Comparative effectiveness of initial antiretroviral therapy regimens: ACTG 5095 and 5142 clinical trials relative to ART-CC cohort study.
Comparative effectiveness of initial antiretroviral therapy regimens: ACTG 5095 and 5142 clinical trials relative to ART-CC cohort study.
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DOI：
10.1097/qai.0b013e318230372e
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发表时间：
2011-11-01
期刊：
影响因子：
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通讯作者：
Antiretroviral Cohort Collaboration
中科院分区：
文献类型：
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作者：
Mugavero MJ;May M;Ribaudo HJ;Gulick RM;Riddler SA;Haubrich R;Napravnik S;Abgrall S;Phillips A;Harris R;Gill MJ;de Wolf F;Hogg R;Günthard HF;Chêne G;D'Arminio Monforte A;Guest JL;Smith C;Murillas J;Berenguer J;Wyen C;Domingo P;Kitahata MM;Sterne JA;Saag MS;AIDS Clinical Trial Group DACS 241 Team;AIDS Clinical Trial Group Study 5095 Team;AIDS Clinical Trial Group Study 5142 team;Antiretroviral Cohort Collaboration
抗逆转录病毒疗法(ART)临床试验疗效结果在常规护理环境中的普适性没有得到很好的研究。我们比较了艾滋病临床试验组(ACTG)随机对照试验中评估的初始ART方案与抗逆转录病毒治疗队列协作(ART-CC)研究站点中接受ART的患者的相对有效性。在ACTG试验(A5095和A5142)和15个ART-CC队列研究地点，未接受治疗的HIV感染患者启动相同的ART方案。病毒学失败(HIV-1RNA和GT；200拷贝/毫升)在24周和48周时，根据研究设计(ART-CC队列与ACTG试验)测量发生的艾滋病定义事件和死亡率，并按第三种药物[Abacavir(ABC)、Efavirenz(EFV)和Lopinavir/r(LPV/r)]分层。我们使用Logistic回归来估计和比较不同方案和研究设计之间的病毒学失败的优势比，并使用COX模型来估计和比较艾滋病和死亡的风险比。与接受ABC的患者相比，接受EFV的患者在ACTG 5095(OR=0.53，95%CI 0.36-0.79)和ART-CC(0.46，0.37-0.57)中24周病毒学失败(>；200拷贝/毫升)的几率大约是后者的一半。在ART-CC和ACTG 5095中，EFV(与ABC)的病毒学优势相当(OR比0.86，95%CI 0.54~1.35)。48周病毒学失败的优势比，比较EFV和LPV/r，在ACTG 5142和ART-CC中也是相似的(OR值为0.87，0.45-1.69)。在ACTG 5095和5142试验中观察到的第三种药物ABC、EFV和LPV/r的ART方案病毒学疗效似乎可推广到ART-CC临床队列的常规护理环境。
The generalizability of antiretroviral therapy (ART) clinical trial efficacy findings to routine care settings is not well studied. We compared the relative effectiveness of initial ART regimens estimated in AIDS Clinical Trial Group (ACTG) randomized controlled trials with that among patients receiving ART at Antiretroviral Therapy Cohort Collaboration (ART-CC) study sites. Treatment-naive HIV-infected patients initiating identical ART regimens in ACTG trials (A5095 and A5142) and at 15 ART-CC cohort study sites were included. Virological failure (HIV-1 RNA >200 copies/ml) at 24- and 48-weeks, incident AIDS-defining events and mortality were measured according to study design (ART-CC cohort vs. ACTG trial) and stratified by 3rd drug [Abacavir (ABC), Efavirenz (EFV), and Lopinavir/r (LPV/r)]. We used logistic regression to estimate and compare odds ratios for virological failure between different regimens and study designs, and used Cox models to estimate and compare hazard ratios for AIDS and death. Compared with patients receiving ABC, those receiving EFV had roughly half the odds of 24-week virologic failure (>200 copies/mL) in both ACTG 5095 (OR=0.53, 95% CI 0.36–0.79) and ART-CC (0.46, 0.37–0.57). Virologic superiority of EFV (vs. ABC) appeared comparable in ART-CC and ACTG 5095 (ratio of ORs 0.86, 95% CI 0.54–1.35). Odds ratios for 48-week virologic failure, comparing EFV with LPV/r, were also comparable in ACTG 5142 and ART-CC (ratio of ORs 0.87, 0.45–1.69). Between ART regimen virologic efficacy of 3rd drugs ABC, EFV, and LPV/r observed in the ACTG 5095 and 5142 trials appear generalizable to the routine care setting of ART-CC clinical cohorts.