Gordon Stuart C, Kachru Nandita, Parker Emily, Korrer Stephanie, Ozbay A Burak, Wong Robert J
Department of Gastroenterology and Hepatology Henry Ford Hospital Wayne State University School of Medicine Detroit MI.
Gilead Sciences Health Economics Outcomes Research Foster City CA.
Hepatol Commun. 2020 May 26;4(7):998-1011. doi: 10.1002/hep4.1524. eCollection 2020 Jul.
Limited evidence exists on the clinical and economic burden of advanced fibrosis in patients with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH) due to the invasiveness of liver biopsies for accurately staging liver disease. The fibrosis-4 (FIB-4) score allows for noninvasive assessment of liver fibrosis by using clinical and laboratory data alone. This study aimed to characterize the comorbidity burden, health care resource use (HCRU), and costs among patients with NAFLD/NASH with FIB-4-defined F3 (bridging fibrosis) and F4 (compensated cirrhosis) fibrosis. Using the Optum Research Database, a retrospective cohort study was conducted among 251,725 commercially insured adult patients with ≥1 NAFLD/NASH diagnosis from January 1, 2008, to August 31, 2016, and laboratory data required to calculate FIB-4 scores. Five criteria using varying FIB-4 score cutoffs were identified based on expert clinical opinion and published literature. Date of the first valid FIB-4 score marked the index date. Mean annual HCRU and costs were calculated during the pre-index and post-index periods. The prevalence of FIB-4-based F3 and F4 fibrosis was 0.40%-2.72% and 1.03%-1.61%, respectively. Almost 50% of patients identified with FIB-4-based F3 or F4 had type 2 diabetes, cardiovascular disease, or renal impairment. Total all-cause health care costs increased significantly from pre-index to post-index for patients with FIB-4-based F3 fibrosis across most criteria (17%-29% increase) and patients with FIB-4-based F4 fibrosis across all criteria (47%-48% increase). Inpatient costs were the primary drivers of this increment. Significant increases in HCRU and costs were observed following FIB-4-based identification of F3 and F4 fibrosis among U.S. adults with NAFLD/NASH. These data suggest the importance of early identification and management of NAFLD/NASH that may halt or reduce the risk of disease progression and limit the underlying burden.
由于肝活检对于准确分期肝病具有侵入性，关于非酒精性脂肪性肝病/非酒精性脂肪性肝炎（NAFLD/NASH）患者中晚期纤维化的临床和经济负担的证据有限。纤维化-4（FIB-4）评分仅通过临床和实验室数据就能对肝纤维化进行非侵入性评估。本研究旨在描述NAFLD/NASH患者中，符合FIB-4定义的F3（桥接纤维化）和F4（代偿期肝硬化）纤维化患者的合并症负担、医疗资源使用（HCRU）和费用情况。利用Optum研究数据库，对2008年1月1日至2016年8月31日期间诊断为NAFLD/NASH且有≥1次诊断记录的251,725名商业保险成年患者，以及计算FIB-4评分所需的实验室数据进行了一项回顾性队列研究。根据专家临床意见和已发表的文献，确定了使用不同FIB-4评分临界值的五条标准。首次有效FIB-4评分的日期为索引日期。计算索引前和索引后期间的年均HCRU和费用。基于FIB-4的F3和F4纤维化的患病率分别为0.40%-2.72%和1.03%-1.61%。几乎50%被确定为基于FIB-4的F3或F4的患者患有2型糖尿病、心血管疾病或肾功能损害。在大多数标准下，基于FIB-4的F3纤维化患者从索引前到索引后的全因医疗总费用显著增加（增加17%-29%），在所有标准下，基于FIB-4的F4纤维化患者的全因医疗总费用显著增加（增加47%-48%）。住院费用是这一增长的主要驱动因素。在美国患有NAFLD/NASH的成年人中，基于FIB-4确定F3和F4纤维化后，观察到HCRU和费用显著增加。这些数据表明早期识别和管理NAFLD/NASH的重要性，这可能会阻止或降低疾病进展风险，并限制潜在负担。
