Class-sparing regimens for initial treatment of HIV-1 infection
Class-sparing regimens for initial treatment of HIV-1 infection
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DOI：
10.1056/nejmoa074609
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发表时间：
2008-05-15
影响因子：
158.5
通讯作者：
Mellors, John W.
中科院分区：
文献类型：
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作者：
Riddler, Sharon A.;Haubrich, Richard;Mellors, John W.
背景资料：对于人类免疫缺陷病毒1型（HIV-1）感染的患者，推荐使用依法韦仑或洛匹那韦-利托那韦加两种核苷逆转录酶抑制剂（NRTI）作为初始治疗，但这两种方案中哪一种疗效更好尚不清楚。Lopinavir利托那韦加依法韦仑的替代方案可能会防止与NRTIs.Methods：在一项开放标签研究中，我们比较了三种初始治疗方案：依法韦仑加两种NRTIs（依法韦仑组），Lopinavir利托那韦加两种NRTIs（Lopinavir利托那韦组），和Lopinavir利托那韦加依法韦仑（NRTIs保留组）。我们将757名中位CD 4计数为每立方毫米191个细胞和中位HIV-1 RNA水平为每毫升4.8 log（10）拷贝的患者随机分为三组。在中位随访112周时，依法韦仑组的病毒学失败时间长于洛匹那韦-利托那韦组（P=0.006），但NRTI保留组与其他两组的时间无显著差异。在第96周，血浆HIV-1 RNA拷贝数低于50/ml的患者比例在依法韦仑组为89%，在洛匹那韦-利托那韦组为77%，在NRTI保留组为83%（依法韦仑组和洛匹那韦-利托那韦组之间的比较P=0.003）。由于毒性作用，两组在停药时间上没有显著差异。在病毒学失败，抗逆转录病毒耐药突变是更频繁的NRTI保留组比在其他两个groups.Conclusions：病毒学失败是不太可能在依法韦仑组比洛匹那韦利托那韦组。NRTI保留方案的病毒学疗效与依法韦仑方案相似，但更可能与耐药性相关。（ClinicalTrials.gov编号，NCT 00050895。）。
Background: The use of either efavirenz or lopinavir-ritonavir plus two nucleoside reverse-transcriptase inhibitors (NRTIs) is recommended for initial therapy for patients with human immunodeficiency virus type 1 (HIV-1) infection, but which of the two regimens has greater efficacy is not known. The alternative regimen of lopinavir-ritonavir plus efavirenz may prevent toxic effects associated with NRTIs.Methods: In an open-label study, we compared three regimens for initial therapy: efavirenz plus two NRTIs (efavirenz group), lopinavir-ritonavir plus two NRTIs (lopinavir-ritonavir group), and lopinavir-ritonavir plus efavirenz (NRTI-sparing group). We randomly assigned 757 patients with a median CD4 count of 191 cells per cubic millimeter and a median HIV-1 RNA level of 4.8 log(10) copies per milliliter to the three groups.Results: At a median follow-up of 112 weeks, the time to virologic failure was longer in the efavirenz group than in the lopinavir-ritonavir group (P=0.006) but was not significantly different in the NRTI-sparing group from the time in either of the other two groups. At week 96, the proportion of patients with fewer than 50 copies of plasma HIV-1 RNA per milliliter was 89% in the efavirenz group, 77% in the lopinavir-ritonavir group, and 83% in the NRTI-sparing group (P=0.003 for the comparison between the efavirenz group and the lopinavir-ritonavir group). The groups did not differ significantly in the time to discontinuation because of toxic effects. At virologic failure, antiretroviral resistance mutations were more frequent in the NRTI-sparing group than in the other two groups.Conclusions: Virologic failure was less likely in the efavirenz group than in the lopinavir-ritonavir group. The virologic efficacy of the NRTI-sparing regimen was similar to that of the efavirenz regimen but was more likely to be associated with drug resistance. (ClinicalTrials.gov number, NCT00050895.).