Nelfinavir, efavirenz, or both after the failure of nucleoside treatment of HIV infection.
Nelfinavir, efavirenz, or both after the failure of nucleoside treatment of HIV infection.
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DOI：
10.1056/nejm200108093450602
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发表时间：
2001-08-09
影响因子：
158.5
通讯作者：
Katzenstein, DA
中科院分区：
文献类型：
--
作者：
Albrecht, MA;Bosch, RJ;Katzenstein, DA
背景资料：尽管使用核苷逆转录酶抑制剂（核苷类似物）治疗，但仍患有人类免疫缺陷病毒（HIV）病毒血症的患者的最佳抗逆转录病毒治疗仍不确定。我们研究了治疗方案，结合两个核苷类似物，其中至少有一个是新的，与蛋白酶抑制剂nelfinavir，非核苷逆转录酶抑制剂efavirenz，或both.Methods：该研究包括195例患者谁曾与核苷类似物只治疗，并有血浆HIV-1型（HIV-1）RNA水平至少500拷贝每毫升。患者被随机分配接受，除了两种核苷类似物，奈非那韦，依法韦仑，或奈非那韦加依法韦仑。主要终点是第16周时血浆HIV-1 RNA水平低于500拷贝/毫升。次要终点是在第40周和第48周测量的HIV-1 RNA水平的复合物。在第16周、第40周和第48周，奈非那韦加依法韦仑组血浆HIV-1 RNA水平低于500拷贝/毫升的患者比例分别为81%和74%，依非韦伦组分别为69%和60%，奈非那韦组分别为64%和35%。四联疗法在短期（P=0.03）和长期（P=0.001）的病毒抑制率均高于奈非那韦三联疗法。与奈非那韦三联疗法相比，依法韦仑三联疗法的长期抑制率更高（P=0.004）。四联疗法也取得了较高的病毒学抑制率比三联疗法与依法韦仑（P=0.008）。结论：在HIV感染的患者以前治疗核苷类似物，奈非那韦加依法韦仑和至少一个新的核苷类似物的治疗方案比核苷类似物和奈非那韦或依法韦仑单独达到更高的病毒抑制率。（N Engl J Med 2001;345：398-407.版权所有（C）2001马萨诸塞州医学会。
Background: The optimal antiretroviral treatment for patients who have human immunodeficiency virus (HIV) viremia despite treatment with nucleoside reverse-transcriptase inhibitors (nucleoside analogues) remains uncertain. We studied treatment with regimens that combined two nucleoside analogues, at least one of which was new, with the protease inhibitor nelfinavir, the nonnucleoside reverse-transcriptase inhibitor efavirenz, or both.Methods: The study included 195 patients who had been treated with nucleoside analogues only, and had a plasma HIV type 1 (HIV-1) RNA level of at least 500 copies per milliliter. Patients were randomly assigned to receive, in addition to two nucleoside analogues, nelfinavir, efavirenz, or nelfinavir plus efavirenz. The primary end point was a plasma HIV-1 RNA level of less than 500 copies per milliliter at week 16. A secondary end point was the composite of the HIV-1 RNA levels measured at weeks 40 and 48.Results: At week 16 and at weeks 40 and 48, the proportions of patients in whom a plasma HIV-1 RNA level of less than 500 copies per milliliter was achieved were, respectively, 81 percent and 74 percent in the nelfinavir-plus-efavirenz group, 69 percent and 60 percent in the efavirenz group, and 64 percent and 35 percent in the nelfinavir group. Quadruple therapy resulted in a higher rate of viral suppression in both the short term (P=0.03) and the long term (P=0.001) than did triple therapy with nelfinavir. Triple therapy with efavirenz conferred a higher rate of long-term suppression than triple therapy with nelfinavir (P=0.004). Quadruple therapy also achieved a higher rate of virologic suppression than triple therapy with efavirenz (P=0.008).Conclusions: In HIV-infected patients previously treated with nucleoside analogues, treatment with nelfinavir plus efavirenz and at least one new nucleoside analogue achieves a higher rate of viral suppression than do regimens with nucleoside analogues and nelfinavir or efavirenz alone. (N Engl J Med 2001;345:398-407. Copyright (C) 2001 Massachusetts Medical Society.