Mortality under early access to antiretroviral therapy vs. Eswatini's national standard of care: the MaxART clustered randomized stepped-wedge trial
Mortality under early access to antiretroviral therapy vs. Eswatini's national standard of care: the MaxART clustered randomized stepped-wedge trial
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DOI：
10.1111/hiv.12876
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发表时间：
2020-05-26
期刊：
影响因子：
3
通讯作者：
Okello, V
中科院分区：
文献类型：
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作者：
Chao, A.;Spiegelman, D.;Okello, V
目前WHO指南建议所有HIV感染者接受抗逆转录病毒治疗（ART），以提高生存率和生活质量，并减少其他人的感染。MaxART是在政府管理的卫生系统中实施这一战略的第一个试验，并将死亡率作为次要结局进行评估。由于主要的研究结果强烈支持规模扩大的“治疗所有”的战略（以下简称治疗所有），本分析探讨死亡率作为一个额外的指标，其impacts.Methods MaxART进行了14个埃斯瓦廷卫生诊所通过临床为基础的阶梯楔形设计，过渡诊所从当时的国家标准的护理（SoC）的治疗所有的干预。使用考克斯比例风险模型分析全因、疾病相关和HIV相关死亡率，在诊所转换时删失SoC参与者。研究参与者的中位随访时间为292天。SoC组死亡36/2034例（1.77%），Treat All组死亡49/1371例（3.57%）。在SoC和Treat All干预中，多变量校正的12个月全因死亡率分别为1.42% [95%置信区间（CI）：0.66-2.17]和1.60%（95%CI：0.78-2.40），疾病相关死亡率为1.02%（95% CI：0.40-1.64）和1.10%（95% CI：0.46-1.73），HIV相关死亡率分别为1.03%（95% CI：0.40-1.65）和0.99%（95% CI：0.40-1.58）。全部治疗对全因[风险比（HR）= 1.12，95% CI：0.58-2.18，P = 0.73]、疾病相关（HR = 1.04，95% CI：0.52-2.11，P = 0.90）或HIV相关死亡率（HR = 0.93，95%CI：0.46-1.87，P = 0.83）结论“治疗所有”策略对死亡率没有立即的益处，也没有损害的证据。需要对参与者进行更长时间的随访，以确定长期后果。
Objectives Current WHO guidelines recommend the treatment of all HIV-infected individuals with antiretroviral therapy (ART) to improve survival and quality of life, and decrease infection of others. MaxART is the first implementation trial of this strategy embedded within a government-managed health system, and assesses mortality as a secondary outcome. Because primary findings strongly supported scale-up of the 'treat all' strategy (hereafter Treat All), this analysis examines mortality as an additional indicator of its impact.Methods MaxART was conducted in 14 Eswatinian health clinics through a clinic-based stepped-wedge design, by transitioning clinics from then-national standard of care (SoC) to the Treat All intervention. All-cause, disease-related, and HIV-related mortality were analysed using the Cox proportional hazards model, censoring SoC participants at clinic transition. Median follow-up time among study participants was 292 days. There were 36/2034 deaths in SoC (1.77%) and 49/1371 deaths in Treat All (3.57%).Results Between September 2014 and August 2017, 3405 participants were enrolled. In SoC and Treat All interventions, respectively, the multivariable-adjusted 12-month all-cause mortality rates were 1.42% [95% confidence interval (CI): 0.66-2.17] and 1.60% (95% CI: 0.78-2.40), disease-related mortality rates were 1.02% (95% CI: 0.40-1.64) and 1.10% (95% CI: 0.46-1.73), and HIV-related mortality rates were 1.03% (95% CI: 0.40-1.65) and 0.99% (95% CI: 0.40-1.58). Treat All had no impact on all-cause [hazard ratio (HR) = 1.12, 95% CI: 0.58-2.18, P = 0.73], disease-related (HR = 1.04, 95% CI: 0.52-2.11, P = 0.90), or HIV-related mortality (HR = 0.93, 95% CI: 0.46-1.87, P = 0.83).Conclusion There was no immediate benefit of the Treat All strategy on mortality, nor evidence of harm. Longer follow-up of participants is needed to establish long-term consequences.