HLA-B*5701 screening for hypersensitivity to abacavir

HLA-B*5701 screening for hypersensitivity to abacavir
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DOI:
10.1056/nejmoa0706135
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发表时间:
2008-02-07
影响因子:
158.5
通讯作者:
Benbow, Alastair
Benbow, Alastair
中科院分区:
医学1区
文献类型:
--
作者:
Mallal, Simon;Phillips, Elizabeth;Benbow, Alastair

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背景:对阿巴卡韦的超敏反应与HLA-B*5701等位基因的存在密切相关。本研究的目的是建立前瞻性的HLA-B*5701筛选,以防止过敏反应abacavir.Methods的有效性:这双盲,前瞻性,随机研究涉及1956例来自19个国家,谁感染了人类免疫缺陷病毒1型,谁以前没有收到abacavir。我们随机分配患者进行前瞻性HLA-B*5701筛查,排除阿巴卡韦治疗的HLA-B*5701阳性患者(前瞻性筛查组),或接受阿巴卡韦使用的标准治疗方法,而不进行前瞻性HLA-B*5701筛查(对照组)。所有开始阿巴卡韦治疗的患者均观察6周。为了免疫学确认,并提高特异性,阿巴卡韦过敏反应的临床诊断,我们进行了表皮斑贴试验与abacavir.Results的使用:HLA-B*5701的患病率为5.6%(109 1956例)。在接受阿巴卡韦治疗的患者中,72%是男性,84%是白色,18%以前没有接受过抗逆转录病毒治疗。筛查消除了免疫学证实的超敏反应(前瞻性筛查组0%对对照组2.7%,P
Background: Hypersensitivity reaction to abacavir is strongly associated with the presence of the HLA-B*5701 allele. This study was designed to establish the effectiveness of prospective HLA-B*5701 screening to prevent the hypersensitivity reaction to abacavir.Methods: This double-blind, prospective, randomized study involved 1956 patients from 19 countries, who were infected with human immunodeficiency virus type 1 and who had not previously received abacavir. We randomly assigned patients to undergo prospective HLA-B*5701 screening, with exclusion of HLA-B*5701-positive patients from abacavir treatment (prospective-screening group), or to undergo a standard-of-care approach of abacavir use without prospective HLA-B*5701 screening (control group). All patients who started abacavir were observed for 6 weeks. To immunologically confirm, and enhance the specificity of, the clinical diagnosis of hypersensitivity reaction to abacavir, we performed epicutaneous patch testing with the use of abacavir.Results: The prevalence of HLA-B*5701 was 5.6% (109 of 1956 patients). Of the patients receiving abacavir, 72% were men, 84% were white, and 18% had not previously received antiretroviral therapy. Screening eliminated immunologically confirmed hypersensitivity reaction (0% in the prospective-screening group vs. 2.7% in the control group, P