BACKGROUND US guidelines recommend standard genotype at HIV diagnosis ("baseline genotype") to detect transmitted drug resistance (TDR) to NNRTIs, NRTIs, and PIs. With INSTI-based regimens now recommended as first-line ART, the clinical and economic value of baseline genotypes is uncertain. METHODS We used the CEPAC model to examine the clinical impact and cost-effectiveness of Baseline Genotype compared to No Baseline Genotype for people starting ART with dolutegravir (DTG) and an NRTI pair. For people with no TDR (83.8%), baseline genotype does not alter regimen selection. Among people with transmitted NRTI resistance (NRTI-R, 5.8%), baseline genotype guides NRTI pair selection and informs subsequent ART after adverse events (DTG AE, 14%). Among people with transmitted NNRTI resistance (NNRTI-R, 7.2%), baseline genotype influences care only for people with DTG AE who move to an NNRTI-based regimen. 48-week virologic suppression varied (40%-92%), depending on TDR. Costs included $320/genotype, $3,000/month for DTG-based and darunavir/ritonavir-based regimens, and $2,500/month for rilpivirine-based regimens. RESULTS Compared to No Baseline Genotype, Baseline Genotype would result in <1 additional undiscounted quality-adjusted life day (QALD), cost $500 more per person, and would not be cost-effective (ICER, $420,000/quality-adjusted life year). In univariate sensitivity analysis, the clinical benefits of Baseline Genotype never exceeded 5 QALDs for all newly diagnosed people with HIV. Baseline Genotype was cost-effective at current TDR prevalence only under unlikely conditions, such as DTG-based regimens achieving ≤50% suppression of transmitted NRTI-R. CONCLUSIONS With INSTI-based first-line regimens in the US, Baseline Genotype offers minimal clinical benefit and is not cost-effective.

中文翻译：

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在美国人类免疫缺陷病毒诊断中进行基因型测试的临床影响和成本效益。

背景技术美国指南推荐在HIV诊断时使用标准基因型（“基线基因型”），以检测对NNRTI，NRTI和PI的传播的耐药性（TDR）。现在将基于INSTI的方案推荐为一线抗逆转录病毒疗法，基线基因型的临床和经济价值尚不确定。方法我们使用CEPAC模型检查了以Dolutegravir（DTG）和NRTI对开始ART的人群与无基线基因型相比，基线基因型的临床影响和成本效益。对于没有TDR的人（83.8％），基线基因型不会改变治疗方案的选择。在具有传播的NRTI耐药性（NRTI-R，5.8％）的人群中，基线基因型指导NRTI对的选择，并在不良事件发生后告知随后的ART（DTG AE，14％）。在传播NNRTI耐药的人群中（NNRTI-R，7.2％），基线基因型仅影响转移至基于NNRTI方案的DTG AE患者的护理。48周病毒学抑制作用有所不同（40％-92％），具体取决于TDR。费用包括$ 320 /基因型，基于DTG和darunavir / ritonavir的方案$ 3,000 /月，以及基于rilpivirine的方案$ 2,500 /月。结果与无基线基因型相比，基线基因型会导致额外的<1个未打折的质量调整生活日（QALD），每人成本增加500美元，并且不具有成本效益（ICER，420,000美元/质量调整生命年）。在单变量敏感性分析中，对于所有新诊断的HIV感染者，基线基因型的临床获益从未超过5个QALD。仅在不太可能的情况下，基线基因型在当前的TDR患病率下才具有成本效益，例如基于DTG的方案可实现对NRTI-R的抑制≤50％。结论在美国采用基于INSTI的一线治疗方案时，基线基因型提供的临床益处极小，且不具有成本效益。