Table 4.
Short-term virologic response to raltegravir at 400 mg once daily, based on raltegravir Ctrough
| Parameter | Value |
|
|---|---|---|
| Subjects with Ctrough of <0.021 mg/liter at time of pharmacokinetic study (n = 9) | Subjects with Ctrough of ≥0.021 mg/liter at time of pharmacokinetic study (n = 8) | |
| Baseline parametersa | ||
| Median (IQR) age (yr) | 42 (39–54) | 49 (44–52) |
| No. (%) of females | 4 (44) | 2 (25) |
| Median (IQR) body wt (kg) | 60.4 (55.9–67.8) | 55.8 (49.9–60.0) |
| Median (SD) CD4 count (cells/mm3) | 387 (213–525) | 434 (286–533) |
| No. of subjects receiving coadministered antiretrovirals | 4 subjects on 5 drugs, 5 subjects on 4 drugs | 4 subjects on 5 drugs, 4 subjects on 4 drugs |
| No. (%) of patients receiving coadministered antiretroviral(s)b | ||
| Lamivudine | 9 (100) | 8 (100) |
| Tenofovir | 4 (44) | 4 (50) |
| Darunavir-ritonavir | 4 (44) | 5 (63) |
| Other protease inhibitors | 5 (56) | 3 (37) |
| Parameters at time of pharmacokinetic study of raltegravir at 400 mg once dailya | ||
| Geometric mean (95% CI) AUC0-24 | 13.6 (9.7–19.0) | 19.5 (11.4–33.3) |
| Geometric mean (95% CI) Cmax | 6.1 (3.7–9.8) | 5.1 (2.5–10.4) |
| Geometric mean (95% CI) Ctrough | 0.014 (0.011–0.018) | 0.066 (0.024–0.184) |
| Parameters at time of last follow-up while on raltegravir at 400 mg once daily | ||
| Median (SD) duration on raltegravir at 400 mg once daily (wk) | 35 (34–39) | 37 (31–39) |
| No. of patients with confirmed HIV RNA load of >50 copies/ml/total no. of patients (%) | 2/9 (22) | 0/0 |
| Geometric mean (95% CI) Ctrough at last follow-up (n = 14) | 0.013 (0.005–0.035) | 0.046 (0.021–0.993) |
| No. of subjects with Ctrough of <0.021 mg/liter/total no. of subjects | 4/8 | 1/6 |
a
All subjects had HIV RNA loads of <50 copies/ml at baseline and at the time of pharmacokinetic study.
b
Other antiretrovirals were administered at standard doses.