Kirk O, Mocroft A, Pradier C, Bruun J N, Hemmer R, Clotet B, Miller V, Viard J P, Phillips A N, Lundgren J D
EuroSIDA Coordinating Centre, Department of Infectious Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
AIDS. 2001 May 25;15(8):999-1008. doi: 10.1097/00002030-200105250-00008.
To compare the clinical response among patients who initiate protease inhibitor therapies with different virological potency.
We analysed patients who started indinavir, ritonavir or saquinavir hard gel capsule (hgc) as part of at least triple therapy during prospective follow-up within the EuroSIDA study.
Changes in plasma viral load (pVL) and CD4 cell count from baseline were compared between treatment groups. Time to new AIDS-defining events and death were compared in Kaplan--Meier models, and Cox models were established to further assess differences in clinical progression (new AIDS/death). Adjustment was made for differences in baseline parameters, in particular pVL, CD4 cell count, and region of Europe.
A total of 2708 patients (median follow-up: 30 months) were included, of which 556 started ritonavir (21%), 1342 indinavir (50%), and 810 saquinavir hgc (30%). The three groups were fairly evenly balanced at baseline regarding CD4 count, previous diagnosis of AIDS and pVL, After 12 months, the median changes in CD4 cell count were 90, 96 and 74 x 10(6) cells/l, respectively;P < 0.001, the proportions of patients with pVL < 500 copies/ml were 47, 54 and 41%; P < 0.001, and the proportions with clinical progression were 11.9, 9.2 and 11.9%, respectively; P = 0.20 (log-rank test). In multivariate models the relative risk of clinical progression for indinavir compared with saquinavir hgc was: 0.77 (0.60--0.99); P = 0.043, and for ritonavir 0.83 (0.62--1.11); P = 0.20.
Saquinavir hgc was associated with an inferior long-term clinical response relative to indinavir, which was consistent with the observed differences in virological and immunological responses.
比较启动具有不同病毒学效力的蛋白酶抑制剂治疗的患者的临床反应。
在欧洲艾滋病临床研究（EuroSIDA）的前瞻性随访期间，我们分析了开始使用茚地那韦、利托那韦或硬明胶胶囊（hgc）沙奎那韦作为至少三联疗法一部分的患者。
比较各治疗组血浆病毒载量（pVL）和CD4细胞计数相对于基线的变化。在Kaplan-Meier模型中比较出现新的艾滋病定义事件和死亡的时间，并建立Cox模型以进一步评估临床进展（新的艾滋病/死亡）的差异。对基线参数的差异进行了调整，特别是pVL、CD4细胞计数和欧洲地区。
共纳入2708例患者（中位随访时间：30个月），其中556例开始使用利托那韦（21%），1342例使用茚地那韦（50%），810例使用沙奎那韦hgc（30%）。三组在基线时CD4细胞计数、既往艾滋病诊断和pVL方面相当均衡。12个月后，CD4细胞计数的中位变化分别为90、96和74×10⁶个细胞/升；P<0.001，pVL<500拷贝/毫升的患者比例分别为47%、54%和41%；P<0.001，临床进展的比例分别为11.9%、9.2%和11.9%；P=0.20（对数秩检验）。在多变量模型中，茚地那韦与沙奎那韦hgc相比临床进展的相对风险为：0.77（0.60-0.99）；P=0.043，利托那韦为0.83（0.62-1.11）；P=0.20。
相对于茚地那韦，沙奎那韦hgc与较差的长期临床反应相关，这与观察到的病毒学和免疫学反应差异一致。
