Konopnicki D, De Wit S, Poll B, Crommentuyn K, Huitema A, Clumeck N
The AIDS Reference Centre, Division of Infectious Diseases, Saint-Pierre University Hospital, Brussels, Belgium.
HIV Med. 2005 Jan;6(1):1-6. doi: 10.1111/j.1468-1293.2005.00255.x.
Objectives To compare the efficacy and tolerability of indinavir (IDV)/ritonavir (RTV) at 800/100 and 400/100 mg twice daily (bid) in antiretroviral therapy (ART)-naive patients. Methods An open comparison of two groups of ART-naive patients treated with IDV/RTV 800/100 or 400/100 mg bid plus two nucleoside analogues was carried out. Viral load, CD4 cell count and tolerability were measured at baseline and at weeks 4, 12, 24 and 48. IDV plasma concentrations were measured retrospectively. Results A total of 107 patients were included in the study. Of these, 57 were treated with 800/100 and 50 with 400/100 mg IDV/RTV bid. At week 48, a viral load of <50 HIV-1 RNA copies/mL was achieved by 77 and 64% of the patients, respectively, and the median CD4 cell count increases were +171 and +164 cells/muL (intent-to-treat; P not significant), respectively. Side effects leading to protease inhibitor discontinuation occurred in 61% of subjects in the 800/100 mg group vs. 20% in the 400/100 mg group (P<0.0001). Switching from 800/100 to 400/100 mg dosage improved adverse events in 16 of 20 patients. IDV concentrations were above 0.15 mg/L in 89% of the 28 patients tested in the 400/100 mg group. Conclusions Indinavir/ritonavir 400/100 mg bid provided the same efficacy as 800/100 mg bid at 48 weeks in an ART-naive population, but safety and tolerance were significantly better for 400/100 mg, while convenience was also improved and cost was reduced.
目的 比较茚地那韦（IDV）/利托那韦（RTV）每日两次（bid）800/100毫克和400/100毫克在初治抗逆转录病毒治疗（ART）患者中的疗效和耐受性。方法 对两组初治ART患者进行开放比较，一组接受IDV/RTV 800/100毫克bid治疗，另一组接受400/100毫克bid治疗，并联合两种核苷类似物。在基线以及第4、12、24和48周时测量病毒载量、CD4细胞计数和耐受性。回顾性测量IDV血浆浓度。结果 共有107例患者纳入研究。其中，57例接受800/100毫克IDV/RTV bid治疗，50例接受400/100毫克bid治疗。在第48周时，分别有77%和64%的患者实现了病毒载量<50拷贝/mL的HIV-1 RNA，CD4细胞计数的中位数增加分别为+171和+164个/微升（意向性分析；P无显著性差异）。导致蛋白酶抑制剂停用的副作用在800/100毫克组的61%的受试者中发生，而在400/100毫克组中为20%（P<0.0001）。20例患者中有16例从800/100毫克剂量转换为400/100毫克剂量后不良事件得到改善。在400/100毫克组接受检测的28例患者中，89%的患者IDV浓度高于0.15毫克/升。结论 在初治人群中，茚地那韦/利托那韦400/100毫克bid在48周时提供了与800/100毫克bid相同的疗效，但400/100毫克的安全性和耐受性明显更好，同时便利性也有所提高且成本降低。
