| Title | The pharmacokinetic and pharmacodynamic interactions between buprenorphine/naloxone and elvitegravir/cobicistat in subjects receiving chronic buprenorphine/naloxone treatment. |
| Publication Type | Journal Article |
| Year of Publication | 2013 |
| Authors | Bruce, Douglas R., P. Winkle, Jm Custodio, X. Wei, M. Rhee, Bp Kearney, S. Ramanathan, and Gerald H. Friedland |
| Journal | Journal of acquired immune deficiency syndromes (1999) |
| Date Published | 2013 Apr 17 |
| ISSN | 1944-7884 |
| Abstract | Interactions between HIV and opioid-dependence therapies are known to occur. We sought to determine if such interactions occurred between buprenorphine/naloxone and elvitegravir boosted with cobicistat.We performed a within subject open labeled pharmacokinetic and pharmacodynamic study in seventeen HIV-seronegative subjects stabilized on at least 2 weeks of buprenorphine/naloxone therapy. Subjects underwent baseline and steady-state evaluation of the effect of elvitegravir 150 mg qD boosted with 150 mg qD of cobicistat (EVG/COBI) on buprenorphine/naloxone (BUP/NLX) parameters. Safety was monitored throughout the study.Compared to baseline values, buprenorphine mean AUCtau(69.0 vs. 95.6 hr*ng/mL) and mean Cmax (8.4 vs. 9.3 ng/mL) increased significantly in the presence of EVG/COBI. Compared to baseline values, norbuprenorphine mean AUCtau(103.4 vs. 163.4 hr*ng/mL) and mean Cmax (6.9 vs. 9 ng/mL) also increased significantly after achieving steady-state EVG/COBI. Naloxone mean AUCtau(0.57 vs. 0.45 hr*ng/mL) and mean Cmax (0.25 vs. 0.16 ng/mL) decreased after the addition of EVG/COBI. The AUCtau, Cmax and Ctau of elvitegravir and cobicistat did not significantly differ from historical controls. Opioid withdrawal or overdose was not observed among subjects in this study.The addition of EVG/COBI to stabilized patients receiving BUP/NLX modestly increased buprenorphine and norbuprenorphine levels without affecting the opioid pharmacodynamics. |
| DOI | 10.1016/j.socscimed.2013.03.020 |
| Alternate Journal | J. Acquir. Immune Defic. Syndr. |
