The pharmacokinetic and pharmacodynamic interactions between buprenorphine/naloxone and elvitegravir/cobicistat in subjects receiving chronic buprenorphine/naloxone treatment.
The pharmacokinetic and pharmacodynamic interactions between buprenorphine/naloxone and elvitegravir/cobicistat in subjects receiving chronic buprenorphine/naloxone treatment.
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在接受长期丁丙诺啡/纳洛酮治疗的受试者中，丁丙诺啡/纳洛酮和埃替拉韦/考比司他之间的药代动力学和药效学相互作用。
DOI：
10.1097/qai.0b013e3182961d31
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发表时间：
2013
期刊：
影响因子：
--
通讯作者：
Friedland,GeraldH
中科院分区：
文献类型：
--
作者：
Bruce,RobertDouglas;Winkle,Peter;Custodio,JosephM;Wei,LilianXuelian;Rhee,MartinS;Kearney,BrianP;Ramanathan,Srinivasan;Friedland,GeraldH
背景：众所周知，艾滋病毒和阿片类药物依赖疗法之间存在相互作用。我们试图确定是否发生这种相互作用之间的丁丙诺啡/纳洛酮和elvitegravir加强与cobicistat.Methods：我们进行了一项受试者内的开放标记的药代动力学和药效学研究，在17个HIV血清阴性受试者稳定至少2周的丁丙诺啡/纳洛酮治疗。受试者接受了基线和稳态评价，评价了埃替拉韦150 mg每日一次与150 mg每日一次可比司他（EVG/COBI）联合加强治疗对丁丙诺啡/纳洛酮参数的影响。结果：与基线值相比，在EVG/COBI存在下，丁丙诺啡的平均AUC tau（69.0 vs 95.6 hr* ng/mL）和平均Cmax（8.4 vs 9.3 ng/mL）显著增加。与基线值相比，达到稳态EVG/COBI后，去甲丁丙诺啡的平均AUC tau（103.4 vs 163.4 hr* ng/mL）和平均Cmax（6.9 vs 9 ng/mL）也显著增加。加入EVG/COBI后，纳洛酮平均AUC tau（0.57 vs 0.45 hr* ng/mL）和平均Cmax（0.25 vs 0.16 ng/mL）降低。EVG和cobicistat的AUC tau、Cmax和C tau与历史对照无显著差异。阿片类药物戒断或过量之间没有观察到subjects in this study.Conclusion：除了EVG/COBI稳定的患者接受丁丙诺啡/纳洛酮适度增加丁丙诺啡和降丁丙诺啡水平，而不影响阿片类药物的药效学。
Background: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.Methods:We performed a within-subject open-labeled pharmacokinetic and pharmacodynamic study in 17 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 once daily boosted with 150 mg once daily of cobicistat (EVG/COBI) on buprenorphine/naloxone parameters. Safety was monitored throughout the study.Results:Compared with baseline values, buprenorphine mean AUC tau (69.0 versus 95.6 hr* ng/mL) and mean C max (8.4 versus 9.3 ng/mL) increased significantly in the presence of EVG/COBI. Compared with baseline values, norbuprenorphine mean AUC tau (103.4 versus 163.4 hr* ng/mL) and mean C max (6.9 versus 9 ng/mL) also increased significantly after achieving steady state EVG/COBI. Naloxone mean AUC tau (0.57 versus 0.45 hr* ng/mL) and mean C max (0.25 versus 0.16 ng/mL) decreased after the addition of EVG/COBI. The AUC tau, C max and C tau of EVG and cobicistat did not significantly differ from historical controls. Opioid withdrawal or overdose was not observed among subjects in this study.Conclusion:The addition of EVG/COBI to stabilized patients receiving buprenorphine/naloxone modestly increased buprenorphine and norbuprenorphine levels without affecting the opioid pharmacodynamics.
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