–1.62) | 0.94 (0.81–1.08) | – |
| 3–<12 months | 4 | 1.23 (0.61–2.48) | 0.97 (0.52–1.81) | 0.79 (0.71–0.88) | – | |
| 12–<24 months | 6 | 1.17 (0.94–1.46) | 1.52 (1.11–2.09) | 1.30 (0.97–1.76) | – | |
| 24–<36 months | 8 | 1.91 (1.44–2.53) | 1.52 (1.29–1.78) | 0.79 (0.66–0.95) | – | |
| PENTA 13 | 14 | 1.58 (1.30–1.93)a | 1.16(1.01–1.34)a | 0.73 (0.64–0.84) | [17] | |
| 2–6 years | 9 | 1.80(1.37–2.36)a | 1.21 (1.00–1.47)a | – | – | |
| >6–13 years | 5 | 1.26 (0.96–1.64)a | 1.08 (0.81–1.44)a | – | – | |
| CAL102120b | 27 | 1.09 (0.91–1.29) | 1.01 (0.86–1.19) | 0.93 (0.86–1.00) | [22] | |
| Cmax, mg/l | PENTA 15 | 1.38 (1.17–1.62) | 4.68 (3.86–5.67) | 2.04(1.73–2.42) | – | |
| 3–<12 months | 4 | 2.43 (1.37–4.31) | 5.89 (2.83–12.26) | 2.42 (1.64–3.59) | – | |
| 12–<24 months | 6 | 3.18 (2.24–4.52) | 5.29 (3.70–7.56) | 1.66 (1.12–2.46) | – | |
| 24–<36 months | 7c | 1.67 (1.10–2.53) | 3.69 (2.95–4.61) | 2.21 (1.74–2.80) | – | |
| PENTA 13 | 14 | 2.14(1.79–2.56)a | 4.80 (4.04–5.71)a | 2.25 (1.83–2.77) | [17] | |
| 2–6 years | 9 | 1.94(1.50–2.51)a | 5.07 (3.92–6.56)a | – | – | |
| >6–13 years | 5 | 2.54 (2.00–3.22)a | 4.36 (3.39–5.60)a | – | – | |
| CAL102120b | 27 | 1.84(1.58–2.15) | 3.85 (3.34–4.42) | 2.09 (1.88–2.32) | [22] | |
| Cmin, mg/l | PENTA 15 | 17d | 0.03 (<0.015–0.08)e | <0.015(<0.015–0.07)e | N/A | – |
| T1/2, h | PENTA 15 | 18 | 1.66 (0.99–2.95)e | 2.15(l.40–4.98)e | N/A | – |
a
90% confidence interval (CI).
b
Adult study.
c
One child excluded because of a missing 1 h plasma concentration on the first pharmacokinetic (PK) sampling day.
d
One child excluded because of a missing 24 h plasma concentration on the second PK sampling day.
eMedian (range). AUC0–24, daily area under the plasma concentration–time curve; CL/F/kg, apparent oral clearance relative to body weight; Cmax, maximum plasma concentration; Cmin, minimum plasma concentration; GM, geometric mean; GMR, geometric mean ratio; N/A, not applicable; T1/2, elimination half-life.