Duvivier Claudine, Myrto Astriti, Marcelin Anne-Geneviève, Ghosn Jade, Ait-Mohand Hocine, Schneider Luminita, Agher Rachid, Bricaire François, Costagliola Dominique, Calvez Vincent, Peytavin Gilles, Katlama Christine
Department of Infectious Diseases, Pitié Salpétrière Hospital, Paris, France.
Antivir Ther. 2003 Dec;8(6):603-9.
To evaluate the efficacy and tolerability of indinavir/ritonavir (IDV/RTV) 400/100 mg twice daily in combination with two nucleoside reverse transcriptase inhibitors in antiretroviral-naive patients.
Antiviral therapy-naive patients with plasma HIV-1 RNA > 5000 copies/ml were enrolled in this pilot, single-arm study. CD4 cell count and viral load were evaluated at weeks (W) 4, 12, 24 and every 3 months until W48. The primary end-point was the percentage (%) of patients with viral load < 400 copies/ml at W48. Intent-to-treat (ITT) (missing values or change in treatment equalled failure) and on-treatment (OT) analyses were performed.
Forty patients were enrolled. Baseline median viral load was 5.36 log10 copies/ml, median CD4 count was 84 cells/mm3. At W48 by ITT analysis, the % patients with viral load < 400 copies/ml was 65% (95% CI: 48-79) and 50% (95% CI: 35-65) with viral load < 50 copies/ml, and 96% (26/27) (95% CI: 89-100) and 74% (95% CI: 57-91], respectively, by OT analysis. The median decrease in viral load at W48 was -3.83 log10 copies/ml (-0.1; -5.19) and the median increase in CD4 was +167 cells/mm3 (6-474 cell/mm3). At W4 (34/40), the median IDV C(min) was 500 ng/ml (range 5-8100) with 91% of patients with an adequate IDV C(min) > 150 ng/ml. Ten patients discontinued the study treatment before W48: adverse events (eight), patient's will (one) and simplification of therapy (one). Three patients were lost to follow-up. Only one virological failure occurred and was associated with poor compliance and sub-optimal concentrations of IDV/RTV.
IDV/RTV 400/100 mg twice daily is an effective and safe first-line antiretroviral therapy. The simplicity and the low cost of IDV/RTV is of major interest particularly in countries with limited resources.
评估茚地那韦/利托那韦（IDV/RTV）400/100毫克每日两次联合两种核苷类逆转录酶抑制剂用于初治抗逆转录病毒治疗患者的疗效和耐受性。
本前瞻性单臂研究纳入了血浆HIV-1 RNA>5000拷贝/毫升的初治抗病毒治疗患者。在第4、12、24周以及直至第48周每3个月评估CD4细胞计数和病毒载量。主要终点是第48周时病毒载量<400拷贝/毫升的患者百分比（%）。进行意向性分析（ITT）（缺失值或治疗改变等同于失败）和治疗中分析（OT）。
40例患者入组。基线病毒载量中位数为5.36 log10拷贝/毫升，CD4计数中位数为84个细胞/立方毫米。通过ITT分析，第48周时病毒载量<400拷贝/毫升的患者百分比为65%（95%置信区间：48 - 79），病毒载量<50拷贝/毫升的患者百分比为50%（95%置信区间：35 - 65）；通过OT分析，分别为96%（26/27）（95%置信区间：89 - 100）和74%（95%置信区间：57 - 91）。第48周时病毒载量中位数下降-3.83 log10拷贝/毫升（-0.1；-5.19），CD4中位数增加+167个细胞/立方毫米（6 - 474个细胞/立方毫米）。在第4周时（34/40），IDV的C(min)中位数为500纳克/毫升（范围5 - 8100），91%的患者IDV的C(min)>150纳克/毫升。10例患者在第48周前停止研究治疗：不良事件（8例）、患者意愿（1例）和简化治疗方案（1例）。3例患者失访。仅发生1例病毒学失败，与依从性差和IDV/RTV浓度未达最佳有关。
IDV/RTV 400/100毫克每日两次是一种有效且安全的一线抗逆转录病毒疗法。IDV/RTV的简便性和低成本尤其在资源有限的国家具有重要意义。
