Unidad de Infección Viral e Inmunidad, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Spain.
Servicio de Medicina Preventiva y Salud Pública, Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain.
Aliment Pharmacol Ther. 2022 Oct;56(8):1224-1234. doi: 10.1111/apt.17198. Epub 2022 Aug 28.
Treatment of hepatitis C virus (HCV) infection with direct-acting antivirals (DAAs) is monitored by assessing plasma HCV-RNA load. However, detection of HCV core antigen (HCVcAg) may be an alternative.
To evaluate the diagnostic performance of the HCVcAg assay to monitor the efficacy of DAAs in HCV-infected patients METHODS: We performed searches in multiple electronic databases until 6 July 2022, of studies evaluating the HCVcAg detection in plasma or serum compared with the HCV-RNA test (gold standard). We calculated pooled measurement at 2 and 4 weeks of treatment, and at end-of-treatment (EOT), as well as sustained virological response (SVR; 12 weeks after EOT).
We selected 16 studies from 2016 to 2022, with 3237 patients and 8958 samples. Overall, the diagnostic performance and clinical utility of the HCVcAg assay were poor at week 2 (sensitivity = 0.40, specificity = 0.96, positive likelihood ratio (PLR) = 9.16, negative likelihood ratio (NLR) = 0.63, and area under the summary receiver operating curve (SROC) = 0.57), fair at week 4 (sensitivity = 0.30, specificity = 0.90, PLR = 3.18, NLR = 0.77, and AUC = 0.79), acceptable at EOT (sensitivity = 0.40, specificity =0.98, PLR = 16.54, NLR = 0.62, and AUC = 0.97) and excellent for SVR (sensitivity = 0.94, specificity = 0.99, PLR = 107.54, NLR = 0.06, and AUC = 0.99).
The HCVcAg assay may be helpful for monitoring the efficacy of HCV treatment with DAAs in HCV-infected patients at EOT and for documenting SVR, but not at weeks 2 and 4 of treatment due to poor diagnostic performance.
直接作用抗病毒药物（DAAs）治疗丙型肝炎病毒（HCV）感染通过评估血浆 HCV-RNA 载量进行监测。然而，检测 HCV 核心抗原（HCVcAg）可能是一种替代方法。
评估 HCVcAg 检测在监测 HCV 感染患者 DAA 治疗效果方面的诊断性能。
我们在多个电子数据库中进行了搜索，截至 2022 年 7 月 6 日，评估了与 HCV-RNA 检测（金标准）相比在血浆或血清中检测 HCVcAg 的研究。我们计算了治疗第 2 周和第 4 周以及治疗结束时（EOT）以及治疗结束后 12 周时（SVR）的汇总测量值。
我们从 2016 年至 2022 年共选择了 16 项研究，涉及 3237 名患者和 8958 个样本。总体而言，HCVcAg 检测在第 2 周时的诊断性能和临床实用性较差（灵敏度=0.40，特异性=0.96，阳性似然比（PLR）=9.16，阴性似然比（NLR）=0.63，汇总接收者操作特征曲线（SROC）下面积（AUC）=0.57），在第 4 周时表现中等（灵敏度=0.30，特异性=0.90，PLR=3.18，NLR=0.77，AUC=0.79），在 EOT 时可接受（灵敏度=0.40，特异性=0.98，PLR=16.54，NLR=0.62，AUC=0.97），对于 SVR 表现出色（灵敏度=0.94，特异性=0.99，PLR=107.54，NLR=0.06，AUC=0.99）。
HCVcAg 检测可能有助于监测 HCV 感染患者接受 DAA 治疗的疗效，以及记录 SVR，但在治疗的第 2 周和第 4 周时由于诊断性能不佳而无法进行监测。
