Accuracy of the Enhanced Liver Fibrosis test, and combination of the Enhanced Liver Fibrosis and non‐invasive tests for the diagnosis of advanced liver fibrosis in patients with non‐alcoholic fatty liver disease

Inadomi, Chika; Takahashi, Hirokazu; Ogawa, Yasuhiro; Oeda, Satoshi; Imajo, Kento; Kubotsu, Yoshihito; Tanaka, Kenichi; Kessoku, Takaomi; Okada, Morio; Isoda, Hiroshi; Akiyama, Takumi; Fukushima, Hideaki; Yoneda, Masato; Anzai, Keizo; Aishima, Shinichi; Nakajima, Atsushi; Eguchi, Yuichiro

doi:10.1111/hepr.13495

Cited by 38 publications

(49 citation statements)

References 51 publications

(93 reference statements)

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“…In Europe, the ELF (enhanced liver fibrosis) test, involving hyaluronic acid and a tissue inhibitor of matrix metalloproteinase type 1 (TIMP-1) along with P3NP (aminoterminal propeptide of type 3 procollagen) is used as the second step [41] (Table 1). A validation study for the efficacy of ELF test was conducted in Japan [42]. In Japan, liver fibrosis markers such as type IV collagen 7S and Mac-2 binding protein glycosylation isomer (M2BPGi) are generally used by hepatologists.…”

Section: Non-invasive Diagnostic Methods For Liver Fibrosismentioning

confidence: 99%

Surveillance of Hepatocellular Carcinoma in Nonalcoholic Fatty Liver Disease

et al. 2020

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Nonalcoholic fatty liver disease (NAFLD) is becoming the leading cause of hepatocellular carcinoma (HCC), liver-related mortality, and liver transplantation. There is sufficient epidemiological cohort data to recommend the surveillance of patients with NAFLD based upon the incidence of HCC. The American Gastroenterology Association (AGA) expert review published in 2020 recommends that NAFLD patients with cirrhosis or advanced fibrosis estimated by non-invasive tests (NITs) consider HCC surveillance. NITs include the fibrosis-4 (FIB-4) index, the enhanced liver fibrosis (ELF) test, FibroScan, and MR elastography. The recommended surveillance modality is abdominal ultrasound (US), which is cost effective and noninvasive with good sensitivity. However, US is limited in obese patients and those with NAFLD. In NAFLD patients with a high likelihood of having an inadequate US, or if an US is attempted but inadequate, CT or MRI may be utilized. The GALAD score, consisting of age, gender, AFP, the lens culinaris-agglutinin-reactive fraction of AFP (AFP-L3), and the protein induced by the absence of vitamin K or antagonist-II (PIVKA-II), can help identify a high risk of HCC in NAFLD patients. Innovative parameters, including a Mac-2 binding protein glycated isomer, type IV collagen 7S, free apoptosis inhibitor of the macrophage, and a combination of single nucleoside polymorphisms, are expected to be established. Considering the large size of the NAFLD population, optimal screening tests must meet several criteria, including high sensitivity, cost effectiveness, and availability.

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Section: Non-invasive Diagnostic Methods For Liver Fibrosismentioning

confidence: 99%

Surveillance of Hepatocellular Carcinoma in Nonalcoholic Fatty Liver Disease

et al. 2020

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“…The use in serial combination of TE, NFS and FIB-4 in patients in the grey area of the first test or in those with high values of liver median stiffness (> 9.6 kPa) or low NFS or FIB-4 value (< -1.45 and < 1.3 respectively), increased the diagnostic performance and reduced the diagnostic uncertainty area compared to the use of these tests alone [122]. The combination of ELF test and TE has shown higher diagnostic accuracy for the diagnosis of AF (Sp 97.9%) compared to ELF test alone (Sp 90.6%) [124]. The FibroScan-AST (FAST) score is a novel model (composed of Liver Median Stiffness, controlled attenuated parameter and AST), that showed a good diagnostic performance in identifying NASH with a Nash Activity Score > 4 + F > 2 with a PPV of 0.83-0.81 and an NPV of 0.85-0.71, respectively in derivation and validation cohort [125].…”

