Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults
Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults
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DOI：
10.1086/424009
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发表时间：
2004-10-01
影响因子：
11.8
通讯作者：
Scott, TR
中科院分区：
文献类型：
--
作者：
DeJesus, E;Herrera, G;Scott, TR
背景资料。齐多夫定、拉米夫定和依法韦仑组成了一种高效且耐受性良好的三联疗法，用于抗逆转录病毒初治患者。评估其他独特的核苷逆转录酶抑制剂(NRTI)组合对病毒的长期抑制作用是可取的。这项多中心、随机、双盲的非劣性临床试验比较了阿巴卡韦与齐多夫定、拉米夫定和伊法韦仑在649名未感染抗逆转录病毒的HIV感染者中的疗效和安全性。主要目标是比较48周内血浆HIV-1RNA水平低于或等于50拷贝/毫升的患者的比例。在48周的研究中，服用阿巴卡韦的患者中有70%的患者，而服用齐多夫定的患者中，有69%的患者的血浆HIV-1RNA水平低于或等于50拷贝/毫升(在有意治疗的暴露人群中)。病毒学失败的情况很少见(阿巴卡韦组为6%，齐多夫定组为4%)。有显著的CD4(+)细胞应答(阿巴卡韦组209个/mm(3)，齐多夫定组155个/mm(3))。安全性分析结果与预期一致。阿巴卡韦与拉米夫定和伊法韦仑联合使用时，提供了一种不逊于齐多夫定的有效和持久的抗逆转录病毒反应。
Background. Zidovudine, lamivudine, and efavirenz comprise a highly effective and well-tolerated triple regimen for antiretroviral-naive patients. Evaluating other unique nucleoside reverse-transcriptase inhibitor( NRTI) combinations for long-term viral suppression is desirable.Methods. This multicenter, randomized, double-blind noninferiority clinical trial compared the efficacy and safety of abacavir with that of zidovudine plus lamivudine and efavirenz in 649 antiretroviral-naive HIV-infected patients. The primary objective was a comparison of proportions of patients achieving plasma HIV-1 RNA levels less than or equal to50 copies/ mL through week 48 of the study.Results. At study week 48, 70% of patients in the abacavir group, compared with 69% in the zidovudine group, maintained confirmed plasma HIV-1 RNA levels of less than or equal to 50 copies/ mL ( in the intent-to-treat exposed population). Virologic failure was infrequent (6% in the abacavir group and 4% in the zidovudine group). There was a significant CD4(+) cell response (209 cells/mm(3) in the abacavir group and 155 cells/mm(3) in the zidovudine group). Safety profiles were as expected.Conclusion. Abacavir provided an effective and durable antiretroviral response that was noninferior to zidovudine, when combined with lamivudine and efavirenz.