Dried blood spots for viral load monitoring in Malawi: feasible and effective.

Dried blood spots for viral load monitoring in Malawi: feasible and effective.
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DOI:
10.1371/journal.pone.0124748
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发表时间:
2015
期刊:
影响因子:
3.7
通讯作者:
Mataya R
Mataya R
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Rutstein SE;Hosseinipour MC;Kamwendo D;Soko A;Mkandawire M;Biddle AK;Miller WC;Weinberger M;Wheeler SB;Sarr A;Gupta S;Chimbwandira F;Mwenda R;Kamiza S;Hoffman I;Mataya R

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评价干血斑(DBS)用于病毒载量(VL)监测的可行性和有效性,描述患者结局和与DBS在撒哈拉以南非洲实施相关的计划挑战。我们从马拉维的五家地区医院招募了成人抗逆转录病毒治疗(ART)患者。资格反映了预期的卫生部VL监测标准。在中心实验室进行检测。病毒学失败定义为>5000拷贝/ml。主要结局是项目可行性(及时获得结果和患者接收)和有效性(二线治疗启动)。我们招募了1,498名参与者; 5.9%在基线时失败。从入组到收到结果的中位时间为42天; 79.6%的参与者在3个月内收到结果。在确认VL升高的参与者中,92.6%开始二线治疗; 90.7%在VL检测后365天内转换。近三分之一(30.8%)基线VL升高的参与者在确证性测试中受到抑制(<5,000拷贝/ml)。入组和样本检测之间的中位时间为23天。调整相关协变量,ART >4年的参与者比治疗1-4年的参与者更容易失败(RR 1.7,95% CI 1.0-2.8);老年参与者失败的可能性较小(RR 0.95,95% CI 0.92-0.98)。基于临床症状的失败可能性无差异(RR 1.17,95% CI 0.65-2.11)。DBS用于VL监测在现实临床环境中是可行且有效的。集中式DBS测试可增加远程设置中VL监测的访问。项目结果令人鼓舞,特别是合格参与者转为二线治疗的比例。
To evaluate the feasibility and effectiveness of dried blood spots (DBS) use for viral load (VL) monitoring, describing patient outcomes and programmatic challenges that are relevant for DBS implementation in sub-Saharan Africa. We recruited adult antiretroviral therapy (ART) patients from five district hospitals in Malawi. Eligibility reflected anticipated Ministry of Health VL monitoring criteria. Testing was conducted at a central laboratory. Virological failure was defined as >5000 copies/ml. Primary outcomes were program feasibility (timely result availability and patient receipt) and effectiveness (second-line therapy initiation). We enrolled 1,498 participants; 5.9% were failing at baseline. Median time from enrollment to receipt of results was 42 days; 79.6% of participants received results within 3 months. Among participants with confirmed elevated VL, 92.6% initiated second-line therapy; 90.7% were switched within 365 days of VL testing. Nearly one-third (30.8%) of participants with elevated baseline VL had suppressed (<5,000 copies/ml) on confirmatory testing. Median period between enrollment and specimen testing was 23 days. Adjusting for relevant covariates, participants on ART >4 years were more likely to be failing than participants on therapy 1–4 years (RR 1.7, 95% CI 1.0-2.8); older participants were less likely to be failing (RR 0.95, 95% CI 0.92-0.98). There was no difference in likelihood of failure based on clinical symptoms (RR 1.17, 95% CI 0.65-2.11). DBS for VL monitoring is feasible and effective in real-world clinical settings. Centralized DBS testing may increase access to VL monitoring in remote settings. Programmatic outcomes are encouraging, especially proportion of eligible participants switched to second-line therapy.
在程序中切换到二线艺术的因果效应,而无需访问常规病毒载荷监测。
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