Influence of Ritonavir, and Lopinavir/ritonavir on fenofibrate pharmacokinetics

所有13例受试者均已完成本药代动力学研究。目前正在分析本研究的药代动力学样本;然而，迄今为止尚无可用结果。关于安全性，1例受试者发生继发于洛匹那韦/利托那韦（LPV/r）治疗的3级转氨酶升高，在研究完成后停药时消退。这导致向IRB提交了2份严重不良事件报告（包括随访报告，解释了转氨酶已消退）。值得注意的是，在我们的研究对象中没有明显的转氨酶升高的重复问题。一名受试者出现1级消化不良和腹胀;另一名受试者出现1级潮红和2级便秘;第三名受试者出现1级头痛和厌食。这些不良事件可能与研究药物相关。最后，1例受试者发生了2级总胆固醇升高（从基线时的198 mg/dL升高至275 mg/dL），这在研究结束时的安全性实验室中观察到，可能是由于洛匹那韦-利托那韦给药所致。到目前为止，在本研究中未发现其他胆固醇升高。

All thirteen subjects have completed this pharmacokinetic study. Pharmacokinetic samples from this study are currently being analyzed; however, to date there are no results available. With regard to safety, one subject experienced Grade 3 transaminitis secondary to treatment with lopinavir/ritonavir (LPV/r) that resolved when the drug was withdrawn secondary to study completion. This resulted in 2 Serious Adverse Event reports to the IRB (including the follow-up report, explaining that the transaminitis resolved). Of note, we have had no repeat problems of marked transaminitis in our study subjects. One subject experienced Grade 1 indigestion and bloating; another experienced Grade 1 flushing and Grade 2 constipation; and a third subject experienced Grade 1 headache and anorexia. These adverse events were possibly related to the study medications. Lastly, one subject experienced a Grade 2 increase in total cholesterol (from 198 mg/dL at baseline to 275 mg/dL) that was noted at end-of-study safety labs and likely due to lopinavir-ritonavir administration. No other increases in cholesterol have been noted thus far in this study.