Pharmacokinetic Interactions between Buprenorphine/Naloxone and Raltegravir in Subjects Receiving Chronic Buprenorphine/Naloxone Treatment

Background: Interactions between human immuno-deficiency virus (HIV) and opioid-dependence therapies can occur. Objectives: We sought to determine whether such interactions occurred between buprenorphine/naloxone and raltegravir. Methods: We performed a within-subject open-labeled pharmacokinetic and pharmacodynamic study in 12 HIV-seronegative subjects stabilized on at least 3 weeks of buprenorphine/naloxone therapy. Subjects underwent baseline and steady-state evaluation of the effect of raltegravir 400 mg BID on buprenorphine/naloxone parameters. Results: Compared with baseline values, buprenorphine AUC0–24 h (58.2 vs. 56.0 hr*ng/mL) and Cmax (7.37 vs. 6.60 ng/mL) did not differ significantly after achieving steady-state raltegravir. Similar analyses of norbuprenorphine, the primary metabolite of buprenorphine, demonstrated no significant difference after raltegravir administration. Naloxone concentrations were unchanged for AUC0–24 h (.595 vs. .581 hr*ng/mL), Cmax (.251 vs. .243 ng/mL) and Tmax (.75 v...