Weverling G J, Lange J M, Jurriaans S, Prins J M, Lukashov V V, Notermans D W, Roos M, Schuitemaker H, Hoetelmans R M, Danner S A, Goudsmit J, de Wolf F
National AIDS Therapy Evaluation Centre, Department of Internal Medicine, University of Amsterdam, The Netherlands.
AIDS. 1998 Jul 30;12(11):F117-22. doi: 10.1097/00002030-199811000-00003.
To compare the viral suppression of two antiretroviral regimens using three drugs or five drugs.
Two open-label studies using a three-drug (zidovudine, lamivudine and ritonavir) and a five-drug regimen (zidovudine, lamivudine, abacavir, indinavir and nevirapine) in study-drug-naive patients, except for one in the five-drug study.
Participants with > or = 10 000 HIV-1 RNA copies/ml in plasma at baseline were compared by means of Kaplan-Meier curves for time to < 50 copies/ml, as well as linear regression analysis for the first phase of decline using log-transformed copy numbers.
The elimination rate constants for HIV-1 RNA in 15 participants of the three-drug study were compared with nine participants of the five-drug study. The level of < 50 copies/ml was reached earlier when using the five-drug than when using the three-drug regimen (P log rank = 0.0005): median time to reach this level was 4 weeks and 12 weeks, respectively. No differences were found in HIV-1 RNA elimination rate constants in the first 2 weeks after the initiation of therapy. When the viral load declines were calculated from day 2 onwards, adjusting for differences in pharmacological delay of the drugs used, again no differences in early viral load decline were found between the two regimens.
With the five drugs used in this study, the median time to reach < 50 HIV-1 RNA copies/ml was 8 weeks shorter than with the three-drug regimen. This finding shows that suppression of viral load in HIV-infection by standard triple-drug therapy can be improved upon.
比较两种抗逆转录病毒治疗方案(三种药物或五种药物)的病毒抑制效果。
两项开放性研究,在初治患者中使用三种药物(齐多夫定、拉米夫定和利托那韦)和五种药物方案(齐多夫定、拉米夫定、阿巴卡韦、茚地那韦和奈韦拉平),五种药物研究中有一名患者除外。
对基线时血浆中HIV-1 RNA拷贝数≥10000/ml的参与者,通过Kaplan-Meier曲线比较达到<50拷贝/ml的时间,并使用对数转换后的拷贝数对下降的第一阶段进行线性回归分析。
将三种药物研究中的15名参与者与五种药物研究中的9名参与者的HIV-1 RNA消除速率常数进行比较。使用五种药物方案比使用三种药物方案更早达到<50拷贝/ml的水平(P对数秩检验=0.0005):达到该水平的中位时间分别为4周和12周。在治疗开始后的前2周,HIV-1 RNA消除速率常数没有差异。从第2天开始计算病毒载量下降情况,并对所用药物的药理学延迟差异进行校正后,两种方案在早期病毒载量下降方面再次没有差异。
使用本研究中的五种药物,达到<50 HIV-1 RNA拷贝/ml的中位时间比三种药物方案短8周。这一发现表明标准三联药物疗法对HIV感染的病毒载量抑制效果可以得到改善。