TY - JOUR
T1 - Diagnostic Performance of LIVERFASt as a Non-invasive Liver Fibrosis Test
T2 - Data from Three Cohorts of Patients with Metabolic Dysfunction-associated Steatotic Liver Disease
AU - Alkhouri, Naim
AU - Mantry, Parvez
AU - Gonzalez, Humberto C.
AU - Patil, Rashmee
AU - McIntyre, Vicki
AU - Kohli, Anita
AU - Rudraraju, Madhavi
AU - Kosinski, Joseph Frank
AU - Vander Veen, Bradley S.
AU - Knapple, Whitfield L.
AU - Ravinuthala, Ravi
AU - Jalal, Prasun Kumar
AU - Satapathy, Sanjaya K.
AU - Bhandari, Bal Raj
AU - Christensen, Christopher J.
AU - Ankoma-Sey, Victor
AU - Phan, Quynh An
AU - Membreno, Fernando E.
AU - Lee, Gabriel H.
AU - Kodali, Sudha
AU - Mubarak, Abdullah
AU - Elbeshbeshy, Hany A.
AU - Morin, Robert P.
AU - Hogan, Reed B.
AU - Sarles, Harry E.
AU - Le Bail, Brigitte
AU - Hiriart, Jean Baptiste
AU - Foucher, Juliette
AU - Chermak, Faiza
AU - Decraecker, Marie
AU - Sylvestre, Pamela
AU - Yeh, Matthew M.
AU - Quiambao, Ronald
AU - Mangee, Kimberly
AU - Tonascia, James
AU - Sakka, Medhi
AU - Alkouri, Rana
AU - Deregnaucourt, Maxime
AU - Bonnefont-Rousselot, Dominique
AU - Harrison, Stephen A.
AU - Alam, Imtiaz
AU - Munteanu, Mona
AU - Bansal, Meena
AU - Alazawi, William
AU - Sanyal, Arun J.
PY - 2025/12/26
Y1 - 2025/12/26
N2 - AIM: This study evaluates the diagnostic performance of the novel blood-based device, LIVERFASt to detect fibrosis stages in patients with metabolic dysfunction-associated steatotic liver disease (MASLD), including those with type 2 diabetes (T2DM), compared to FIB-4 in a subgroup analysis. METHODS: LIVERFASt is computed with 10 blood biomarkers and four anthropometric measures and provides a quantitative score (0.00-1.00) to stage cirrhosis (F4), advanced fibrosis (≥F3), and clinically significant fibrosis (≥F2). Three cohorts of patients (two retrospective and one prospective) from tertiary centers in Europe and the U.S. with histological-proven biopsy were used to assess LIVERFASt and FIB-4 diagnostic performance using area under the receiver operating curve (AUROC), sensitivity (Sn), specificity, and predictive values (PV) for varying fibrosis prevalence levels. RESULTS: 497 MASLD adult patients were included (median age 56 years, 56.7% female, 50.3% T2DM, 44.1% advanced fibrosis, and 20.1% cirrhosis). In the pooled analysis, the AUROCs for fibrosis stages F4, ≥F3, and ≥F2 were: 0.868, 0.846, 0.748, as well as for the T2DM subgroup (n=250): 0.846, 0.798, 0.736, respectively. For 35% advanced fibrosis prevalence, the positive/negative PVs were 77.2%/81.3% for the overall cohort and 65.52%/79.81% for the subgroup with tT2DM, respectively. At high (90%) to low (1%) advanced fibrosis prevalences, the positive and negative PVs ranged from 93% to 4.28% and from 43.06% to 99.73%, respectively. For F4 and ≥F3 fibrosis stages, LIVERFASt outperformed FIB-4: AUROC 0.870 vs 0.851 and 0.874 vs 0.821 (p<0.01), with Sn 74.07 vs 48.15 and 65.54 vs 37.29, respectively. CONCLUSIONS: LIVERFASt is a highly sensitive and clinically useful diagnostic test for staging fibrosis in MASLD patients, including those with T2DM and has a higher Sn for detecting advanced fibrosis when compared with FIB-4.
AB - AIM: This study evaluates the diagnostic performance of the novel blood-based device, LIVERFASt to detect fibrosis stages in patients with metabolic dysfunction-associated steatotic liver disease (MASLD), including those with type 2 diabetes (T2DM), compared to FIB-4 in a subgroup analysis. METHODS: LIVERFASt is computed with 10 blood biomarkers and four anthropometric measures and provides a quantitative score (0.00-1.00) to stage cirrhosis (F4), advanced fibrosis (≥F3), and clinically significant fibrosis (≥F2). Three cohorts of patients (two retrospective and one prospective) from tertiary centers in Europe and the U.S. with histological-proven biopsy were used to assess LIVERFASt and FIB-4 diagnostic performance using area under the receiver operating curve (AUROC), sensitivity (Sn), specificity, and predictive values (PV) for varying fibrosis prevalence levels. RESULTS: 497 MASLD adult patients were included (median age 56 years, 56.7% female, 50.3% T2DM, 44.1% advanced fibrosis, and 20.1% cirrhosis). In the pooled analysis, the AUROCs for fibrosis stages F4, ≥F3, and ≥F2 were: 0.868, 0.846, 0.748, as well as for the T2DM subgroup (n=250): 0.846, 0.798, 0.736, respectively. For 35% advanced fibrosis prevalence, the positive/negative PVs were 77.2%/81.3% for the overall cohort and 65.52%/79.81% for the subgroup with tT2DM, respectively. At high (90%) to low (1%) advanced fibrosis prevalences, the positive and negative PVs ranged from 93% to 4.28% and from 43.06% to 99.73%, respectively. For F4 and ≥F3 fibrosis stages, LIVERFASt outperformed FIB-4: AUROC 0.870 vs 0.851 and 0.874 vs 0.821 (p<0.01), with Sn 74.07 vs 48.15 and 65.54 vs 37.29, respectively. CONCLUSIONS: LIVERFASt is a highly sensitive and clinically useful diagnostic test for staging fibrosis in MASLD patients, including those with T2DM and has a higher Sn for detecting advanced fibrosis when compared with FIB-4.
UR - https://www.scopus.com/pages/publications/105026116228
UR - https://www.scopus.com/inward/citedby.url?scp=105026116228&partnerID=8YFLogxK
U2 - 10.15403/jgld-6432
DO - 10.15403/jgld-6432
M3 - Article
C2 - 41453093
AN - SCOPUS:105026116228
SN - 1841-8724
VL - 34
SP - 437
EP - 450
JO - Journal of Gastrointestinal and Liver Diseases
JF - Journal of Gastrointestinal and Liver Diseases
IS - 4
ER -