同伴支持对接受抗逆转录病毒治疗的HIV感染患者病毒学失败的影响——越南一项整群随机对照试验
Impact of peer support on virologic failure in HIV-infected patients on antiretroviral therapy - a cluster randomized controlled trial in Vietnam.
作者信息
Cuong Do Duy, Sönnerborg Anders, Van Tam Vu, El-Khatib Ziad, Santacatterina Michele, Marrone Gaetano, Chuc Nguyen Thi Kim, Diwan Vinod, Thorson Anna, Le Nicole K, An Pham Nhat, Larsson Mattias
机构信息
Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
Infectious Diseases Department, Bach Mai Hospital, Hanoi, Vietnam.
出版信息
BMC Infect Dis. 2016 Dec 16;16(1):759. doi: 10.1186/s12879-016-2017-x.
BACKGROUND
The effect of peer support on virologic and immunologic treatment outcomes among HIVinfected patients receiving antiretroviral therapy (ART) was assessed in a cluster randomized controlled trial in Vietnam.
METHODS
Seventy-one clusters (communes) were randomized in intervention or control, and a total of 640 patients initiating ART were enrolled. The intervention group received peer support with weekly home-visits. Both groups received first-line ART regimens according to the National Treatment Guidelines. Viral load (VL) (ExaVir™ Load) and CD4 counts were analyzed every 6 months. The primary endpoint was virologic failure (VL >1000 copies/ml). Patients were followed up for 24 months. Intention-to-treat analysis was used. Cluster longitudinal and survival analyses were used to study time to virologic failure and CD4 trends.
RESULTS
Of 640 patients, 71% were males, mean age 32 years, 83% started with stavudine/lamivudine/nevirapine regimen. After a mean of 20.8 months, 78% completed the study, and the median CD4 increase was 286 cells/μl. Cumulative virologic failure risk was 7.2%. There was no significant difference between intervention and control groups in risk for and time to virologic failure and in CD4 trends. Risk factors for virologic failure were ART-non-naïve status [aHR 6.9;(95% CI 3.2-14.6); p < 0.01]; baseline VL ≥100,000 copies/ml [aHR 2.3;(95% CI 1.2-4.3); p < 0.05] and incomplete adherence (self-reported missing more than one dose during 24 months) [aHR 3.1;(95% CI 1.1-8.9); p < 0.05]. Risk factors associated with slower increase of CD4 counts were: baseline VL ≥100,000 copies/ml [adj.sq.Coeff (95% CI): -0.9 (-1.5;-0.3); p < 0.01] and baseline CD4 count <100 cells/μl [adj.sq.Coeff (95% CI): -5.7 (-6.3;-5.4); p < 0.01]. Having an HIV-infected family member was also significantly associated with gain in CD4 counts [adj.sq.Coeff (95% CI): 1.3 (0.8;1.9); p < 0.01].
CONCLUSION
There was a low virologic failure risk during the first 2 years of ART follow-up in a rural low-income setting in Vietnam. Peer support did not show any impact on virologic and immunologic outcomes after 2 years of follow up.
TRIAL REGISTRATION
NCT01433601 .
背景
在越南开展的一项整群随机对照试验中，评估了同伴支持对接受抗逆转录病毒治疗（ART）的HIV感染患者病毒学和免疫学治疗结局的影响。
方法
71个整群（公社）被随机分为干预组或对照组，共纳入640例开始接受ART治疗的患者。干预组接受同伴支持及每周一次的家访。两组均根据国家治疗指南接受一线ART方案。每6个月分析病毒载量（VL）（ExaVir™ Load）和CD4细胞计数。主要终点为病毒学失败（VL>1000拷贝/ml）。对患者进行24个月的随访。采用意向性分析。使用整群纵向分析和生存分析来研究病毒学失败时间和CD4细胞计数趋势。
结果
640例患者中，71%为男性，平均年龄32岁，83%开始使用司他夫定/拉米夫定/奈韦拉平方案。平均20.8个月后，78%的患者完成研究，CD4细胞计数的中位数增加为286个/μl。累积病毒学失败风险为7.2%。干预组和对照组在病毒学失败风险、病毒学失败时间及CD4细胞计数趋势方面无显著差异。病毒学失败的危险因素为：非初治ART状态[aHR 6.9；（95%CI 3.2 - 14.6）；p<0.01]；基线VL≥100,000拷贝/ml[aHR 2.3；（95%CI 1.2 - 4.3）；p<0.05]以及依从性不完全（自我报告在24个月内漏服超过一剂）[aHR 3.1；（95%CI 1.1 - 8.9）；p<0.05]。与CD4细胞计数增加较慢相关的危险因素为：基线VL≥100,000拷贝/ml[调整后平方系数（95%CI）：-0.9（-1.5；-0.3）；p<0.01]和基线CD4细胞计数<100个/μl[调整后平方系数（95%CI）：-5.7（-6.3；-5.4）；p<0.01]。有HIV感染家庭成员也与CD4细胞计数增加显著相关[调整后平方系数（95%CI）：1.3（0.8；1.9）；p<0.01]。
结论
在越南农村低收入地区，ART随访的前2年病毒学失败风险较低。随访2年后，同伴支持对病毒学和免疫学结局未显示出任何影响。
试验注册号
NCT01433601
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