Imaz Arkaitz, Llibre Josep M, Navarro Jordi, Curto Jordi, Clotet Bonaventura, Crespo Manuel, Ferrer Elena, Saumoy Maria, Tiraboschi Juan M, Murillo Oscar, Podzamczer Daniel
HIV Unit, Department of Infectious Diseases, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain.
Antivir Ther. 2014;19(6):569-77. doi: 10.3851/IMP2736. Epub 2014 Jan 23.
There are no clinical trials in which the main objective is to compare the efficacy of efavirenz versus ritonavir-boosted protease inhibitor (PI/r)-based initial antiretroviral therapy (ART) in patients with high plasma HIV-1 RNA levels. This study aims to compare these regimens in this patient population in the setting of routine clinical practice.
This was a multicentre, observational cohort study, including 596 consecutive treatment-naive patients with plasma HIV-1 RNA>100,000 copies/ml initiating efavirenz or PI/r-based ART between 2000 and 2010. The primary effectiveness end point was the percentage of patients with HIV-1 RNA<50 copies/ml at week 48 by intent-to-treat analysis.
Among a total of 596 patients, 57% initiated efavirenz and 43% PI/r-regimens (73% lopinavir and fosamprenavir [62% lopinavir, 11% fosamprenavir]). HIV-1 RNA suppression to <50 copies/ml at week 48 was higher in the efavirenz group (84% versus 74% [difference 10%, 95% CI 3.4%, 16.7%; P=0.002]). The percentage of virological failures was similar (efavirenz 4% versus PI/r 4%; P=0.686), but voluntary discontinuations and toxicity-related treatment changes were higher with PI/r (4% versus 1%; P=0.006 and 11% versus 6%; P=0.069, respectively). However, resistance selection at failure was higher in patients receiving efavirenz (89% versus 50%; P=0.203). Efavirenz was significantly more effective than lopinavir/r or fosamprenavir/r, whereas no significant differences were observed between efavirenz and darunavir/r or atazanavir/r. The high viral suppression in the efavirenz group was also evident in patients with very high viral loads (>500,000 copies/ml) and in those with low CD4(+) T-cell counts.
In routine clinical practice, the effectiveness of initial efavirenz-based regimens was at least similar to or even higher than various PI/r-based regimens in HIV-1-infected patients with plasma HIV-1 RNA>100,000 copies/ml.
尚无主要目的为比较依非韦伦与基于利托那韦增效蛋白酶抑制剂（PI/r）的初始抗逆转录病毒疗法（ART）对血浆HIV-1 RNA水平较高患者疗效的临床试验。本研究旨在比较常规临床实践中该患者群体的这些治疗方案。
这是一项多中心观察性队列研究，纳入了2000年至2010年间596例连续的初治患者，这些患者血浆HIV-1 RNA>100,000拷贝/ml，开始接受基于依非韦伦或PI/r的ART治疗。主要有效性终点是意向性分析中第48周时HIV-1 RNA<50拷贝/ml的患者百分比。
在总共596例患者中，57%开始使用依非韦伦，43%开始使用PI/r方案（73%为洛匹那韦和福沙普那韦[62%洛匹那韦，11%福沙普那韦]）。依非韦伦组在第48周时HIV-1 RNA抑制至<50拷贝/ml的比例更高（84%对74%[差异10%，95%CI 3.4%，16.7%；P=0.002]）。病毒学失败的百分比相似（依非韦伦4%对PI/r 4%；P=0.686），但PI/r组的自愿停药和与毒性相关的治疗改变更高（分别为4%对1%；P=0.006和11%对6%；P=0.069）。然而，治疗失败时接受依非韦伦治疗的患者耐药选择更高（89%对50%；P=0.203）。依非韦伦比洛匹那韦/利托那韦或福沙普那韦/利托那韦显著更有效，而依非韦伦与达芦那韦/利托那韦或阿扎那韦/利托那韦之间未观察到显著差异。依非韦伦组的高病毒抑制在病毒载量非常高（>500,000拷贝/ml）的患者和CD4(+)T细胞计数低的患者中也很明显。
在常规临床实践中，对于血浆HIV-1 RNA>100,000拷贝/ml的HIV-1感染患者，基于依非韦伦的初始治疗方案的有效性至少与各种基于PI/r的方案相似，甚至更高。
