Vallecillo Gabriel, Domingo Pere, Mallolas Josep, Blanch Jesús, Ferrer Elena, Cervantes Manuel, Pedrol Enric, Knobel Hernando, Llibre Josep M
Department of Internal Medicine, Hospital del Mar, Barcelona, Spain.
AIDS Res Hum Retroviruses. 2012 Feb;28(2):165-70. doi: 10.1089/aid.2011.0092. Epub 2011 Jul 26.
Despite having demonstrated noninferior efficacy against atazanavir/ritonavir plus coformulated tenofovir/emtricitabine (cTDF/FTC), the combination of nevirapine plus cTDF/FTC is not included among preferred regimens in some international guidelines. This combination is frequently used in Spain. We analyzed its effectiveness and safety as first-line therapy in a routine clinical practice. A retrospective, multicenter study was performed in treatment-naive HIV-1-infected subjects who started nevirapine plus cTDF/FTC as first-line therapy according to the nevirapine CD4(+) cell count threshold. The primary endpoint was the proportion of subjects with plasma HIV-1 RNA <50 copies/ml at week 48. We included 123 subjects starting the regimen from 2005 to 2008. The median age was 41.0 years, the median baseline CD4(+) cell count was 215 cells/μl, the median plasma viral load (VL) was 4.83 log(10) copies/ml, and 22% had hepatitis C coinfection. At week 48, 96 subjects (78%; 95% CI: 69.9-84.4) had a VL <50 copies/ml in an ITT analysis, and the median rise in the CD4(+) cell count was 118 cells/μl. Virological failure was observed in 6.5% (8/123) of subjects, all them before week 24 and related to poor adherence. There was no relationship between virological failure and baseline CD4(+) cell count or VL. Ten percent (13/123) of the subjects discontinued the treatment due to adverse events. There was a significant decrease in total/HDL-cholesterol ratio (p=0.03) with an increase in HDL-cholesterol (p=0.01) over 48 weeks. The combination of nevirapine plus cTDF/FTC showed a high virological efficacy without unexpected toxicities as a first-line treatment in a routine clinical practice.
尽管已证明奈韦拉平联合替诺福韦酯/恩曲他滨（cTDF/FTC）对阿扎那韦/利托那韦疗效非劣效，但在一些国际指南的首选方案中并未包含奈韦拉平联合cTDF/FTC。这种联合方案在西班牙经常使用。我们在常规临床实践中分析了其作为一线治疗的有效性和安全性。对未接受过治疗的HIV-1感染受试者进行了一项回顾性多中心研究，这些受试者根据奈韦拉平CD4(+)细胞计数阈值开始接受奈韦拉平联合cTDF/FTC作为一线治疗。主要终点是第48周时血浆HIV-1 RNA<50拷贝/ml的受试者比例。我们纳入了2005年至2008年开始该方案治疗的123名受试者。中位年龄为41.0岁，基线CD4(+)细胞计数中位数为215个/μl，血浆病毒载量（VL）中位数为4.83 log(10)拷贝/ml，22%的受试者合并丙型肝炎感染。在ITT分析中，第48周时，96名受试者（78%；95%CI：69.9-84.4）的VL<50拷贝/ml，CD4(+)细胞计数的中位数升高为118个/μl。6.5%（8/123）的受试者出现病毒学失败，均在第24周之前，且与依从性差有关。病毒学失败与基线CD4(+)细胞计数或VL之间无关联。10%（13/123）的受试者因不良事件停药。在48周内，总胆固醇/高密度脂蛋白胆固醇比值显著降低（p=0.03），高密度脂蛋白胆固醇升高（p=0.01）。在常规临床实践中，奈韦拉平联合cTDF/FTC作为一线治疗显示出高病毒学疗效且无意外毒性。
