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

Aim To assess whether non‐invasive test cutoffs recommended in Western guidelines appropriately identify treatment‐eligible fibrosis (F2–3) in Japanese patients with MASLD. Methods 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. Results 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. Conclusions 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.