Fishman Jesse, O'Connell Tom, Parrinello Christina M, Woolley Jonathan J, Bercaw Eric, Charlton Michael R
Madrigal Pharmaceuticals, West Conshohocken, Pennsylvania, USA.
Medicus Economics, Boston, Massachusetts, USA.
J Health Econ Outcomes Res. 2024 Feb 14;11(1):32-43. doi: 10.36469/001c.92223. eCollection 2024.
Nonalcoholic fatty liver disease (NAFLD) is believed to be the most common chronic liver disease worldwide. Therapies are under development for nonalcoholic steatohepatitis (NASH), the progressive form of NAFLD, such that the prevalence of NASH with liver fibrosis, which is likely to require treatment, may be of interest to healthcare decision makers. Noninvasive tests are used in initial screening for NASH, as well as in observational studies of NASH prevalence. However, existing evidence does not address how estimated prevalence varies with different noninvasive tests. This analysis estimated the prevalence of NASH among US adults and assessed variation with different noninvasive tests. A cross-sectional analysis was conducted using the 2017-March 2020 National Health and Nutrition Examination Survey cycle. Participants with presumed NAFLD (steatosis and without alternative causes of liver disease) were identified, among whom NASH was predicted based on FAST score, Fibrosis-4 (FIB-4), and AST-to-Platelet Ratio Index (APRI) cutoffs across 11 scenarios. Among NASH participants, fibrosis stages were explored based on distribution across the spectrum of liver-stiffness measurements. Among participants with complete data for the analysis (N=6969), prevalence of presumed NAFLD was 25.6%. Within presumed NAFLD, prediction of NASH using imaging-based NIT cutoffs yielded estimated prevalence of 1.3%-4.8% (3.3 million-12.2 million) based on FAST score cutoffs from 0.35-0.67. Using biomarker-based NIT cutoffs yielded estimated prevalence of 0.4%-12.3% (1.0 million-14.5 million) based on FIB-4 cutoffs from 0.90-2.67, and 0.1%-1.9% (0.2-5.0 million) based on APRI cutoffs from 0.50-1.50. Prevalence of NASH among US adults was estimated to range from 1.3% to 4.8% when predicted using imaging-based noninvasive test values for participants with presumed NAFLD, generally aligning with estimates in the literature of prevalence of biopsy-confirmed NASH. Use of biomarker-based noninvasive test values for prediction of NASH yielded a wider range of estimates with FIB-4, and a considerably lower range of estimates with APRI.
非酒精性脂肪性肝病（NAFLD）被认为是全球最常见的慢性肝病。针对非酒精性脂肪性肝炎（NASH，NAFLD的进展形式）的治疗方法正在研发中，因此，可能需要治疗的伴有肝纤维化的NASH的患病率，可能会引起医疗保健决策者的兴趣。非侵入性检测用于NASH的初步筛查以及NASH患病率的观察性研究。然而，现有证据并未涉及估计的患病率如何因不同的非侵入性检测而有所不同。本分析估计了美国成年人中NASH的患病率，并评估了不同非侵入性检测方法之间的差异。使用2017年3月至2020年的国家健康与营养检查调查周期进行了横断面分析。确定了疑似患有NAFLD（肝脂肪变性且无其他肝病病因）的参与者，并根据11种情况的FIB-4评分、Fibrosis-4（FIB-4）和AST与血小板比值指数（APRI）临界值，在这些参与者中预测NASH。在NASH参与者中，根据肝脏硬度测量范围的分布情况探讨了纤维化阶段。在有完整分析数据的参与者（N = 6969）中，疑似NAFLD的患病率为25.6%。在疑似NAFLD患者中，使用基于成像的非侵入性检测临界值预测NASH，基于0.35 - 0.67的FIB-4评分临界值，估计患病率为1.3% - 4.8%（330万 - 1220万）。使用基于生物标志物的非侵入性检测临界值，基于0.90 - 2.67的FIB-4临界值，估计患病率为0.4% - 12.3%（100万 - 1450万），基于0.50 - 1.50的APRI临界值，估计患病率为0.1% - 1.9%（20万 - 500万）。当使用基于成像的非侵入性检测值对疑似NAFLD的参与者进行预测时，美国成年人中NASH的患病率估计在1.3%至4.8%之间，这与文献中活检确诊的NASH患病率估计值基本一致。使用基于生物标志物的非侵入性检测值预测NASH时，FIB-4的估计范围更广，而APRI的估计范围则低得多。
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