Molina Jean-Michel, Cohen Calvin, Katlama Christine, Grinsztejn Beatriz, Timerman Artur, Pedro Rogerio de Jesus, Vangeneugden Tony, Miralles Diego, Meyer Sandra De, Parys Wim, Lefebvre Eric
Assistance Publique--Hôpitaux de Paris, Department of Infectious Diseases, Hôpital St. Louis, Paris, France.
J Acquir Immune Defic Syndr. 2007 Sep 1;46(1):24-31. doi: 10.1097/QAI.0b013e3181359cfb.
In POWER 1 and POWER 2, darunavir (TMC114) with low-dose ritonavir (darunavir/r) demonstrated greater efficacy versus control protease inhibitors (PIs). To examine the efficacy and safety of the selected darunavir/r dose further, additional patients were analyzed.
Treatment-experienced HIV-1-infected patients received darunavir/r at a dose of 600/100 mg twice daily plus an optimized background regimen. The primary intent-to-treat analysis was the proportion of patients with an HIV-1 RNA reduction >or=1 log10 at week 24.
Three hundred twenty-seven patients were treated; the baseline mean HIV-1 RNA was 4.6 log10 copies/mL, and the median CD4 count was 115 cells/mm3 (median primary PI mutations = 3, PI resistance-associated mutations = 9). Two hundred forty-six patients reached week 24 by the cutoff date and were included in the efficacy analysis: 65% and 40% achieved HIV-1 RNA reductions of >or=1 log10 and <50 copies/mL, respectively, at week 24. The mean CD4 count increase was 80 cells/mm3. The most common adverse events (AEs) were diarrhea (14%), nasopharyngitis (11%), and nausea (10%). Nine (3%) patients discontinued treatment because of AEs or HIV-1-related events. Six treatment-unrelated deaths (2%) were reported.
These results corroborate POWER 1 and POWER 2. In this larger set of treatment-experienced patients, darunavir/r at a dose of 600/100 mg twice daily provided substantial virologic and immunologic responses and was generally safe and well tolerated.
在POWER 1和POWER 2研究中，低剂量利托那韦的达芦那韦（达芦那韦/利托那韦）对比对照蛋白酶抑制剂（PI）显示出更高的疗效。为进一步研究选定的达芦那韦/利托那韦剂量的疗效和安全性，对更多患者进行了分析。
有治疗经验的HIV-1感染患者接受每日两次600/100 mg剂量的达芦那韦/利托那韦，外加优化的背景治疗方案。主要的意向性治疗分析是第24周时HIV-1 RNA降低≥1 log10的患者比例。
327名患者接受了治疗；基线时HIV-1 RNA的平均水平为4.6 log10拷贝/毫升，CD4细胞计数中位数为115个细胞/立方毫米（主要PI突变中位数 = 3，PI耐药相关突变 = 9）。到截止日期时，246名患者进入第24周，并纳入疗效分析：第24周时，分别有65%和40%的患者HIV-1 RNA降低≥1 log10和<50拷贝/毫升。CD4细胞计数平均增加80个细胞/立方毫米。最常见的不良事件（AE）为腹泻（14%）、鼻咽炎（11%）和恶心（10%）。9名（3%）患者因AE或HIV-1相关事件停药。报告了6例与治疗无关的死亡（2%）。
这些结果证实了POWER 1和POWER 2研究。在这组更多有治疗经验的患者中，每日两次600/100 mg剂量的达芦那韦/利托那韦产生了显著的病毒学和免疫学反应，总体上安全且耐受性良好。
