TABLE 3.
Comparison of predose (and 24 h for QD) values for ZDV and 3TC metabolites on QD and BID regimens collapsed over order of administration
| Variable | Dosing regimen | n | <LLOQ (n)a | Medianb (95% CI) | CVc (%) | P (dose effect)d |
|---|---|---|---|---|---|---|
| ZDV | QD | 27 | 5 | 23.5 (12.1-40.2) | 191.1 | 0.560 |
| BID | 26 | 3 | 23.5 (8.7-40.8) | 251.8 | ||
| ZDV-MP | QD | 27 | 2 | 76.2 (57.7-131.5) | 183.0 | 0.666 |
| BID | 26 | 2 | 75.3 (32.4-172.6) | 153.8 | ||
| ZDV-DP | QD | 27 | 4 | 11.5 (9.2-19.1) | 108.7 | 0.594 |
| BID | 26 | 1 | 12.2 (7.7-22.9) | 90.2 | ||
| ZDV-TP | QD | 27 | 3 | 9.3 (6.4-12.9) | 74.2 | 0.056 |
| BID | 26 | 3 | 15.4 (7.7-23.6) | 96.5 | ||
| 3TC | QD | 26 | 2 | 302 (204-441) | 195.8 | 0.142 |
| BID | 27 | 1 | 437 (284-632) | 113.6 | ||
| 3TP-MP | QD | 26 | 2 | 282 (205-390) | 92.8 | 0.107 |
| BID | 27 | 2 | 396 (238-529) | 129.8 | ||
| 3TC-DP | QD | 26 | 1 | 1,934 (1,359-2,476) | 87.5 | 0.170 |
| BID | 27 | 1 | 2,393 (1,194-2,931) | 92.5 | ||
| 3TC-TP | QD | 25 | 1 | 1,115 (724-2,445) | 90.1 | 0.090 |
| BID | 27 | 1 | 2,163 (671-3,790) | 97.3 | ||
| 24 h | QD | |||||
| ZDV | 27 | 2 | 23.6 (11.4-38.4) | 134.3 | ||
| ZDV-MP | 27 | 0 | 60.5 (38.8-84.4) | 107.3 | ||
| ZDV-DP | 27 | 2 | 11.1 (7.9-19.9) | 79.5 | ||
| ZDV-TP | 27 | 4 | 9.8 (4.9-13.2) | 84.2 | ||
| 3TC | 27 | 3 | 262 (208-452) | 80.5 | ||
| 3TC-MP | 27 | 1 | 353 (225-401) | 62.8 | ||
| 3TC-DP | 27 | 0 | 1,684 (932-2,683) | 63.2 | ||
| 3TC-TP | 27 | 1 | 1,315 (988-2,463) | 88.0 |
a
That is, the number of measurements where one-half the lower limit of quantification (LLOQ) was imputed.
b
Median and 95% CI reported in fmol/106 cells for ZDV and in pmol/106 cells for 3TC.
c
CV, coefficient of variation.
d
Significance value as determined by the Wilcoxon rank-sum test for differences in median values on the QD versus the BID regimen.