Kuritzkes Daniel R, Ribaudo Heather J, Squires Kathleen E, Koletar Susan L, Santana Jorge, Riddler Sharon A, Reichman Richard, Shikuma Cecilia, Meyer William A, Klingman Karin L, Gulick Roy M
Section of Retroviral Therapeutics, Brigham and Women's Hospital, Cambridge, MA 02139, USA.
J Infect Dis. 2007 Apr 15;195(8):1169-76. doi: 10.1086/512619. Epub 2007 Mar 6.
We sought to compare clearance rates of plasma human immunodeficiency virus type 1 (HIV-1) RNA in men and women starting triple-nucleoside-based versus efavirenz (EFV)-based regimens.
First- and second-phase decay rates of plasma HIV-1 were compared in men and women initiating a triple nucleoside reverse-transcriptase inhibitor (NRTI) regimen versus regimens that included EFV plus an NRTI. Subjects (n=64) were randomized to receive zidovudine/lamivudine/abacavir (triple-nucleoside regimen), zidovudine/lamivudine plus EFV (3-drug EFV regimen) or zidovudine/lamivudine/abacavir plus EFV (4-drug EFV regimen). Plasma HIV-1 RNA levels were fitted to a biexponential viral-dynamics model using a nonlinear mixed-effects model. Nonparametric Wilcoxon tests compared empirical Bayes estimates of first- and second-phase viral decay rates between treatment arms and sex.
Median first-phase viral decay rates were significantly faster in subjects receiving the 3-drug EFV regimen (0.67/day), compared with those receiving the triple-nucleoside regimen (0.56/day; P=.02). The second-phase viral decay rate was also faster in the 3-drug EFV group than in the triple-nucleoside group (P=.09). Decay rates in the 4-drug EFV group were intermediate. Viral decay rates were not significantly different in men and women. CONCLUSIONS Faster initial viral decay in subjects randomized to a 3-drug EFV-based regimen corresponded to the overall superior efficacy of that regimen. Viral decay rates did not differ by sex.
我们试图比较开始使用基于三联核苷与基于依非韦伦（EFV）方案的男性和女性血浆1型人类免疫缺陷病毒（HIV-1）RNA的清除率。
比较开始使用三联核苷逆转录酶抑制剂（NRTI）方案与包含EFV加一种NRTI方案的男性和女性血浆HIV-1的第一阶段和第二阶段衰减率。受试者（n = 64）被随机分配接受齐多夫定/拉米夫定/阿巴卡韦（三联核苷方案）、齐多夫定/拉米夫定加EFV（三联EFV方案）或齐多夫定/拉米夫定/阿巴卡韦加EFV（四联EFV方案）。使用非线性混合效应模型将血浆HIV-1 RNA水平拟合到双指数病毒动力学模型。非参数Wilcoxon检验比较了治疗组和性别之间第一阶段和第二阶段病毒衰减率的经验贝叶斯估计值。
接受三联EFV方案的受试者（0.67/天）的第一阶段病毒衰减率中位数明显快于接受三联核苷方案的受试者（0.56/天；P = 0.02）。三联EFV组的第二阶段病毒衰减率也比三联核苷组快（P = 0.09）。四联EFV组的衰减率处于中间水平。男性和女性的病毒衰减率没有显著差异。结论：随机接受基于三联EFV方案的受试者中较快的初始病毒衰减与该方案总体上更好的疗效相对应。病毒衰减率不存在性别差异。
