评估HIV基因型耐药性检测的应用情况：来自意大利传染病科室的见解。

Assessing the utilization of HIV genotype resistance testing: Insight from Italian Infectious Diseases Units.

作者信息

De Vito Andrea, Bezenchek Antonia, Scutari Rossana, Colagrossi Luna, Valenti Giacomo, Bellocchi Maria Concetta, Pipitò Luca, Ferrara Sergio, Malandrin Sergio, Tallarita Monica, Cozzi-Lepri Alessandro, Ceccherini-Silberstein Francesca, Lo Caputo Sergio, Rusconi Stefano

机构信息

Department of Medicine, Surgery, and Pharmacy, Unit of Infectious Diseases, University of Sassari, Sassari, Italy; Biomedical Science Department, School in Biomedical Science, University of Sassari, Sassari, Italy.

IPRO-InformaPRO S.r.l., EuResist Network GEIE, Rome, Italy.

出版信息

J Glob Antimicrob Resist. 2025 May;42:1-6. doi: 10.1016/j.jgar.2025.01.018. Epub 2025 Jan 29.

DOI:10.1016/j.jgar.2025.01.018

PMID:39884500

Abstract

PURPOSE

We aimed to assess the utilization of genotype resistance testing (GRT) by Infectious Diseases Units across Italy.

METHODS

A cross-sectional study was conducted involving a questionnaire distributed to the Infectious Diseases Unit in Italy. A web-based survey using Google Forms software was utilized and spread via email or cellphone.

RESULTS

Responses were obtained from 101 Infectious Diseases Units. Among these centres, only seven (6.9%) reported not performing GRT at any time. Of the 94 centres performing GRT, 52 (55.3%) sent blood samples to external laboratories. Notably, only 6/35 (17.1%) small centres had internal laboratories, compared to 14/35 (40.0%) medium centres and 22/24 (91.7%) large centres (P < 0.001). Most centres requested GRT for treatment-naïve individuals and all cases of virological failure. Only 24 (25.5%) requested GRT of HIVDNA before treatment changes. Regarding virological failure, most centres (38, 40.4%) requested GRT when HIV-RNA levels exceeded 200 copies/mL, while 26 (27.7%) requested it at levels exceeding 50 copies/mL. Additionally, 18 (19.1%) and 12 (12.8%) centres requested GRT at thresholds of 500 copies/mL and 1000 copies/mL, respectively. Regarding the specific GRT test used, 34 (36.2%) were unsure, while 16 (17.0%) reported using both next-generation sequencing and Sanger methods. Furthermore, 30 (31.9%) and 14 (14.9%) centres exclusively used next-generation sequencing and Sanger, respectively. Most centres reported receiving GRT results within 1 month (n = 72, 76.6%), while 22 (23.4%) centres obtained results within 2 weeks. However, 22 (23.4%) centres typically experienced more than 1-month delays. Finally, most participants (86, 91.5%) regarded GRT as a crucial routine test for the treatment of naïve people living with HIV.

CONCLUSIONS

This study demonstrates that most Infectious Diseases Units in Italy continue to consider GRT an essential test for newly diagnosed people living with HIV in clinical practice. However, the utilization of GRT on HIV-DNA remains limited. Further efforts are required to decrease turnaround time in centres experiencing prolonged delays in obtaining results.

摘要

目的

我们旨在评估意大利各地传染病科室对基因型耐药性检测（GRT）的使用情况。

方法

开展了一项横断面研究，向意大利的传染病科室发放问卷。采用基于网络的调查，利用谷歌表单软件，并通过电子邮件或手机进行传播。

结果

收到了来自101个传染病科室的回复。在这些中心中，只有7个（6.9%）报告从未进行过GRT。在进行GRT的94个中心中，52个（55.3%）将血样送到外部实验室。值得注意的是，小型中心中只有6/35（17.1%）有内部实验室，而中型中心为14/35（40.0%），大型中心为22/24（91.7%）（P<0.001）。大多数中心对初治个体和所有病毒学失败病例都要求进行GRT。只有24个（25.5%）在治疗方案改变前要求对HIVDNA进行GRT。关于病毒学失败，大多数中心（38个，40.4%）在HIV-RNA水平超过200拷贝/mL时要求进行GRT，而26个（27.7%）在水平超过50拷贝/mL时要求进行。此外，18个（19.1%）和12个（12.8%）中心分别在阈值为500拷贝/mL和1000拷贝/mL时要求进行GRT。关于所使用的具体GRT检测方法，34个（36.2%）不确定，而16个（17.0%）报告同时使用了下一代测序和桑格法。此外，分别有30个（31.9%）和14个（14.9%）中心专门使用下一代测序和桑格法。大多数中心报告在1个月内收到GRT结果（n = 72，76.6%），而22个（23.4%）中心在2周内获得结果。然而，22个（23.4%）中心通常经历超过1个月的延迟。最后，大多数参与者（86个，91.5%）认为GRT是治疗初治HIV感染者的关键常规检测。