Evaluation of sex differences of Fosamprenavir (with and without ritonavir) in HIV-infected men and women
Evaluation of sex differences of Fosamprenavir (with and without ritonavir) in HIV-infected men and women
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DOI：
10.1310/hct0806-371
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发表时间：
2007-11-01
影响因子：
--
通讯作者：
Currier, Judith S.
中科院分区：
文献类型：
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作者：
Hoffman, Risa M.;Umeh, Cibiamiwe C.;Currier, Judith S.
目的：最近对HIV-1感染妇女的研究表明，在自然史、抗逆转录病毒药物动力学、疗效和耐受性方面存在性别相关差异。本文分析了蛋白酶抑制剂（PI）福沙那韦（FPV）的三项关键试验，以期更好地了解有效性和安全性的潜在性别差异。方法：对三项FPV试验中700例受试者（26%为女性）的数据进行了事后描述性分析，以评价疗效、停药率和治疗相关不良事件方面的性别差异。结果如下：男性和女性的抗病毒反应相似，超过60%的治疗前受试者在48周达到病毒学抑制（< 400拷贝/mL）。在接受每日一次FPWr的背景下，有PI经验的女性因病毒学失败而停药的发生率最高（女性29%，男性8%）。女性的肝酶升高率一般略低，总胆固醇和甘油三酯异常较少。结论：没有重大的性别差异提供了保证，但这些试验中的女性人数很少，限制了得出结论的能力。未来的试验应该特别有把握度来检测安全性和有效性的性别差异。
Purpose: Recent studies focusing on HIV-1-infected women have suggested the existence of sex-related differences in natural history, antiretroviral pharmacokinetics, efficacy, and tolerability. This article analyzes three pivotal trials of the protease inhibitor (PI) fosamprenavir (FPV) with a view to providing a better understanding of potential sex differences in efficacy and safety. Method: A post hoc, descriptive analysis was performed on data from 700 subjects (26% women) in three trials of FPV to evaluate sex differences with regard to efficacy, rates of discontinuation, and treatment-related adverse events. Results: No major sex differences were found. Men and women had similarly good antiviral responses, with greater than 60% of treatment-ndive subjects achieving virologic suppression (< 400 copies/mL) at 48 weeks. PI-experienced women in CONTEXT receiving once-daily FPWr experienced the highest rates of discontinuations due to virologic failure (29% in women vs. 8% in men). Women generally had slightly lower rates of liver enzyme elevations and fewer abnormalities of total cholesterol and triglycerides. Conclusion: The absence of major sex differences provides reassurance, but the small number of women in these trials limited the ability to draw conclusions. Future trials should be specifically powered to detect sex differences in safety and efficacy.