Clinically relevant thresholds for ultrasensitive HIV drug resistance testing: a multi-country nested case-control study

Clinically relevant thresholds for ultrasensitive HIV drug resistance testing: a multi-country nested case-control study
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DOI:
10.1016/s2352-3018(18)30177-2
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发表时间:
2018-11-01
期刊:
影响因子:
16.1
通讯作者:
Paredes, Roger
Paredes, Roger
中科院分区:
医学1区
文献类型:
--
作者:
Inzaule, Seth C.;Hamers, Raph L.;Paredes, Roger

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背景:由于对耐药少数变异体的临床相关性的不确定性,常规临床使用的超灵敏HIV耐药检测的实施受到阻碍。我们评估了不同的检测阈值的治疗前耐药,以预测增加的风险virologicfailure.Methods我们做了一个前瞻性多国队列嵌套的病例对照研究。我们的研究包括来自肯尼亚、尼日利亚、南非、乌干达和赞比亚12个临床中心的患者。我们将病例定义为病毒学失败的患者(即12个月时病毒载量≥ 400拷贝/mL或12个月前因病毒学失败而改用二线抗逆转录病毒治疗[ART]的患者),对照组定义为病毒抑制(病毒载量≥ 400拷贝/mL)的患者。
Background Implementation of ultrasensitive HIV drug resistance tests for routine clinical use is hampered by uncertainty about the clinical relevance of drug-resistant minority variants. We assessed different detection thresholds for pretreatment drug resistance to predict an increased risk of virological failure.Methods We did a case-control study nested within a prospective multicountry cohort. Our study included patients from 12 clinical sites in Kenya, Nigeria, South Africa, Uganda, and Zambia. We defined cases as patients with virological failure (ie, those who had either viral load >= 400 copies per mL at 12 months or had switched to second-line antiretroviral therapy [ART] as a result of virological failure before 12 months) and controls as those with viral suppression (viral load