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Clinical impact of pharmacokinetic interactions between the HCV protease inhibitor simeprevir and frequently used concomitant medications

机译:HCV蛋白酶抑制剂中药代动力学相互作用的临床影响Simeprevir和经常使用的伴随药物

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Aims Direct‐acting antiviral agents (DAAs) for the treatment of hepatitis C (HCV) can be associated with drug–drug interactions (DDIs) with concomitant medications. The practical clinical implications of such DDIs are poorly understood. We assessed the clinical impact of possible pharmacokinetic (PK) interactions between simeprevir and frequently prescribed concomitant medications. Methods This post hoc analysis pooled data from nine studies which evaluated simeprevir (SMV)‐based interferon‐free HCV treatment. Three classes of frequently used concomitant medications of interest (CMOIs) were analysed [antihypertensive drugs (AHDs), anxiolytic drugs (AXDs) and lipid‐lowering drugs (LLDs)] and categorized as amber or green according to their DDI potential with SMV (green: no DDIs; amber: potential/known PK interactions). Concomitant medications not recommended to be coadministered with SMV were not included. The composite primary endpoint was defined as the frequency of either discontinuation, interruption or dose modification of the CMOI during 12?weeks of SMV treatment. Results Few patients met the composite endpoint in the various subgroups. Patients on amber CMOIs tended to experience CMOI modification more often (13.4–19.4%) than those on green CMOIs (3.1–10.8%). There was no difference in the frequency of adverse events between patients taking green and those taking amber CMOIs. Conclusions In this large pooled analysis, coadministration of the evaluated commonly prescribed medications with known or potential PK interactions with SMV was manageable and resulted in few adjustments of concomitant medications. Our method could serve as a blueprint for the evaluation of the impact of DDIs.
机译:目的是用于治疗丙型肝炎(HCV)的直接作用抗病毒剂(DAAs)可以与伴随药物的药物 - 药物相互作用(DDIS)相关。这种DDIS的实际临床意义知之甚少。我们评估了Simeprevir可能的药代动力学(PK)相互作用和经常规定的伴随药物的临床影响。方法采用九项研究汇总数据,评估SIMEPREVIR(SMV)的无干扰素HCV治疗。分析了感兴趣的三种常用伴随药物(CMOIS)(抗高血压药物(AHDS),抗抑郁药物(AXDS)和脂降低药物(LLD)],并根据其DDI电位与SMV(绿色)分类为琥珀色或绿色:没有DDI;琥珀色:潜在/已知的PK相互作用)。不包括不包括与SMV共同加入SMV的伴随药物。复合初级终点被定义为CMOI期间的停药,中断或剂量修饰的频率在12?周的SMV处理期间。结果少数患者在各个亚组中满足复合终点。琥珀色CMOIS的患者往往比绿色CMOIS(3.1-10.8%)更常见的(13.4-19.4%)经历CMOI改性。患者在绿色和琥珀色Cmois的患者之间不良事件的频率没有差异。结论在这一大型汇总分析中,具有已知或潜在的PK相互作用的评估的常用药物与SMV的共同分析是可管理的,导致伴随药物的少数调整。我们的方法可以作为评估DDI的影响的蓝图。

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