Long-term Prognostic Value of the FibroTest in Patients With Non-alcoholic Fatty Liver Disease, Compared to Chronic Hepatitis C, B, and Alcoholic Liver Disease

Mona Munteanu; Raluca Pais; Valentina Peta; Olivier Deckmyn; Joseph Moussalli; Yen Ngo; Marika Rudler; Pascal Lebray; Frederic Charlotte; Vincent Thibault; Olivier Lucidarme; An Ngo; Françoise Imbert-Bismut; Chantal Housset; Dominique Thabut; Vlad Ratziu; Thierry Poynard

Disclosures

Aliment Pharmacol Ther. 2018;48(10):1117-1127. 

In This Article

Abstract and Introduction

Abstract

Background: Although the FibroTest has been validated as a biomarker to determine the stage of fibrosis in non-alcoholic fatty liver disease (NAFLD) with results similar to those in chronic hepatitis C (CHC), B (CHB), and alcoholic liver disease (ALD), it has not yet been confirmed for the prediction of liver-related death.

Aim: To validate the 10-year prognostic value of FibroTest in NAFLD for the prediction of liver-related death.

Method: Patients in the prospective FibroFrance cohort who underwent a FibroTest between 1997 and 2012 were pre-included. Mortality status was obtained from physicians, hospitals or the national register. Survival analyses were based on univariate (Kaplan-Meier, log rank, AUROC) and multivariate Cox risk ratio taking into account age, sex and response to anti-viral treatment as covariates. The comparator was the performance of the FibroTest in CHC, the most validated population.

Results: 7082 patients were included; 1079, 3449, 2051, and 503 with NAFLD, CHC, CHB, and ALD, respectively. Median (range) follow-up was 6.0 years (0.1–19.3). Ten year survival (95% CI) without liver-related death in patients with NAFLD was 0.956 (0.940–0.971; 38 events) and 0.832 (0.818–0.847; 226 events; P = 0.004) in CHC. The prognostic value (AUROC/Cox risk ratio) of FibroTest in patients with NAFLD was 0.941 (0.905–0.978)/1638 (342–7839) and even higher than in patients with CHC 0.875 (0.849–0.901; P = 0.01)/2657 (993–6586).

Conclusions: The FibroTest has a high prognostic value in NAFLD for the prediction of liver-related death. (ClinicalTrials.gov number, NCT01927133).

Introduction

The FibroTest has been validated as a biomarker for the diagnosis of the stages of fibrosis in NAFLD[1,2] with results similar to those in CHC,[3–5] CHB,[5,6] and ALD,[7,8] although no study has validated its prognostic value for liver-related death. This could be due to the natural history of NAFLD, with lower incidence of liver-related death and higher non-liver-related causes of mortality in comparison with the viral or alcoholic liver diseases. In a study of FibroTest in 2312 patients with type 2 diabetes or dyslipidemias, we found a significant prognostic value of FibroTest, for the overall survival.[9] In type 2 diabetes, FibroTest predicted cardiovascular events and improved the Framingham-risk score. For the prediction of liver-related death the number of events at 10 years was too small (n = 7) for any conclusion. Therefore, the primary aim was to assess the prognostic value on liver-related death, and we focused on subjects of the FibroFrance program followed since 1997 in the department of Hepatology for chronic liver diseases in Pitié–Salpêtrière hospital), and compared the performances of FibroTest in NAFLD to those of CHC, in order to have a sufficient sample size.

The second aim was to assess the prognostic values of apolipoprotein-A1 (ApoA1) and haptoglobin, two hepatoprotective proteins[10–13] also associated with lower risk of non-liver mortality, including cancer and cardiovascular related deaths. The third aim was to assess the prognostic performance of two new quantitative tests, assessing the severity of NASH (NashTest–2)[14] and of steatosis (SteatoTest–2).[14]

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