raltegravir治疗艾滋病的临床疗效和安全性的5年BENCHMRK研究:两个随机的最终结果,安慰剂对照试验。
文章的细节
-
引用
复制到剪贴板 -
Eron JJ,库珀哒,Steigbigel RT, Clotet B, Gatell JM, Kumar PN Rockstroh JK, Schechter M,马科维茨M, Yeni P, Loutfy先生,Lazzarin, Lennox杰,Strohmaier公里,Wan H,巴纳德RJ阮,Teppler H
raltegravir治疗艾滋病的临床疗效和安全性的5年BENCHMRK研究:两个随机的最终结果,安慰剂对照试验。
柳叶刀感染说。2013年7月,13 (7):587 - 96。doi: 10.1016 / s1473 - 3099 (13) 70093 - 8。2013年5月7日Epub。
- PubMed ID
-
23664333 (在PubMed]
- 文摘
-
背景:两个随机、安慰剂对照trials-BENCHMRK-1 BENCHMRK-2-investigated raltegravir的疗效和安全性,hiv - 1整合酶strand-transfer抑制剂。我们报告的最终结果BENCHMRK-1和BENCHMRK-2总和的3年(双盲的最后阶段)和5年(的研究)。方法:Integrase-inhibitor-naive艾滋病患者抗三个类的药物和抗逆转录病毒治疗失败被录取。患者被随机分配(2:1)raltegravir每天两次400毫克或安慰剂,两个优化背景治疗。病人和调查人员掩蔽治疗分配到156年一周,之后,所有患者提供非盲raltegravir直到240年周。之前评估的主要终点是在16周。我们评估长期疗效端点的HIV病毒载量患者的比例每毫升不到50份,不到400拷贝/毫升,CD4细胞计数和平均变化,在156年和240年周。结果:1012名患者筛查包容。462人接受raltegravir和237与安慰剂。在156周,51% raltegravir组与安慰剂组的22% (non-completer列为失败)病毒载量低于50份每毫升和54%和23%的病毒载量低于400拷贝/毫升。意思是CD4细胞计数增加(由观察故障分析方法)是164细胞/ muL与63细胞/ muL。 After week 156, 251 patients (54%) from the raltegravir group and 47 (20%) from the placebo group entered the open-label raltergravir phase; 221 (47%) versus 44 (19%) completed the entire study. At week 240, viral load was less than 50 copies per mL in 193 (42%) of all patients initially assigned to raltegravir and less than 400 copies per mL in 210 (45%); mean CD4 cell count increased by 183 cells per muL. Virological failure occurred in 166 raltegravir recipients (36%) during the double-blind phase and in 17 of all patients (6%) during the open-label phase. The most common drug-related adverse events at 5 years in both groups were nausea, headache, and diarrhoea, and occurred in similar proportions in each group. Laboratory test results were similar in both treatment groups and showed little change after year 2. INTERPRETATION: Raltegravir has a favourable long-term efficacy and safety profile in integrase-inhibitor-naive patients with triple-class resistant HIV in whom antiretroviral therapy is failing. Raltegravir is an alternative for treatment-experienced patients, particularly those with few treatment options. FUNDING: Merck Sharp & Dohme.
DrugBank数据引用了这篇文章
- 药物