Optimizing VCTE and ELF Thresholds for Treatment-Eligible F2-F3 Fibrosis in Japanese Patients With MASLD

To assess whether non-invasive test cutoffs recommended in Western guidelines appropriately identify treatment-eligible fibrosis (F2-3) in Japanese patients with MASLD.

We analyzed Japanese patients with biopsy-proven MASLD who underwent FIB-4 screening, followed by VCTE or ELF testing. Patients with FIB-4 < 1.3 at age < 65 years or < 2.0 at age ≥ 65 years were excluded, leaving 838 patients in the VCTE cohort and 657 in the ELF cohort. Receiver operating characteristic (ROC) analyses were used to derive cohort-specific cutoffs.

For predicting F2-4, a VCTE cutoff of 8 kPa yielded sensitivity/specificity/positive predictive value (PPV)/negative predictive value (NPV) of 83.7%/61.2%/80.2%/66.7%. For predicting F4, a VCTE cutoff of 15 kPa yielded 88.1%/76.8%/22.3%/98.8%. For ELF, a cutoff of 9.2 for predicting F2-4 yielded 94.7%/23.1%/66.5%/73.1%. For predicting F4, a ELF cutoff of 10.5 yielded 80.0%/58.4%/9.9%/98.1%. Using ROC-derived cutoffs (VCTE 9.5 and 15 kPa; ELF 10.3 and 10.8), the performance for predicting F2-4 was 74.0%/75.6%/85.1%/60.8% for VCTE and 66.2%/73.9%/80.6%/57.1% for ELF, whereas the performance for predicting F4 was 88.1%/76.8%/22.3%/98.8% for VCTE and 77.1%/69.8%/12.6%/98.2% for ELF. Among test-positive patients, the distribution of F0-1/F2-3/F4 was 28.7%/69.2%/2.1% for VCTE 8-15 kPa and 47.8%/49.8%/2.4% for ELF 9.2-10.5.

Western guideline-recommended VCTE and ELF cutoffs showed high sensitivity in Japanese patients and can be used to exclude cirrhosis. Because the likelihood of cirrhosis increases with VCTE > 15 kPa or ELF > 10.5, treatment eligibility should be determined in conjunction with other clinical information, and confirmatory assessment should be considered when appropriate.