TABLE 4.
Effect of tenofovir on buprenorphine and buprenorphine metabolites in plasma
| Pharmacokinetic parameter | Pre-tenofovir | Post-tenofovir | p value |
|---|---|---|---|
| Buprenorphine | |||
| AUC0–24 (ng h/ml) | 36.8 (5.4) | 40.7 (6.2) | 0.42 |
| Cl/F (L/h) | 527 (77) | 467 (61) | 0.26 |
| Cmax (ng/ml) | 4.72 (1.03) | 5.64 (1.18) | 0.21 |
| Tmax (h) | 1.5 (0.5–2) | 1.25 (0.5–4) | NS |
| Cmin (ng/ml) | 0.94 (0.17) | 0.94 (0.17) | 0.99 |
| Norbuprenorphine | |||
| AUC0–24 (ng h/ml) | 47.9 (8.4) | 55.3 (9.4) | 0.29 |
| Cl/F (L/h) | 425 (61) | 351 (45) | 0.19 |
| Cmax (ng/ml) | 3.54 (0.70) | 3.95 (0.68) | 0.41 |
| Tmax (h) | 1.75 (1–6) | 1.5 (1–4) | NS |
| Cmin (ng/ml) | 1.65 (0.32) | 1.70 (0.28) | 0.85 |
| Buprenorphine-3-glucuronide | |||
| AUC0–24 (ng h/ml) | 35.7 (14.0) | 26.7 (5.6) | 0.49 |
| Cl/F (L/h) | 1,106 (311) | 1,100 (339) | 0.96 |
| Cmax (ng/ml) | 7.32 (1.93) | 8.82 (1.74) | 0.29 |
| Tmax (h) | 0.75 (0.5–12) | 0.5 (0.5–1.5) | NS |
| Cmin (ng/ml) | 0.60 (0.23) | 0.50 (0.12) | 0.54 |
| Norbuprenorphine-3-glucuronide | |||
| AUC0–24 (ng h/ml) | 198 (26) | 204 (37) | 0.83 |
| Cl/F (L/h) | 97 (15) | 93 (11) | 0.82 |
| Cmax (ng/ml) | 17.0 (2.6) | 16.0 (3.2) | 0.68 |
| Tmax (h) | 2.0 (1.5–6) | 1.75 (1–6) | NS |
| Cmin (ng/ml) | 6.04 (0.92) | 5.99 (1.14) | 0.97 |
Note: For pharmacokinetics analyses of the effect of NRTIs on buprenorphine: values are the mean (standard error of the mean) for 10 subjects who participated in both sessions, except that Tmax is given as median (range). Student's paired t-test was used to determine p-values for all parameters except Tmax, where the Wilcoxon test was used.