Department of Medicine, Section of Infectious Diseases, Boston University Chobanian and Avedisian School of Medicine, Boston, Massachusetts, USA.
Department of Pediatrics, Section of Infectious Diseases, Boston University Chobanian and Avedisian School of Medicine, Boston, Massachusetts, USA.
J Viral Hepat. 2024 Jun;31(6):277-292. doi: 10.1111/jvh.13925. Epub 2024 Feb 7.
Non-invasive methods have largely replaced biopsy to identify advanced fibrosis in hepatitis C virus (HCV). Guidelines vary regarding testing strategy to balance accuracy, costs and loss to follow-up. Although individual test characteristics are well-described, data comparing the accuracy of using two tests together are limited. We calculated combined test characteristics to determine the utility of combined strategies. This study synthesizes empirical data from fibrosis staging trials and the literature to estimate test characteristics for Fibrosis-4 (FIB4), APRI or a commercial serum panel (FibroSure®), followed by transient elastography (TE) or FibroSure®. We simulated two testing strategies: (1) second test only for those with intermediate first test results (staged approach), and (2) second test for all. We summarized empiric data with multinomial distributions and used this to estimate test characteristics of each strategy on a simulated population of 10,000 individuals with 4.2% cirrhosis prevalence. Negative predictive value (NPV) for cirrhosis from a single test ranged from 98.2% (95% CB 97.6-98.8%) for FIB-4 to 99.4% (95% CB 99.0-99.8%) for TE. Using a staged approach with TE second, sensitivity for cirrhosis rose to 93.3-96.9%, NPV to 99.7-99.8%, while PPV dropped to <32%. Using TE as a second test for all minimally changed estimated test characteristics compared with the staged approach. Combining two non-invasive fibrosis tests barely improves NPV and decreases or does not change PPV compared with a single test, challenging the utility of serial testing modalities. These calculated combined test characteristics can inform best methods to identify advanced fibrosis in various populations.
非侵入性方法在很大程度上已取代肝活检，用于确定丙型肝炎病毒 (HCV) 患者的肝纤维化程度。针对检测策略，指南各有不同，旨在平衡准确性、成本和失访率。尽管各项检测的特点已有详细描述，但联合使用两种检测方法的准确性数据有限。我们计算了联合检测的特点，以确定联合策略的实用性。本研究综合纤维化分期试验和文献中的实证数据，估算 Fibrosis-4 (FIB4)、APRI 或商业血清学检测 (FibroSure®) 联合瞬时弹性成像 (TE) 或 FibroSure® 的检测特点。我们模拟了两种检测策略：（1）仅对初次检测结果处于中间范围的患者进行第二次检测（分期策略），以及（2）对所有患者进行第二次检测。我们采用多项分布对实证数据进行总结，并使用该分布在模拟的 10000 例个体人群中估计每种策略的检测特点，其中肝硬化患病率为 4.2%。单项检测对肝硬化的阴性预测值 (NPV) 范围从 FIB-4 的 98.2%（95% CB 97.6-98.8%）到 TE 的 99.4%（95% CB 99.0-99.8%）。采用分期策略，以 TE 作为第二次检测，肝硬化的敏感性提高至 93.3-96.9%，NPV 提高至 99.7-99.8%，而阳性预测值 (PPV) 降低至 <32%。对所有患者均采用 TE 作为第二次检测，与分期策略相比，估计的检测特点几乎没有变化。与单项检测相比，联合两种非侵入性纤维化检测对 NPV 的改善作用不大，反而会降低或不改变 PPV，这对连续检测模式的实用性提出了挑战。这些计算出的联合检测特点可用于确定不同人群中肝纤维化的最佳方法。
