Cohn S E, Park J-G, Watts D H, Stek A, Hitti J, Clax P A, Yu S, Lertora J J L
Department of Medicine, University of Rochester Medical Center, Rochester, NY, USA.
Clin Pharmacol Ther. 2007 Feb;81(2):222-7. doi: 10.1038/sj.clpt.6100040. Epub 2006 Dec 27.
We conducted an open-label, steady-state pharmacokinetic (PK) study of drug interactions among HIV-infected women treated with depo-medroxyprogesterone acetate (DMPA) while on nucleoside analogues plus nelfinavir (N=21), efavirenz (N=17), or nevirapine (N=16); or nucleosides only or no antiretroviral therapy as a control group (N=16). PK parameters were estimated using non-compartmental analysis, with between-group comparisons of medroxyprogesterone acetate (MPA) PKs and within-subject comparisons of ARV PKs before and 4 weeks after DMPA dosing. Plasma progesterone levels were measured at baseline and at 2, 4, 6, 8, 10, and 12 weeks after DMPA dosing. There were no significant changes in MPA area under the concentration curve, peak or trough concentrations, or apparent clearance in the nelfinavir, efavirenz, or nevirapine groups compared to the control group. Minor changes in nelfinavir and nevirapine drug exposure were seen after DMPA, but were not considered clinically significant. Suppression of ovulation was maintained.
我们开展了一项开放标签的稳态药代动力学(PK)研究,以评估在接受醋酸甲羟孕酮(DMPA)治疗的HIV感染女性中,同时服用核苷类似物加奈非那韦(N = 21)、依非韦伦(N = 17)或奈韦拉平(N = 16)时的药物相互作用;或以仅服用核苷或不接受抗逆转录病毒治疗作为对照组(N = 16)。使用非房室分析估计PK参数,对醋酸甲羟孕酮(MPA)的PK进行组间比较,并对DMPA给药前及给药后4周的抗逆转录病毒药物(ARV)PK进行受试者内比较。在DMPA给药的基线以及给药后2、4、6、8、10和12周测量血浆孕酮水平。与对照组相比,奈非那韦、依非韦伦或奈韦拉平组的MPA浓度曲线下面积、峰浓度或谷浓度以及表观清除率均无显著变化。DMPA给药后,奈非那韦和奈韦拉平的药物暴露有轻微变化,但未被认为具有临床意义。排卵抑制得以维持。