Table 2.
Effect of HCV serostatus on buprenorphine and buprenorphine metabolite pharmacokinetic parameters.
| Pharmacokinetic Parameter | HCV Seropositive (n = 20) | HCV Seronegative (n = 29) | P-value |
|---|---|---|---|
| Buprenorphine | |||
| AUC0-24 (ng-h/ml) | 53.4 (5.9) | 40.5 (2.4) | .03 |
| Cl/F (L/h) | 425 (86) | 460 (45) | .70 |
| Cmax (ng/ml) | 7.2 (0.8) | 5.3 (0.4) | .02 |
| Tmax (h) | 1.0 (0.5–2.0) | 1.0 (0.5–2.0)) | .36 |
| C24 | 1.22 (0.17) | 0.94 (0.08) | .11 |
| Half-life (h) | 32.0 (3.7) | 27.7 (3.5) | .40 |
| Norbuprenorphine | |||
| AUC0-24 (ng*h/ml) | 72 (9.7) | 73 (7.3) | .95 |
| Cl/F (L/h) | 418 (120) | 274 (23) | .17 |
| Cmax (ng/ml) | 4.5 (0.5) | 4.7 (0.4) | .76 |
| Tmax (h) | 1.25 (0.5 – 6) | 1.5 (0.5 – 6) | .36 |
| C24 | 2.5 (0.3) | 2.4 (0.3) | .83 |
| Half-life (h) | 69.4 (8.8) | 68.6 (9.2) | .95 |
| Buprenorphine-3-Glucuronide | |||
| AUC0-24 (ng*h/ml) | 67 (20) | 29 (4.1) | .03 |
| Cl/F (L/h) | 799 (221) | 903 (139) | .68 |
| Cmax (ng/ml) | 9.5 (2.8) | 6.74 (0.9) | .29 |
| Tmax (h) | 1.0 (0.5–2) | 1.0 (0.5–2) | .39 |
| C24 | 0.49 (0.16) | 1.41 (0.57) | .07 |
| Norbuprenorphine-3-Glucuronide | |||
| AUC0-24 (ng*h/ml) | 426 (78) | 281 (24) | .05 |
| Cl/F (L/h) | 96 (36) | 69 (6) | .39 |
| Cmax (ng/ml) | 25.1 (4.1) | 21.1 (1.7) | .32 |
| Tmax (h) | 2 (1–12) | 2 (0.5–8) | .71 |
| C24 | 15.4 (3.0) | 9.1 (1.2) | .03 |
Note: Concentration data were normalized to a standard dose of 16 mg buprenorphine before analysis. Values are the mean (standard error of the mean), except that Tmax is given as median (range). The unpaired t-test was used to determine P-values for all parameters except Tmax, where the Mann-Whitney U test was used.