Table 3.
Summary Statistics for Raltegravir Sparse Pharmacokinetic Parameters by Gender and Race
| PK parameter | N | LS mean (95% CI)a | %CVb | Median | Min | Max |
|---|---|---|---|---|---|---|
| Female | ||||||
| GM all (nM) | 91 | 338 (273, 419) | 147 | 330 | 14 | 7,039 |
| GM C12 (nM) | 60 | 331 (251, 437) | 137 | 311 | 57 | 6,394 |
| Cmin (nM) | 91 | 99 (76, 128) | 196 | 96 | 6 | 4,566 |
| Male | ||||||
| GM all (nM) | 105 | 381 (312, 466) | 134 | 344 | 5 | 5,800 |
| GM C12 (nM) | 58 | 282 (212, 374) | 165 | 274 | 7 | 15,291 |
| Cmin (nM) | 105 | 83 (65, 105) | 197 | 80 | 5 | 5,800 |
| Black | ||||||
| GM all (nM) | 146 | 353 (298, 418) | 121 | 302 | 29 | 5,800 |
| GM C12 (nM) | 90 | 285 (227, 357) | 139 | 274 | 7 | 6,394 |
| Cmin (nM) | 146 | 93 (76, 115) | 189 | 89 | 6 | 5,800 |
| Nonblack | ||||||
| GM all (nM) | 50 | 385 (288, 514) | 203 | 409 | 5 | 7,039 |
| GM C12 (nM) | 28 | 385 (257, 578) | 186 | 336 | 62 | 15,291 |
| Cmin (nM) | 50 | 80 (56, 114) | 221 | 86 | 5 | 1,154 |
| Female vs. male comparison | GMR (90% CI) | |||||
| GM all female/GM all male | 0.89 (0.69, 1.13) | |||||
| GM C12h female/GM C12h male | 1.17 (0.84, 1.64) | |||||
| Cmin female/Cmin male | 1.20 (0.89, 1.61) | |||||
| Black vs. nonblack comparison | GMR (90% CI) | |||||
| GM all black/GM all nonblack | 0.92 (0.69, 1.22) | |||||
| GM C12h black/GM C12h nonblack | 0.74 (0.50, 1.09) | |||||
| Cmin black/Cmin nonblack | 1.17 (0.83, 1.64) | |||||
a
Back-transformed from log scale. LS mean, geometric least-squares mean.
b
%CV=100×sqrt[exp(s2)−1], where s2 is the observed variance on the natural log-scale.
Note: Raltegravir was administered with background antiretroviral therapy.
min, minimum; max, maximum; CI, confidence interval; CV, coefficient of variation; PK, pharmacokinetic; GM, geometric mean.