Section: Us-based Imagining Technique Tementioning

confidence: 97%

The diagnostic conundrum in non-alcoholic fatty liver disease

Rosato

Masarone

Aglitti

et al. 2020

Exploration of Medicine

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Non-alcoholic fatty liver disease (NAFLD) has become the most common liver alteration worldwide. It encompasses a spectrum of disorders that range from simple steatosis to a progressive form, defined non-alcoholic steatohepatitis (NASH), that can lead to advanced fibrosis and eventually cirrhosis and hepatocellular carcinoma. On liver histology, NASH is characterized by the concomitant presence of significant fat accumulation and inflammatory reaction with hepatocellular injury. Until now, liver biopsy is still required to differentiate simple steatosis from NASH and evaluate the degree of liver fibrosis. Unfortunately, this technique has well-known limitations, including invasiveness and expensiveness. Moreover, it may be biased by sampling error and intra- or inter-observed variability. Furthermore, due to the increasing prevalence of NAFLD worldwide, to program a systematic screening with liver biopsy is not imaginable. In recent years, different techniques were developed and validated with the aim of non-invasively identifying NASH and assess liver fibrosis degrees. The non-invasive tests range from simple blood-tests analyses to composite scores and complex imaging techniques. Nevertheless, even if they could represent cost-effective strategies for diagnosing NASH, advanced fibrosis and cirrhosis, their accuracy and consequent usefulness are to be discussed. With this aim, in this review the authors summarize the current state of non-invasive assessment of NAFLD. In particular, in addition to the well-established tests, the authors describe the future perspectives in this field, reporting the latest tests based on OMICS, gut-miocrobioma and micro-RNAs. Finally, the authors provide an accurate assessment of how these non-invasive tools perform in clinical practice depending on the clinical context, with the aim of giving the clinicians a useful tool to try to resolve the diagnostic conundrum of NAFLD.

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“…24 Other studies have confirmed the accuracy of the ELF score in the assessment of hepatic fibrosis in PLWH and in those with NAFLD. [25][26][27][28] Assuming the SD of the ELF score is 1.12, with 20 patients in each group for the analysis, a difference in ELF of 1 point can be estimated with a 95% CI from 0.6 to 1.4. Assuming an attrition rate of 33%, a target of 30 individuals will be recruited per group.…”

Section: Post-trial Carementioning

confidence: 99%

Protocol for a phase IV, open-label feasibility study investigating non-invasive markers of hepatic fibrosis in people living with HIV-1 and non-alcoholic fatty liver disease randomised to receiving optimised background therapy (OBT) plus maraviroc or OBT alone

et al. 2020

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IntroductionAt least 30% of people living with HIV (PLWH) infection have non-alcoholic fatty liver disease (NAFLD), which has now become a leading cause of hepatic fibrosis and cirrhosis. Management is based largely on lifestyle modifications, which are difficult to achieve, and therapeutic options are urgently needed. Maraviroc (MVC), through antagonism of CCR5 receptors, may reduce hepatic fibrosis progression and could be an effective treatment for NAFLD. However, dosing is usually two times per day, unlike most currently recommended antiretroviral therapies. This study will investigate the feasibility and acceptability of addition of MVC to combination antiretroviral therapy in PLWH and NAFLD as a treatment for NAFLD.Methods and analysisThis is a phase IV, randomised, open-label, non-invasive feasibility study. Sixty individuals with well-controlled HIV-1 and NAFLD will be recruited from UK HIV clinics and randomised 1:1 to receive either optimised background therapy (OBT) plus MVC or OBT alone. Follow-up will be every 24 weeks for 96 weeks. The primary outcome measures will include recruitment and retention rates, adverse events and adherence. Secondary outcomes will include changes in markers of hepatic fibrosis, including the Enhanced Liver Fibrosis score, median liver stiffness measurement and controlled attenuation parameter scores on Fibroscan, and quality of life assessments. Analyses will be performed according to intention-to-treat principles. For secondary outcomes, estimated differences and 95% CIs between the groups using a t-method will be presented for continuous variables and as exact 95% binomial CIs for categorical variables.Ethics and disseminationEthical approval was obtained through the London Dulwich UK Research Ethics Committee (reference 17/LO/2093). Results will be disseminated both through community groups and peer-reviewed scientific literature.Trial registration number SRCTN31461655. EudraCT number 2017-004141-24; Pre-results.

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Accuracy of the Enhanced Liver Fibrosis test, and combination of the Enhanced Liver Fibrosis and non‐invasive tests for the diagnosis of advanced liver fibrosis in patients with non‐alcoholic fatty liver disease

Cited by 38 publications

References 51 publications

Surveillance of Hepatocellular Carcinoma in Nonalcoholic Fatty Liver Disease

Surveillance of Hepatocellular Carcinoma in Nonalcoholic Fatty Liver Disease

The diagnostic conundrum in non-alcoholic fatty liver disease

Protocol for a phase IV, open-label feasibility study investigating non-invasive markers of hepatic fibrosis in people living with HIV-1 and non-alcoholic fatty liver disease randomised to receiving optimised background therapy (OBT) plus maraviroc or OBT alone

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