Wood E, Hogg R S, Yip B, Moore D, Harrigan P R, Montaner J S G
British Columbia Centre for Excellence in HIV/AIDS, St Paul's Hospital, Vancouver, BC, Canada.
HIV Med. 2007 Mar;8(2):80-5. doi: 10.1111/j.1468-1293.2007.00430.x.
The use of boosted protease inhibitor (PI)-based antiretroviral therapy has become increasingly recommended in international HIV treatment consensus guidelines based on the results of randomized clinical trials. However, the impact of this new treatment strategy has not yet been evaluated in community-treated cohorts.
We evaluated baseline characteristics and plasma HIV RNA responses to unboosted and boosted PI-based highly active antiretroviral therapy (HAART) among antiretroviral-naïve HIV-infected patients in British Columbia, Canada who initiated HAART between August 1997 and September 2003 and who were followed until September 2004. We evaluated time to HIV-1 RNA suppression (<500 HIV-1 RNA copies/mL) and HIV-1 RNA rebound (>or=500 copies/mL), while stratifying patients into those that received boosted and unboosted PI-based HAART as the initial regimen, using Kaplan-Meier methods and Cox proportional hazards regression.
During the study period, 682 patients initiated therapy with unboosted PI and 320 individuals initiated HAART with a boosted PI. Those who initiated therapy with a boosted PI were more likely to have a CD4 cell count <200 cells/muL and to have a plasma HIV RNA>100 000 copies/mL, and to have AIDS at baseline (all P<0.001). However, when we examined virological response rates, those who initiated HAART with a boosted PI achieved more rapid virological suppression [relative hazard 1.26, 95% confidence interval (CI) 1.06-1.51, P=0.010].
Patients prescribed boosted PIs achieved superior virological response rates despite baseline factors that have been associated with inferior virological responses to HAART. Despite the inherent limitations of observational studies which require this study be interpreted with caution, these findings support the use of boosted PIs for initial HAART therapy.
基于随机临床试验结果,在国际艾滋病治疗共识指南中,越来越推荐使用增强型蛋白酶抑制剂(PI)的抗逆转录病毒疗法。然而,这种新治疗策略在社区治疗队列中的影响尚未得到评估。
我们评估了1997年8月至2003年9月在加拿大不列颠哥伦比亚省开始接受高效抗逆转录病毒治疗(HAART)且之前未接受过抗逆转录病毒治疗的HIV感染患者,对未增强和增强型PI的高效抗逆转录病毒疗法(HAART)的基线特征和血浆HIV RNA反应。这些患者随访至2004年9月。我们评估了HIV-1 RNA抑制(<500 HIV-1 RNA拷贝/mL)和HIV-1 RNA反弹(≥500拷贝/mL)的时间,同时将患者分为接受增强型和未增强型PI为初始治疗方案的两组,采用Kaplan-Meier方法和Cox比例风险回归分析。
在研究期间,682例患者开始使用未增强型PI治疗,320例患者开始使用增强型PI进行HAART治疗。开始使用增强型PI治疗的患者更有可能CD4细胞计数<200个/μL,血浆HIV RNA>100 000拷贝/mL,且基线时患有艾滋病(所有P<0.001)。然而,当我们检查病毒学反应率时,开始使用增强型PI进行HAART治疗的患者实现了更快的病毒学抑制[相对风险1.26,95%置信区间(CI)1.06 - 1.51,P = 0.010]。
尽管基线因素与HAART的病毒学反应较差有关,但接受增强型PI治疗的患者实现了更好的病毒学反应率。尽管观察性研究存在固有局限性,需要谨慎解读本研究结果,但这些发现支持将增强型PI用于初始HAART治疗。