Table 2.
Pharmacokinetic parameters for nevirapine in parients given 200 mg twice daily
| Parameter | Men, group 1, mean (95% CI) | Women, group 2 mean (95% CI) | Pregnant women, group 3 mean (95% CI) | Difference group 1 vs. 2 % (95% CI) | T-test, P-valuea | Difference group 3 vs. 2 % (95% CI) | T-test, P-valuea |
|---|---|---|---|---|---|---|---|
| Cmin (ng ml−1) | 3343 (2907, 3779) | 3462 (2536, 4387) | 2925 (2312, 3538) | −3.4 (−13.9, 14.6) | NS | −18.4 (−9.4, −24.0) | NS |
| Cmax (ng ml−1) | 5221 (4267, 6175) | 5871 (4848, 6895) | 4505(3644, 5366) | −11.1(−12.0, − 10.5) | NS | −30.3 (−28.5, − 33.0) | 0.010 |
| AUCss (ng h−1 ml−1) | 50 789 (43 453, 58 125) | 57 045 (45 997, 68 093) | 44 579 (36 564, 52 594) | −11.0 (−14.6, − 5.5) | NS | −28.0 (−25.8, − 29.5) | 0.028 |
| t1/2 (h) | 15.02 (10.34, 19.70) | 14.09 (10.13, 18.05) | 15.16 (11.95, 18.37) | 6.6 (2.1, 9.1) | NS | 7.1 (15.5, 1.7) | NS |
| Cltot (ml min−1) | 69.9 (58.9, 80.9) | 65.5 (49.9, 81.2) | 82.1 (68.0, 96.2) | 6.7 (0.4, 18.0) | NS | 20.2 (26.6, 15.6) | 0.028 |
| Vd (l) | 86.6 (65.5, 107.8) | 72.9 (54.3, 91.5) | 106.3 (80.5, 132.0) | 18.8 (17.8, 20.6) | NS | 31.4 (32.5, 30.7) | 0.062 |
| AUCss mg−1 kg−1 (ng h−1 ml−1) | 15 679 (13 332, 18 025) | 19 325 (16 656, 21 994) | 15 722 (12 400, 19 045) | −18.9 (−20.0, − 18.0) | 0.036 | −23 (−15.5, −34.3) | NS |
| Dose/weight (mg kg−1) | 2.62 (2.50, 2.74) | 3.62 (3.19, 4.06) | 2.90 (2.70, 3.10) | −27.6 (−32.5, − 21.6) | <0.001−24.8 (−18.1, −140.0) | 0.002 |
a
Difference between the groups according the T-Test; CI = Confidence Interval; AUCss = area under the concentration-time curve at steady state; Cmin = minimum concentration; Cmax = maximum concentration; Cl tot = total clearance; t1/2 = elimination half-life; V d = volume of distribution.